uniWIKI - User contributions [en]

Information Systems:Health Canada Drug Product Database

2023-03-09T17:09:02Z

Johnt:

=Overview=

Health Canada makes information on drugs (DPD) and natural health products (NHP) available through database extracts that can be downloaded from their website. There are two sets; the drug files are refreshed at the beginning of every month; the NHP files less often. We build a database (e.g. set of tables) from these files so that the information can be displayed in Web Orders (and in ''Display Items'', ''Work with Items'' in Infonet).

Consult the official pages for the [https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html '''drugs'''] and [https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/applications-submissions/product-licensing/licensed-natural-health-product-database-data-extract.html '''NHP'''] extracts for more information.

=Instructions for updating our database=
==Downloading the extract (drugs)==

# Go to Health Canada’s web site, www.hc-sc.gc.ca
# Click on ‘English’
# Under ‘Main Menu’, click on ‘Drugs & Health Products’
# Click on ‘Drug Products’
# Click on ‘Drug Product Database (DPD)’
# On the right hand side, click on ‘Access the Drug Product Database’
# On the upper part of the page, click on ‘DPD Data Extracts’
# Check the date under ‘Last Updated’ (right hand column). Don’t continue with this process unless this has changed. There shouldn’t be an issue as it is usually updated early on the first work day of the month.
# Before saving the new files - move old data files (NOTE: do not touch the files starting with NHP) - (superserver/staging/Health Canada) to archive folder - yes to replace
# Download ‘ALL FILES’ (bottom of the list - do ALL 4) to your PC; both active (allfiles.zip) and inactive (allfiles_ia.zip) and (allfiles_ap.zip) - Open then Open
# As of April 1, 2022 they now also have 4 other files that need to be extracted and saved version 1 of the Therapeudic class
# Unzip and copy to SuperServer / staging / Health Canada

==Downloading the extract (Natural Health Products)==
'''NOTE: These records were last updated by HC in Sept. 2017. They are working on a new data extract - TBD (as of Aug 2018 - still no progress)(as of Sept 2019 still no progress on getting new extracts for NHP).
'''
# Go to Health Canada’s web site, www.hc-sc.gc.ca
# Click on ‘English’
# Under ‘Main Menu’, click on ‘Drugs & Health Products’
# Click on ‘Natural Health Products’
# On the right hand side, click on ‘Licensed Natural Health Products Database’
# Scroll down to the bottom of the page, and click on ‘Access the Licensed Natural Health Products Database Data Extract’
# Health Canada updates these files less often the drug product ones. Check the last updated date (at the top of the list of files) to see if it is necessary to continue. If the dates are the same, then don't do anything else. Check the next time.
# Go to SuperServer / staging / Health Canada and move the previous files to the archive folder.
# Download ‘All NHP Files’ to your PC.
# Unzip and copy to SuperServer / staging / Health Canada

==Updating Health Canada files on Bart==

'''Note:''' Need to use John T - user account to access the PL system and Web Orders Dev. We have had issues with the Health Canada data files. They are apparently extracted manually, which means there can be errors. One month there were no record delimiters; which meant we couldn’t use them. Another time instead of all related files being zipped together, each was zipped separately, then zipped together. Another issue is that users EODJOB and SHEILAV cannot access SUPERSERVER from the i, so the scheduled job has been changed to run under JOHNT (2014Dec04).

'''To validate the data files, first manually run the rebuild in the test environment (PL):'''

* From a command line in ASW (easiest to do in Mocha), key in 88, press Enter, key in PL, and press Enter twice.
* Key in SBMJOB CMD(CALL PGM(HCDBBLD01C)) JOBQ(QS36EVOKE) and press enter (Note: just press enter ONCE!). (This is run from job queue QS36EVOKE so that production jobs are not delayed.) This program is being submitted to run in batch – you won’t see it on your screen.
* To start job running, key in WRKACTJOB SBS(QBATCH) and press enter (Note: just press enter ONCE!).

Work with Active Jobs BART
10/01/14 12:16:27
CPU %: .0 Elapsed time: 00:00:00 Active jobs: 563

Type options, press Enter.
2=Change 3=Hold 4=End 5=Work with 6=Release 7=Display message
8=Work with spooled files 13=Disconnect ...
Current
Opt Subsystem/Job User Type CPU % Function Status
QBATCH QSYS SBS .0 DEQW
QDFTJOBD SHEILAV BCH .0 PGM-HCDBBLD01C RUN

Parameters or command
===>
F3=Exit F5=Refresh F7=Find F10=Restart statistics
F11=Display elapsed data F12=Cancel F23=More options F24=More keys

* Press F5 or F10 to refresh. Process will take approx. 6 minutes to complete.
* When completed the “RUN” will disappear
* Key in the command DSPFD UWDASWVOLD/HCDBDATAP and press enter. Then press page down until you see ‘Current number of records’ (about three times). There should be around 26,000 records in it (as of Nov 2014; it will increase with time). F3 to exit

Display Spooled File
File . . . . . : QPDSPFD Page/Line 2/11
Control . . . . . Columns 1 - 130
Find . . . . . .
*...+....1....+....2....+....3....+....4....+....5....+....6....+....7....+....8....+....9....+....0....+....1
Number of key fields . . . . . . . . . . . : 1
Record format . . . . . . . . . . . . . . . : HCDBDATAR
Key field . . . . . . . . . . . . . . . . : HCPRDC
Sequence . . . . . . . . . . . . . . . : Ascending
Sign specified . . . . . . . . . . . . : UNSIGNED
Zone/digit specified . . . . . . . . . : *NONE
Alternative collating sequence . . . . : No
Sort Sequence . . . . . . . . . . . . . . . : SRTSEQ *HEX
Language identifier . . . . . . . . . . . . : LANGID ENU
Member Description
Member . . . . . . . . . . . . . . . . . . : MBR HCDBDATAP
Member level identifier . . . . . . . . . : 1140529130244
Member creation date . . . . . . . . . . : 05/29/14
Text 'description' . . . . . . . . . . . : TEXT Health Canada Data Base - consolidated
Expiration date for member . . . . . . . : EXPDATE *NONE
Access path maintenance . . . . . . . . . : MAINT *IMMED
Access path recovery . . . . . . . . . . : RECOVER *NO
Member size . . . . . . . . . . . . . . . : SIZE *NOMAX
Current number of records . . . . . . . . : 25717

F3=Exit F12=Cancel F19=Left F20=Right F24=More keys

* When this program has completed, go into Web Orders '''test''' (https://orders.unipharm.com/unidev/uw_logind.pgm) to make sure the files have been correctly built.
* Should also check in ASW for the printer output file for job QPQUPRFIL - this should typically only be 2 pages (one page is header), and the second page typically only shows items in error. Stocked can then be checked as needed and item file maintenance updated.

'''If the files are correct in test, then they can be updated in production – not now, but tonight when stores are not using Web Orders.'''

* Go into ASW production by keying 88, enter, VA, enter, enter.
* Key in WRKJOBSCDE and press Enter.
* Page down to job HCDATABASE.

Work with Job Schedule Entries BART
10/01/14 12:34:49

Type options, press Enter.
2=Change 3=Hold 4=Remove 5=Display details 6=Release
8=Work with last submission 10=Submit immediately

Next
-----Schedule------ Recovery Submit
Opt Job Status Date Time Frequency Action Date
2 HCDATABASE SAV 09/05/14 06:00:00 *ONCE *NOSBM
__ IMRCHDJOB HLD USER DEF 04:30:00 *WEEKLY *SBMRLS 10/02/14
__ IMRSCKSTS1 SCD *ALL 05:30:00 *WEEKLY *SBMRLS 10/02/14
__ IMRSCKSTS2 SCD 10/01/14 12:35:00 *ONCE *SBMRLS 10/01/14
__ INTERREPLN HLD *TUE 05:00:00 *WEEKLY *NOSBM 10/07/14
__ MAXAVA SCD *SAT 20:00:00 *ONCE *NOSBM 10/04/14
__ MXIOSTATS2 SAV *TUE 12:30:00 *ONCE *SBMRLS
More...
Parameters or command
===>
F3=Exit F4=Prompt F5=Refresh F6=Add F9=Retrieve
F11=Display job queue data F12=Cancel F17=Top F18=Bottom

* Use option 2 to change it.

Change Job Schedule Entry (CHGJOBSCDE)

Type choices, press Enter.

Job name . . . . . . . . . . . . > HCDATABASE Name
Entry number . . . . . . . . . . > 572242 000001-999999, *ONLY
Command to run . . . . . . . . . SBMJOB CMD(CALL PGM(HCDBBLD01C)) JOBQ(QS36EV
OKE)____________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
Frequency . . . . . . . . . . . *ONCE *SAME, *ONCE, *WEEKLY...
Schedule date . . . . . . . . . '10/02/14' Date, *SAME, *CURRENT...
Schedule day . . . . . . . . . . *NONE *SAME, *NONE, *ALL, *MON...
+ for more values _____
Schedule time . . . . . . . . . '06:00:00' Time, *SAME, *CURRENT

Bottom
F3=Exit F4=Prompt F5=Refresh F10=Additional parameters F12=Cancel
F13=How to use this display F24=More keys

* Set it to run on the '''first Saturday''' after doing this data refresh (this is highly recommended to ensure the job has enough time to run without causing issues) the format is MM/DD/YY), and press enter twice.
* Send an email to the I.T. Group to let them know that the HC Database will be running this Saturday.

'''Check it the next business day to make sure the files have been correctly built.'''

* Key in the command DSPFD UWDASWPRDD/HCDBDATAP and press enter. Then press page down until you see ‘Current number of records’ (about three times). There should be around 26,000 records in it (as of Nov 2014; it will increase with time). (Note that this command is slightly different than the previous one in that it looks at production instead of development.)
* Go into Web Orders production. (spot check several items, suggestion to look for DIN’s that are newer (higher numbers)).
* Should also check in ASW for the printer output file for job QPQUPRFIL - this should typically only be 2 pages (one page is header), and the second page typically only shows items in error. Stocked can then be checked as needed and item file maintenance updated.

=Additional Notes=
===Changes to the drug extract (Sept. 2017)===
[https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database/what-data-extract-drug-product-database.html Consult the '''official page'''] for an explanation of the structure of the drug extract.

There are three main changes to the drug extract:
* A new set of files for dormant products (not marketed for the last 12 months). These are now recognized by the current program.
* New columns to each file in a set (mostly French versions of existing columns). These are ignored by the current program.
* UTF-8 encoding. Some files are encoded in UTF-8-BOM, which bombs the program.

[[Category: Health Canada]]

Information Systems:Health Canada Drug Product Database

2023-02-09T16:32:36Z

Johnt:

=Overview=

Health Canada makes information on drugs (DPD) and natural health products (NHP) available through database extracts that can be downloaded from their website. There are two sets; the drug files are refreshed at the beginning of every month; the NHP files less often. We build a database (e.g. set of tables) from these files so that the information can be displayed in Web Orders (and in ''Display Items'', ''Work with Items'' in Infonet).

Consult the official pages for the [https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html '''drugs'''] and [https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/applications-submissions/product-licensing/licensed-natural-health-product-database-data-extract.html '''NHP'''] extracts for more information.

=Instructions for updating our database=
==Downloading the extract (drugs)==

# Go to Health Canada’s web site, www.hc-sc.gc.ca
# Click on ‘English’
# Under ‘Main Menu’, click on ‘Drugs & Health Products’
# Click on ‘Drug Products’
# Click on ‘Drug Product Database (DPD)’
# On the right hand side, click on ‘Access the Drug Product Database’
# On the upper part of the page, click on ‘DPD Data Extracts’
# Check the date under ‘Last Updated’ (right hand column). Don’t continue with this process unless this has changed. There shouldn’t be an issue as it is usually updated early on the first work day of the month.
# Before saving the new files - move old data files (NOTE: do not touch the files starting with NHP) - (superserver/staging/Health Canada) to archive folder - yes to replace
# Download ‘ALL FILES’ (bottom of the list - do ALL 4) to your PC; both active (allfiles.zip) and inactive (allfiles_ia.zip) and (allfiles_ap.zip) - Open then Open
# As of April 1, 2022 they now also have 4 other files that need to be extracted and saved version 1 of the Therapeudic class
# Unzip and copy to SuperServer / staging / Health Canada

==Downloading the extract (Natural Health Products)==
'''NOTE: These records were last updated by HC in Sept. 2017. They are working on a new data extract - TBD (as of Aug 2018 - still no progress)(as of Sept 2019 still no progress on getting new extracts for NHP).
'''
# Go to Health Canada’s web site, www.hc-sc.gc.ca
# Click on ‘English’
# Under ‘Main Menu’, click on ‘Drugs & Health Products’
# Click on ‘Natural Health Products’
# On the right hand side, click on ‘Licensed Natural Health Products Database’
# Scroll down to the bottom of the page, and click on ‘Access the Licensed Natural Health Products Database Data Extract’
# Health Canada updates these files less often the drug product ones. Check the last updated date (at the top of the list of files) to see if it is necessary to continue. If the dates are the same, then don't do anything else. Check the next time.
# Go to SuperServer / staging / Health Canada and move the previous files to the archive folder.
# Download ‘All NHP Files’ to your PC.
# Unzip and copy to SuperServer / staging / Health Canada

==Updating Health Canada files on Bart==

'''Note:''' Need to use John T - user account to access the PL system and Web Orders Dev. We have had issues with the Health Canada data files. They are apparently extracted manually, which means there can be errors. One month there were no record delimiters; which meant we couldn’t use them. Another time instead of all related files being zipped together, each was zipped separately, then zipped together. Another issue is that users EODJOB and SHEILAV cannot access SUPERSERVER from the i, so the scheduled job has been changed to run under JOHNT (2014Dec04).

'''To validate the data files, first manually run the rebuild in the test environment (PL):'''

* From a command line in ASW (easiest to do in Mocha), key in 88, press Enter, key in PL, and press Enter twice.
* Key in SBMJOB CMD(CALL PGM(HCDBBLD01C)) JOBQ(QS36EVOKE) and press enter (Note: just press enter ONCE!). (This is run from job queue QS36EVOKE so that production jobs are not delayed.) This program is being submitted to run in batch – you won’t see it on your screen.
* To see this job running, key in WRKACTJOB SBS(QBATCH) and press enter (Note: just press enter ONCE!).

Work with Active Jobs BART
10/01/14 12:16:27
CPU %: .0 Elapsed time: 00:00:00 Active jobs: 563

Type options, press Enter.
2=Change 3=Hold 4=End 5=Work with 6=Release 7=Display message
8=Work with spooled files 13=Disconnect ...
Current
Opt Subsystem/Job User Type CPU % Function Status
QBATCH QSYS SBS .0 DEQW
QDFTJOBD SHEILAV BCH .0 PGM-HCDBBLD01C RUN

Parameters or command
===>
F3=Exit F5=Refresh F7=Find F10=Restart statistics
F11=Display elapsed data F12=Cancel F23=More options F24=More keys

* Press F5 or F10 to refresh. Process will take approx. 6 minutes to complete.
* When completed the “RUN” will disappear
* Key in the command DSPFD UWDASWVOLD/HCDBDATAP and press enter. Then press page down until you see ‘Current number of records’ (about three times). There should be around 26,000 records in it (as of Nov 2014; it will increase with time). F3 to exit

Display Spooled File
File . . . . . : QPDSPFD Page/Line 2/11
Control . . . . . Columns 1 - 130
Find . . . . . .
*...+....1....+....2....+....3....+....4....+....5....+....6....+....7....+....8....+....9....+....0....+....1
Number of key fields . . . . . . . . . . . : 1
Record format . . . . . . . . . . . . . . . : HCDBDATAR
Key field . . . . . . . . . . . . . . . . : HCPRDC
Sequence . . . . . . . . . . . . . . . : Ascending
Sign specified . . . . . . . . . . . . : UNSIGNED
Zone/digit specified . . . . . . . . . : *NONE
Alternative collating sequence . . . . : No
Sort Sequence . . . . . . . . . . . . . . . : SRTSEQ *HEX
Language identifier . . . . . . . . . . . . : LANGID ENU
Member Description
Member . . . . . . . . . . . . . . . . . . : MBR HCDBDATAP
Member level identifier . . . . . . . . . : 1140529130244
Member creation date . . . . . . . . . . : 05/29/14
Text 'description' . . . . . . . . . . . : TEXT Health Canada Data Base - consolidated
Expiration date for member . . . . . . . : EXPDATE *NONE
Access path maintenance . . . . . . . . . : MAINT *IMMED
Access path recovery . . . . . . . . . . : RECOVER *NO
Member size . . . . . . . . . . . . . . . : SIZE *NOMAX
Current number of records . . . . . . . . : 25717

F3=Exit F12=Cancel F19=Left F20=Right F24=More keys

* When this program has completed, go into Web Orders '''test''' (https://orders.unipharm.com/unidev/uw_logind.pgm) to make sure the files have been correctly built.
* Should also check in ASW for the printer output file for job QPQUPRFIL - this should typically only be 2 pages (one page is header), and the second page typically only shows items in error. Stocked can then be checked as needed and item file maintenance updated.

'''If the files are correct in test, then they can be updated in production – not now, but tonight when stores are not using Web Orders.'''

* Go into ASW production by keying 88, enter, VA, enter, enter.
* Key in WRKJOBSCDE and press Enter.
* Page down to job HCDATABASE.

Work with Job Schedule Entries BART
10/01/14 12:34:49

Type options, press Enter.
2=Change 3=Hold 4=Remove 5=Display details 6=Release
8=Work with last submission 10=Submit immediately

Next
-----Schedule------ Recovery Submit
Opt Job Status Date Time Frequency Action Date
2 HCDATABASE SAV 09/05/14 06:00:00 *ONCE *NOSBM
__ IMRCHDJOB HLD USER DEF 04:30:00 *WEEKLY *SBMRLS 10/02/14
__ IMRSCKSTS1 SCD *ALL 05:30:00 *WEEKLY *SBMRLS 10/02/14
__ IMRSCKSTS2 SCD 10/01/14 12:35:00 *ONCE *SBMRLS 10/01/14
__ INTERREPLN HLD *TUE 05:00:00 *WEEKLY *NOSBM 10/07/14
__ MAXAVA SCD *SAT 20:00:00 *ONCE *NOSBM 10/04/14
__ MXIOSTATS2 SAV *TUE 12:30:00 *ONCE *SBMRLS
More...
Parameters or command
===>
F3=Exit F4=Prompt F5=Refresh F6=Add F9=Retrieve
F11=Display job queue data F12=Cancel F17=Top F18=Bottom

* Use option 2 to change it.

Change Job Schedule Entry (CHGJOBSCDE)

Type choices, press Enter.

Job name . . . . . . . . . . . . > HCDATABASE Name
Entry number . . . . . . . . . . > 572242 000001-999999, *ONLY
Command to run . . . . . . . . . SBMJOB CMD(CALL PGM(HCDBBLD01C)) JOBQ(QS36EV
OKE)____________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
Frequency . . . . . . . . . . . *ONCE *SAME, *ONCE, *WEEKLY...
Schedule date . . . . . . . . . '10/02/14' Date, *SAME, *CURRENT...
Schedule day . . . . . . . . . . *NONE *SAME, *NONE, *ALL, *MON...
+ for more values _____
Schedule time . . . . . . . . . '06:00:00' Time, *SAME, *CURRENT

Bottom
F3=Exit F4=Prompt F5=Refresh F10=Additional parameters F12=Cancel
F13=How to use this display F24=More keys

* Set it to run on the '''first Saturday''' after doing this data refresh (this is highly recommended to ensure the job has enough time to run without causing issues) the format is MM/DD/YY), and press enter twice.
* Send an email to the I.T. Group to let them know that the HC Database will be running this Saturday.

'''Check it the next business day to make sure the files have been correctly built.'''

* Key in the command DSPFD UWDASWPRDD/HCDBDATAP and press enter. Then press page down until you see ‘Current number of records’ (about three times). There should be around 26,000 records in it (as of Nov 2014; it will increase with time). (Note that this command is slightly different than the previous one in that it looks at production instead of development.)
* Go into Web Orders production. (spot check several items, suggestion to look for DIN’s that are newer (higher numbers)).
* Should also check in ASW for the printer output file for job QPQUPRFIL - this should typically only be 2 pages (one page is header), and the second page typically only shows items in error. Stocked can then be checked as needed and item file maintenance updated.

=Additional Notes=
===Changes to the drug extract (Sept. 2017)===
[https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database/what-data-extract-drug-product-database.html Consult the '''official page'''] for an explanation of the structure of the drug extract.

There are three main changes to the drug extract:
* A new set of files for dormant products (not marketed for the last 12 months). These are now recognized by the current program.
* New columns to each file in a set (mostly French versions of existing columns). These are ignored by the current program.
* UTF-8 encoding. Some files are encoded in UTF-8-BOM, which bombs the program.

[[Category: Health Canada]]

Distribution Centre:Health Canada Audits & Inspections

2023-02-08T16:32:23Z

Johnt:

'''Health Canada Audits & Inspections'''

==Background==
This information is recorded to assist with the preparation and conduct when faced with a Health Canada Inspection.

==Types of Health Canada Inspections==
* GMP (Good Manufacturing Practise)
* Narcotic & Controlled Substances
* Precursors
* Medical Devices
* Other not applicable to uniPHARM - GXP-Clinical, Pharmacovigilance and CFIA (Canadian Food Inspection Agency)

==Challenges==
* Data Integrity
* Good documentation practices for QA/QC
* Transportation/storage-temperature control/mapping studies/qualified pack out solutions/IQ/OQ or DQ/PQ (should be done at least every 5 years)
* Inspection program for active pharmaceutical ingredients (Human only)

==Preparation==
* Ensure good communication with all colleagues that could be involved in the audit and review "The Golden Rules" & topics that will typically be covered during the inspection
* Make sure suitable location is booked for the duration of the time that an inspector will be on-site (suggestion to book the boardroom or the UTC for the day)
* When inspector(s) arrive - ask them for their Health Canada I.D.

==Golden Rules==
'''Rule #1'''
* Be well prepared - it's important to be knowledgeable of the HC regulations
* Where possible - simulate inspection process in the organization
* Test internal SOP (Standard Operating Procedures)
* Test staff knowledge
* How are questions answered

'' Inspection "Don'ts..."''
* Don't - Guess, lie or make misleading statements
* Don't - Get uptight, overly anxious, or defensive
* Don't - Volunteer more information than necessary to answer the question
* Don't - Engage in unconstructive arguments

'' Inspection "Do's"
* Ensure that documents are readily retrievable
* Use relevant guidelines as resources
* Important to have senior management support as preparation takes resources

'''Rule #2'''
* Good documentation practices
* Accurate records
* Record all necessary information immediately upon completion of a task
* Never trust your memory or write results on loose pieces of paper or a post-it note
* Write your name legibly in ink. Remember that by signing records you are certifying that the record is correct and that you have performed the task as per the defined procedure.
* Draw a single line through any mistakes, and initial and date the correction. Include a reason for the correction at the bottom of the page.
* Record details if you deviate from a procedure
* Never assume that undocumentated work has been properly completed - if it's not written down then it didn't happen
* Review SOP's and processes regularly to assure that they are up to date
* Document changes (change control)

'''Rule #3'''
* Write good procedures and follow them - "Walk the talk"

'''Rule #4'''
* Train and develop staff
* Training should be documented on a training form

'''Rule #5'''
* Perform regular audits
* Self inspections - complete, update SOP's as needed

'''Rule #6'''
* When the inspector requests a document
** Provide the required document ONLY
* When the inspector asks a question
** Answer the question directly and honestly - DO NOT provide any further details or information if it's not necessary
** If you don't know that answer - DON'T guess - state you will find out and come back with the information

'''Rule #7'''
* Key people must be present on the day of the inspection - if this is not possible, then ensure a suitable back up or request a reschedule if possible
* Important documents to be available
* Organizational Chart
* SOP's
* Training records
* Transactional details
[[Category:Health Canada-DC]]
[[Category:Health Canada]]

Information Systems:Health Canada Drug Product Database

2022-05-12T22:26:32Z

Johnt: /* Updating Health Canada files on Bart */

=Overview=

Health Canada makes information on drugs and natural health products available through database extracts that can be downloaded from their website. There are two sets; the drug files are refreshed at the beginning of every month; the NHP files less often. We build a database (e.g. set of tables) from these files so that the information can be displayed in Web Orders (and in ''Display Items'', ''Work with Items'' in Infonet).

Consult the official pages for the [https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html '''drugs'''] and [https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/applications-submissions/product-licensing/licensed-natural-health-product-database-data-extract.html '''NHP'''] extracts for more information.

=Instructions for updating our database=
==Downloading the extract (drugs)==

# Go to Health Canada’s web site, www.hc-sc.gc.ca
# Click on ‘English’
# Under ‘Main Menu’, click on ‘Drugs & Health Products’
# Click on ‘Drug Products’
# Click on ‘Drug Product Database (DPD)’
# On the right hand side, click on ‘Access the Drug Product Database’
# On the upper part of the page, click on ‘DPD Data Extracts’
# Check the date under ‘Last Updated’ (right hand column). Don’t continue with this process unless this has changed. There shouldn’t be an issue as it is usually updated early on the first work day of the month.
# Before saving the new files - move old data files (NOTE: do not touch the files starting with NHP) - (superserver/staging/Health Canada) to archive folder - yes to replace
# Download ‘ALL FILES’ (bottom of the list - do ALL 4) to your PC; both active (allfiles.zip) and inactive (allfiles_ia.zip) and (allfiles_ap.zip) - Open then Open
# As of April 1, 2022 they now also have 4 other files that need to be extracted and saved version 1 of the Therapeudic class
# Unzip and copy to SuperServer / staging / Health Canada

==Downloading the extract (Natural Health Products)==
'''NOTE: These records were last updated by HC in Sept. 2017. They are working on a new data extract - TBD (as of Aug 2018 - still no progress)(as of Sept 2019 still no progress on getting new extracts for NHP).
'''
# Go to Health Canada’s web site, www.hc-sc.gc.ca
# Click on ‘English’
# Under ‘Main Menu’, click on ‘Drugs & Health Products’
# Click on ‘Natural Health Products’
# On the right hand side, click on ‘Licensed Natural Health Products Database’
# Scroll down to the bottom of the page, and click on ‘Access the Licensed Natural Health Products Database Data Extract’
# Health Canada updates these files less often the drug product ones. Check the last updated date (at the top of the list of files) to see if it is necessary to continue. If the dates are the same, then don't do anything else. Check the next time.
# Go to SuperServer / staging / Health Canada and move the previous files to the archive folder.
# Download ‘All NHP Files’ to your PC.
# Unzip and copy to SuperServer / staging / Health Canada

==Updating Health Canada files on Bart==

'''Note:''' Need to use John T - user account to access the PL system and Web Orders Dev. We have had issues with the Health Canada data files. They are apparently extracted manually, which means there can be errors. One month there were no record delimiters; which meant we couldn’t use them. Another time instead of all related files being zipped together, each was zipped separately, then zipped together. Another issue is that users EODJOB and SHEILAV cannot access SUPERSERVER from the i, so the scheduled job has been changed to run under JOHNT (2014Dec04).

'''To validate the data files, first manually run the rebuild in the test environment (PL):'''

* From a command line in ASW (easiest to do in Mocha), key in 88, press Enter, key in PL, and press Enter twice.
* Key in SBMJOB CMD(CALL PGM(HCDBBLD01C)) JOBQ(QS36EVOKE) and press enter (Note: just press enter ONCE!). (This is run from job queue QS36EVOKE so that production jobs are not delayed.) This program is being submitted to run in batch – you won’t see it on your screen.
* To see this job running, key in WRKACTJOB SBS(QBATCH) and press enter (Note: just press enter ONCE!).

Work with Active Jobs BART
10/01/14 12:16:27
CPU %: .0 Elapsed time: 00:00:00 Active jobs: 563

Type options, press Enter.
2=Change 3=Hold 4=End 5=Work with 6=Release 7=Display message
8=Work with spooled files 13=Disconnect ...
Current
Opt Subsystem/Job User Type CPU % Function Status
QBATCH QSYS SBS .0 DEQW
QDFTJOBD SHEILAV BCH .0 PGM-HCDBBLD01C RUN

Parameters or command
===>
F3=Exit F5=Refresh F7=Find F10=Restart statistics
F11=Display elapsed data F12=Cancel F23=More options F24=More keys

* Press F5 or F10 to refresh. Process will take approx. 6 minutes to complete.
* When completed the “RUN” will disappear
* Key in the command DSPFD UWDASWVOLD/HCDBDATAP and press enter. Then press page down until you see ‘Current number of records’ (about three times). There should be around 26,000 records in it (as of Nov 2014; it will increase with time). F3 to exit

Display Spooled File
File . . . . . : QPDSPFD Page/Line 2/11
Control . . . . . Columns 1 - 130
Find . . . . . .
*...+....1....+....2....+....3....+....4....+....5....+....6....+....7....+....8....+....9....+....0....+....1
Number of key fields . . . . . . . . . . . : 1
Record format . . . . . . . . . . . . . . . : HCDBDATAR
Key field . . . . . . . . . . . . . . . . : HCPRDC
Sequence . . . . . . . . . . . . . . . : Ascending
Sign specified . . . . . . . . . . . . : UNSIGNED
Zone/digit specified . . . . . . . . . : *NONE
Alternative collating sequence . . . . : No
Sort Sequence . . . . . . . . . . . . . . . : SRTSEQ *HEX
Language identifier . . . . . . . . . . . . : LANGID ENU
Member Description
Member . . . . . . . . . . . . . . . . . . : MBR HCDBDATAP
Member level identifier . . . . . . . . . : 1140529130244
Member creation date . . . . . . . . . . : 05/29/14
Text 'description' . . . . . . . . . . . : TEXT Health Canada Data Base - consolidated
Expiration date for member . . . . . . . : EXPDATE *NONE
Access path maintenance . . . . . . . . . : MAINT *IMMED
Access path recovery . . . . . . . . . . : RECOVER *NO
Member size . . . . . . . . . . . . . . . : SIZE *NOMAX
Current number of records . . . . . . . . : 25717

F3=Exit F12=Cancel F19=Left F20=Right F24=More keys

* When this program has completed, go into Web Orders '''test''' (https://orders.unipharm.com/unidev/uw_logind.pgm) to make sure the files have been correctly built.
* Should also check in ASW for the printer output file for job QPQUPRFIL - this should typically only be 2 pages (one page is header), and the second page typically only shows items in error. Stocked can then be checked as needed and item file maintenance updated.

'''If the files are correct in test, then they can be updated in production – not now, but tonight when stores are not using Web Orders.'''

* Go into ASW production by keying 88, enter, VA, enter, enter.
* Key in WRKJOBSCDE and press Enter.
* Page down to job HCDATABASE.

Work with Job Schedule Entries BART
10/01/14 12:34:49

Type options, press Enter.
2=Change 3=Hold 4=Remove 5=Display details 6=Release
8=Work with last submission 10=Submit immediately

Next
-----Schedule------ Recovery Submit
Opt Job Status Date Time Frequency Action Date
2 HCDATABASE SAV 09/05/14 06:00:00 *ONCE *NOSBM
__ IMRCHDJOB HLD USER DEF 04:30:00 *WEEKLY *SBMRLS 10/02/14
__ IMRSCKSTS1 SCD *ALL 05:30:00 *WEEKLY *SBMRLS 10/02/14
__ IMRSCKSTS2 SCD 10/01/14 12:35:00 *ONCE *SBMRLS 10/01/14
__ INTERREPLN HLD *TUE 05:00:00 *WEEKLY *NOSBM 10/07/14
__ MAXAVA SCD *SAT 20:00:00 *ONCE *NOSBM 10/04/14
__ MXIOSTATS2 SAV *TUE 12:30:00 *ONCE *SBMRLS
More...
Parameters or command
===>
F3=Exit F4=Prompt F5=Refresh F6=Add F9=Retrieve
F11=Display job queue data F12=Cancel F17=Top F18=Bottom

* Use option 2 to change it.

Change Job Schedule Entry (CHGJOBSCDE)

Type choices, press Enter.

Job name . . . . . . . . . . . . > HCDATABASE Name
Entry number . . . . . . . . . . > 572242 000001-999999, *ONLY
Command to run . . . . . . . . . SBMJOB CMD(CALL PGM(HCDBBLD01C)) JOBQ(QS36EV
OKE)____________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
Frequency . . . . . . . . . . . *ONCE *SAME, *ONCE, *WEEKLY...
Schedule date . . . . . . . . . '10/02/14' Date, *SAME, *CURRENT...
Schedule day . . . . . . . . . . *NONE *SAME, *NONE, *ALL, *MON...
+ for more values _____
Schedule time . . . . . . . . . '06:00:00' Time, *SAME, *CURRENT

Bottom
F3=Exit F4=Prompt F5=Refresh F10=Additional parameters F12=Cancel
F13=How to use this display F24=More keys

* Set it to run on the '''first Saturday''' after doing this data refresh (this is highly recommended to ensure the job has enough time to run without causing issues) the format is MM/DD/YY), and press enter twice.
* Send an email to the I.T. Group to let them know that the HC Database will be running this Saturday.

'''Check it the next business day to make sure the files have been correctly built.'''

* Key in the command DSPFD UWDASWPRDD/HCDBDATAP and press enter. Then press page down until you see ‘Current number of records’ (about three times). There should be around 26,000 records in it (as of Nov 2014; it will increase with time). (Note that this command is slightly different than the previous one in that it looks at production instead of development.)
* Go into Web Orders production. (spot check several items, suggestion to look for DIN’s that are newer (higher numbers)).
* Should also check in ASW for the printer output file for job QPQUPRFIL - this should typically only be 2 pages (one page is header), and the second page typically only shows items in error. Stocked can then be checked as needed and item file maintenance updated.

=Additional Notes=
===Changes to the drug extract (Sept. 2017)===
[https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database/what-data-extract-drug-product-database.html Consult the '''official page'''] for an explanation of the structure of the drug extract.

There are three main changes to the drug extract:
* A new set of files for dormant products (not marketed for the last 12 months). These are now recognized by the current program.
* New columns to each file in a set (mostly French versions of existing columns). These are ignored by the current program.
* UTF-8 encoding. Some files are encoded in UTF-8-BOM, which bombs the program.

[[Category: Health Canada]]

Information Systems:Health Canada Drug Product Database

2022-05-12T22:23:56Z

Johnt: /* Downloading the extract (drugs) */

=Overview=

Health Canada makes information on drugs and natural health products available through database extracts that can be downloaded from their website. There are two sets; the drug files are refreshed at the beginning of every month; the NHP files less often. We build a database (e.g. set of tables) from these files so that the information can be displayed in Web Orders (and in ''Display Items'', ''Work with Items'' in Infonet).

Consult the official pages for the [https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html '''drugs'''] and [https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/applications-submissions/product-licensing/licensed-natural-health-product-database-data-extract.html '''NHP'''] extracts for more information.

=Instructions for updating our database=
==Downloading the extract (drugs)==

# Go to Health Canada’s web site, www.hc-sc.gc.ca
# Click on ‘English’
# Under ‘Main Menu’, click on ‘Drugs & Health Products’
# Click on ‘Drug Products’
# Click on ‘Drug Product Database (DPD)’
# On the right hand side, click on ‘Access the Drug Product Database’
# On the upper part of the page, click on ‘DPD Data Extracts’
# Check the date under ‘Last Updated’ (right hand column). Don’t continue with this process unless this has changed. There shouldn’t be an issue as it is usually updated early on the first work day of the month.
# Before saving the new files - move old data files (NOTE: do not touch the files starting with NHP) - (superserver/staging/Health Canada) to archive folder - yes to replace
# Download ‘ALL FILES’ (bottom of the list - do ALL 4) to your PC; both active (allfiles.zip) and inactive (allfiles_ia.zip) and (allfiles_ap.zip) - Open then Open
# As of April 1, 2022 they now also have 4 other files that need to be extracted and saved version 1 of the Therapeudic class
# Unzip and copy to SuperServer / staging / Health Canada

==Downloading the extract (Natural Health Products)==
'''NOTE: These records were last updated by HC in Sept. 2017. They are working on a new data extract - TBD (as of Aug 2018 - still no progress)(as of Sept 2019 still no progress on getting new extracts for NHP).
'''
# Go to Health Canada’s web site, www.hc-sc.gc.ca
# Click on ‘English’
# Under ‘Main Menu’, click on ‘Drugs & Health Products’
# Click on ‘Natural Health Products’
# On the right hand side, click on ‘Licensed Natural Health Products Database’
# Scroll down to the bottom of the page, and click on ‘Access the Licensed Natural Health Products Database Data Extract’
# Health Canada updates these files less often the drug product ones. Check the last updated date (at the top of the list of files) to see if it is necessary to continue. If the dates are the same, then don't do anything else. Check the next time.
# Go to SuperServer / staging / Health Canada and move the previous files to the archive folder.
# Download ‘All NHP Files’ to your PC.
# Unzip and copy to SuperServer / staging / Health Canada

==Updating Health Canada files on Bart==

'''Note:''' We have had issues with the Health Canada data files. They are apparently extracted manually, which means there can be errors. One month there were no record delimiters; which meant we couldn’t use them. Another time instead of all related files being zipped together, each was zipped separately, then zipped together. Another issue is that users EODJOB and SHEILAV cannot access SUPERSERVER from the i, so the scheduled job has been changed to run under JOHNT (2014Dec04).

'''To validate the data files, first manually run the rebuild in the test environment (PL):'''

* From a command line in ASW (easiest to do in Mocha), key in 88, press Enter, key in PL, and press Enter twice.
* Key in SBMJOB CMD(CALL PGM(HCDBBLD01C)) JOBQ(QS36EVOKE) and press enter (Note: just press enter ONCE!). (This is run from job queue QS36EVOKE so that production jobs are not delayed.) This program is being submitted to run in batch – you won’t see it on your screen.
* To see this job running, key in WRKACTJOB SBS(QBATCH) and press enter (Note: just press enter ONCE!).

Work with Active Jobs BART
10/01/14 12:16:27
CPU %: .0 Elapsed time: 00:00:00 Active jobs: 563

Type options, press Enter.
2=Change 3=Hold 4=End 5=Work with 6=Release 7=Display message
8=Work with spooled files 13=Disconnect ...
Current
Opt Subsystem/Job User Type CPU % Function Status
QBATCH QSYS SBS .0 DEQW
QDFTJOBD SHEILAV BCH .0 PGM-HCDBBLD01C RUN

Parameters or command
===>
F3=Exit F5=Refresh F7=Find F10=Restart statistics
F11=Display elapsed data F12=Cancel F23=More options F24=More keys

* Press F5 or F10 to refresh. Process will take approx. 6 minutes to complete.
* When completed the “RUN” will disappear
* Key in the command DSPFD UWDASWVOLD/HCDBDATAP and press enter. Then press page down until you see ‘Current number of records’ (about three times). There should be around 26,000 records in it (as of Nov 2014; it will increase with time). F3 to exit

Display Spooled File
File . . . . . : QPDSPFD Page/Line 2/11
Control . . . . . Columns 1 - 130
Find . . . . . .
*...+....1....+....2....+....3....+....4....+....5....+....6....+....7....+....8....+....9....+....0....+....1
Number of key fields . . . . . . . . . . . : 1
Record format . . . . . . . . . . . . . . . : HCDBDATAR
Key field . . . . . . . . . . . . . . . . : HCPRDC
Sequence . . . . . . . . . . . . . . . : Ascending
Sign specified . . . . . . . . . . . . : UNSIGNED
Zone/digit specified . . . . . . . . . : *NONE
Alternative collating sequence . . . . : No
Sort Sequence . . . . . . . . . . . . . . . : SRTSEQ *HEX
Language identifier . . . . . . . . . . . . : LANGID ENU
Member Description
Member . . . . . . . . . . . . . . . . . . : MBR HCDBDATAP
Member level identifier . . . . . . . . . : 1140529130244
Member creation date . . . . . . . . . . : 05/29/14
Text 'description' . . . . . . . . . . . : TEXT Health Canada Data Base - consolidated
Expiration date for member . . . . . . . : EXPDATE *NONE
Access path maintenance . . . . . . . . . : MAINT *IMMED
Access path recovery . . . . . . . . . . : RECOVER *NO
Member size . . . . . . . . . . . . . . . : SIZE *NOMAX
Current number of records . . . . . . . . : 25717

F3=Exit F12=Cancel F19=Left F20=Right F24=More keys

* When this program has completed, go into Web Orders '''test''' (https://orders.unipharm.com/unidev/uw_logind.pgm) to make sure the files have been correctly built.
* Should also check in ASW for the printer output file for job QPQUPRFIL - this should typically only be 2 pages (one page is header), and the second page typically only shows items in error. Stocked can then be checked as needed and item file maintenance updated.

'''If the files are correct in test, then they can be updated in production – not now, but tonight when stores are not using Web Orders.'''

* Go into ASW production by keying 88, enter, VA, enter, enter.
* Key in WRKJOBSCDE and press Enter.
* Page down to job HCDATABASE.

Work with Job Schedule Entries BART
10/01/14 12:34:49

Type options, press Enter.
2=Change 3=Hold 4=Remove 5=Display details 6=Release
8=Work with last submission 10=Submit immediately

Next
-----Schedule------ Recovery Submit
Opt Job Status Date Time Frequency Action Date
2 HCDATABASE SAV 09/05/14 06:00:00 *ONCE *NOSBM
__ IMRCHDJOB HLD USER DEF 04:30:00 *WEEKLY *SBMRLS 10/02/14
__ IMRSCKSTS1 SCD *ALL 05:30:00 *WEEKLY *SBMRLS 10/02/14
__ IMRSCKSTS2 SCD 10/01/14 12:35:00 *ONCE *SBMRLS 10/01/14
__ INTERREPLN HLD *TUE 05:00:00 *WEEKLY *NOSBM 10/07/14
__ MAXAVA SCD *SAT 20:00:00 *ONCE *NOSBM 10/04/14
__ MXIOSTATS2 SAV *TUE 12:30:00 *ONCE *SBMRLS
More...
Parameters or command
===>
F3=Exit F4=Prompt F5=Refresh F6=Add F9=Retrieve
F11=Display job queue data F12=Cancel F17=Top F18=Bottom

* Use option 2 to change it.

Change Job Schedule Entry (CHGJOBSCDE)

Type choices, press Enter.

Job name . . . . . . . . . . . . > HCDATABASE Name
Entry number . . . . . . . . . . > 572242 000001-999999, *ONLY
Command to run . . . . . . . . . SBMJOB CMD(CALL PGM(HCDBBLD01C)) JOBQ(QS36EV
OKE)____________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
Frequency . . . . . . . . . . . *ONCE *SAME, *ONCE, *WEEKLY...
Schedule date . . . . . . . . . '10/02/14' Date, *SAME, *CURRENT...
Schedule day . . . . . . . . . . *NONE *SAME, *NONE, *ALL, *MON...
+ for more values _____
Schedule time . . . . . . . . . '06:00:00' Time, *SAME, *CURRENT

Bottom
F3=Exit F4=Prompt F5=Refresh F10=Additional parameters F12=Cancel
F13=How to use this display F24=More keys

* Set it to run on the '''first Saturday''' after doing this data refresh (this is highly recommended to ensure the job has enough time to run without causing issues) the format is MM/DD/YY), and press enter twice.
* Send an email to the I.T. Group to let them know that the HC Database will be running this Saturday.

'''Check it the next business day to make sure the files have been correctly built.'''

* Key in the command DSPFD UWDASWPRDD/HCDBDATAP and press enter. Then press page down until you see ‘Current number of records’ (about three times). There should be around 26,000 records in it (as of Nov 2014; it will increase with time). (Note that this command is slightly different than the previous one in that it looks at production instead of development.)
* Go into Web Orders production. (spot check several items, suggestion to look for DIN’s that are newer (higher numbers)).
* Should also check in ASW for the printer output file for job QPQUPRFIL - this should typically only be 2 pages (one page is header), and the second page typically only shows items in error. Stocked can then be checked as needed and item file maintenance updated.

=Additional Notes=
===Changes to the drug extract (Sept. 2017)===
[https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database/what-data-extract-drug-product-database.html Consult the '''official page'''] for an explanation of the structure of the drug extract.

There are three main changes to the drug extract:
* A new set of files for dormant products (not marketed for the last 12 months). These are now recognized by the current program.
* New columns to each file in a set (mostly French versions of existing columns). These are ignored by the current program.
* UTF-8 encoding. Some files are encoded in UTF-8-BOM, which bombs the program.

[[Category: Health Canada]]

Information Systems:Health Canada Drug Product Database

2021-10-14T17:00:37Z

Johnt:

=Overview=

Health Canada makes information on drugs and natural health products available through database extracts that can be downloaded from their website. There are two sets; the drug files are refreshed at the beginning of every month; the NHP files less often. We build a database (e.g. set of tables) from these files so that the information can be displayed in Web Orders (and in ''Display Items'', ''Work with Items'' in Infonet).

Consult the official pages for the [https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html '''drugs'''] and [https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/applications-submissions/product-licensing/licensed-natural-health-product-database-data-extract.html '''NHP'''] extracts for more information.

=Instructions for updating our database=
==Downloading the extract (drugs)==

# Go to Health Canada’s web site, www.hc-sc.gc.ca
# Click on ‘English’
# Under ‘Main Menu’, click on ‘Drugs & Health Products’
# Click on ‘Drug Products’
# Click on ‘Drug Product Database (DPD)’
# On the right hand side, click on ‘Access the Drug Product Database’
# On the upper part of the page, click on ‘DPD Data Extracts’
# Check the date under ‘Last Updated’ (right hand column). Don’t continue with this process unless this has changed. There shouldn’t be an issue as it is usually updated early on the first work day of the month.
# Before saving the new files - move old data files (NOTE: do not touch the files starting with NHP) - (superserver/staging/Health Canada) to archive folder - yes to replace
# Download ‘ALL FILES’ (bottom of the list - do ALL 4) to your PC; both active (allfiles.zip) and inactive (allfiles_ia.zip) and (allfiles_ap.zip) - Open then Open
# Unzip and copy to SuperServer / staging / Health Canada

==Downloading the extract (Natural Health Products)==
'''NOTE: These records were last updated by HC in Sept. 2017. They are working on a new data extract - TBD (as of Aug 2018 - still no progress)(as of Sept 2019 still no progress on getting new extracts for NHP).
'''
# Go to Health Canada’s web site, www.hc-sc.gc.ca
# Click on ‘English’
# Under ‘Main Menu’, click on ‘Drugs & Health Products’
# Click on ‘Natural Health Products’
# On the right hand side, click on ‘Licensed Natural Health Products Database’
# Scroll down to the bottom of the page, and click on ‘Access the Licensed Natural Health Products Database Data Extract’
# Health Canada updates these files less often the drug product ones. Check the last updated date (at the top of the list of files) to see if it is necessary to continue. If the dates are the same, then don't do anything else. Check the next time.
# Go to SuperServer / staging / Health Canada and move the previous files to the archive folder.
# Download ‘All NHP Files’ to your PC.
# Unzip and copy to SuperServer / staging / Health Canada

==Updating Health Canada files on Bart==

'''Note:''' We have had issues with the Health Canada data files. They are apparently extracted manually, which means there can be errors. One month there were no record delimiters; which meant we couldn’t use them. Another time instead of all related files being zipped together, each was zipped separately, then zipped together. Another issue is that users EODJOB and SHEILAV cannot access SUPERSERVER from the i, so the scheduled job has been changed to run under JOHNT (2014Dec04).

'''To validate the data files, first manually run the rebuild in the test environment (PL):'''

* From a command line in ASW (easiest to do in Mocha), key in 88, press Enter, key in PL, and press Enter twice.
* Key in SBMJOB CMD(CALL PGM(HCDBBLD01C)) JOBQ(QS36EVOKE) and press enter (Note: just press enter ONCE!). (This is run from job queue QS36EVOKE so that production jobs are not delayed.) This program is being submitted to run in batch – you won’t see it on your screen.
* To see this job running, key in WRKACTJOB SBS(QBATCH) and press enter (Note: just press enter ONCE!).

Work with Active Jobs BART
10/01/14 12:16:27
CPU %: .0 Elapsed time: 00:00:00 Active jobs: 563

Type options, press Enter.
2=Change 3=Hold 4=End 5=Work with 6=Release 7=Display message
8=Work with spooled files 13=Disconnect ...
Current
Opt Subsystem/Job User Type CPU % Function Status
QBATCH QSYS SBS .0 DEQW
QDFTJOBD SHEILAV BCH .0 PGM-HCDBBLD01C RUN

Parameters or command
===>
F3=Exit F5=Refresh F7=Find F10=Restart statistics
F11=Display elapsed data F12=Cancel F23=More options F24=More keys

* Press F5 or F10 to refresh. Process will take approx. 6 minutes to complete.
* When completed the “RUN” will disappear
* Key in the command DSPFD UWDASWVOLD/HCDBDATAP and press enter. Then press page down until you see ‘Current number of records’ (about three times). There should be around 26,000 records in it (as of Nov 2014; it will increase with time). F3 to exit

Display Spooled File
File . . . . . : QPDSPFD Page/Line 2/11
Control . . . . . Columns 1 - 130
Find . . . . . .
*...+....1....+....2....+....3....+....4....+....5....+....6....+....7....+....8....+....9....+....0....+....1
Number of key fields . . . . . . . . . . . : 1
Record format . . . . . . . . . . . . . . . : HCDBDATAR
Key field . . . . . . . . . . . . . . . . : HCPRDC
Sequence . . . . . . . . . . . . . . . : Ascending
Sign specified . . . . . . . . . . . . : UNSIGNED
Zone/digit specified . . . . . . . . . : *NONE
Alternative collating sequence . . . . : No
Sort Sequence . . . . . . . . . . . . . . . : SRTSEQ *HEX
Language identifier . . . . . . . . . . . . : LANGID ENU
Member Description
Member . . . . . . . . . . . . . . . . . . : MBR HCDBDATAP
Member level identifier . . . . . . . . . : 1140529130244
Member creation date . . . . . . . . . . : 05/29/14
Text 'description' . . . . . . . . . . . : TEXT Health Canada Data Base - consolidated
Expiration date for member . . . . . . . : EXPDATE *NONE
Access path maintenance . . . . . . . . . : MAINT *IMMED
Access path recovery . . . . . . . . . . : RECOVER *NO
Member size . . . . . . . . . . . . . . . : SIZE *NOMAX
Current number of records . . . . . . . . : 25717

F3=Exit F12=Cancel F19=Left F20=Right F24=More keys

* When this program has completed, go into Web Orders '''test''' (https://orders.unipharm.com/unidev/uw_logind.pgm) to make sure the files have been correctly built.
* Should also check in ASW for the printer output file for job QPQUPRFIL - this should typically only be 2 pages (one page is header), and the second page typically only shows items in error. Stocked can then be checked as needed and item file maintenance updated.

'''If the files are correct in test, then they can be updated in production – not now, but tonight when stores are not using Web Orders.'''

* Go into ASW production by keying 88, enter, VA, enter, enter.
* Key in WRKJOBSCDE and press Enter.
* Page down to job HCDATABASE.

Work with Job Schedule Entries BART
10/01/14 12:34:49

Type options, press Enter.
2=Change 3=Hold 4=Remove 5=Display details 6=Release
8=Work with last submission 10=Submit immediately

Next
-----Schedule------ Recovery Submit
Opt Job Status Date Time Frequency Action Date
2 HCDATABASE SAV 09/05/14 06:00:00 *ONCE *NOSBM
__ IMRCHDJOB HLD USER DEF 04:30:00 *WEEKLY *SBMRLS 10/02/14
__ IMRSCKSTS1 SCD *ALL 05:30:00 *WEEKLY *SBMRLS 10/02/14
__ IMRSCKSTS2 SCD 10/01/14 12:35:00 *ONCE *SBMRLS 10/01/14
__ INTERREPLN HLD *TUE 05:00:00 *WEEKLY *NOSBM 10/07/14
__ MAXAVA SCD *SAT 20:00:00 *ONCE *NOSBM 10/04/14
__ MXIOSTATS2 SAV *TUE 12:30:00 *ONCE *SBMRLS
More...
Parameters or command
===>
F3=Exit F4=Prompt F5=Refresh F6=Add F9=Retrieve
F11=Display job queue data F12=Cancel F17=Top F18=Bottom

* Use option 2 to change it.

Change Job Schedule Entry (CHGJOBSCDE)

Type choices, press Enter.

Job name . . . . . . . . . . . . > HCDATABASE Name
Entry number . . . . . . . . . . > 572242 000001-999999, *ONLY
Command to run . . . . . . . . . SBMJOB CMD(CALL PGM(HCDBBLD01C)) JOBQ(QS36EV
OKE)____________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
Frequency . . . . . . . . . . . *ONCE *SAME, *ONCE, *WEEKLY...
Schedule date . . . . . . . . . '10/02/14' Date, *SAME, *CURRENT...
Schedule day . . . . . . . . . . *NONE *SAME, *NONE, *ALL, *MON...
+ for more values _____
Schedule time . . . . . . . . . '06:00:00' Time, *SAME, *CURRENT

Bottom
F3=Exit F4=Prompt F5=Refresh F10=Additional parameters F12=Cancel
F13=How to use this display F24=More keys

* Set it to run on the '''first Saturday''' after doing this data refresh (this is highly recommended to ensure the job has enough time to run without causing issues) the format is MM/DD/YY), and press enter twice.
* Send an email to the I.T. Group to let them know that the HC Database will be running this Saturday.

'''Check it the next business day to make sure the files have been correctly built.'''

* Key in the command DSPFD UWDASWPRDD/HCDBDATAP and press enter. Then press page down until you see ‘Current number of records’ (about three times). There should be around 26,000 records in it (as of Nov 2014; it will increase with time). (Note that this command is slightly different than the previous one in that it looks at production instead of development.)
* Go into Web Orders production. (spot check several items, suggestion to look for DIN’s that are newer (higher numbers)).
* Should also check in ASW for the printer output file for job QPQUPRFIL - this should typically only be 2 pages (one page is header), and the second page typically only shows items in error. Stocked can then be checked as needed and item file maintenance updated.

=Additional Notes=
===Changes to the drug extract (Sept. 2017)===
[https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database/what-data-extract-drug-product-database.html Consult the '''official page'''] for an explanation of the structure of the drug extract.

There are three main changes to the drug extract:
* A new set of files for dormant products (not marketed for the last 12 months). These are now recognized by the current program.
* New columns to each file in a set (mostly French versions of existing columns). These are ignored by the current program.
* UTF-8 encoding. Some files are encoded in UTF-8-BOM, which bombs the program.

[[Category: Health Canada]]

Purchasing:How to - Drop Sales Orders - allocation process

2021-06-16T16:28:16Z

Johnt:

'''''Protocol for dropping of sales orders (allocation process)'''''
 
 
'''Personnel trained''' (as of June 2021)
 
*Matt Bahi (Primary)
*Ruby Shergill (Secondary)
*Monica Tiwari (backup)
*Eliza Goodyer
*Shannon McDonald
*John Targett

 

'''Background'''
* The system (ASW) will automatically switch the order allocation flag (Item File Maintenance) on the item master record once the stock on hand runs out and there is a sales order entered for the item. It will do this for all regular stock items (Item Cat. 1 <=549)
* Once the stock is received for the item and all open sales orders are dropped, the order allocation flag will be automatically turned off for the item.
* The system will allocate and drop sales orders every 30 minutes (on the hour and half hour) provided there is more inventory available than the amount of open sales orders.
* For items that we don’t have enough stock available (on SO > Avail OH), the system will leave these items and they will require a person to run the sales order allocation process and determine which customers will receive the stock.
* Based on above, back orders may need to be put into the system for a specific customer and item. This is done by logging in using the '''DISADMIN''' login. (please see John if you need training and the password).
* Recommended timing. It is suggested that the items that fall into #4 should be run at the following times (times are approx). 8:10 am / 10:10 am / 12:10 pm / 2:10 pm / 3:45 pm '''(every 2 hours)'''. The reason is so this does not interfere with the automated processes.
* It is recommended that sales orders have notes added to the line level (each item) indicating if the customer does not want the quantity split up (Note: Please ship full quantity).
* For any items that have a price override done – please note this on the sales order line.
* Person(s) responsible for allocating & dropping orders should watch for these notes and not split the lines. Also, for customers such as Morton Clarke, Product Distribution Centre, EDKA, Henry Schein, Bowers Medical – order lines should not be split.
* All persons noted on the top must take the responsibility to cover for anyone away.
** Barry is responsible for regular/promo items each morning/afternoon.
** Ruby is back up then Monica/Jonathon.
** Alternates - Eliza, Shannon - then John.
** At a minimum of twice a day, BUYREP006 should be run and orders should be dropped for current promo’s (IFP/MCF based on schedule) and BNA/NAB’s.
** Also you may look at BUYREP005 – this will show details on each order.

'''STEPS'''
 
# Log into ASW
# From main menu, click on Sales
# Click on Work with Sales Order Allocation
# Click on Add
[[File:Sales order allocation.JPG|500px]]

# As indicated above, typical settings are to run the allocation for all items. Therefore, leave item fields blank (as shown above).
# Press enter to ignore promo items. Or, if you are allocating a specific promo and or prebook enter it in here.
[[File:Sales order allocation promo.JPG|500px]]
# Refresh screen (F5) as needed
[[File:Sales order allocation details.JPG|500px]]
# Click on first item
[[File:Work with Sales order allocation details.JPG|500px]]
 
# Looking at list of stores, determine best way to share stock available (limit or exclude duplicate store entries).
# Either click on auto allocation, fair share, or manually enter amount.
## Note: May need to log in now as DISADMIN in order to change store order quantity and back order the line balance.
# Watch disp date on order line (must be changed to current date)
# Repeat process for remaining lines/items.
# Once complete, click on create pick list.
## Remember once done to log out of DISADMIN.

 

[[Category:Workflows-Purchasing]]

Customer Service:InfoNext - Missing Freight Customer/Vendor Account Numbers

2021-04-01T01:31:19Z

Johnt:

==Overview==
Freight invoice data is imported into the InfoNext system daily & weekly but there will be missing customer account numbers (due to incomplete information being returned in the invoice records from the couriers) which must be identified and entered to ensure the freight cost has been allocated to the correct customer/vendor accounts.

==InfoNext==
Use only '''Chrome''' to access InfoNext or fields may not appear properly.

#Log into Infonet – go to [https://infonet.unipharm.com/unipharm/in_login.pgm https://infonet.unipharm.com/unipharm/in_login.pgm]
#Enter '''Username'''
#Enter '''Password'''
#Click '''Login'''
#Click '''InfoNext'''
#Click '''Carriers'''
#Click '''Carriers''' again
#Click '''Freight Costs'''
#Click '''Search Filters'''
#Click Show errors dropdown and select '''Only'''
#Click Show edited dropdown and select '''No'''
#Click '''Apply'''

==Enter Missing Account Number==
Look at the FName (From Name)column and the TName (To Name) column
Use Comments/Additional Notes to assist with the selection of the correct customer/vendor account number. It is best to use the reference field which is likely the Hotline number and the additional notes. You can also click on ''raw data''' to see if there is any additional information you can use.
Many times the information may be a Loomis waybill or a Purolator waybill that using their tracking system may help find the store to charge the freight record to.

#Right-click on first record and select '''View Invoice Line Details'''
#Click '''X"" to move back to previous screen
#Right-click on first record and select '''Link UWD Customer'''
#Enter '''Customer/Vendor''' (name or number)
#Click '''Save''' (Success will appear)
#Click '''OK'''

===Exceptions===
*Seaair - post to Pender Island Pharmacy
*Mccue to Edmonds/Northview - post to Mccue

===Unknown records===
*If unsure of specific records, please check with John or Gerald for guidance

[[Category:Workflows-Customer Service]]
[[Category:Freight]]

Customer Service:InfoNext - Missing Freight Customer/Vendor Account Numbers

2021-04-01T01:28:44Z

Johnt:

==Overview==
Freight invoice data is imported into the InfoNext system daily but there will be missing customer account numbers which must be identified and entered to ensure the freight cost has been allocated to the correct customer/vendor accounts.

==InfoNext==
Use only Chrome to access InfoNext or fields may not appear properly.

#Log into Infonet – go to [https://infonet.unipharm.com/unipharm/in_login.pgm https://infonet.unipharm.com/unipharm/in_login.pgm]
#Enter '''Username'''
#Enter '''Password'''
#Click '''Login'''
#Click '''InfoNext'''
#Click '''Carriers'''
#Click '''Carriers''' again
#Click '''Freight Costs'''
#Click '''Search Filters'''
#Click Show errors dropdown and select '''Only'''
#Click Show edited dropdown and select '''No'''
#Click '''Apply'''

==Enter Missing Account Number==
Look at the FName (From Name)column and the TName (To Name) column
Use Comments/Additional Notes to assist with the selection of the correct customer/vendor account number. It is best to use the reference field which is likely the Hotline number and the additional notes. You can also click on ''raw data''' to see if there is any additional information you can use.
Many times the information may be a Loomis waybill or a Purolator waybill that using their tracking system may help find the store to charge the freight record to.

#Right-click on first record and select '''View Invoice Line Details'''
#Click '''X"" to move back to previous screen
#Right-click on first record and select '''Link UWD Customer'''
#Enter '''Customer/Vendor''' (name or number)
#Click '''Save''' (Success will appear)
#Click '''OK'''

===Exceptions===
*Seaair - post to Pender Island Pharmacy
*Mccue to Edmonds/Northview - post to Mccue

===Unknown records===
*If unsure of specific records, please check with John or Gerald for guidance

[[Category:Workflows-Customer Service]]
[[Category:Freight]]

Purchasing:How to - Drop Sales Orders - allocation process

2020-08-06T16:14:11Z

Johnt: Personnel name changes

'''''Protocol for dropping of sales orders (allocation process)'''''
 
 
'''Personnel trained''' (as of August 2020)
 
*Barry Fagen (Primary)
*Ruby Shergill (Secondary)
*Monica Tiwari / Jonathon McIntyre(backup)
*Eliza Goodyer
*Shannon McDonald
*John Targett

 

'''Background'''
* The system (ASW) will automatically switch the order allocation flag (Item File Maintenance) on the item master record once the stock on hand runs out and there is a sales order entered for the item. It will do this for all regular stock items (Item Cat. 1 <=549)
* Once the stock is received for the item and all open sales orders are dropped, the order allocation flag will be automatically turned off for the item.
* The system will allocate and drop sales orders every 30 minutes (on the hour and half hour) provided there is more inventory available than the amount of open sales orders.
* For items that we don’t have enough stock available (on SO > Avail OH), the system will leave these items and they will require a person to run the sales order allocation process and determine which customers will receive the stock.
* Based on above, back orders may need to be put into the system for a specific customer and item. This is done by logging in using the '''DISADMIN''' login. (please see John if you need training and the password).
* Recommended timing. It is suggested that the items that fall into #4 should be run at the following times (times are approx). 8:10 am / 10:10 am / 12:10 pm / 2:10 pm / 4:10 pm '''(every 2 hours)'''. The reason is so this does not interfere with the automated processes.
* It is recommended that sales orders have notes added to the line level (each item) indicating if the customer does not want the quantity split up (Note: Please ship full quantity).
* For any items that have a price override done – please note this on the sales order line.
* Person(s) responsible for allocating & dropping orders should watch for these notes and not split the lines. Also, for customers such as Morton Clarke, Product Distribution Centre, EDKA, Henry Schein, Bowers Medical – order lines should not be split.
* All persons noted on the top must take the responsibility to cover for anyone away.
** Barry is responsible for regular/promo items each morning/afternoon.
** Ruby is back up then Monica/Jonathon.
** Alternates - Eliza, Shannon - then John.
** At a minimum of twice a day, BUYREP006 should be run and orders should be dropped for current promo’s (IFP/MCF based on schedule) and BNA/NAB’s.
** Also you may look at BUYREP005 – this will show details on each order.

'''STEPS'''
 
# Log into ASW
# From main menu, click on Sales
# Click on Work with Sales Order Allocation
# Click on Add
[[File:Sales order allocation.JPG|500px]]

# As indicated above, typical settings are to run the allocation for all items. Therefore, leave item fields blank (as shown above).
# Press enter to ignore promo items. Or, if you are allocating a specific promo and or prebook enter it in here.
[[File:Sales order allocation promo.JPG|500px]]
# Refresh screen (F5) as needed
[[File:Sales order allocation details.JPG|500px]]
# Click on first item
[[File:Work with Sales order allocation details.JPG|500px]]
 
# Looking at list of stores, determine best way to share stock available (limit or exclude duplicate store entries).
# Either click on auto allocation, fair share, or manually enter amount.
## Note: May need to log in now as DISADMIN in order to change store order quantity and back order the line balance.
# Watch disp date on order line (must be changed to current date)
# Repeat process for remaining lines/items.
# Once complete, click on create pick list.
## Remember once done to log out of DISADMIN.

 

[[Category:Workflows-Purchasing]]

Purchasing:How to - Drop Sales Orders - allocation process

2020-08-06T16:12:30Z

Johnt:

'''''Protocol for dropping of sales orders (allocation process)'''''
 
 
'''Personnel trained''' (as of August 2020)
 
*Barry Fagen (Primary)
*Ruby Shergill (Secondary)
*Monica Tiwari / Jonathon McIntyre(backup)
*Eliza Goodyer
*Shannon McDonald
*John Targett

 

'''Background'''
* The system (ASW) will automatically switch the order allocation flag (Item File Maintenance) on the item master record once the stock on hand runs out and there is a sales order entered for the item. It will do this for all regular stock items (Item Cat. 1 <=549)
* Once the stock is received for the item and all open sales orders are dropped, the order allocation flag will be automatically turned off for the item.
* The system will allocate and drop sales orders every 30 minutes (on the hour and half hour) provided there is more inventory available than the amount of open sales orders.
* For items that we don’t have enough stock available (on SO > Avail OH), the system will leave these items and they will require a person to run the sales order allocation process and determine which customers will receive the stock.
* Based on above, back orders may need to be put into the system for a specific customer and item. This is done by logging in using the '''DISADMIN''' login. (please see John if you need training and the password).
* Recommended timing. It is suggested that the items that fall into #4 should be run at the following times (times are approx). 8:10 am / 10:10 am / 12:10 pm / 2:10 pm / 4:10 pm '''(every 2 hours)'''. The reason is so this does not interfere with the automated processes.
* It is recommended that sales orders have notes added to the line level (each item) indicating if the customer does not want the quantity split up (Note: Please ship full quantity).
* For any items that have a price override done – please note this on the sales order line.
* Person(s) responsible for allocating & dropping orders should watch for these notes and not split the lines. Also, for customers such as Morton Clarke, Product Distribution Centre, EDKA – order lines should not be split.
* All persons noted on the top must take the responsibility to cover for anyone away.
** Simon is responsible for regular/promo items each morning/afternoon.
** Ruby is back up then Monica.
** Alternates - Eliza, Shannon - then John.
** At a minimum of twice a day, BUYREP006 should be run and orders should be dropped for current promo’s (IFP/MCF based on schedule) and BNA/NAB’s.
** Also you may look at BUYREP005 – this will show details on each order.

'''STEPS'''
 
# Log into ASW
# From main menu, click on Sales
# Click on Work with Sales Order Allocation
# Click on Add
[[File:Sales order allocation.JPG|500px]]

# As indicated above, typical settings are to run the allocation for all items. Therefore, leave item fields blank (as shown above).
# Press enter to ignore promo items. Or, if you are allocating a specific promo and or prebook enter it in here.
[[File:Sales order allocation promo.JPG|500px]]
# Refresh screen (F5) as needed
[[File:Sales order allocation details.JPG|500px]]
# Click on first item
[[File:Work with Sales order allocation details.JPG|500px]]
 
# Looking at list of stores, determine best way to share stock available (limit or exclude duplicate store entries).
# Either click on auto allocation, fair share, or manually enter amount.
## Note: May need to log in now as DISADMIN in order to change store order quantity and back order the line balance.
# Watch disp date on order line (must be changed to current date)
# Repeat process for remaining lines/items.
# Once complete, click on create pick list.
## Remember once done to log out of DISADMIN.

 

[[Category:Workflows-Purchasing]]

Information Systems:Health Canada Drug Product Database

2020-08-06T15:52:22Z

Johnt:

=Overview=

Health Canada makes information on drugs and natural health products available through database extracts that can be downloaded from their website. There are two sets; the drug files are refreshed at the beginning of every month; the NHP files less often. We build a database (e.g. set of tables) from these files so that the information can be displayed in Web Orders (and in ''Display Items'', ''Work with Items'' in Infonet).

Consult the official pages for the [https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html '''drugs'''] and [https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/applications-submissions/product-licensing/licensed-natural-health-product-database-data-extract.html '''NHP'''] extracts for more information.

=Instructions for updating our database=
==Downloading the extract (drugs)==

# Go to Health Canada’s web site, www.hc-sc.gc.ca
# Click on ‘English’
# Under ‘Main Menu’, click on ‘Drugs & Health Products’
# Click on ‘Drug Products’
# Click on ‘Drug Product Database (DPD)’
# On the right hand side, click on ‘Access the Drug Product Database’
# On the upper part of the page, click on ‘DPD Data Extracts’
# Check the date under ‘Last Updated’ (right hand column). Don’t continue with this process unless this has changed. There shouldn’t be an issue as it is usually updated early on the first work day of the month.
# Before saving the new files - move old data files (NOTE: do not touch the files starting with NHP) - (superserver/staging/Health Canada) to archive folder - yes to replace
# Download ‘ALL FILES’ (bottom of the list - do ALL 4) to your PC; both active (allfiles.zip) and inactive (allfiles_ia.zip) and (allfiles_ap.zip) - Open then Open
# Unzip and copy to SuperServer / staging / Health Canada

==Downloading the extract (Natural Health Products)==
'''NOTE: These records were last updated by HC in Sept. 2017. They are working on a new data extract - TBD (as of Aug 2018 - still no progress)(as of Sept 2019 still no progress on getting new extracts for NHP).
'''
# Go to Health Canada’s web site, www.hc-sc.gc.ca
# Click on ‘English’
# Under ‘Main Menu’, click on ‘Drugs & Health Products’
# Click on ‘Natural Health Products’
# On the right hand side, click on ‘Licensed Natural Health Products Database’
# Scroll down to the bottom of the page, and click on ‘Access the Licensed Natural Health Products Database Data Extract’
# Health Canada updates these files less often the drug product ones. Check the last updated date (at the top of the list of files) to see if it is necessary to continue. If the dates are the same, then don't do anything else. Check the next time.
# Go to SuperServer / staging / Health Canada and move the previous files to the archive folder.
# Download ‘All NHP Files’ to your PC.
# Unzip and copy to SuperServer / staging / Health Canada

==Updating Health Canada files on Bart==

'''Note:''' We have had issues with the Health Canada data files. They are apparently extracted manually, which means there can be errors. One month there were no record delimiters; which meant we couldn’t use them. Another time instead of all related files being zipped together, each was zipped separately, then zipped together. Another issue is that users EODJOB and SHEILAV cannot access SUPERSERVER from the i, so the scheduled job has been changed to run under JOHNT (2014Dec04).

'''To validate the data files, first manually run the rebuild in the test environment (PL):'''

* From a command line in ASW (easiest to do in Mocha), key in 88, press Enter, key in PL, and press Enter twice.
* Key in SBMJOB CMD(CALL PGM(HCDBBLD01C)) JOBQ(QS36EVOKE) and press enter (Note: just press enter ONCE!). (This is run from job queue QS36EVOKE so that production jobs are not delayed.) This program is being submitted to run in batch – you won’t see it on your screen.
* To see this job running, key in WRKACTJOB SBS(QBATCH) and press enter (Note: just press enter ONCE!).

Work with Active Jobs BART
10/01/14 12:16:27
CPU %: .0 Elapsed time: 00:00:00 Active jobs: 563

Type options, press Enter.
2=Change 3=Hold 4=End 5=Work with 6=Release 7=Display message
8=Work with spooled files 13=Disconnect ...
Current
Opt Subsystem/Job User Type CPU % Function Status
QBATCH QSYS SBS .0 DEQW
QDFTJOBD SHEILAV BCH .0 PGM-HCDBBLD01C RUN

Parameters or command
===>
F3=Exit F5=Refresh F7=Find F10=Restart statistics
F11=Display elapsed data F12=Cancel F23=More options F24=More keys

* Press F5 or F10 to refresh. Process will take approx. 6 minutes to complete.
* When completed the “RUN” will disappear
* Key in the command DSPFD UWDASWVOLD/HCDBDATAP and press enter. Then press page down until you see ‘Current number of records’ (about three times). There should be around 26,000 records in it (as of Nov 2014; it will increase with time). F3 to exit

Display Spooled File
File . . . . . : QPDSPFD Page/Line 2/11
Control . . . . . Columns 1 - 130
Find . . . . . .
*...+....1....+....2....+....3....+....4....+....5....+....6....+....7....+....8....+....9....+....0....+....1
Number of key fields . . . . . . . . . . . : 1
Record format . . . . . . . . . . . . . . . : HCDBDATAR
Key field . . . . . . . . . . . . . . . . : HCPRDC
Sequence . . . . . . . . . . . . . . . : Ascending
Sign specified . . . . . . . . . . . . : UNSIGNED
Zone/digit specified . . . . . . . . . : *NONE
Alternative collating sequence . . . . : No
Sort Sequence . . . . . . . . . . . . . . . : SRTSEQ *HEX
Language identifier . . . . . . . . . . . . : LANGID ENU
Member Description
Member . . . . . . . . . . . . . . . . . . : MBR HCDBDATAP
Member level identifier . . . . . . . . . : 1140529130244
Member creation date . . . . . . . . . . : 05/29/14
Text 'description' . . . . . . . . . . . : TEXT Health Canada Data Base - consolidated
Expiration date for member . . . . . . . : EXPDATE *NONE
Access path maintenance . . . . . . . . . : MAINT *IMMED
Access path recovery . . . . . . . . . . : RECOVER *NO
Member size . . . . . . . . . . . . . . . : SIZE *NOMAX
Current number of records . . . . . . . . : 25717

F3=Exit F12=Cancel F19=Left F20=Right F24=More keys

* When this program has completed, go into Web Orders '''test''' (https://orders.unipharm.com/unidev/uw_logind.pgm) to make sure the files have been correctly built.
* Should also check in ASW for the printer output file for job QPQUPRFIL - this should typically only be 2 pages (one page is header), and the second page typically only shows items in error. Stocked can then be checked as needed and item file maintenance updated.

'''If the files are correct in test, then they can be updated in production – not now, but tonight when stores are not using Web Orders.'''

* Go into ASW production by keying 88, enter, VA, enter, enter.
* Key in WRKJOBSCDE and press Enter.
* Page down to job HCDATABASE.

Work with Job Schedule Entries BART
10/01/14 12:34:49

Type options, press Enter.
2=Change 3=Hold 4=Remove 5=Display details 6=Release
8=Work with last submission 10=Submit immediately

Next
-----Schedule------ Recovery Submit
Opt Job Status Date Time Frequency Action Date
2 HCDATABASE SAV 09/05/14 06:00:00 *ONCE *NOSBM
__ IMRCHDJOB HLD USER DEF 04:30:00 *WEEKLY *SBMRLS 10/02/14
__ IMRSCKSTS1 SCD *ALL 05:30:00 *WEEKLY *SBMRLS 10/02/14
__ IMRSCKSTS2 SCD 10/01/14 12:35:00 *ONCE *SBMRLS 10/01/14
__ INTERREPLN HLD *TUE 05:00:00 *WEEKLY *NOSBM 10/07/14
__ MAXAVA SCD *SAT 20:00:00 *ONCE *NOSBM 10/04/14
__ MXIOSTATS2 SAV *TUE 12:30:00 *ONCE *SBMRLS
More...
Parameters or command
===>
F3=Exit F4=Prompt F5=Refresh F6=Add F9=Retrieve
F11=Display job queue data F12=Cancel F17=Top F18=Bottom

* Use option 2 to change it.

Change Job Schedule Entry (CHGJOBSCDE)

Type choices, press Enter.

Job name . . . . . . . . . . . . > HCDATABASE Name
Entry number . . . . . . . . . . > 572242 000001-999999, *ONLY
Command to run . . . . . . . . . SBMJOB CMD(CALL PGM(HCDBBLD01C)) JOBQ(QS36EV
OKE)____________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
Frequency . . . . . . . . . . . *ONCE *SAME, *ONCE, *WEEKLY...
Schedule date . . . . . . . . . '10/02/14' Date, *SAME, *CURRENT...
Schedule day . . . . . . . . . . *NONE *SAME, *NONE, *ALL, *MON...
+ for more values _____
Schedule time . . . . . . . . . '06:00:00' Time, *SAME, *CURRENT

Bottom
F3=Exit F4=Prompt F5=Refresh F10=Additional parameters F12=Cancel
F13=How to use this display F24=More keys

* Set it to run on the '''first Saturday''' after doing this data refresh (this is highly recommended to ensure the job has enough time to run without causing issues) the format is MM/DD/YY), and press enter twice.

'''Check it the next business day to make sure the files have been correctly built.'''

* Key in the command DSPFD UWDASWPRDD/HCDBDATAP and press enter. Then press page down until you see ‘Current number of records’ (about three times). There should be around 26,000 records in it (as of Nov 2014; it will increase with time). (Note that this command is slightly different than the previous one in that it looks at production instead of development.)
* Go into Web Orders production. (spot check several items, suggestion to look for DIN’s that are newer (higher numbers)).
* Should also check in ASW for the printer output file for job QPQUPRFIL - this should typically only be 2 pages (one page is header), and the second page typically only shows items in error. Stocked can then be checked as needed and item file maintenance updated.

=Additional Notes=
===Changes to the drug extract (Sept. 2017)===
[https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database/what-data-extract-drug-product-database.html Consult the '''official page'''] for an explanation of the structure of the drug extract.

There are three main changes to the drug extract:
* A new set of files for dormant products (not marketed for the last 12 months). These are now recognized by the current program.
* New columns to each file in a set (mostly French versions of existing columns). These are ignored by the current program.
* UTF-8 encoding. Some files are encoded in UTF-8-BOM, which bombs the program.

[[Category: Health Canada]]

Purchasing:Purchasing-Ordering specific items from Pfizer/Hospira

2019-11-14T23:10:42Z

Johnt:

==Procedures (specific) for ordering from Pfizer (legacy Hospira items)==

===Background===
* Recently Pfizer (#22337) acquired the marketing rights to a number of products that we used to purchase from Hospira.
* Pfizer has specific criteria for ordering these items (related to unit of measure UofM) that are unique to how our normal item/ordering processes work.
* We have been ordering these items using Purchase Order type PO, but Pfizer would like these items to come through the EDI system - type PE.
* More details - When we create an item it has to be built based on established "rules" concerning UofM, UPC, size fields, pricing etc. that are critical for purchasing/receiving/put-away/picking processes. Pfizer has asked us to order a product that we sell as an each (EA) with a UPC printed on the selling box and is packed as 25 eaches in a pack (PK) - as an EA on the PO (but as a pack of 25). Example below;

===Example===
* Current set up of item
* Item #00052308
* Description - STERILE WATER FOR INJ. W/PRES 3977 (13) BACTERIOSTATIC
* Size - 30ML
* UPC - 0118821353977004 - EA (each)
* UofM - Each = 1, Box = 25
* Vend item # 03977030
* Selling EA
* Pricing = $92.95 BX

* Item notes used indicating linkage between both items - ITEM NOTES
* ITEMNOTPO 1 ITEM TO ORDER IS 002603264

* To comply with Pfizer's requirements the following solution has been developed. Pfizer has told us that they will be able to process our Purchase Order's will only the vendor item # (no UPC) - NOTE PE type.
*
* We have created another item # that will be used/switched by the purchasing department before sending PE's to Pfizer (more details below).
*
* Set up of secondary item (real item in our system, but only for PE ordering purposes).
* Item #02603264
* Description - STERILE WATER FOR INJ. W/PRES 3977 (13) BACTERIOSTATIC
* Size - 25X30ML '''(NOTE difference)'''
* UPC - left blank on purpose
* UofM - Each = 25 '''(NOTE difference)'''
* Vend item # 03977030
* Selling EA
* Pricing = $92.95 EA '''(NOTE difference)'''

* Item notes used indicating linkage between both items - ITEM NOTES
* ITEMNOTPO 1 ITEM TO ORDER IS 00052308

===Processes===
* Buyer/Buyers Assistant will review Purchase Suggestions and determine item/quantities based on usual criteria.
* Purchase Suggestion will be imported into "Create PO" - using PE type
* Buyer/Assistant will replace the original item #'s and quantities with the new item #'s
* PE will be printed and sent to Pfizer via normal EDI processes
* After sending - Buyer/Assistant will replace the item #'s and quantities back to the original item #'s
** Critical that this is done before product is received by uniPHARM. Recommended that work is completed all within same day!

[[Category:Workflows-Purchasing]]

Purchasing:Purchasing-Ordering specific items from Pfizer/Hospira

2019-11-14T23:10:08Z

Johnt:

==Procedures (specific) for ordering from Pfizer (legacy Hospira items)==

===Background===
* Recently Pfizer (#22337) acquired the marketing rights to a number of products that we used to purchase from Hospira.
* Pfizer has specific criteria for ordering these items (related to unit of measure UofM) that are unique to how our normal item/ordering processes work.
* We have been ordering these items using Purchase Order type PO, but Pfizer would like these items to come through the EDI system - type PE.
* More details - When we create an item it has to be built based on established "rules" concerning UofM, UPC, size fields, pricing etc. that are critical for purchasing/receiving/put-away/picking processes. Pfizer has asked us to order a product that we sell as an each (EA) with a UPC printed on the selling box and is packed as 25 eaches in a pack (PK) - as an EA on the PO (but as a pack of 25). Example below;

===Example===
* Current set up of item
* Item #00052308
* Description - STERILE WATER FOR INJ. W/PRES 3977 (13) BACTERIOSTATIC
* Size - 30ML
* UPC - 0118821353977004 - EA (each)
* UofM - Each = 1, Box = 25
* Vend item # 03977030
* Selling EA
* Pricing = $92.95 BX

* Item notes used indicating linkage between both items - ITEM NOTES
* ITEMNOTPO 1 ITEM TO ORDER IS 002603264

* To comply with Pfizer's requirements the following solution has been developed. Pfizer has told us that they will be able to process our Purchase Order's will only the vendor item # (no UPC) - NOTE PE type.
*
* We have created another item # that will be used/switched by the purchasing department before sending PE's to Pfizer (more details below).
*
* Set up of secondary item (real item in our system, but only for PE ordering purposes).
* Item #02603264
* Description - STERILE WATER FOR INJ. W/PRES 3977 (13) BACTERIOSTATIC
* Size - 25X30ML '''(NOTE difference)'''
* UPC - left blank on purpose
* UofM - Each = 25 '''(NOTE difference)'''
* Vend item # 03977030
* Selling EA
* Pricing = $92.95 EA '''(NOTE difference)'''

* Item notes used indicating linkage between both items - ITEM NOTES
* ITEMNOTPO 1 ITEM TO ORDER IS 00052308

===Processes===
* Buyer/Buyers Assistant will review Purchase Suggestions and determine item/quantities based on usual criteria.
* Purchase Suggestion will be imported into "Create PE"
* Buyer/Assistant will replace the original item #'s and quantities with the new item #'s
* PE will be printed and sent to Pfizer via normal EDI processes
* After sending - Buyer/Assistant will replace the item #'s and quantities back to the original item #'s
** Critical that this is done before product is received by uniPHARM. Recommended that work is completed all within same day!

[[Category:Workflows-Purchasing]]

Purchasing:Purchasing-Ordering specific items from Pfizer/Hospira

2019-11-14T23:06:07Z

Johnt:

==Procedures (specific) for ordering from Pfizer (legacy Hospira items)==

===Background===
* Recently Pfizer (#22337) acquired the marketing rights to a number of products that we used to purchase from Hospira.
* Pfizer has specific criteria for ordering these items (related to unit of measure UofM) that are unique to how our normal item/ordering processes work.
* More details - When we create an item it has to be built based on established "rules" concerning UofM, UPC, size fields, pricing etc. that are critical for purchasing/receiving/put-away/picking processes. Pfizer has asked us to order a product that we sell as an each (EA) with a UPC printed on the selling box and is packed as 25 eaches in a pack (PK) - as an EA on the PO (but as a pack of 25). Example below;

===Example===
* Current set up of item
* Item #00052308
* Description - STERILE WATER FOR INJ. W/PRES 3977 (13) BACTERIOSTATIC
* Size - 30ML
* UPC - 0118821353977004 - EA (each)
* UofM - Each = 1, Box = 25
* Vend item # 03977030
* Selling EA
* Pricing = $92.95 BX

* Item notes used indicating linkage between both items - ITEM NOTES
* ITEMNOTPO 1 ITEM TO ORDER IS 002603264

* To comply with Pfizer's requirements the following solution has been developed. Pfizer has told us that they will be able to process our PO's will only the vendor item # (no UPC).
*
* We have created another item # that will be used/switched by the purchasing department before sending PO's to Pfizer (more details below).
*
* Set up of secondary item (real item in our system, but only for PO ordering purposes).
* Item #02603264
* Description - STERILE WATER FOR INJ. W/PRES 3977 (13) BACTERIOSTATIC
* Size - 25X30ML '''(NOTE difference)'''
* UPC - left blank on purpose
* UofM - Each = 25 '''(NOTE difference)'''
* Vend item # 03977030
* Selling EA
* Pricing = $92.95 EA '''(NOTE difference)'''

* Item notes used indicating linkage between both items - ITEM NOTES
* ITEMNOTPO 1 ITEM TO ORDER IS 00052308

===Processes===
* Buyer/Buyers Assistant will review Purchase Suggestions and determine item/quantities based on usual criteria.
* Purchase Suggestion will be imported into "Create PO"
* Buyer/Assistant will replace the original item #'s and quantities with the new item #'s
* PO will be printed and sent to Pfizer via normal EDI processes
* After sending - Buyer/Assistant will replace the item #'s and quantities back to the original item #'s

[[Category:Workflows-Purchasing]]

Purchasing:Purchasing-Ordering specific items from Pfizer/Hospira

2019-11-14T22:59:31Z

Johnt:

==Procedures (specific) for ordering from Pfizer (legacy Hospira items)==

===Background===
* Recently Pfizer (#22337) acquired the marketing rights to a number of products that we used to purchase from Hospira.
* Pfizer has specific criteria for ordering these items (related to unit of measure UofM) that are unique to how our normal item/ordering processes work.
* More details - When we create an item it has to be built based on established "rules" concerning UofM, UPC, size fields, pricing etc. that are critical for purchasing/receiving/put-away/picking processes. Pfizer has asked us to order a product that we sell as an each (EA) with a UPC printed on the selling box and is packed as 25 eaches in a pack (PK) - as an EA on the PO (but as a pack of 25). Example below;

===Example===
* Current set up of item
* Item #00052308
* Description - STERILE WATER FOR INJ. W/PRES 3977 (13) BACTERIOSTATIC
* Size - 30ML
* UPC - 0118821353977004 - EA (each)
* UofM - Each = 1, Box = 25
* Vend item # 03977030
* Selling EA
* Pricing = $92.95 BX

* Item notes used indicating linkage between both items - ITEM NOTES
* ITEMNOTPO 1 ITEM TO ORDER IS 002603264

* To comply with Pfizer's requirements the following solution has been developed. Pfizer has told us that they will be able to process our PO's will only the vendor item # (no UPC).
*
* We have created another item # that will be used/switched by the purchasing department before sending PO's to Pfizer (more details below).
*
* Set up of secondary item (real item in our system, but only for PO ordering purposes).
* Item #02603264
* Description - STERILE WATER FOR INJ. W/PRES 3977 (13) BACTERIOSTATIC
* Size - 25X30ML '''(NOTE difference)'''
* UPC - left blank on purpose
* UofM - Each = 25 '''(NOTE difference)'''
* Vend item # 03977030
* Selling EA
* Pricing = $92.95 EA '''(NOTE difference)'''

* Item notes used indicating linkage between both items - ITEM NOTES
* ITEMNOTPO 1 ITEM TO ORDER IS 00052308

===Processes===
* Buyer/Buyers Assistant will review Purchase Suggestions and determine item/quantities based on usual criteria.
* Purchase Suggestion will be imported into "Create PO"
* Buyer/Assistant will replace the original item #'s and quantities with the new item #'s
* PO will be printed and sent to Pfizer via normal EDI processes
* After sending - Buyer/Assistant will replace the item #'s and quantities back to the original item #'s

===Details===

* Below is the link to the table provided to us from Pfizer

*

[[Category:Workflows-Purchasing]]

Purchasing:Purchasing-Ordering specific items from Pfizer/Hospira

2019-11-14T22:58:16Z

Johnt:

==Procedures (specific) for ordering from Pfizer (legacy Hospira items)==

===Background===
* Recently Pfizer (#22337) acquired the marketing rights to a number of products that we used to purchase from Hospira.
* Pfizer has specific criteria for ordering these items (related to unit of measure UofM) that are unique to how our normal item/ordering processes work.
* More details - When we create an item it has to be built based on established "rules" concerning UofM, UPC, size fields, pricing etc. that are critical for purchasing/receiving/put-away/picking processes. Pfizer has asked us to order a product that we sell as an each (EA) with a UPC printed on the selling box and is packed as 25 eaches in a pack (PK) - as an EA on the PO (but as a pack of 25). Example below;

===Example===
* Current set up of item
* Item #00052308
* Description - STERILE WATER FOR INJ. W/PRES 3977 (13) BACTERIOSTATIC
* Size - 30ML
* UPC - 0118821353977004 - EA (each)
* UofM - Each = 1, Box = 25
* Vend item # 03977030
* Selling EA
* Pricing = $92.95 BX

* Item notes used indicating linkage between both items - ITEM NOTES
* ITEMNOTPO 1 ITEM TO ORDER IS 002603264

* To comply with Pfizer's requirements the following solution has been developed. Pfizer has told us that they will be able to process our PO's will only the vendor item # (no UPC).
*
* We have created another item # that will be used/switched by the purchasing department before sending PO's to Pfizer (more details below).
*
* Set up of secondary item (real item in our system, but only for PO ordering purposes).
* Item #02603264
* Description - STERILE WATER FOR INJ. W/PRES 3977 (13) BACTERIOSTATIC
* Size - 25X30ML (NOTE difference)
* UPC - left blank on purpose
* UofM - Each = 25 (NOTE difference)
* Vend item # 03977030
* Selling EA
* Pricing = $92.95 EA (NOTE difference)

* Item notes used indicating linkage between both items - ITEM NOTES
* ITEMNOTPO 1 ITEM TO ORDER IS 00052308

===Processes===
* Buyer/Buyers Assistant will review Purchase Suggestions and determine item/quantities based on usual criteria.
* Purchase Suggestion will be imported into "Create PO"
* Buyer/Assistant will replace the original item #'s and quantities with the new item #'s
* PO will be printed and sent to Pfizer via normal EDI processes
* After sending - Buyer/Assistant will replace the item #'s and quantities back to the original item #'s

===Details===

* Below is the link to the table provided to us from Pfizer

*

[[Category:Workflows-Purchasing]]

Purchasing:Purchasing-Ordering specific items from Pfizer/Hospira

2019-11-14T22:45:59Z

Johnt:

==Procedures (specific) for ordering from Pfizer (legacy Hospira items)==

===Background===
* Recently Pfizer (#22337) acquired the marketing rights to a number of products that we used to purchase from Hospira.
* Pfizer has specific criteria for ordering these items (related to unit of measure UofM) that are unique to how our normal item/ordering processes work.
* More details - When we create an item it has to be built based on established "rules" concerning UofM, UPC, size fields, pricing etc. that are critical for purchasing/receiving/put-away/picking processes. Pfizer has asked us to order a product that we sell as an each (EA) with a UPC printed on the selling box and is packed as 25 eaches in a pack (PK) - as an EA on the PO (but as a pack of 25). Example below;

===Example===
* Current set up of item
* Item #00052308
* Description - STERILE WATER FOR INJ. W/PRES 3977 (13) BACTERIOSTATIC
* Size - 30ML
* UPC - 0118821353977004 - EA (each)
* UofM - Each = 1, Box = 25
* Vend item # 03977030
* Selling EA
* Pricing = $92.95 BX

* Item notes used indicating linkage between both items - ITEM NOTES
* ITEMNOTPO 1 ITEM TO ORDER IS 002603264

* To comply with Pfizer's requirements the following solution has been developed. Pfizer has told us that they will be able to process our PO's will only the vendor item # (no UPC).
*
* We have created another item # that will be used/switched by the purchasing department before sending PO's to Pfizer (more details below).
*
* Set up of secondary item (real item in our system, but only for PO ordering purposes).
* Item #02603264
* Description - STERILE WATER FOR INJ. W/PRES 3977 (13) BACTERIOSTATIC
* Size - 25X30ML
* UPC - left blank on purpose
* UofM - Each = 25
* Vend item # 03977030
* Selling EA
* Pricing = $92.95 EA

* Item notes used indicating linkage between both items - ITEM NOTES
* ITEMNOTPO 1 ITEM TO ORDER IS 00052308

===Processes===
* Buyer/Buyers Assistant will review Purchase Suggestions and determine item/quantities based on usual criteria.
* Purchase Suggestion will be imported into "Create PO"
* Buyer/Assistant will replace the original item #'s and quantities with the new item #'s
* PO will be printed and sent to Pfizer via normal EDI processes
* After sending - Buyer/Assistant will replace the item #'s and quantities back to the original item #'s

===Details===

* Below is the link to the table provided to us from Pfizer

*

[[Category:Workflows-Purchasing]]

Purchasing:Purchasing-Ordering specific items from Pfizer/Hospira

2019-11-14T22:42:51Z

Johnt:

==Procedures (specific) for ordering from Pfizer (legacy Hospira items)==

===Background===
* Recently Pfizer (#22337) acquired the marketing rights to a number of products that we used to purchase from Hospira.
* Pfizer has specific criteria for ordering these items (related to unit of measure UofM) that are unique to how our normal item/ordering processes work.
* More details - When we create an item it has to be built based on established "rules" concerning UofM, UPC, size fields, pricing etc. that are critical for purchasing/receiving/put-away/picking processes. Pfizer has asked us to order a product that we sell as an each (EA) with a UPC printed on the selling box and is packed as 25 eaches in a pack (PK) - as an EA on the PO (but as a pack of 25). Example below;

===Example===
* Current set up of item
* Item #00052308
* Description - STERILE WATER FOR INJ. W/PRES 3977 (13) BACTERIOSTATIC
* Size - 30ML
* UPC - 0118821353977004 - EA (each)
* UofM - Each = 1, Box = 25
* Vend item # 03977030
* Selling EA
* Pricing = $92.95 BX

* Item notes used indicating linkage between both items - ITEM NOTES
* ITEMNOTPO 1 ITEM TO ORDER IS 002603264

* To comply with Pfizer's requirements the following solution has been developed. Pfizer has told us that they will be able to process our PO's will only the vendor item # (no UPC).
*
* We have created another item # that will be used/switched by the purchasing department before sending PO's to Pfizer (more details below).
*
* Set up of secondary item (real item in our system, but only for PO ordering purposes).
* Item #02603264
* Description - STERILE WATER FOR INJ. W/PRES 3977 (13) BACTERIOSTATIC
* Size - 25X30ML
* UPC - left blank on purpose
* UofM - Each = 25
* Vend item # 03977030
* Selling EA
* Pricing = $92.95 EA

* Item notes used indicating linkage between both items - ITEM NOTES
* ITEMNOTPO 1 ITEM TO ORDER IS 00052308

===Processes===
* Buyer/Buyers Assistant will review Purchase Suggestions and determine item/quantities based on usual criteria.
* Purchase Suggestion will be imported into "Create PO"
* Buyer/Assistant will replace the original item #'s and quantities with the new item #'s
* PO will be printed and sent to Pfizer
* After sending - Buyer/Assistant will replace the item #'s and quantities back to the original item #'s

===Details===

* Below is the link to the table provided to us from Pfizer

[[Category:Workflows-Purchasing]]

Purchasing:Purchasing-Ordering specific items from Pfizer/Hospira

2019-11-14T22:42:08Z

Johnt:

==Procedures (specific) for ordering from Pfizer (legacy Hospira items)==

===Background===
* Recently Pfizer (#22337) acquired the marketing rights to a number of products that we used to purchase from Hospira.
* Pfizer has specific criteria for ordering these items (related to unit of measure UofM) that are unique to how our normal item/ordering processes work.
* More details - When we create an item it has to be built based on established "rules" concerning UofM, UPC, size fields, pricing etc. that are critical for purchasing/receiving/put-away/picking processes. Pfizer has asked us to order a product that we sell as an each (EA) with a UPC printed on the selling box and is packed as 25 eaches in a pack (PK) - as an EA on the PO (but as a pack of 25). Example below;

===Example===
* Current set up of item
* Item #00052308
* Description - STERILE WATER FOR INJ. W/PRES 3977 (13) BACTERIOSTATIC
* Size - 30ML
* UPC - 0118821353977004 - EA (each)
* UofM - Each = 1, Box = 25
* Vend item # 03977030
* Selling EA
* Pricing = $92.95 BX

* Item notes used indicating linkage between both items - ITEM NOTES
* ITEMNOTPO 1 ITEM TO ORDER IS 002603264

* To comply with Pfizer's requirements the following solution has been developed. Pfizer has told us that they will be able to process our PO's will only the vendor item # (no UPC).

* We have created another item # that will be used/switched by the purchasing department before sending PO's to Pfizer (more details below).

* Set up of secondary item (real item in our system, but only for PO ordering purposes).
* Item #02603264
* Description - STERILE WATER FOR INJ. W/PRES 3977 (13) BACTERIOSTATIC
* Size - 25X30ML
* UPC - left blank on purpose
* UofM - Each = 25
* Vend item # 03977030
* Selling EA
* Pricing = $92.95 EA

* Item notes used indicating linkage between both items - ITEM NOTES
* ITEMNOTPO 1 ITEM TO ORDER IS 00052308

===Processes===
* Buyer/Buyers Assistant will review Purchase Suggestions and determine item/quantities based on usual criteria.
* Purchase Suggestion will be imported into "Create PO"
* Buyer/Assistant will replace the original item #'s and quantities with the new item #'s
* PO will be printed and sent to Pfizer
* After sending - Buyer/Assistant will replace the item #'s and quantities back to the original item #'s

===Details===

* Below is the link to the table provided to us from Pfizer

[[Category:Workflows-Purchasing]]

Purchasing:Purchasing-Ordering specific items from Pfizer/Hospira

2019-11-14T22:00:13Z

Johnt: Created page with "==Procedures (specific) for ordering from Pfizer (legacy Hospira items)== ===Background=== * Recently Pfizer (#22337) acquired the marketing rights to a number of products th..."

Information Systems:Health Canada Drug Product Database

2019-11-05T23:36:35Z

Johnt:

=Overview=

Health Canada makes information on drugs and natural health products available through database extracts that can be downloaded from their website. There are two sets; the drug files are refreshed at the beginning of every month; the NHP files less often. We build a database (e.g. set of tables) from these files so that the information can be displayed in Web Orders (and in ''Display Items'', ''Work with Items'' in Infonet).

Consult the official pages for the [https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html '''drugs'''] and [https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/applications-submissions/product-licensing/licensed-natural-health-product-database-data-extract.html '''NHP'''] extracts for more information.

=Instructions for updating our database=
==Downloading the extract (drugs)==

# Go to Health Canada’s web site, www.hc-sc.gc.ca
# Click on ‘English’
# Under ‘Main Menu’, click on ‘Drugs & Health Products’
# Click on ‘Drug Products’
# Click on ‘Drug Product Database (DPD)’
# On the right hand side, click on ‘Access the Drug Product Database’
# On the upper part of the page, click on ‘DPD Data Extracts’
# Check the date under ‘Last Updated’ (right hand column). Don’t continue with this process unless this has changed. There shouldn’t be an issue as it is usually updated early on the first work day of the month.
# Before saving the new files - move old data files to archive folder - yes to replace
# Download ‘ALL FILES’ (bottom of the list) to your PC; both active (allfiles.zip) and inactive (allfiles_ia.zip) and (allfiles_ap.zip) - Open then Open
# Unzip and copy to SuperServer / staging / Health Canada

==Downloading the extract (Natural Health Products)==
'''NOTE: These records were last updated by HC in Sept. 2017. They are working on a new data extract - TBD (as of Aug 2018 - still no progress)(as of Sept 2019 still no progress on getting new extracts for NHP).
'''
# Go to Health Canada’s web site, www.hc-sc.gc.ca
# Click on ‘English’
# Under ‘Main Menu’, click on ‘Drugs & Health Products’
# Click on ‘Natural Health Products’
# On the right hand side, click on ‘Licensed Natural Health Products Database’
# Scroll down to the bottom of the page, and click on ‘Access the Licensed Natural Health Products Database Data Extract’
# Health Canada updates these files less often the drug product ones. Check the last updated date (at the top of the list of files) to see if it is necessary to continue. If the dates are the same, then don't do anything else. Check the next time.
# Go to SuperServer / staging / Health Canada and move the previous files to the archive folder.
# Download ‘All NHP Files’ to your PC.
# Unzip and copy to SuperServer / staging / Health Canada

==Updating Health Canada files on Bart==

'''Note:''' We have had issues with the Health Canada data files. They are apparently extracted manually, which means there can be errors. One month there were no record delimiters; which meant we couldn’t use them. Another time instead of all related files being zipped together, each was zipped separately, then zipped together. Another issue is that users EODJOB and SHEILAV cannot access SUPERSERVER from the i, so the scheduled job has been changed to run under JOHNT (2014Dec04).

'''To validate the data files, first manually run the rebuild in the test environment (PL):'''

* From a command line in ASW (easiest to do in Mocha), key in 88, press Enter, key in PL, and press Enter twice.
* Key in SBMJOB CMD(CALL PGM(HCDBBLD01C)) JOBQ(QS36EVOKE) and press enter (Note: just press enter ONCE!). (This is run from job queue QS36EVOKE so that production jobs are not delayed.) This program is being submitted to run in batch – you won’t see it on your screen.
* To see this job running, key in WRKACTJOB SBS(QBATCH) and press enter (Note: just press enter ONCE!).

Work with Active Jobs BART
10/01/14 12:16:27
CPU %: .0 Elapsed time: 00:00:00 Active jobs: 563

Type options, press Enter.
2=Change 3=Hold 4=End 5=Work with 6=Release 7=Display message
8=Work with spooled files 13=Disconnect ...
Current
Opt Subsystem/Job User Type CPU % Function Status
QBATCH QSYS SBS .0 DEQW
QDFTJOBD SHEILAV BCH .0 PGM-HCDBBLD01C RUN

Parameters or command
===>
F3=Exit F5=Refresh F7=Find F10=Restart statistics
F11=Display elapsed data F12=Cancel F23=More options F24=More keys

* Press F5 or F10 to refresh. Process will take approx. 6 minutes to complete.
* When completed the “RUN” will disappear
* Key in the command DSPFD UWDASWVOLD/HCDBDATAP and press enter. Then press page down until you see ‘Current number of records’ (about three times). There should be around 26,000 records in it (as of Nov 2014; it will increase with time). F3 to exit

Display Spooled File
File . . . . . : QPDSPFD Page/Line 2/11
Control . . . . . Columns 1 - 130
Find . . . . . .
*...+....1....+....2....+....3....+....4....+....5....+....6....+....7....+....8....+....9....+....0....+....1
Number of key fields . . . . . . . . . . . : 1
Record format . . . . . . . . . . . . . . . : HCDBDATAR
Key field . . . . . . . . . . . . . . . . : HCPRDC
Sequence . . . . . . . . . . . . . . . : Ascending
Sign specified . . . . . . . . . . . . : UNSIGNED
Zone/digit specified . . . . . . . . . : *NONE
Alternative collating sequence . . . . : No
Sort Sequence . . . . . . . . . . . . . . . : SRTSEQ *HEX
Language identifier . . . . . . . . . . . . : LANGID ENU
Member Description
Member . . . . . . . . . . . . . . . . . . : MBR HCDBDATAP
Member level identifier . . . . . . . . . : 1140529130244
Member creation date . . . . . . . . . . : 05/29/14
Text 'description' . . . . . . . . . . . : TEXT Health Canada Data Base - consolidated
Expiration date for member . . . . . . . : EXPDATE *NONE
Access path maintenance . . . . . . . . . : MAINT *IMMED
Access path recovery . . . . . . . . . . : RECOVER *NO
Member size . . . . . . . . . . . . . . . : SIZE *NOMAX
Current number of records . . . . . . . . : 25717

F3=Exit F12=Cancel F19=Left F20=Right F24=More keys

* When this program has completed, go into Web Orders '''test''' (https://orders.unipharm.com/unidev/uw_logind.pgm) to make sure the files have been correctly built.
* Should also check in ASW for the printer output file for job QPQUPRFIL - this should typically only be 2 pages (one page is header), and the second page typically only shows items in error. Stocked can then be checked as needed and item file maintenance updated.

'''If the files are correct in test, then they can be updated in production – not now, but tonight when stores are not using Web Orders.'''

* Go into ASW production by keying 88, enter, VA, enter, enter.
* Key in WRKJOBSCDE and press Enter.
* Page down to job HCDATABASE.

Work with Job Schedule Entries BART
10/01/14 12:34:49

Type options, press Enter.
2=Change 3=Hold 4=Remove 5=Display details 6=Release
8=Work with last submission 10=Submit immediately

Next
-----Schedule------ Recovery Submit
Opt Job Status Date Time Frequency Action Date
2 HCDATABASE SAV 09/05/14 06:00:00 *ONCE *NOSBM
__ IMRCHDJOB HLD USER DEF 04:30:00 *WEEKLY *SBMRLS 10/02/14
__ IMRSCKSTS1 SCD *ALL 05:30:00 *WEEKLY *SBMRLS 10/02/14
__ IMRSCKSTS2 SCD 10/01/14 12:35:00 *ONCE *SBMRLS 10/01/14
__ INTERREPLN HLD *TUE 05:00:00 *WEEKLY *NOSBM 10/07/14
__ MAXAVA SCD *SAT 20:00:00 *ONCE *NOSBM 10/04/14
__ MXIOSTATS2 SAV *TUE 12:30:00 *ONCE *SBMRLS
More...
Parameters or command
===>
F3=Exit F4=Prompt F5=Refresh F6=Add F9=Retrieve
F11=Display job queue data F12=Cancel F17=Top F18=Bottom

* Use option 2 to change it.

Change Job Schedule Entry (CHGJOBSCDE)

Type choices, press Enter.

Job name . . . . . . . . . . . . > HCDATABASE Name
Entry number . . . . . . . . . . > 572242 000001-999999, *ONLY
Command to run . . . . . . . . . SBMJOB CMD(CALL PGM(HCDBBLD01C)) JOBQ(QS36EV
OKE)____________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
Frequency . . . . . . . . . . . *ONCE *SAME, *ONCE, *WEEKLY...
Schedule date . . . . . . . . . '10/02/14' Date, *SAME, *CURRENT...
Schedule day . . . . . . . . . . *NONE *SAME, *NONE, *ALL, *MON...
+ for more values _____
Schedule time . . . . . . . . . '06:00:00' Time, *SAME, *CURRENT

Bottom
F3=Exit F4=Prompt F5=Refresh F10=Additional parameters F12=Cancel
F13=How to use this display F24=More keys

* Set it to run on the '''first Saturday''' after doing this data refresh (this is highly recommended to ensure the job has enough time to run without causing issues) the format is MM/DD/YY), and press enter twice.

'''Check it the next business day to make sure the files have been correctly built.'''

* Key in the command DSPFD UWDASWPRDD/HCDBDATAP and press enter. Then press page down until you see ‘Current number of records’ (about three times). There should be around 26,000 records in it (as of Nov 2014; it will increase with time). (Note that this command is slightly different than the previous one in that it looks at production instead of development.)
* Go into Web Orders production. (spot check several items, suggestion to look for DIN’s that are newer (higher numbers)).
* Should also check in ASW for the printer output file for job QPQUPRFIL - this should typically only be 2 pages (one page is header), and the second page typically only shows items in error. Stocked can then be checked as needed and item file maintenance updated.

=Additional Notes=
===Changes to the drug extract (Sept. 2017)===
[https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database/what-data-extract-drug-product-database.html Consult the '''official page'''] for an explanation of the structure of the drug extract.

There are three main changes to the drug extract:
* A new set of files for dormant products (not marketed for the last 12 months). These are now recognized by the current program.
* New columns to each file in a set (mostly French versions of existing columns). These are ignored by the current program.
* UTF-8 encoding. Some files are encoded in UTF-8-BOM, which bombs the program.

[[Category: Health Canada]]

Information Systems:Health Canada Drug Product Database

2019-11-05T23:35:53Z

Johnt:

=Overview=

Health Canada makes information on drugs and natural health products available through database extracts that can be downloaded from their website. There are two sets; the drug files are refreshed at the beginning of every month; the NHP files less often. We build a database (e.g. set of tables) from these files so that the information can be displayed in Web Orders (and in ''Display Items'', ''Work with Items'' in Infonet).

Consult the official pages for the [https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html '''drugs'''] and [https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/applications-submissions/product-licensing/licensed-natural-health-product-database-data-extract.html '''NHP'''] extracts for more information.

=Instructions for updating our database=
==Downloading the extract (drugs)==

# Go to Health Canada’s web site, www.hc-sc.gc.ca
# Click on ‘English’
# Under ‘Main Menu’, click on ‘Drugs & Health Products’
# Click on ‘Drug Products’
# Click on ‘Drug Product Database (DPD)’
# On the right hand side, click on ‘Access the Drug Product Database’
# On the upper part of the page, click on ‘DPD Data Extracts’
# Check the date under ‘Last Updated’ (right hand column). Don’t continue with this process unless this has changed. There shouldn’t be an issue as it is usually updated early on the first work day of the month.
# Before saving the new files - move old data files to archive folder - yes to replace
# Download ‘ALL FILES’ (bottom of the list) to your PC; both active (allfiles.zip) and inactive (allfiles_ia.zip) and (allfiles_ap.zip) - Open then Open
# Unzip and copy to SuperServer / staging / Health Canada

==Downloading the extract (Natural Health Products)==
'''NOTE: These records were last updated by HC in Sept. 2017. They are working on a new data extract - TBD (as of Aug 2018 - still no progress)(as of Sept 2019 still no progress on getting new extracts for NHP).
'''
# Go to Health Canada’s web site, www.hc-sc.gc.ca
# Click on ‘English’
# Under ‘Main Menu’, click on ‘Drugs & Health Products’
# Click on ‘Natural Health Products’
# On the right hand side, click on ‘Licensed Natural Health Products Database’
# Scroll down to the bottom of the page, and click on ‘Access the Licensed Natural Health Products Database Data Extract’
# Health Canada updates these files less often the drug product ones. Check the last updated date (at the top of the list of files) to see if it is necessary to continue. If the dates are the same, then don't do anything else. Check the next time.
# Go to SuperServer / staging / Health Canada and move the previous files to the archive folder.
# Download ‘All NHP Files’ to your PC.
# Unzip and copy to SuperServer / staging / Health Canada

==Updating Health Canada files on Bart==

'''Note:''' We have had issues with the Health Canada data files. They are apparently extracted manually, which means there can be errors. One month there were no record delimiters; which meant we couldn’t use them. Another time instead of all related files being zipped together, each was zipped separately, then zipped together. Another issue is that users EODJOB and SHEILAV cannot access SUPERSERVER from the i, so the scheduled job has been changed to run under JOHNT (2014Dec04).

'''To validate the data files, first manually run the rebuild in the test environment (PL):'''

* From a command line in ASW (easiest to do in Mocha), key in 88, press Enter, key in PL, and press Enter twice.
* Key in SBMJOB CMD(CALL PGM(HCDBBLD01C)) JOBQ(QS36EVOKE) and press enter (Note: just press enter ONCE!). (This is run from job queue QS36EVOKE so that production jobs are not delayed.) This program is being submitted to run in batch – you won’t see it on your screen.
* To see this job running, key in WRKACTJOB SBS(QBATCH) and press enter (Note: just press enter ONCE!).

Work with Active Jobs BART
10/01/14 12:16:27
CPU %: .0 Elapsed time: 00:00:00 Active jobs: 563

Type options, press Enter.
2=Change 3=Hold 4=End 5=Work with 6=Release 7=Display message
8=Work with spooled files 13=Disconnect ...
Current
Opt Subsystem/Job User Type CPU % Function Status
QBATCH QSYS SBS .0 DEQW
QDFTJOBD SHEILAV BCH .0 PGM-HCDBBLD01C RUN

Parameters or command
===>
F3=Exit F5=Refresh F7=Find F10=Restart statistics
F11=Display elapsed data F12=Cancel F23=More options F24=More keys

* Press F5 or F10 to refresh. Process will take approx. 6 minutes to complete.
* When completed the “RUN” will disappear
* Key in the command DSPFD UWDASWVOLD/HCDBDATAP and press enter. Then press page down until you see ‘Current number of records’ (about three times). There should be around 26,000 records in it (as of Nov 2014; it will increase with time). F3 to exit

Display Spooled File
File . . . . . : QPDSPFD Page/Line 2/11
Control . . . . . Columns 1 - 130
Find . . . . . .
*...+....1....+....2....+....3....+....4....+....5....+....6....+....7....+....8....+....9....+....0....+....1
Number of key fields . . . . . . . . . . . : 1
Record format . . . . . . . . . . . . . . . : HCDBDATAR
Key field . . . . . . . . . . . . . . . . : HCPRDC
Sequence . . . . . . . . . . . . . . . : Ascending
Sign specified . . . . . . . . . . . . : UNSIGNED
Zone/digit specified . . . . . . . . . : *NONE
Alternative collating sequence . . . . : No
Sort Sequence . . . . . . . . . . . . . . . : SRTSEQ *HEX
Language identifier . . . . . . . . . . . . : LANGID ENU
Member Description
Member . . . . . . . . . . . . . . . . . . : MBR HCDBDATAP
Member level identifier . . . . . . . . . : 1140529130244
Member creation date . . . . . . . . . . : 05/29/14
Text 'description' . . . . . . . . . . . : TEXT Health Canada Data Base - consolidated
Expiration date for member . . . . . . . : EXPDATE *NONE
Access path maintenance . . . . . . . . . : MAINT *IMMED
Access path recovery . . . . . . . . . . : RECOVER *NO
Member size . . . . . . . . . . . . . . . : SIZE *NOMAX
Current number of records . . . . . . . . : 25717

F3=Exit F12=Cancel F19=Left F20=Right F24=More keys

* When this program has completed, go into Web Orders '''test''' (https://orders.unipharm.com/unidev/uw_logind.pgm) to make sure the files have been correctly built.
* Should also check in ASW for the printer output file for job QPQUPRFIL - this should typically only be 2 pages (one page is header), and the second page typically only shows items in error. Stocked can then be checked as needed and item file maintenance updated.

'''If the files are correct in test, then they can be updated in production – not now, but tonight when stores are not using Web Orders.'''

* Go into ASW production by keying 88, enter, VA, enter, enter.
* Key in WRKJOBSCDE and press Enter.
* Page down to job HCDATABASE.

Work with Job Schedule Entries BART
10/01/14 12:34:49

Type options, press Enter.
2=Change 3=Hold 4=Remove 5=Display details 6=Release
8=Work with last submission 10=Submit immediately

Next
-----Schedule------ Recovery Submit
Opt Job Status Date Time Frequency Action Date
2 HCDATABASE SAV 09/05/14 06:00:00 *ONCE *NOSBM
__ IMRCHDJOB HLD USER DEF 04:30:00 *WEEKLY *SBMRLS 10/02/14
__ IMRSCKSTS1 SCD *ALL 05:30:00 *WEEKLY *SBMRLS 10/02/14
__ IMRSCKSTS2 SCD 10/01/14 12:35:00 *ONCE *SBMRLS 10/01/14
__ INTERREPLN HLD *TUE 05:00:00 *WEEKLY *NOSBM 10/07/14
__ MAXAVA SCD *SAT 20:00:00 *ONCE *NOSBM 10/04/14
__ MXIOSTATS2 SAV *TUE 12:30:00 *ONCE *SBMRLS
More...
Parameters or command
===>
F3=Exit F4=Prompt F5=Refresh F6=Add F9=Retrieve
F11=Display job queue data F12=Cancel F17=Top F18=Bottom

* Use option 2 to change it.

Change Job Schedule Entry (CHGJOBSCDE)

Type choices, press Enter.

Job name . . . . . . . . . . . . > HCDATABASE Name
Entry number . . . . . . . . . . > 572242 000001-999999, *ONLY
Command to run . . . . . . . . . SBMJOB CMD(CALL PGM(HCDBBLD01C)) JOBQ(QS36EV
OKE)____________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
Frequency . . . . . . . . . . . *ONCE *SAME, *ONCE, *WEEKLY...
Schedule date . . . . . . . . . '10/02/14' Date, *SAME, *CURRENT...
Schedule day . . . . . . . . . . *NONE *SAME, *NONE, *ALL, *MON...
+ for more values _____
Schedule time . . . . . . . . . '06:00:00' Time, *SAME, *CURRENT

Bottom
F3=Exit F4=Prompt F5=Refresh F10=Additional parameters F12=Cancel
F13=How to use this display F24=More keys

* Set it to run on the '''first Saturday''' after doing this data refresh (this is highly recommend to ensure the job has enough time to run without causing issues) the format is MM/DD/YY), and press enter twice.

'''Check it the next business day to make sure the files have been correctly built.'''

* Key in the command DSPFD UWDASWPRDD/HCDBDATAP and press enter. Then press page down until you see ‘Current number of records’ (about three times). There should be around 26,000 records in it (as of Nov 2014; it will increase with time). (Note that this command is slightly different than the previous one in that it looks at production instead of development.)
* Go into Web Orders production. (spot check several items, suggestion to look for DIN’s that are newer (higher numbers)).
* Should also check in ASW for the printer output file for job QPQUPRFIL - this should typically only be 2 pages (one page is header), and the second page typically only shows items in error. Stocked can then be checked as needed and item file maintenance updated.

=Additional Notes=
===Changes to the drug extract (Sept. 2017)===
[https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database/what-data-extract-drug-product-database.html Consult the '''official page'''] for an explanation of the structure of the drug extract.

There are three main changes to the drug extract:
* A new set of files for dormant products (not marketed for the last 12 months). These are now recognized by the current program.
* New columns to each file in a set (mostly French versions of existing columns). These are ignored by the current program.
* UTF-8 encoding. Some files are encoded in UTF-8-BOM, which bombs the program.

[[Category: Health Canada]]

Information Systems:Health Canada Drug Product Database

2019-10-10T23:16:40Z

Johnt:

=Overview=

Health Canada makes information on drugs and natural health products available through database extracts that can be downloaded from their website. There are two sets; the drug files are refreshed at the beginning of every month; the NHP files less often. We build a database (e.g. set of tables) from these files so that the information can be displayed in Web Orders (and in ''Display Items'', ''Work with Items'' in Infonet).

Consult the official pages for the [https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html '''drugs'''] and [https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/applications-submissions/product-licensing/licensed-natural-health-product-database-data-extract.html '''NHP'''] extracts for more information.

=Instructions for updating our database=
==Downloading the extract (drugs)==

# Go to Health Canada’s web site, www.hc-sc.gc.ca
# Click on ‘English’
# Under ‘Main Menu’, click on ‘Drugs & Health Products’
# Click on ‘Drug Products’
# Click on ‘Drug Product Database (DPD)’
# On the right hand side, click on ‘Access the Drug Product Database’
# On the upper part of the page, click on ‘DPD Data Extracts’
# Check the date under ‘Last Updated’ (right hand column). Don’t continue with this process unless this has changed. There shouldn’t be an issue as it is usually updated early on the first work day of the month.
# Before saving the new files - move old data files to archive folder - yes to replace
# Download ‘ALL FILES’ (bottom of the list) to your PC; both active (allfiles.zip) and inactive (allfiles_ia.zip) and (allfiles_ap.zip) - Open then Open
# Unzip and copy to SuperServer / staging / Health Canada

==Downloading the extract (Natural Health Products)==
'''NOTE: These records were last updated by HC in Sept. 2017. They are working on a new data extract - TBD (as of Aug 2018 - still no progress)(as of Sept 2019 still no progress on getting new extracts for NHP).
'''
# Go to Health Canada’s web site, www.hc-sc.gc.ca
# Click on ‘English’
# Under ‘Main Menu’, click on ‘Drugs & Health Products’
# Click on ‘Natural Health Products’
# On the right hand side, click on ‘Licensed Natural Health Products Database’
# Scroll down to the bottom of the page, and click on ‘Access the Licensed Natural Health Products Database Data Extract’
# Health Canada updates these files less often the drug product ones. Check the last updated date (at the top of the list of files) to see if it is necessary to continue. If the dates are the same, then don't do anything else. Check the next time.
# Go to SuperServer / staging / Health Canada and move the previous files to the archive folder.
# Download ‘All NHP Files’ to your PC.
# Unzip and copy to SuperServer / staging / Health Canada

==Updating Health Canada files on Bart==

'''Note:''' We have had issues with the Health Canada data files. They are apparently extracted manually, which means there can be errors. One month there were no record delimiters; which meant we couldn’t use them. Another time instead of all related files being zipped together, each was zipped separately, then zipped together. Another issue is that users EODJOB and SHEILAV cannot access SUPERSERVER from the i, so the scheduled job has been changed to run under JOHNT (2014Dec04).

'''To validate the data files, first manually run the rebuild in the test environment (PL):'''

* From a command line in ASW (easiest to do in Mocha), key in 88, press Enter, key in PL, and press Enter twice.
* Key in SBMJOB CMD(CALL PGM(HCDBBLD01C)) JOBQ(QS36EVOKE) and press enter (Note: just press enter ONCE!). (This is run from job queue QS36EVOKE so that production jobs are not delayed.) This program is being submitted to run in batch – you won’t see it on your screen.
* To see this job running, key in WRKACTJOB SBS(QBATCH) and press enter (Note: just press enter ONCE!).

Work with Active Jobs BART
10/01/14 12:16:27
CPU %: .0 Elapsed time: 00:00:00 Active jobs: 563

Type options, press Enter.
2=Change 3=Hold 4=End 5=Work with 6=Release 7=Display message
8=Work with spooled files 13=Disconnect ...
Current
Opt Subsystem/Job User Type CPU % Function Status
QBATCH QSYS SBS .0 DEQW
QDFTJOBD SHEILAV BCH .0 PGM-HCDBBLD01C RUN

Parameters or command
===>
F3=Exit F5=Refresh F7=Find F10=Restart statistics
F11=Display elapsed data F12=Cancel F23=More options F24=More keys

* Press F5 or F10 to refresh. Process will take approx. 6 minutes to complete.
* When completed the “RUN” will disappear
* Key in the command DSPFD UWDASWVOLD/HCDBDATAP and press enter. Then press page down until you see ‘Current number of records’ (about three times). There should be around 26,000 records in it (as of Nov 2014; it will increase with time). F3 to exit

Display Spooled File
File . . . . . : QPDSPFD Page/Line 2/11
Control . . . . . Columns 1 - 130
Find . . . . . .
*...+....1....+....2....+....3....+....4....+....5....+....6....+....7....+....8....+....9....+....0....+....1
Number of key fields . . . . . . . . . . . : 1
Record format . . . . . . . . . . . . . . . : HCDBDATAR
Key field . . . . . . . . . . . . . . . . : HCPRDC
Sequence . . . . . . . . . . . . . . . : Ascending
Sign specified . . . . . . . . . . . . : UNSIGNED
Zone/digit specified . . . . . . . . . : *NONE
Alternative collating sequence . . . . : No
Sort Sequence . . . . . . . . . . . . . . . : SRTSEQ *HEX
Language identifier . . . . . . . . . . . . : LANGID ENU
Member Description
Member . . . . . . . . . . . . . . . . . . : MBR HCDBDATAP
Member level identifier . . . . . . . . . : 1140529130244
Member creation date . . . . . . . . . . : 05/29/14
Text 'description' . . . . . . . . . . . : TEXT Health Canada Data Base - consolidated
Expiration date for member . . . . . . . : EXPDATE *NONE
Access path maintenance . . . . . . . . . : MAINT *IMMED
Access path recovery . . . . . . . . . . : RECOVER *NO
Member size . . . . . . . . . . . . . . . : SIZE *NOMAX
Current number of records . . . . . . . . : 25717

F3=Exit F12=Cancel F19=Left F20=Right F24=More keys

* When this program has completed, go into Web Orders '''test''' (https://orders.unipharm.com/unidev/uw_logind.pgm) to make sure the files have been correctly built.
* Should also check in ASW for the printer output file for job QPQUPRFIL - this should typically only be 2 pages (one page is header), and the second page typically only shows items in error. Stocked can then be checked as needed and item file maintenance updated.

'''If the files are correct in test, then they can be updated in production – not now, but tonight when stores are not using Web Orders.'''

* Go into ASW production by keying 88, enter, VA, enter, enter.
* Key in WRKJOBSCDE and press Enter.
* Page down to job HCDATABASE.

Work with Job Schedule Entries BART
10/01/14 12:34:49

Type options, press Enter.
2=Change 3=Hold 4=Remove 5=Display details 6=Release
8=Work with last submission 10=Submit immediately

Next
-----Schedule------ Recovery Submit
Opt Job Status Date Time Frequency Action Date
2 HCDATABASE SAV 09/05/14 06:00:00 *ONCE *NOSBM
__ IMRCHDJOB HLD USER DEF 04:30:00 *WEEKLY *SBMRLS 10/02/14
__ IMRSCKSTS1 SCD *ALL 05:30:00 *WEEKLY *SBMRLS 10/02/14
__ IMRSCKSTS2 SCD 10/01/14 12:35:00 *ONCE *SBMRLS 10/01/14
__ INTERREPLN HLD *TUE 05:00:00 *WEEKLY *NOSBM 10/07/14
__ MAXAVA SCD *SAT 20:00:00 *ONCE *NOSBM 10/04/14
__ MXIOSTATS2 SAV *TUE 12:30:00 *ONCE *SBMRLS
More...
Parameters or command
===>
F3=Exit F4=Prompt F5=Refresh F6=Add F9=Retrieve
F11=Display job queue data F12=Cancel F17=Top F18=Bottom

* Use option 2 to change it.

Change Job Schedule Entry (CHGJOBSCDE)

Type choices, press Enter.

Job name . . . . . . . . . . . . > HCDATABASE Name
Entry number . . . . . . . . . . > 572242 000001-999999, *ONLY
Command to run . . . . . . . . . SBMJOB CMD(CALL PGM(HCDBBLD01C)) JOBQ(QS36EV
OKE)____________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
Frequency . . . . . . . . . . . *ONCE *SAME, *ONCE, *WEEKLY...
Schedule date . . . . . . . . . '10/02/14' Date, *SAME, *CURRENT...
Schedule day . . . . . . . . . . *NONE *SAME, *NONE, *ALL, *MON...
+ for more values _____
Schedule time . . . . . . . . . '06:00:00' Time, *SAME, *CURRENT

Bottom
F3=Exit F4=Prompt F5=Refresh F10=Additional parameters F12=Cancel
F13=How to use this display F24=More keys

* Set it to run tomorrow (the format is MM/DD/YY), and press enter twice.

'''Check it the next morning to make sure the files have been correctly built.'''

* Key in the command DSPFD UWDASWPRDD/HCDBDATAP and press enter. Then press page down until you see ‘Current number of records’ (about three times). There should be around 26,000 records in it (as of Nov 2014; it will increase with time). (Note that this command is slightly different than the previous one in that it looks at production instead of development.)
* Go into Web Orders production. (spot check several items, suggestion to look for DIN’s that are newer (higher numbers)).
* Should also check in ASW for the printer output file for job QPQUPRFIL - this should typically only be 2 pages (one page is header), and the second page typically only shows items in error. Stocked can then be checked as needed and item file maintenance updated.

=Additional Notes=
===Changes to the drug extract (Sept. 2017)===
[https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database/what-data-extract-drug-product-database.html Consult the '''official page'''] for an explanation of the structure of the drug extract.

There are three main changes to the drug extract:
* A new set of files for dormant products (not marketed for the last 12 months). These are now recognized by the current program.
* New columns to each file in a set (mostly French versions of existing columns). These are ignored by the current program.
* UTF-8 encoding. Some files are encoded in UTF-8-BOM, which bombs the program.

[[Category: Health Canada]]

Information Systems:Health Canada Drug Product Database

2019-09-04T16:08:12Z

Johnt:

=Overview=

Health Canada makes information on drugs and natural health products available through database extracts that can be downloaded from their website. There are two sets; the drug files are refreshed at the beginning of every month; the NHP files less often. We build a database (e.g. set of tables) from these files so that the information can be displayed in Web Orders (and in ''Display Items'', ''Work with Items'' in Infonet).

Consult the official pages for the [https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html '''drugs'''] and [https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/applications-submissions/product-licensing/licensed-natural-health-product-database-data-extract.html '''NHP'''] extracts for more information.

=Instructions for updating our database=
==Downloading the extract (drugs)==

# Go to Health Canada’s web site, www.hc-sc.gc.ca
# Click on ‘English’
# Under ‘Main Menu’, click on ‘Drugs & Health Products’
# Click on ‘Drug Products’
# Click on ‘Drug Product Database (DPD)’
# On the right hand side, click on ‘Access the Drug Product Database’
# On the upper part of the page, click on ‘DPD Data Extracts’
# Check the date under ‘Last Updated’ (right hand column). Don’t continue with this process unless this has changed. There shouldn’t be an issue as it is usually updated early on the first work day of the month.
# Before saving the new files - move old data files to archive folder - yes to replace
# Download ‘ALL FILES’ (bottom of the list) to your PC; both active (allfiles.zip) and inactive (allfiles_ia.zip) and (allfiles_ap.zip) - Open then Open
# Unzip and copy to SuperServer / staging / Health Canada

==Downloading the extract (Natural Health Products)==
'''NOTE: These records were last updated by HC in Sept. 2017. They are working on a new data extract - TBD (as of Aug 2018 - still no progress)(as of Sept 2019 still no progress on getting new extracts for NHP).
'''
# Go to Health Canada’s web site, www.hc-sc.gc.ca
# Click on ‘English’
# Under ‘Main Menu’, click on ‘Drugs & Health Products’
# Click on ‘Natural Health Products’
# On the right hand side, click on ‘Licensed Natural Health Products Database’
# Scroll down to the bottom of the page, and click on ‘Access the Licensed Natural Health Products Database Data Extract’
# Health Canada updates these files less often the drug product ones. Check the last updated date (at the top of the list of files) to see if it is necessary to continue. If the dates are the same, then don't do anything else. Check the next time.
# Go to SuperServer / staging / Health Canada and move the previous files to the archive folder.
# Download ‘All NHP Files’ to your PC.
# Unzip and copy to SuperServer / staging / Health Canada

==Updating Health Canada files on Bart==

'''Note:''' We have had issues with the Health Canada data files. They are apparently extracted manually, which means there can be errors. One month there were no record delimiters; which meant we couldn’t use them. Another time instead of all related files being zipped together, each was zipped separately, then zipped together. Another issue is that users EODJOB and SHEILAV cannot access SUPERSERVER from the i, so the scheduled job has been changed to run under JOHNT (2014Dec04).

'''To validate the data files, first manually run the rebuild in the test environment (PL):'''

* From a command line in ASW (easiest to do in Mocha), key in 88, press Enter, key in PL, and press Enter twice.
* Key in SBMJOB CMD(CALL PGM(HCDBBLD01C)) JOBQ(QS36EVOKE) and press enter (Note: just press enter ONCE!). (This is run from job queue QS36EVOKE so that production jobs are not delayed.) This program is being submitted to run in batch – you won’t see it on your screen.
* To see this job running, key in WRKACTJOB SBS(QBATCH) and press enter (Note: just press enter ONCE!).

Work with Active Jobs BART
10/01/14 12:16:27
CPU %: .0 Elapsed time: 00:00:00 Active jobs: 563

Type options, press Enter.
2=Change 3=Hold 4=End 5=Work with 6=Release 7=Display message
8=Work with spooled files 13=Disconnect ...
Current
Opt Subsystem/Job User Type CPU % Function Status
QBATCH QSYS SBS .0 DEQW
QDFTJOBD SHEILAV BCH .0 PGM-HCDBBLD01C RUN

Parameters or command
===>
F3=Exit F5=Refresh F7=Find F10=Restart statistics
F11=Display elapsed data F12=Cancel F23=More options F24=More keys

* Press F5 or F10 to refresh. Process will take approx. 6 minutes to complete.
* When completed the “RUN” will disappear
* Key in the command DSPFD UWDASWVOLD/HCDBDATAP and press enter. Then press page down until you see ‘Current number of records’ (about three times). There should be around 26,000 records in it (as of Nov 2014; it will increase with time). F3 to exit

Display Spooled File
File . . . . . : QPDSPFD Page/Line 2/11
Control . . . . . Columns 1 - 130
Find . . . . . .
*...+....1....+....2....+....3....+....4....+....5....+....6....+....7....+....8....+....9....+....0....+....1
Number of key fields . . . . . . . . . . . : 1
Record format . . . . . . . . . . . . . . . : HCDBDATAR
Key field . . . . . . . . . . . . . . . . : HCPRDC
Sequence . . . . . . . . . . . . . . . : Ascending
Sign specified . . . . . . . . . . . . : UNSIGNED
Zone/digit specified . . . . . . . . . : *NONE
Alternative collating sequence . . . . : No
Sort Sequence . . . . . . . . . . . . . . . : SRTSEQ *HEX
Language identifier . . . . . . . . . . . . : LANGID ENU
Member Description
Member . . . . . . . . . . . . . . . . . . : MBR HCDBDATAP
Member level identifier . . . . . . . . . : 1140529130244
Member creation date . . . . . . . . . . : 05/29/14
Text 'description' . . . . . . . . . . . : TEXT Health Canada Data Base - consolidated
Expiration date for member . . . . . . . : EXPDATE *NONE
Access path maintenance . . . . . . . . . : MAINT *IMMED
Access path recovery . . . . . . . . . . : RECOVER *NO
Member size . . . . . . . . . . . . . . . : SIZE *NOMAX
Current number of records . . . . . . . . : 25717

F3=Exit F12=Cancel F19=Left F20=Right F24=More keys

* When this program has completed, go into Web Orders test to make sure the files have been correctly built.
* Should also check in ASW for the printer output file for job QPQUPRFIL - this should typically only be 2 pages (one page is header), and the second page typically only shows items in error. Stocked can then be checked as needed and item file maintenance updated.

'''If the files are correct in test, then they can be updated in production – not now, but tonight when stores are not using Web Orders.'''

* Go into ASW production by keying 88, enter, VA, enter, enter.
* Key in WRKJOBSCDE and press Enter.
* Page down to job HCDATABASE.

Work with Job Schedule Entries BART
10/01/14 12:34:49

Type options, press Enter.
2=Change 3=Hold 4=Remove 5=Display details 6=Release
8=Work with last submission 10=Submit immediately

Next
-----Schedule------ Recovery Submit
Opt Job Status Date Time Frequency Action Date
2 HCDATABASE SAV 09/05/14 06:00:00 *ONCE *NOSBM
__ IMRCHDJOB HLD USER DEF 04:30:00 *WEEKLY *SBMRLS 10/02/14
__ IMRSCKSTS1 SCD *ALL 05:30:00 *WEEKLY *SBMRLS 10/02/14
__ IMRSCKSTS2 SCD 10/01/14 12:35:00 *ONCE *SBMRLS 10/01/14
__ INTERREPLN HLD *TUE 05:00:00 *WEEKLY *NOSBM 10/07/14
__ MAXAVA SCD *SAT 20:00:00 *ONCE *NOSBM 10/04/14
__ MXIOSTATS2 SAV *TUE 12:30:00 *ONCE *SBMRLS
More...
Parameters or command
===>
F3=Exit F4=Prompt F5=Refresh F6=Add F9=Retrieve
F11=Display job queue data F12=Cancel F17=Top F18=Bottom

* Use option 2 to change it.

Change Job Schedule Entry (CHGJOBSCDE)

Type choices, press Enter.

Job name . . . . . . . . . . . . > HCDATABASE Name
Entry number . . . . . . . . . . > 572242 000001-999999, *ONLY
Command to run . . . . . . . . . SBMJOB CMD(CALL PGM(HCDBBLD01C)) JOBQ(QS36EV
OKE)____________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
Frequency . . . . . . . . . . . *ONCE *SAME, *ONCE, *WEEKLY...
Schedule date . . . . . . . . . '10/02/14' Date, *SAME, *CURRENT...
Schedule day . . . . . . . . . . *NONE *SAME, *NONE, *ALL, *MON...
+ for more values _____
Schedule time . . . . . . . . . '06:00:00' Time, *SAME, *CURRENT

Bottom
F3=Exit F4=Prompt F5=Refresh F10=Additional parameters F12=Cancel
F13=How to use this display F24=More keys

* Set it to run tomorrow (the format is MM/DD/YY), and press enter twice.

'''Check it the next morning to make sure the files have been correctly built.'''

* Key in the command DSPFD UWDASWPRDD/HCDBDATAP and press enter. Then press page down until you see ‘Current number of records’ (about three times). There should be around 26,000 records in it (as of Nov 2014; it will increase with time). (Note that this command is slightly different than the previous one in that it looks at production instead of development.)
* Go into Web Orders production. (spot check several items, suggestion to look for DIN’s that are newer (higher numbers)).
* Should also check in ASW for the printer output file for job QPQUPRFIL - this should typically only be 2 pages (one page is header), and the second page typically only shows items in error. Stocked can then be checked as needed and item file maintenance updated.

=Additional Notes=
===Changes to the drug extract (Sept. 2017)===
[https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database/what-data-extract-drug-product-database.html Consult the '''official page'''] for an explanation of the structure of the drug extract.

There are three main changes to the drug extract:
* A new set of files for dormant products (not marketed for the last 12 months). These are now recognized by the current program.
* New columns to each file in a set (mostly French versions of existing columns). These are ignored by the current program.
* UTF-8 encoding. Some files are encoded in UTF-8-BOM, which bombs the program.

[[Category: Health Canada]]

Purchasing:Health Canada Communication Tools

2019-08-07T20:59:15Z

Johnt:

== '''Health Canada Communication Tools''' ==
''These four categories of communication tools include a few documents that may or may not be familiar to industry. These links and descriptions have been provided for your reference.''

=== 1.''' Guidance and regulations (Guidance Documents, guidelines and all regulation-related communications)'''===
* Industry and other healthcare professionals have specific guidance and regulations they must adhere to in order to meet Health Canada’s requirements. If you are a healthcare professional, or represent industry, these may be familiar to you. Please see the links below for examples of such guidance.
- https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada.html then scroll down to Guidance Documents and Guidelines.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements-advertising/policies-guidance-documents.html for examples of advertising regulations.
=== 2.''' Risk communications'''===
* Risk Communication tools may also be familiar to healthcare professionals:
'''Canadian Medical Devices Sentinel Network Bulletin (CMDSNet)'''
* The CMDSNet issues a monthly bulletin to keep the members of the network aware of a number of items related to adverse events associated with medical devices. For instance: updates to the program, recent reports of adverse events, recent regulatory actions and outcomes which have resulted from their reports, lessons learned, highlighted issues, recently completed and upcoming safety reviews, and educational opportunities. A list of all reports submitted to the Network is also included with the monthly bulletin. '''The distribution of the bulletin and list of reports is limited to Health Canada and those in the CMDSNet, and are not to be distributed beyond the Network, and therefore, no example is provided.'''
* For more information:
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/medeffect-canada-canadian-medical-devices-sentinel-network-pilot-project.html

'''Annual Trends Report'''
* The primary objective of the Annual Trends Report is to provide the numbers and trends of adverse drug reaction case reports and medical device incident reports to Health Canada on an annual basis. The data are based on reports submitted to Health Canada through the Canada Vigilance Adverse Reaction Online Database (more below) for reporting adverse reactions to drugs, the CV-MDS (where people report problems with medical devices), and CMDSNet.

- https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/annual-trends-adverse-reaction-case-reports-health-products-medical-device-problem-incidents.html

'''Health Product InfoWatch'''
* This is a Health Canada monthly publication to raise awareness and to provide clinically relevant information to healthcare professionals concerning marketed health products and their safety. In some cases, information is intended to stimulate reporting of similar adverse reactions.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/health-product-infowatch.html

'''Recalls and Safety Alerts'''

* Health Canada sometimes needs to recall a product that is on the market, or issue a safety alert. There are several ways these recalls and safety notices are communicated. These are detailed below.
** a) '''Health Product Risk Communications (HPRC’s)''': Includes three types of communications
*** - Dear Healthcare Professional Letter (DHCPL);
*** - Public communication; and,
*** - Notice to hospitals. (Type I risk: 48 hours - Type II risk 2-10 days). Communications are targeted to healthcare professionals, mainly written by industry and endorsed by Health Canada.
** b) '''Information Updates''': Health Canada’s communication for less urgent risk issues, e.g., some labelling updates, can take anywhere from 2-3 days to a week or more.
** c) '''Public advisory''': Health Canada’s communication to warn the public of a potential hazard.
** d) '''Recall notice''': This communication is written and distributed by Industry. An “extract” of the information is posted by Health Canada at regular intervals on Health Canada’s Recalls and Safety Alerts website link (see below).
** e) '''Foreign product alert''': Health Canada’s communication related to unauthorized products from other countries which may have been brought into the country by travellers or purchased online.

* You can search for recalls and safety alerts through this link:

- http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php?cat=3

===3. '''Health Product Safety Information'''===
* Health Product Safety Information tools may also be familiar to healthcare professionals and industry:

* Health-related products in Canada must be safe and effective. Each drug product has information associated with it, and this information is easily accessible through the drugs and health products portion of the Health Canada website. In addition, Health Canada has specific guidelines for each product that includes providing clear directions and ensuring the proper labelling of products.

'''Product Monographs'''

* A Product Monograph is a factual, scientific document on a drug product that describes the properties, claims, indications, and conditions of use of the drug, and contains any other information that may be required for optimal, safe and effective use of the drug.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html

'''Directions for use/Product Labelling'''

*These are the directions and labels on each product.

'''The Drug and Health Product Register (DHPR)'''

*The DHPR was created to make information on health products available to Canadians.

- https://hpr-rps.hres.ca/index.php?lang=en

=== 4. '''Communications around Transparency/Transparency Initiatives for the Public'''===

* Transparency tools may also be familiar to healthcare professionals and industry:

*'''Summary Safety Reviews (SSRs)'''

*SSRs are Health Canada’s summaries of its safety reviews of products and drugs on the market. These are intended to provide greater transparency to Canadians. They are brief 3-page summaries that outline what was assessed, what was found and what action was taken by Health Canada, if any. These are found in the DHPR. Here is the link:

- https://hpr-rps.hres.ca/reg-content/summary-safety-review-result.php?lang=en&term=

*'''New Safety and Effectiveness Reviews'''

*Health Canada posts lists of new safety reviews to increase transparency with Canadians and inform them of the products and risks that Health Canada is assessing. Once a new safety and effectiveness review is completed, an SSR (see above) is published to inform Canadians of what was found and what action was taken by Health Canada, if any.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/safety-reviews/new.html

*'''Medical Devices Online Incidents Database'''

* The Medical Device Online Incidents Database is an online initiative for reporting adverse reactions to medical devices. It contains medical device incident reports and information regarding recalls in a user-friendly, searchable, online format. There is also a full data extract available for download.

- https://hpr-rps.hres.ca/mdi_landing.php

*'''MedEffect Canada'''

* MedEffect Canada provides consumers, patients, and health professionals with an easy way to: report an adverse reaction or side effect; obtain new safety information on drugs and other health products; and, learn and better understand the importance of reporting side effects.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html

*'''Canada Vigilance Adverse Reaction Online Database'''

* The Canada Vigilance Adverse Reaction Online Database contains information about suspected adverse drug reactions reported to Health Canada by consumers, health professionals and market authorization holders.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-database.html

=== 5. '''General Health Canada websites'''===

* Drug Product Database
- https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html

* Drug & Health Product Inspections (also - search for Drug Establishment License Numbers)
- http://www.healthycanadians.gc.ca/apps/gmp-bpf/index-en.html?_ga=1.228540445.1862695909.1493335158

* Inspection Tracker: Drug Manufacturing Establishments
- https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/compliance-enforcement/inspection-tracker-drug-manufacturing-establishments.html

* Medical Device Inspections
- http://www.healthycanadians.gc.ca/apps/md-im/index-en.html

* Medical Devices Active License Listing (MDALL)
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/licences/medical-devices-active-licence-listing.html

[[Category: Purchasing]]

Purchasing:Health Canada Communication Tools

2019-08-07T20:49:07Z

Johnt:

== '''Health Canada Communication Tools''' ==
''These four categories of communication tools include a few documents that may or may not be familiar to industry. These links and descriptions have been provided for your reference.''

=== 1.''' Guidance and regulations (Guidance Documents, guidelines and all regulation-related communications)'''===
* Industry and other healthcare professionals have specific guidance and regulations they must adhere to in order to meet Health Canada’s requirements. If you are a healthcare professional, or represent industry, these may be familiar to you. Please see the links below for examples of such guidance.
- https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada.html then scroll down to Guidance Documents and Guidelines.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements-advertising/policies-guidance-documents.html for examples of advertising regulations.
=== 2.''' Risk communications'''===
* Risk Communication tools may also be familiar to healthcare professionals:
'''Canadian Medical Devices Sentinel Network Bulletin (CMDSNet)'''
* The CMDSNet issues a monthly bulletin to keep the members of the network aware of a number of items related to adverse events associated with medical devices. For instance: updates to the program, recent reports of adverse events, recent regulatory actions and outcomes which have resulted from their reports, lessons learned, highlighted issues, recently completed and upcoming safety reviews, and educational opportunities. A list of all reports submitted to the Network is also included with the monthly bulletin. '''The distribution of the bulletin and list of reports is limited to Health Canada and those in the CMDSNet, and are not to be distributed beyond the Network, and therefore, no example is provided.'''
* For more information:
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/medeffect-canada-canadian-medical-devices-sentinel-network-pilot-project.html

'''Annual Trends Report'''
* The primary objective of the Annual Trends Report is to provide the numbers and trends of adverse drug reaction case reports and medical device incident reports to Health Canada on an annual basis. The data are based on reports submitted to Health Canada through the Canada Vigilance Adverse Reaction Online Database (more below) for reporting adverse reactions to drugs, the CV-MDS (where people report problems with medical devices), and CMDSNet.

- https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/annual-trends-adverse-reaction-case-reports-health-products-medical-device-problem-incidents.html

'''Health Product InfoWatch'''
* This is a Health Canada monthly publication to raise awareness and to provide clinically relevant information to healthcare professionals concerning marketed health products and their safety. In some cases, information is intended to stimulate reporting of similar adverse reactions.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/health-product-infowatch.html

'''Recalls and Safety Alerts'''

* Health Canada sometimes needs to recall a product that is on the market, or issue a safety alert. There are several ways these recalls and safety notices are communicated. These are detailed below.
** a) '''Health Product Risk Communications (HPRC’s)''': Includes three types of communications
*** - Dear Healthcare Professional Letter (DHCPL);
*** - Public communication; and,
*** - Notice to hospitals. (Type I risk: 48 hours - Type II risk 2-10 days). Communications are targeted to healthcare professionals, mainly written by industry and endorsed by Health Canada.
** b) '''Information Updates''': Health Canada’s communication for less urgent risk issues, e.g., some labelling updates, can take anywhere from 2-3 days to a week or more.
** c) '''Public advisory''': Health Canada’s communication to warn the public of a potential hazard.
** d) '''Recall notice''': This communication is written and distributed by Industry. An “extract” of the information is posted by Health Canada at regular intervals on Health Canada’s Recalls and Safety Alerts website link (see below).
** e) '''Foreign product alert''': Health Canada’s communication related to unauthorized products from other countries which may have been brought into the country by travellers or purchased online.

* You can search for recalls and safety alerts through this link:

- http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php?cat=3

===3. '''Health Product Safety Information'''===
* Health Product Safety Information tools may also be familiar to healthcare professionals and industry:

* Health-related products in Canada must be safe and effective. Each drug product has information associated with it, and this information is easily accessible through the drugs and health products portion of the Health Canada website. In addition, Health Canada has specific guidelines for each product that includes providing clear directions and ensuring the proper labelling of products.

'''Product Monographs'''

* A Product Monograph is a factual, scientific document on a drug product that describes the properties, claims, indications, and conditions of use of the drug, and contains any other information that may be required for optimal, safe and effective use of the drug.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html

'''Directions for use/Product Labelling'''

*These are the directions and labels on each product.

'''The Drug and Health Product Register (DHPR)'''

*The DHPR was created to make information on health products available to Canadians.

- https://hpr-rps.hres.ca/index.php?lang=en

=== 4. '''Communications around Transparency/Transparency Initiatives for the Public'''===

* Transparency tools may also be familiar to healthcare professionals and industry:

*'''Summary Safety Reviews (SSRs)'''

*SSRs are Health Canada’s summaries of its safety reviews of products and drugs on the market. These are intended to provide greater transparency to Canadians. They are brief 3-page summaries that outline what was assessed, what was found and what action was taken by Health Canada, if any. These are found in the DHPR. Here is the link:

- https://hpr-rps.hres.ca/reg-content/summary-safety-review-result.php?lang=en&term=

*'''New Safety and Effectiveness Reviews'''

*Health Canada posts lists of new safety reviews to increase transparency with Canadians and inform them of the products and risks that Health Canada is assessing. Once a new safety and effectiveness review is completed, an SSR (see above) is published to inform Canadians of what was found and what action was taken by Health Canada, if any.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/safety-reviews/new.html

*'''Medical Devices Online Incidents Database'''

* The Medical Device Online Incidents Database is an online initiative for reporting adverse reactions to medical devices. It contains medical device incident reports and information regarding recalls in a user-friendly, searchable, online format. There is also a full data extract available for download.

- https://hpr-rps.hres.ca/mdi_landing.php

*'''MedEffect Canada'''

* MedEffect Canada provides consumers, patients, and health professionals with an easy way to: report an adverse reaction or side effect; obtain new safety information on drugs and other health products; and, learn and better understand the importance of reporting side effects.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html

*'''Canada Vigilance Adverse Reaction Online Database'''
* The Canada Vigilance Adverse Reaction Online Database contains information about suspected adverse drug reactions reported to Health Canada by consumers, health professionals and market authorization holders.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-database.html

=== 5. '''General Health Canada websites'''===

* Drug Product Database
- https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html

[[Category: Purchasing]]

Purchasing:Health Canada Communication Tools

2019-08-07T20:31:46Z

Johnt:

== '''Health Canada Communication Tools''' ==
''These four categories of communication tools include a few documents that may or may not be familiar to industry. These links and descriptions have been provided for your reference.''

=== 1.''' Guidance and regulations (Guidance Documents, guidelines and all regulation-related communications)'''===
* Industry and other healthcare professionals have specific guidance and regulations they must adhere to in order to meet Health Canada’s requirements. If you are a healthcare professional, or represent industry, these may be familiar to you. Please see the links below for examples of such guidance.
- https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada.html then scroll down to Guidance Documents and Guidelines.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements-advertising/policies-guidance-documents.html for examples of advertising regulations.
=== 2.''' Risk communications'''===
* Risk Communication tools may also be familiar to healthcare professionals:
'''Canadian Medical Devices Sentinel Network Bulletin (CMDSNet)'''
* The CMDSNet issues a monthly bulletin to keep the members of the network aware of a number of items related to adverse events associated with medical devices. For instance: updates to the program, recent reports of adverse events, recent regulatory actions and outcomes which have resulted from their reports, lessons learned, highlighted issues, recently completed and upcoming safety reviews, and educational opportunities. A list of all reports submitted to the Network is also included with the monthly bulletin. '''The distribution of the bulletin and list of reports is limited to Health Canada and those in the CMDSNet, and are not to be distributed beyond the Network, and therefore, no example is provided.'''
* For more information:
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/medeffect-canada-canadian-medical-devices-sentinel-network-pilot-project.html

'''Annual Trends Report'''
* The primary objective of the Annual Trends Report is to provide the numbers and trends of adverse drug reaction case reports and medical device incident reports to Health Canada on an annual basis. The data are based on reports submitted to Health Canada through the Canada Vigilance Adverse Reaction Online Database (more below) for reporting adverse reactions to drugs, the CV-MDS (where people report problems with medical devices), and CMDSNet.

- https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/annual-trends-adverse-reaction-case-reports-health-products-medical-device-problem-incidents.html

'''Health Product InfoWatch'''
* This is a Health Canada monthly publication to raise awareness and to provide clinically relevant information to healthcare professionals concerning marketed health products and their safety. In some cases, information is intended to stimulate reporting of similar adverse reactions.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/health-product-infowatch.html

'''Recalls and Safety Alerts'''

* Health Canada sometimes needs to recall a product that is on the market, or issue a safety alert. There are several ways these recalls and safety notices are communicated. These are detailed below.
** a) '''Health Product Risk Communications (HPRC’s)''': Includes three types of communications
*** - Dear Healthcare Professional Letter (DHCPL);
*** - Public communication; and,
*** - Notice to hospitals. (Type I risk: 48 hours - Type II risk 2-10 days). Communications are targeted to healthcare professionals, mainly written by industry and endorsed by Health Canada.
** b) '''Information Updates''': Health Canada’s communication for less urgent risk issues, e.g., some labelling updates, can take anywhere from 2-3 days to a week or more.
** c) '''Public advisory''': Health Canada’s communication to warn the public of a potential hazard.
** d) '''Recall notice''': This communication is written and distributed by Industry. An “extract” of the information is posted by Health Canada at regular intervals on Health Canada’s Recalls and Safety Alerts website link (see below).
** e) '''Foreign product alert''': Health Canada’s communication related to unauthorized products from other countries which may have been brought into the country by travellers or purchased online.

* You can search for recalls and safety alerts through this link:

- http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php?cat=3

===3. '''Health Product Safety Information'''===
* Health Product Safety Information tools may also be familiar to healthcare professionals and industry:

* Health-related products in Canada must be safe and effective. Each drug product has information associated with it, and this information is easily accessible through the drugs and health products portion of the Health Canada website. In addition, Health Canada has specific guidelines for each product that includes providing clear directions and ensuring the proper labelling of products.

'''Product Monographs'''

* A Product Monograph is a factual, scientific document on a drug product that describes the properties, claims, indications, and conditions of use of the drug, and contains any other information that may be required for optimal, safe and effective use of the drug.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html

'''Directions for use/Product Labelling'''

*These are the directions and labels on each product.

'''The Drug and Health Product Register (DHPR)'''

*The DHPR was created to make information on health products available to Canadians.

- https://hpr-rps.hres.ca/index.php?lang=en

=== 4. '''Communications around Transparency/Transparency Initiatives for the Public'''===

* Transparency tools may also be familiar to healthcare professionals and industry:

*'''Summary Safety Reviews (SSRs)'''

*SSRs are Health Canada’s summaries of its safety reviews of products and drugs on the market. These are intended to provide greater transparency to Canadians. They are brief 3-page summaries that outline what was assessed, what was found and what action was taken by Health Canada, if any. These are found in the DHPR. Here is the link:

- https://hpr-rps.hres.ca/reg-content/summary-safety-review-result.php?lang=en&term=

*'''New Safety and Effectiveness Reviews'''

*Health Canada posts lists of new safety reviews to increase transparency with Canadians and inform them of the products and risks that Health Canada is assessing. Once a new safety and effectiveness review is completed, an SSR (see above) is published to inform Canadians of what was found and what action was taken by Health Canada, if any.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/safety-reviews/new.html

*'''Medical Devices Online Incidents Database'''

* The Medical Device Online Incidents Database is an online initiative for reporting adverse reactions to medical devices. It contains medical device incident reports and information regarding recalls in a user-friendly, searchable, online format. There is also a full data extract available for download.

- https://hpr-rps.hres.ca/mdi_landing.php

*'''MedEffect Canada'''

* MedEffect Canada provides consumers, patients, and health professionals with an easy way to: report an adverse reaction or side effect; obtain new safety information on drugs and other health products; and, learn and better understand the importance of reporting side effects.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html

*'''Canada Vigilance Adverse Reaction Online Database'''
* The Canada Vigilance Adverse Reaction Online Database contains information about suspected adverse drug reactions reported to Health Canada by consumers, health professionals and market authorization holders.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-database.html

[[Category: Purchasing]]

Purchasing:Health Canada Communication Tools

2019-08-07T20:29:48Z

Johnt:

== '''Health Canada Communication Tools''' ==
''These four categories of communication tools include a few documents that may or may not be familiar to you. If the document is unfamiliar, you will have an opportunity to share this with the interviewer. We have provided links and descriptions for your reference.''
=== 1.''' Guidance and regulations (Guidance Documents, guidelines and all regulation-related communications)'''===
* Industry and other healthcare professionals have specific guidance and regulations they must adhere to in order to meet Health Canada’s requirements. If you are a healthcare professional, or represent industry, these may be familiar to you. Please see the links below for examples of such guidance.
- https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada.html then scroll down to Guidance Documents and Guidelines.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements-advertising/policies-guidance-documents.html for examples of advertising regulations.
=== 2.''' Risk communications'''===
* Risk Communication tools may also be familiar to healthcare professionals:
'''Canadian Medical Devices Sentinel Network Bulletin (CMDSNet)'''
* The CMDSNet issues a monthly bulletin to keep the members of the network aware of a number of items related to adverse events associated with medical devices. For instance: updates to the program, recent reports of adverse events, recent regulatory actions and outcomes which have resulted from their reports, lessons learned, highlighted issues, recently completed and upcoming safety reviews, and educational opportunities. A list of all reports submitted to the Network is also included with the monthly bulletin. '''The distribution of the bulletin and list of reports is limited to Health Canada and those in the CMDSNet, and are not to be distributed beyond the Network, and therefore, no example is provided.'''
* For more information:
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/medeffect-canada-canadian-medical-devices-sentinel-network-pilot-project.html

'''Annual Trends Report'''
* The primary objective of the Annual Trends Report is to provide the numbers and trends of adverse drug reaction case reports and medical device incident reports to Health Canada on an annual basis. The data are based on reports submitted to Health Canada through the Canada Vigilance Adverse Reaction Online Database (more below) for reporting adverse reactions to drugs, the CV-MDS (where people report problems with medical devices), and CMDSNet.

- https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/annual-trends-adverse-reaction-case-reports-health-products-medical-device-problem-incidents.html

'''Health Product InfoWatch'''
* This is a Health Canada monthly publication to raise awareness and to provide clinically relevant information to healthcare professionals concerning marketed health products and their safety. In some cases, information is intended to stimulate reporting of similar adverse reactions.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/health-product-infowatch.html

'''Recalls and Safety Alerts'''

* Health Canada sometimes needs to recall a product that is on the market, or issue a safety alert. There are several ways these recalls and safety notices are communicated. These are detailed below.
** a) '''Health Product Risk Communications (HPRC’s)''': Includes three types of communications
*** - Dear Healthcare Professional Letter (DHCPL);
*** - Public communication; and,
*** - Notice to hospitals. (Type I risk: 48 hours - Type II risk 2-10 days). Communications are targeted to healthcare professionals, mainly written by industry and endorsed by Health Canada.
** b) '''Information Updates''': Health Canada’s communication for less urgent risk issues, e.g., some labelling updates, can take anywhere from 2-3 days to a week or more.
** c) '''Public advisory''': Health Canada’s communication to warn the public of a potential hazard.
** d) '''Recall notice''': This communication is written and distributed by Industry. An “extract” of the information is posted by Health Canada at regular intervals on Health Canada’s Recalls and Safety Alerts website link (see below).
** e) '''Foreign product alert''': Health Canada’s communication related to unauthorized products from other countries which may have been brought into the country by travellers or purchased online.

* You can search for recalls and safety alerts through this link:

- http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php?cat=3

===3. '''Health Product Safety Information'''===
* Health Product Safety Information tools may also be familiar to healthcare professionals and industry:

* Health-related products in Canada must be safe and effective. Each drug product has information associated with it, and this information is easily accessible through the drugs and health products portion of the Health Canada website. In addition, Health Canada has specific guidelines for each product that includes providing clear directions and ensuring the proper labelling of products.

'''Product Monographs'''

* A Product Monograph is a factual, scientific document on a drug product that describes the properties, claims, indications, and conditions of use of the drug, and contains any other information that may be required for optimal, safe and effective use of the drug.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html

'''Directions for use/Product Labelling'''

*These are the directions and labels on each product.

'''The Drug and Health Product Register (DHPR)'''

*The DHPR was created to make information on health products available to Canadians.

- https://hpr-rps.hres.ca/index.php?lang=en

=== 4. '''Communications around Transparency/Transparency Initiatives for the Public'''===

* Transparency tools may also be familiar to healthcare professionals and industry:

*'''Summary Safety Reviews (SSRs)'''

*SSRs are Health Canada’s summaries of its safety reviews of products and drugs on the market. These are intended to provide greater transparency to Canadians. They are brief 3-page summaries that outline what was assessed, what was found and what action was taken by Health Canada, if any. These are found in the DHPR. Here is the link:

- https://hpr-rps.hres.ca/reg-content/summary-safety-review-result.php?lang=en&term=

*'''New Safety and Effectiveness Reviews'''

*Health Canada posts lists of new safety reviews to increase transparency with Canadians and inform them of the products and risks that Health Canada is assessing. Once a new safety and effectiveness review is completed, an SSR (see above) is published to inform Canadians of what was found and what action was taken by Health Canada, if any.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/safety-reviews/new.html

*'''Medical Devices Online Incidents Database'''

* The Medical Device Online Incidents Database is an online initiative for reporting adverse reactions to medical devices. It contains medical device incident reports and information regarding recalls in a user-friendly, searchable, online format. There is also a full data extract available for download.

- https://hpr-rps.hres.ca/mdi_landing.php

*'''MedEffect Canada'''

* MedEffect Canada provides consumers, patients, and health professionals with an easy way to: report an adverse reaction or side effect; obtain new safety information on drugs and other health products; and, learn and better understand the importance of reporting side effects.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html

*'''Canada Vigilance Adverse Reaction Online Database'''
* The Canada Vigilance Adverse Reaction Online Database contains information about suspected adverse drug reactions reported to Health Canada by consumers, health professionals and market authorization holders.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-database.html

[[Category: Purchasing]]

Purchasing:Health Canada Communication Tools

2019-08-07T20:28:44Z

Johnt:

Purchasing:Health Canada Communication Tools

2019-08-07T20:23:57Z

Johnt:

== '''Health Canada Communication Tools''' ==
''These four categories of communication tools include a few documents that may or may not be familiar to you. If the document is unfamiliar, you will have an opportunity to share this with the interviewer. We have provided links and descriptions for your reference.''
=== 1.''' Guidance and regulations (Guidance Documents, guidelines and all regulation-related communications)'''===
* Industry and other healthcare professionals have specific guidance and regulations they must adhere to in order to meet Health Canada’s requirements. If you are a healthcare professional, or represent industry, these may be familiar to you. Please see the links below for examples of such guidance.
- https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada.html then scroll down to Guidance Documents and Guidelines.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements-advertising/policies-guidance-documents.html for examples of advertising regulations.
=== 2.''' Risk communications'''===
* Risk Communication tools may also be familiar to healthcare professionals:
'''Canadian Medical Devices Sentinel Network Bulletin (CMDSNet)'''
* The CMDSNet issues a monthly bulletin to keep the members of the network aware of a number of items related to adverse events associated with medical devices. For instance: updates to the program, recent reports of adverse events, recent regulatory actions and outcomes which have resulted from their reports, lessons learned, highlighted issues, recently completed and upcoming safety reviews, and educational opportunities. A list of all reports submitted to the Network is also included with the monthly bulletin. '''The distribution of the bulletin and list of reports is limited to Health Canada and those in the CMDSNet, and are not to be distributed beyond the Network, and therefore, no example is provided.'''
* For more information:
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/medeffect-canada-canadian-medical-devices-sentinel-network-pilot-project.html

'''Annual Trends Report'''
* The primary objective of the Annual Trends Report is to provide the numbers and trends of adverse drug reaction case reports and medical device incident reports to Health Canada on an annual basis. The data are based on reports submitted to Health Canada through the Canada Vigilance Adverse Reaction Online Database (more below) for reporting adverse reactions to drugs, the CV-MDS (where people report problems with medical devices), and CMDSNet.

- https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/annual-trends-adverse-reaction-case-reports-health-products-medical-device-problem-incidents.html

'''Health Product InfoWatch'''
* This is a Health Canada monthly publication to raise awareness and to provide clinically relevant information to healthcare professionals concerning marketed health products and their safety. In some cases, information is intended to stimulate reporting of similar adverse reactions.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/health-product-infowatch.html

'''Recalls and Safety Alerts'''

* Health Canada sometimes needs to recall a product that is on the market, or issue a safety alert. There are several ways these recalls and safety notices are communicated. These are detailed below.
** a) Health Product Risk Communications (HPRC’s): Includes three types of communications
*** o Dear Healthcare Professional Letter (DHCPL);
*** o Public communication; and,
*** o Notice to hospitals. (Type I risk: 48 hours - Type II risk 2-10 days). Communications are targeted to healthcare professionals, mainly written by industry and endorsed by Health Canada.
** b) Information Updates: Health Canada’s communication for less urgent risk issues, e.g., some labelling updates, can take anywhere from 2-3 days to a week or more.
** c) Public advisory: Health Canada’s communication to warn the public of a potential hazard.
** d) Recall notice: This communication is written and distributed by Industry. An “extract” of the information is posted by Health Canada at regular intervals on Health Canada’s Recalls and Safety Alerts website link (see below).
** e) Foreign product alert: Health Canada’s communication related to unauthorized products from other countries which may have been brought into the country by travellers or purchased online.

* You can search for recalls and safety alerts through this link:

- http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php?cat=3

===3. '''Health Product Safety Information'''===
* Health Product Safety Information tools may also be familiar to healthcare professionals and industry:

* Health-related products in Canada must be safe and effective. Each drug product has information associated with it, and this information is easily accessible through the drugs and health products portion of the Health Canada website. In addition, Health Canada has specific guidelines for each product that includes providing clear directions and ensuring the proper labelling of products.

'''Product Monographs'''

*A Product Monograph is a factual, scientific document on a drug product that describes the properties, claims, indications, and conditions of use of the drug, and contains any other information that may be required for optimal, safe and effective use of the drug.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html

'''Directions for use/Product Labelling'''

*These are the directions and labels on each product.

'''The Drug and Health Product Register (DHPR)'''

*The DHPR was created to make information on health products available to Canadians.

- https://hpr-rps.hres.ca/index.php?lang=en

=== 4. '''Communications around Transparency/Transparency Initiatives for the Public'''===

* Transparency tools may also be familiar to healthcare professionals and industry:

*'''Summary Safety Reviews (SSRs)'''

*SSRs are Health Canada’s summaries of its safety reviews of products and drugs on the market. These are intended to provide greater transparency to Canadians. They are brief 3-page summaries that outline what was assessed, what was found and what action was taken by Health Canada, if any. These are found in the DHPR. Here is the link:

- https://hpr-rps.hres.ca/reg-content/summary-safety-review-result.php?lang=en&term=

'''New Safety and Effectiveness Reviews'''

*Health Canada posts lists of new safety reviews to increase transparency with Canadians and inform them of the products and risks that Health Canada is assessing. Once a new safety and effectiveness review is completed, an SSR (see above) is published to inform Canadians of what was found and what action was taken by Health Canada, if any.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/safety-reviews/new.html

Medical Devices Online Incidents Database
The Medical Device Online Incidents Database is an online initiative for reporting adverse reactions to medical devices. It contains medical device incident reports and information regarding recalls in a user-friendly, searchable, online format. There is also a full data extract available for download.
https://hpr-rps.hres.ca/mdi_landing.php
MedEffect Canada
MedEffect Canada provides consumers, patients, and health professionals with an easy way to: report an adverse reaction or side effect; obtain new safety information on drugs and other health products; and, learn and better understand the importance of reporting side effects.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html
Canada Vigilance Adverse Reaction Online Database
The Canada Vigilance Adverse Reaction Online Database contains information about suspected adverse drug reactions reported to Health Canada by consumers, health professionals and market authorization holders.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-database.html

Purchasing:Health Canada Communication Tools

2019-08-07T20:21:15Z

Johnt:

== '''Health Canada Communication Tools''' ==
''These four categories of communication tools include a few documents that may or may not be familiar to you. If the document is unfamiliar, you will have an opportunity to share this with the interviewer. We have provided links and descriptions for your reference.''
=== 1.''' Guidance and regulations (Guidance Documents, guidelines and all regulation-related communications)'''===
* Industry and other healthcare professionals have specific guidance and regulations they must adhere to in order to meet Health Canada’s requirements. If you are a healthcare professional, or represent industry, these may be familiar to you. Please see the links below for examples of such guidance.
- https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada.html then scroll down to Guidance Documents and Guidelines.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements-advertising/policies-guidance-documents.html for examples of advertising regulations.
=== 2.''' Risk communications'''===
* Risk Communication tools may also be familiar to healthcare professionals:
'''Canadian Medical Devices Sentinel Network Bulletin (CMDSNet)'''
* The CMDSNet issues a monthly bulletin to keep the members of the network aware of a number of items related to adverse events associated with medical devices. For instance: updates to the program, recent reports of adverse events, recent regulatory actions and outcomes which have resulted from their reports, lessons learned, highlighted issues, recently completed and upcoming safety reviews, and educational opportunities. A list of all reports submitted to the Network is also included with the monthly bulletin. '''The distribution of the bulletin and list of reports is limited to Health Canada and those in the CMDSNet, and are not to be distributed beyond the Network, and therefore, no example is provided.'''
* For more information:
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/medeffect-canada-canadian-medical-devices-sentinel-network-pilot-project.html

'''Annual Trends Report'''
* The primary objective of the Annual Trends Report is to provide the numbers and trends of adverse drug reaction case reports and medical device incident reports to Health Canada on an annual basis. The data are based on reports submitted to Health Canada through the Canada Vigilance Adverse Reaction Online Database (more below) for reporting adverse reactions to drugs, the CV-MDS (where people report problems with medical devices), and CMDSNet.

- https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/annual-trends-adverse-reaction-case-reports-health-products-medical-device-problem-incidents.html

'''Health Product InfoWatch'''
* This is a Health Canada monthly publication to raise awareness and to provide clinically relevant information to healthcare professionals concerning marketed health products and their safety. In some cases, information is intended to stimulate reporting of similar adverse reactions.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/health-product-infowatch.html

'''Recalls and Safety Alerts'''

* Health Canada sometimes needs to recall a product that is on the market, or issue a safety alert. There are several ways these recalls and safety notices are communicated. These are detailed below.
a) Health Product Risk Communications (HPRC’s): Includes three types of communications
o Dear Healthcare Professional Letter (DHCPL);
o Public communication; and,
o Notice to hospitals. (Type I risk: 48 hours - Type II risk 2-10 days). Communications are targeted to healthcare professionals, mainly written by industry and endorsed by Health Canada.
b) Information Updates: Health Canada’s communication for less urgent risk issues, e.g., some labelling updates, can take anywhere from 2-3 days to a week or more.
c) Public advisory: Health Canada’s communication to warn the public of a potential hazard.
d) Recall notice: This communication is written and distributed by Industry. An “extract” of the information is posted by Health Canada at regular intervals on Health Canada’s Recalls and Safety Alerts website link (see below).
e) Foreign product alert: Health Canada’s communication related to unauthorized products from other countries which may have been brought into the country by travellers or purchased online.

* You can search for recalls and safety alerts through this link:

- http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php?cat=3

===3. '''Health Product Safety Information'''===
* Health Product Safety Information tools may also be familiar to healthcare professionals and industry:

* Health-related products in Canada must be safe and effective. Each drug product has information associated with it, and this information is easily accessible through the drugs and health products portion of the Health Canada website. In addition, Health Canada has specific guidelines for each product that includes providing clear directions and ensuring the proper labelling of products.

'''Product Monographs'''

*A Product Monograph is a factual, scientific document on a drug product that describes the properties, claims, indications, and conditions of use of the drug, and contains any other information that may be required for optimal, safe and effective use of the drug.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html

'''Directions for use/Product Labelling'''

*These are the directions and labels on each product.

'''The Drug and Health Product Register (DHPR)'''

*The DHPR was created to make information on health products available to Canadians.

- https://hpr-rps.hres.ca/index.php?lang=en

=== 4. '''Communications around Transparency/Transparency Initiatives for the Public'''===

* Transparency tools may also be familiar to healthcare professionals and industry:

*'''Summary Safety Reviews (SSRs)'''

*SSRs are Health Canada’s summaries of its safety reviews of products and drugs on the market. These are intended to provide greater transparency to Canadians. They are brief 3-page summaries that outline what was assessed, what was found and what action was taken by Health Canada, if any. These are found in the DHPR. Here is the link:

- https://hpr-rps.hres.ca/reg-content/summary-safety-review-result.php?lang=en&term=

'''New Safety and Effectiveness Reviews'''

*Health Canada posts lists of new safety reviews to increase transparency with Canadians and inform them of the products and risks that Health Canada is assessing. Once a new safety and effectiveness review is completed, an SSR (see above) is published to inform Canadians of what was found and what action was taken by Health Canada, if any.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/safety-reviews/new.html

Medical Devices Online Incidents Database
The Medical Device Online Incidents Database is an online initiative for reporting adverse reactions to medical devices. It contains medical device incident reports and information regarding recalls in a user-friendly, searchable, online format. There is also a full data extract available for download.
https://hpr-rps.hres.ca/mdi_landing.php
MedEffect Canada
MedEffect Canada provides consumers, patients, and health professionals with an easy way to: report an adverse reaction or side effect; obtain new safety information on drugs and other health products; and, learn and better understand the importance of reporting side effects.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html
Canada Vigilance Adverse Reaction Online Database
The Canada Vigilance Adverse Reaction Online Database contains information about suspected adverse drug reactions reported to Health Canada by consumers, health professionals and market authorization holders.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-database.html

Purchasing:Health Canada Communication Tools

2019-08-07T20:19:49Z

Johnt:

== '''Health Canada Communication Tools''' ==
''These four categories of communication tools include a few documents that may or may not be familiar to you. If the document is unfamiliar, you will have an opportunity to share this with the interviewer. We have provided links and descriptions for your reference.''
=== 1.''' Guidance and regulations (Guidance Documents, guidelines and all regulation-related communications)'''===
* Industry and other healthcare professionals have specific guidance and regulations they must adhere to in order to meet Health Canada’s requirements. If you are a healthcare professional, or represent industry, these may be familiar to you. Please see the links below for examples of such guidance.
- https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada.html then scroll down to Guidance Documents and Guidelines.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements-advertising/policies-guidance-documents.html for examples of advertising regulations.
=== 2.''' Risk communications'''===
* Risk Communication tools may also be familiar to healthcare professionals:
'''Canadian Medical Devices Sentinel Network Bulletin (CMDSNet)'''
* The CMDSNet issues a monthly bulletin to keep the members of the network aware of a number of items related to adverse events associated with medical devices. For instance: updates to the program, recent reports of adverse events, recent regulatory actions and outcomes which have resulted from their reports, lessons learned, highlighted issues, recently completed and upcoming safety reviews, and educational opportunities. A list of all reports submitted to the Network is also included with the monthly bulletin. '''The distribution of the bulletin and list of reports is limited to Health Canada and those in the CMDSNet, and are not to be distributed beyond the Network, and therefore, no example is provided.'''
* For more information:
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/medeffect-canada-canadian-medical-devices-sentinel-network-pilot-project.html

'''Annual Trends Report'''
* The primary objective of the Annual Trends Report is to provide the numbers and trends of adverse drug reaction case reports and medical device incident reports to Health Canada on an annual basis. The data are based on reports submitted to Health Canada through the Canada Vigilance Adverse Reaction Online Database (more below) for reporting adverse reactions to drugs, the CV-MDS (where people report problems with medical devices), and CMDSNet.

- https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/annual-trends-adverse-reaction-case-reports-health-products-medical-device-problem-incidents.html

'''Health Product InfoWatch'''
This is a Health Canada monthly publication to raise awareness and to provide clinically relevant information to healthcare professionals concerning marketed health products and their safety. In some cases, information is intended to stimulate reporting of similar adverse reactions.

-https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/health-product-infowatch.html

'''Recalls and Safety Alerts'''

* Health Canada sometimes needs to recall a product that is on the market, or issue a safety alert. There are several ways these recalls and safety notices are communicated. These are detailed below.
a) Health Product Risk Communications (HPRC’s): Includes three types of communications
o Dear Healthcare Professional Letter (DHCPL);
o Public communication; and,
o Notice to hospitals. (Type I risk: 48 hours - Type II risk 2-10 days). Communications are targeted to healthcare professionals, mainly written by industry and endorsed by Health Canada.
b) Information Updates: Health Canada’s communication for less urgent risk issues, e.g., some labelling updates, can take anywhere from 2-3 days to a week or more.
c) Public advisory: Health Canada’s communication to warn the public of a potential hazard.
d) Recall notice: This communication is written and distributed by Industry. An “extract” of the information is posted by Health Canada at regular intervals on Health Canada’s Recalls and Safety Alerts website link (see below).
e) Foreign product alert: Health Canada’s communication related to unauthorized products from other countries which may have been brought into the country by travellers or purchased online.

* You can search for recalls and safety alerts through this link:

- http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php?cat=3

===3. '''Health Product Safety Information'''===
* Health Product Safety Information tools may also be familiar to healthcare professionals and industry:

* Health-related products in Canada must be safe and effective. Each drug product has information associated with it, and this information is easily accessible through the drugs and health products portion of the Health Canada website. In addition, Health Canada has specific guidelines for each product that includes providing clear directions and ensuring the proper labelling of products.

'''Product Monographs'''

*A Product Monograph is a factual, scientific document on a drug product that describes the properties, claims, indications, and conditions of use of the drug, and contains any other information that may be required for optimal, safe and effective use of the drug.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html

'''Directions for use/Product Labelling'''

*These are the directions and labels on each product.

'''The Drug and Health Product Register (DHPR)'''

*The DHPR was created to make information on health products available to Canadians.

- https://hpr-rps.hres.ca/index.php?lang=en

=== 4. '''Communications around Transparency/Transparency Initiatives for the Public'''===

* Transparency tools may also be familiar to healthcare professionals and industry:

*'''Summary Safety Reviews (SSRs)'''

*SSRs are Health Canada’s summaries of its safety reviews of products and drugs on the market. These are intended to provide greater transparency to Canadians. They are brief 3-page summaries that outline what was assessed, what was found and what action was taken by Health Canada, if any. These are found in the DHPR. Here is the link:

- https://hpr-rps.hres.ca/reg-content/summary-safety-review-result.php?lang=en&term=

'''New Safety and Effectiveness Reviews'''

*Health Canada posts lists of new safety reviews to increase transparency with Canadians and inform them of the products and risks that Health Canada is assessing. Once a new safety and effectiveness review is completed, an SSR (see above) is published to inform Canadians of what was found and what action was taken by Health Canada, if any.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/safety-reviews/new.html

Medical Devices Online Incidents Database
The Medical Device Online Incidents Database is an online initiative for reporting adverse reactions to medical devices. It contains medical device incident reports and information regarding recalls in a user-friendly, searchable, online format. There is also a full data extract available for download.
https://hpr-rps.hres.ca/mdi_landing.php
MedEffect Canada
MedEffect Canada provides consumers, patients, and health professionals with an easy way to: report an adverse reaction or side effect; obtain new safety information on drugs and other health products; and, learn and better understand the importance of reporting side effects.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html
Canada Vigilance Adverse Reaction Online Database
The Canada Vigilance Adverse Reaction Online Database contains information about suspected adverse drug reactions reported to Health Canada by consumers, health professionals and market authorization holders.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-database.html

Purchasing:Health Canada Communication Tools

2019-08-07T20:18:47Z

Johnt:

== '''Health Canada Communication Tools''' ==
''These four categories of communication tools include a few documents that may or may not be familiar to you. If the document is unfamiliar, you will have an opportunity to share this with the interviewer. We have provided links and descriptions for your reference.''
=== 1.''' Guidance and regulations (Guidance Documents, guidelines and all regulation-related communications)'''===
* Industry and other healthcare professionals have specific guidance and regulations they must adhere to in order to meet Health Canada’s requirements. If you are a healthcare professional, or represent industry, these may be familiar to you. Please see the links below for examples of such guidance.
- https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada.html then scroll down to Guidance Documents and Guidelines.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements-advertising/policies-guidance-documents.html for examples of advertising regulations.
=== 2.''' Risk communications'''===
Risk Communication tools may also be familiar to healthcare professionals:
'''Canadian Medical Devices Sentinel Network Bulletin (CMDSNet)'''
* The CMDSNet issues a monthly bulletin to keep the members of the network aware of a number of items related to adverse events associated with medical devices. For instance: updates to the program, recent reports of adverse events, recent regulatory actions and outcomes which have resulted from their reports, lessons learned, highlighted issues, recently completed and upcoming safety reviews, and educational opportunities. A list of all reports submitted to the Network is also included with the monthly bulletin. '''The distribution of the bulletin and list of reports is limited to Health Canada and those in the CMDSNet, and are not to be distributed beyond the Network, and therefore, no example is provided.'''
* For more information:
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/medeffect-canada-canadian-medical-devices-sentinel-network-pilot-project.html

'''Annual Trends Report'''
* The primary objective of the Annual Trends Report is to provide the numbers and trends of adverse drug reaction case reports and medical device incident reports to Health Canada on an annual basis. The data are based on reports submitted to Health Canada through the Canada Vigilance Adverse Reaction Online Database (more below) for reporting adverse reactions to drugs, the CV-MDS (where people report problems with medical devices), and CMDSNet.

- https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/annual-trends-adverse-reaction-case-reports-health-products-medical-device-problem-incidents.html

'''Health Product InfoWatch'''
This is a Health Canada monthly publication to raise awareness and to provide clinically relevant information to healthcare professionals concerning marketed health products and their safety. In some cases, information is intended to stimulate reporting of similar adverse reactions.

-https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/health-product-infowatch.html

'''Recalls and Safety Alerts'''

* Health Canada sometimes needs to recall a product that is on the market, or issue a safety alert. There are several ways these recalls and safety notices are communicated. These are detailed below.
a) Health Product Risk Communications (HPRC’s): Includes three types of communications
o Dear Healthcare Professional Letter (DHCPL);
o Public communication; and,
o Notice to hospitals. (Type I risk: 48 hours - Type II risk 2-10 days). Communications are targeted to healthcare professionals, mainly written by industry and endorsed by Health Canada.
b) Information Updates: Health Canada’s communication for less urgent risk issues, e.g., some labelling updates, can take anywhere from 2-3 days to a week or more.
c) Public advisory: Health Canada’s communication to warn the public of a potential hazard.
d) Recall notice: This communication is written and distributed by Industry. An “extract” of the information is posted by Health Canada at regular intervals on Health Canada’s Recalls and Safety Alerts website link (see below).
e) Foreign product alert: Health Canada’s communication related to unauthorized products from other countries which may have been brought into the country by travellers or purchased online.

* You can search for recalls and safety alerts through this link:

- http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php?cat=3

===3. '''Health Product Safety Information'''===
* Health Product Safety Information tools may also be familiar to healthcare professionals and industry:

* Health-related products in Canada must be safe and effective. Each drug product has information associated with it, and this information is easily accessible through the drugs and health products portion of the Health Canada website. In addition, Health Canada has specific guidelines for each product that includes providing clear directions and ensuring the proper labelling of products.

'''Product Monographs'''

*A Product Monograph is a factual, scientific document on a drug product that describes the properties, claims, indications, and conditions of use of the drug, and contains any other information that may be required for optimal, safe and effective use of the drug.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html

'''Directions for use/Product Labelling'''

*These are the directions and labels on each product.

'''The Drug and Health Product Register (DHPR)'''

*The DHPR was created to make information on health products available to Canadians.

- https://hpr-rps.hres.ca/index.php?lang=en

=== 4. '''Communications around Transparency/Transparency Initiatives for the Public'''===

* Transparency tools may also be familiar to healthcare professionals and industry:

*'''Summary Safety Reviews (SSRs)'''

*SSRs are Health Canada’s summaries of its safety reviews of products and drugs on the market. These are intended to provide greater transparency to Canadians. They are brief 3-page summaries that outline what was assessed, what was found and what action was taken by Health Canada, if any. These are found in the DHPR. Here is the link:

- https://hpr-rps.hres.ca/reg-content/summary-safety-review-result.php?lang=en&term=

'''New Safety and Effectiveness Reviews'''

*Health Canada posts lists of new safety reviews to increase transparency with Canadians and inform them of the products and risks that Health Canada is assessing. Once a new safety and effectiveness review is completed, an SSR (see above) is published to inform Canadians of what was found and what action was taken by Health Canada, if any.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/safety-reviews/new.html

Medical Devices Online Incidents Database
The Medical Device Online Incidents Database is an online initiative for reporting adverse reactions to medical devices. It contains medical device incident reports and information regarding recalls in a user-friendly, searchable, online format. There is also a full data extract available for download.
https://hpr-rps.hres.ca/mdi_landing.php
MedEffect Canada
MedEffect Canada provides consumers, patients, and health professionals with an easy way to: report an adverse reaction or side effect; obtain new safety information on drugs and other health products; and, learn and better understand the importance of reporting side effects.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html
Canada Vigilance Adverse Reaction Online Database
The Canada Vigilance Adverse Reaction Online Database contains information about suspected adverse drug reactions reported to Health Canada by consumers, health professionals and market authorization holders.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-database.html

Purchasing:Health Canada Communication Tools

2019-08-07T20:16:23Z

Johnt: /* 1.Guidance and regulations (Guidance Documents, guidelines and all regulation-related communications) */

== '''Health Canada Communication Tools''' ==
''These four categories of communication tools include a few documents that may or may not be familiar to you. If the document is unfamiliar, you will have an opportunity to share this with the interviewer. We have provided links and descriptions for your reference.''
=== 1.''' Guidance and regulations (Guidance Documents, guidelines and all regulation-related communications)'''===
* Industry and other healthcare professionals have specific guidance and regulations they must adhere to in order to meet Health Canada’s requirements. If you are a healthcare professional, or represent industry, these may be familiar to you. Please see the links below for examples of such guidance.
- https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada.html then scroll down to Guidance Documents and Guidelines.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements-advertising/policies-guidance-documents.html for examples of advertising regulations.
#'''Risk communications'''
Risk Communication tools may also be familiar to healthcare professionals:
'''Canadian Medical Devices Sentinel Network Bulletin (CMDSNet)'''
* The CMDSNet issues a monthly bulletin to keep the members of the network aware of a number of items related to adverse events associated with medical devices. For instance: updates to the program, recent reports of adverse events, recent regulatory actions and outcomes which have resulted from their reports, lessons learned, highlighted issues, recently completed and upcoming safety reviews, and educational opportunities. A list of all reports submitted to the Network is also included with the monthly bulletin. '''The distribution of the bulletin and list of reports is limited to Health Canada and those in the CMDSNet, and are not to be distributed beyond the Network, and therefore, no example is provided.'''
* For more information:
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/medeffect-canada-canadian-medical-devices-sentinel-network-pilot-project.html

'''Annual Trends Report'''
* The primary objective of the Annual Trends Report is to provide the numbers and trends of adverse drug reaction case reports and medical device incident reports to Health Canada on an annual basis. The data are based on reports submitted to Health Canada through the Canada Vigilance Adverse Reaction Online Database (more below) for reporting adverse reactions to drugs, the CV-MDS (where people report problems with medical devices), and CMDSNet.

- https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/annual-trends-adverse-reaction-case-reports-health-products-medical-device-problem-incidents.html

'''Health Product InfoWatch'''
This is a Health Canada monthly publication to raise awareness and to provide clinically relevant information to healthcare professionals concerning marketed health products and their safety. In some cases, information is intended to stimulate reporting of similar adverse reactions.

-https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/health-product-infowatch.html

'''Recalls and Safety Alerts'''

* Health Canada sometimes needs to recall a product that is on the market, or issue a safety alert. There are several ways these recalls and safety notices are communicated. These are detailed below.
a) Health Product Risk Communications (HPRC’s): Includes three types of communications
o Dear Healthcare Professional Letter (DHCPL);
o Public communication; and,
o Notice to hospitals. (Type I risk: 48 hours - Type II risk 2-10 days). Communications are targeted to healthcare professionals, mainly written by industry and endorsed by Health Canada.
b) Information Updates: Health Canada’s communication for less urgent risk issues, e.g., some labelling updates, can take anywhere from 2-3 days to a week or more.
c) Public advisory: Health Canada’s communication to warn the public of a potential hazard.
d) Recall notice: This communication is written and distributed by Industry. An “extract” of the information is posted by Health Canada at regular intervals on Health Canada’s Recalls and Safety Alerts website link (see below).
e) Foreign product alert: Health Canada’s communication related to unauthorized products from other countries which may have been brought into the country by travellers or purchased online.

* You can search for recalls and safety alerts through this link:

- http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php?cat=3

#'''Health Product Safety Information'''
* Health Product Safety Information tools may also be familiar to healthcare professionals and industry:

* Health-related products in Canada must be safe and effective. Each drug product has information associated with it, and this information is easily accessible through the drugs and health products portion of the Health Canada website. In addition, Health Canada has specific guidelines for each product that includes providing clear directions and ensuring the proper labelling of products.

'''Product Monographs'''

*A Product Monograph is a factual, scientific document on a drug product that describes the properties, claims, indications, and conditions of use of the drug, and contains any other information that may be required for optimal, safe and effective use of the drug.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html

'''Directions for use/Product Labelling'''

*These are the directions and labels on each product.

'''The Drug and Health Product Register (DHPR)'''

*The DHPR was created to make information on health products available to Canadians.

- https://hpr-rps.hres.ca/index.php?lang=en

#'''Communications around Transparency/Transparency Initiatives for the Public'''

* Transparency tools may also be familiar to healthcare professionals and industry:

*'''Summary Safety Reviews (SSRs)'''

*SSRs are Health Canada’s summaries of its safety reviews of products and drugs on the market. These are intended to provide greater transparency to Canadians. They are brief 3-page summaries that outline what was assessed, what was found and what action was taken by Health Canada, if any. These are found in the DHPR. Here is the link:

- https://hpr-rps.hres.ca/reg-content/summary-safety-review-result.php?lang=en&term=

'''New Safety and Effectiveness Reviews'''

*Health Canada posts lists of new safety reviews to increase transparency with Canadians and inform them of the products and risks that Health Canada is assessing. Once a new safety and effectiveness review is completed, an SSR (see above) is published to inform Canadians of what was found and what action was taken by Health Canada, if any.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/safety-reviews/new.html

Medical Devices Online Incidents Database
The Medical Device Online Incidents Database is an online initiative for reporting adverse reactions to medical devices. It contains medical device incident reports and information regarding recalls in a user-friendly, searchable, online format. There is also a full data extract available for download.
https://hpr-rps.hres.ca/mdi_landing.php
MedEffect Canada
MedEffect Canada provides consumers, patients, and health professionals with an easy way to: report an adverse reaction or side effect; obtain new safety information on drugs and other health products; and, learn and better understand the importance of reporting side effects.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html
Canada Vigilance Adverse Reaction Online Database
The Canada Vigilance Adverse Reaction Online Database contains information about suspected adverse drug reactions reported to Health Canada by consumers, health professionals and market authorization holders.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-database.html

Purchasing:Health Canada Communication Tools

2019-08-07T20:16:07Z

Johnt: /* #Guidance and regulations (Guidance Documents, guidelines and all regulation-related communications) */

== '''Health Canada Communication Tools''' ==
''These four categories of communication tools include a few documents that may or may not be familiar to you. If the document is unfamiliar, you will have an opportunity to share this with the interviewer. We have provided links and descriptions for your reference.''
=== 1.'''Guidance and regulations (Guidance Documents, guidelines and all regulation-related communications)'''===
* Industry and other healthcare professionals have specific guidance and regulations they must adhere to in order to meet Health Canada’s requirements. If you are a healthcare professional, or represent industry, these may be familiar to you. Please see the links below for examples of such guidance.
- https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada.html then scroll down to Guidance Documents and Guidelines.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements-advertising/policies-guidance-documents.html for examples of advertising regulations.
#'''Risk communications'''
Risk Communication tools may also be familiar to healthcare professionals:
'''Canadian Medical Devices Sentinel Network Bulletin (CMDSNet)'''
* The CMDSNet issues a monthly bulletin to keep the members of the network aware of a number of items related to adverse events associated with medical devices. For instance: updates to the program, recent reports of adverse events, recent regulatory actions and outcomes which have resulted from their reports, lessons learned, highlighted issues, recently completed and upcoming safety reviews, and educational opportunities. A list of all reports submitted to the Network is also included with the monthly bulletin. '''The distribution of the bulletin and list of reports is limited to Health Canada and those in the CMDSNet, and are not to be distributed beyond the Network, and therefore, no example is provided.'''
* For more information:
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/medeffect-canada-canadian-medical-devices-sentinel-network-pilot-project.html

'''Annual Trends Report'''
* The primary objective of the Annual Trends Report is to provide the numbers and trends of adverse drug reaction case reports and medical device incident reports to Health Canada on an annual basis. The data are based on reports submitted to Health Canada through the Canada Vigilance Adverse Reaction Online Database (more below) for reporting adverse reactions to drugs, the CV-MDS (where people report problems with medical devices), and CMDSNet.

- https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/annual-trends-adverse-reaction-case-reports-health-products-medical-device-problem-incidents.html

'''Health Product InfoWatch'''
This is a Health Canada monthly publication to raise awareness and to provide clinically relevant information to healthcare professionals concerning marketed health products and their safety. In some cases, information is intended to stimulate reporting of similar adverse reactions.

-https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/health-product-infowatch.html

'''Recalls and Safety Alerts'''

* Health Canada sometimes needs to recall a product that is on the market, or issue a safety alert. There are several ways these recalls and safety notices are communicated. These are detailed below.
a) Health Product Risk Communications (HPRC’s): Includes three types of communications
o Dear Healthcare Professional Letter (DHCPL);
o Public communication; and,
o Notice to hospitals. (Type I risk: 48 hours - Type II risk 2-10 days). Communications are targeted to healthcare professionals, mainly written by industry and endorsed by Health Canada.
b) Information Updates: Health Canada’s communication for less urgent risk issues, e.g., some labelling updates, can take anywhere from 2-3 days to a week or more.
c) Public advisory: Health Canada’s communication to warn the public of a potential hazard.
d) Recall notice: This communication is written and distributed by Industry. An “extract” of the information is posted by Health Canada at regular intervals on Health Canada’s Recalls and Safety Alerts website link (see below).
e) Foreign product alert: Health Canada’s communication related to unauthorized products from other countries which may have been brought into the country by travellers or purchased online.

* You can search for recalls and safety alerts through this link:

- http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php?cat=3

#'''Health Product Safety Information'''
* Health Product Safety Information tools may also be familiar to healthcare professionals and industry:

* Health-related products in Canada must be safe and effective. Each drug product has information associated with it, and this information is easily accessible through the drugs and health products portion of the Health Canada website. In addition, Health Canada has specific guidelines for each product that includes providing clear directions and ensuring the proper labelling of products.

'''Product Monographs'''

*A Product Monograph is a factual, scientific document on a drug product that describes the properties, claims, indications, and conditions of use of the drug, and contains any other information that may be required for optimal, safe and effective use of the drug.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html

'''Directions for use/Product Labelling'''

*These are the directions and labels on each product.

'''The Drug and Health Product Register (DHPR)'''

*The DHPR was created to make information on health products available to Canadians.

- https://hpr-rps.hres.ca/index.php?lang=en

#'''Communications around Transparency/Transparency Initiatives for the Public'''

* Transparency tools may also be familiar to healthcare professionals and industry:

*'''Summary Safety Reviews (SSRs)'''

*SSRs are Health Canada’s summaries of its safety reviews of products and drugs on the market. These are intended to provide greater transparency to Canadians. They are brief 3-page summaries that outline what was assessed, what was found and what action was taken by Health Canada, if any. These are found in the DHPR. Here is the link:

- https://hpr-rps.hres.ca/reg-content/summary-safety-review-result.php?lang=en&term=

'''New Safety and Effectiveness Reviews'''

*Health Canada posts lists of new safety reviews to increase transparency with Canadians and inform them of the products and risks that Health Canada is assessing. Once a new safety and effectiveness review is completed, an SSR (see above) is published to inform Canadians of what was found and what action was taken by Health Canada, if any.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/safety-reviews/new.html

Medical Devices Online Incidents Database
The Medical Device Online Incidents Database is an online initiative for reporting adverse reactions to medical devices. It contains medical device incident reports and information regarding recalls in a user-friendly, searchable, online format. There is also a full data extract available for download.
https://hpr-rps.hres.ca/mdi_landing.php
MedEffect Canada
MedEffect Canada provides consumers, patients, and health professionals with an easy way to: report an adverse reaction or side effect; obtain new safety information on drugs and other health products; and, learn and better understand the importance of reporting side effects.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html
Canada Vigilance Adverse Reaction Online Database
The Canada Vigilance Adverse Reaction Online Database contains information about suspected adverse drug reactions reported to Health Canada by consumers, health professionals and market authorization holders.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-database.html

Purchasing:Health Canada Communication Tools

2019-08-07T20:14:25Z

Johnt:

== '''Health Canada Communication Tools''' ==
''These four categories of communication tools include a few documents that may or may not be familiar to you. If the document is unfamiliar, you will have an opportunity to share this with the interviewer. We have provided links and descriptions for your reference.''
=== #'''Guidance and regulations (Guidance Documents, guidelines and all regulation-related communications)'''===
* Industry and other healthcare professionals have specific guidance and regulations they must adhere to in order to meet Health Canada’s requirements. If you are a healthcare professional, or represent industry, these may be familiar to you. Please see the links below for examples of such guidance.
- https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada.html then scroll down to Guidance Documents and Guidelines.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements-advertising/policies-guidance-documents.html for examples of advertising regulations.
#'''Risk communications'''
Risk Communication tools may also be familiar to healthcare professionals:
'''Canadian Medical Devices Sentinel Network Bulletin (CMDSNet)'''
* The CMDSNet issues a monthly bulletin to keep the members of the network aware of a number of items related to adverse events associated with medical devices. For instance: updates to the program, recent reports of adverse events, recent regulatory actions and outcomes which have resulted from their reports, lessons learned, highlighted issues, recently completed and upcoming safety reviews, and educational opportunities. A list of all reports submitted to the Network is also included with the monthly bulletin. '''The distribution of the bulletin and list of reports is limited to Health Canada and those in the CMDSNet, and are not to be distributed beyond the Network, and therefore, no example is provided.'''
* For more information:
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/medeffect-canada-canadian-medical-devices-sentinel-network-pilot-project.html

'''Annual Trends Report'''
* The primary objective of the Annual Trends Report is to provide the numbers and trends of adverse drug reaction case reports and medical device incident reports to Health Canada on an annual basis. The data are based on reports submitted to Health Canada through the Canada Vigilance Adverse Reaction Online Database (more below) for reporting adverse reactions to drugs, the CV-MDS (where people report problems with medical devices), and CMDSNet.

- https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/annual-trends-adverse-reaction-case-reports-health-products-medical-device-problem-incidents.html

'''Health Product InfoWatch'''
This is a Health Canada monthly publication to raise awareness and to provide clinically relevant information to healthcare professionals concerning marketed health products and their safety. In some cases, information is intended to stimulate reporting of similar adverse reactions.

-https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/health-product-infowatch.html

'''Recalls and Safety Alerts'''

* Health Canada sometimes needs to recall a product that is on the market, or issue a safety alert. There are several ways these recalls and safety notices are communicated. These are detailed below.
a) Health Product Risk Communications (HPRC’s): Includes three types of communications
o Dear Healthcare Professional Letter (DHCPL);
o Public communication; and,
o Notice to hospitals. (Type I risk: 48 hours - Type II risk 2-10 days). Communications are targeted to healthcare professionals, mainly written by industry and endorsed by Health Canada.
b) Information Updates: Health Canada’s communication for less urgent risk issues, e.g., some labelling updates, can take anywhere from 2-3 days to a week or more.
c) Public advisory: Health Canada’s communication to warn the public of a potential hazard.
d) Recall notice: This communication is written and distributed by Industry. An “extract” of the information is posted by Health Canada at regular intervals on Health Canada’s Recalls and Safety Alerts website link (see below).
e) Foreign product alert: Health Canada’s communication related to unauthorized products from other countries which may have been brought into the country by travellers or purchased online.

* You can search for recalls and safety alerts through this link:

- http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php?cat=3

#'''Health Product Safety Information'''
* Health Product Safety Information tools may also be familiar to healthcare professionals and industry:

* Health-related products in Canada must be safe and effective. Each drug product has information associated with it, and this information is easily accessible through the drugs and health products portion of the Health Canada website. In addition, Health Canada has specific guidelines for each product that includes providing clear directions and ensuring the proper labelling of products.

'''Product Monographs'''

*A Product Monograph is a factual, scientific document on a drug product that describes the properties, claims, indications, and conditions of use of the drug, and contains any other information that may be required for optimal, safe and effective use of the drug.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html

'''Directions for use/Product Labelling'''

*These are the directions and labels on each product.

'''The Drug and Health Product Register (DHPR)'''

*The DHPR was created to make information on health products available to Canadians.

- https://hpr-rps.hres.ca/index.php?lang=en

#'''Communications around Transparency/Transparency Initiatives for the Public'''

* Transparency tools may also be familiar to healthcare professionals and industry:

*'''Summary Safety Reviews (SSRs)'''

*SSRs are Health Canada’s summaries of its safety reviews of products and drugs on the market. These are intended to provide greater transparency to Canadians. They are brief 3-page summaries that outline what was assessed, what was found and what action was taken by Health Canada, if any. These are found in the DHPR. Here is the link:

- https://hpr-rps.hres.ca/reg-content/summary-safety-review-result.php?lang=en&term=

'''New Safety and Effectiveness Reviews'''

*Health Canada posts lists of new safety reviews to increase transparency with Canadians and inform them of the products and risks that Health Canada is assessing. Once a new safety and effectiveness review is completed, an SSR (see above) is published to inform Canadians of what was found and what action was taken by Health Canada, if any.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/safety-reviews/new.html

Medical Devices Online Incidents Database
The Medical Device Online Incidents Database is an online initiative for reporting adverse reactions to medical devices. It contains medical device incident reports and information regarding recalls in a user-friendly, searchable, online format. There is also a full data extract available for download.
https://hpr-rps.hres.ca/mdi_landing.php
MedEffect Canada
MedEffect Canada provides consumers, patients, and health professionals with an easy way to: report an adverse reaction or side effect; obtain new safety information on drugs and other health products; and, learn and better understand the importance of reporting side effects.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html
Canada Vigilance Adverse Reaction Online Database
The Canada Vigilance Adverse Reaction Online Database contains information about suspected adverse drug reactions reported to Health Canada by consumers, health professionals and market authorization holders.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-database.html

Purchasing:Health Canada Communication Tools

2019-08-07T20:14:10Z

Johnt:

== '''Health Canada Communication Tools''' ==
''These four categories of communication tools include a few documents that may or may not be familiar to you. If the document is unfamiliar, you will have an opportunity to share this with the interviewer. We have provided links and descriptions for your reference.''
===#'''Guidance and regulations (Guidance Documents, guidelines and all regulation-related communications)'''===
* Industry and other healthcare professionals have specific guidance and regulations they must adhere to in order to meet Health Canada’s requirements. If you are a healthcare professional, or represent industry, these may be familiar to you. Please see the links below for examples of such guidance.
- https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada.html then scroll down to Guidance Documents and Guidelines.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements-advertising/policies-guidance-documents.html for examples of advertising regulations.
#'''Risk communications'''
Risk Communication tools may also be familiar to healthcare professionals:
'''Canadian Medical Devices Sentinel Network Bulletin (CMDSNet)'''
* The CMDSNet issues a monthly bulletin to keep the members of the network aware of a number of items related to adverse events associated with medical devices. For instance: updates to the program, recent reports of adverse events, recent regulatory actions and outcomes which have resulted from their reports, lessons learned, highlighted issues, recently completed and upcoming safety reviews, and educational opportunities. A list of all reports submitted to the Network is also included with the monthly bulletin. '''The distribution of the bulletin and list of reports is limited to Health Canada and those in the CMDSNet, and are not to be distributed beyond the Network, and therefore, no example is provided.'''
* For more information:
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/medeffect-canada-canadian-medical-devices-sentinel-network-pilot-project.html

'''Annual Trends Report'''
* The primary objective of the Annual Trends Report is to provide the numbers and trends of adverse drug reaction case reports and medical device incident reports to Health Canada on an annual basis. The data are based on reports submitted to Health Canada through the Canada Vigilance Adverse Reaction Online Database (more below) for reporting adverse reactions to drugs, the CV-MDS (where people report problems with medical devices), and CMDSNet.

- https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/annual-trends-adverse-reaction-case-reports-health-products-medical-device-problem-incidents.html

'''Health Product InfoWatch'''
This is a Health Canada monthly publication to raise awareness and to provide clinically relevant information to healthcare professionals concerning marketed health products and their safety. In some cases, information is intended to stimulate reporting of similar adverse reactions.

-https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/health-product-infowatch.html

'''Recalls and Safety Alerts'''

* Health Canada sometimes needs to recall a product that is on the market, or issue a safety alert. There are several ways these recalls and safety notices are communicated. These are detailed below.
a) Health Product Risk Communications (HPRC’s): Includes three types of communications
o Dear Healthcare Professional Letter (DHCPL);
o Public communication; and,
o Notice to hospitals. (Type I risk: 48 hours - Type II risk 2-10 days). Communications are targeted to healthcare professionals, mainly written by industry and endorsed by Health Canada.
b) Information Updates: Health Canada’s communication for less urgent risk issues, e.g., some labelling updates, can take anywhere from 2-3 days to a week or more.
c) Public advisory: Health Canada’s communication to warn the public of a potential hazard.
d) Recall notice: This communication is written and distributed by Industry. An “extract” of the information is posted by Health Canada at regular intervals on Health Canada’s Recalls and Safety Alerts website link (see below).
e) Foreign product alert: Health Canada’s communication related to unauthorized products from other countries which may have been brought into the country by travellers or purchased online.

* You can search for recalls and safety alerts through this link:

- http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php?cat=3

#'''Health Product Safety Information'''
* Health Product Safety Information tools may also be familiar to healthcare professionals and industry:

* Health-related products in Canada must be safe and effective. Each drug product has information associated with it, and this information is easily accessible through the drugs and health products portion of the Health Canada website. In addition, Health Canada has specific guidelines for each product that includes providing clear directions and ensuring the proper labelling of products.

'''Product Monographs'''

*A Product Monograph is a factual, scientific document on a drug product that describes the properties, claims, indications, and conditions of use of the drug, and contains any other information that may be required for optimal, safe and effective use of the drug.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html

'''Directions for use/Product Labelling'''

*These are the directions and labels on each product.

'''The Drug and Health Product Register (DHPR)'''

*The DHPR was created to make information on health products available to Canadians.

- https://hpr-rps.hres.ca/index.php?lang=en

#'''Communications around Transparency/Transparency Initiatives for the Public'''

* Transparency tools may also be familiar to healthcare professionals and industry:

*'''Summary Safety Reviews (SSRs)'''

*SSRs are Health Canada’s summaries of its safety reviews of products and drugs on the market. These are intended to provide greater transparency to Canadians. They are brief 3-page summaries that outline what was assessed, what was found and what action was taken by Health Canada, if any. These are found in the DHPR. Here is the link:

- https://hpr-rps.hres.ca/reg-content/summary-safety-review-result.php?lang=en&term=

'''New Safety and Effectiveness Reviews'''

*Health Canada posts lists of new safety reviews to increase transparency with Canadians and inform them of the products and risks that Health Canada is assessing. Once a new safety and effectiveness review is completed, an SSR (see above) is published to inform Canadians of what was found and what action was taken by Health Canada, if any.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/safety-reviews/new.html

Medical Devices Online Incidents Database
The Medical Device Online Incidents Database is an online initiative for reporting adverse reactions to medical devices. It contains medical device incident reports and information regarding recalls in a user-friendly, searchable, online format. There is also a full data extract available for download.
https://hpr-rps.hres.ca/mdi_landing.php
MedEffect Canada
MedEffect Canada provides consumers, patients, and health professionals with an easy way to: report an adverse reaction or side effect; obtain new safety information on drugs and other health products; and, learn and better understand the importance of reporting side effects.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html
Canada Vigilance Adverse Reaction Online Database
The Canada Vigilance Adverse Reaction Online Database contains information about suspected adverse drug reactions reported to Health Canada by consumers, health professionals and market authorization holders.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-database.html

Purchasing:Health Canada Communication Tools

2019-08-07T20:13:29Z

Johnt:

== '''Health Canada Communication Tools''' ==
''These four categories of communication tools include a few documents that may or may not be familiar to you. If the document is unfamiliar, you will have an opportunity to share this with the interviewer. We have provided links and descriptions for your reference.''
#'''Guidance and regulations (Guidance Documents, guidelines and all regulation-related communications)'''
* Industry and other healthcare professionals have specific guidance and regulations they must adhere to in order to meet Health Canada’s requirements. If you are a healthcare professional, or represent industry, these may be familiar to you. Please see the links below for examples of such guidance.
- https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada.html then scroll down to Guidance Documents and Guidelines.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements-advertising/policies-guidance-documents.html for examples of advertising regulations.
#'''Risk communications'''
Risk Communication tools may also be familiar to healthcare professionals:
'''Canadian Medical Devices Sentinel Network Bulletin (CMDSNet)'''
* The CMDSNet issues a monthly bulletin to keep the members of the network aware of a number of items related to adverse events associated with medical devices. For instance: updates to the program, recent reports of adverse events, recent regulatory actions and outcomes which have resulted from their reports, lessons learned, highlighted issues, recently completed and upcoming safety reviews, and educational opportunities. A list of all reports submitted to the Network is also included with the monthly bulletin. '''The distribution of the bulletin and list of reports is limited to Health Canada and those in the CMDSNet, and are not to be distributed beyond the Network, and therefore, no example is provided.'''
* For more information:
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/medeffect-canada-canadian-medical-devices-sentinel-network-pilot-project.html

'''Annual Trends Report'''
* The primary objective of the Annual Trends Report is to provide the numbers and trends of adverse drug reaction case reports and medical device incident reports to Health Canada on an annual basis. The data are based on reports submitted to Health Canada through the Canada Vigilance Adverse Reaction Online Database (more below) for reporting adverse reactions to drugs, the CV-MDS (where people report problems with medical devices), and CMDSNet.

- https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/annual-trends-adverse-reaction-case-reports-health-products-medical-device-problem-incidents.html

'''Health Product InfoWatch'''
This is a Health Canada monthly publication to raise awareness and to provide clinically relevant information to healthcare professionals concerning marketed health products and their safety. In some cases, information is intended to stimulate reporting of similar adverse reactions.

-https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/health-product-infowatch.html

'''Recalls and Safety Alerts'''

* Health Canada sometimes needs to recall a product that is on the market, or issue a safety alert. There are several ways these recalls and safety notices are communicated. These are detailed below.
a) Health Product Risk Communications (HPRC’s): Includes three types of communications
o Dear Healthcare Professional Letter (DHCPL);
o Public communication; and,
o Notice to hospitals. (Type I risk: 48 hours - Type II risk 2-10 days). Communications are targeted to healthcare professionals, mainly written by industry and endorsed by Health Canada.
b) Information Updates: Health Canada’s communication for less urgent risk issues, e.g., some labelling updates, can take anywhere from 2-3 days to a week or more.
c) Public advisory: Health Canada’s communication to warn the public of a potential hazard.
d) Recall notice: This communication is written and distributed by Industry. An “extract” of the information is posted by Health Canada at regular intervals on Health Canada’s Recalls and Safety Alerts website link (see below).
e) Foreign product alert: Health Canada’s communication related to unauthorized products from other countries which may have been brought into the country by travellers or purchased online.

* You can search for recalls and safety alerts through this link:

- http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php?cat=3

#'''Health Product Safety Information'''
* Health Product Safety Information tools may also be familiar to healthcare professionals and industry:

* Health-related products in Canada must be safe and effective. Each drug product has information associated with it, and this information is easily accessible through the drugs and health products portion of the Health Canada website. In addition, Health Canada has specific guidelines for each product that includes providing clear directions and ensuring the proper labelling of products.

'''Product Monographs'''

*A Product Monograph is a factual, scientific document on a drug product that describes the properties, claims, indications, and conditions of use of the drug, and contains any other information that may be required for optimal, safe and effective use of the drug.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html

'''Directions for use/Product Labelling'''

*These are the directions and labels on each product.

'''The Drug and Health Product Register (DHPR)'''

*The DHPR was created to make information on health products available to Canadians.

- https://hpr-rps.hres.ca/index.php?lang=en

#'''Communications around Transparency/Transparency Initiatives for the Public'''

* Transparency tools may also be familiar to healthcare professionals and industry:

*'''Summary Safety Reviews (SSRs)'''

*SSRs are Health Canada’s summaries of its safety reviews of products and drugs on the market. These are intended to provide greater transparency to Canadians. They are brief 3-page summaries that outline what was assessed, what was found and what action was taken by Health Canada, if any. These are found in the DHPR. Here is the link:

- https://hpr-rps.hres.ca/reg-content/summary-safety-review-result.php?lang=en&term=

'''New Safety and Effectiveness Reviews'''

*Health Canada posts lists of new safety reviews to increase transparency with Canadians and inform them of the products and risks that Health Canada is assessing. Once a new safety and effectiveness review is completed, an SSR (see above) is published to inform Canadians of what was found and what action was taken by Health Canada, if any.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/safety-reviews/new.html

Medical Devices Online Incidents Database
The Medical Device Online Incidents Database is an online initiative for reporting adverse reactions to medical devices. It contains medical device incident reports and information regarding recalls in a user-friendly, searchable, online format. There is also a full data extract available for download.
https://hpr-rps.hres.ca/mdi_landing.php
MedEffect Canada
MedEffect Canada provides consumers, patients, and health professionals with an easy way to: report an adverse reaction or side effect; obtain new safety information on drugs and other health products; and, learn and better understand the importance of reporting side effects.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html
Canada Vigilance Adverse Reaction Online Database
The Canada Vigilance Adverse Reaction Online Database contains information about suspected adverse drug reactions reported to Health Canada by consumers, health professionals and market authorization holders.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-database.html

Purchasing:Health Canada Communication Tools

2019-08-07T19:02:24Z

Johnt:

'''Health Canada Communication Tools'''
''These four categories of communication tools include a few documents that may or may not be familiar to you. If the document is unfamiliar, you will have an opportunity to share this with the interviewer. We have provided links and descriptions for your reference.''
#'''Guidance and regulations (Guidance Documents, guidelines and all regulation-related communications)'''
* Industry and other healthcare professionals have specific guidance and regulations they must adhere to in order to meet Health Canada’s requirements. If you are a healthcare professional, or represent industry, these may be familiar to you. Please see the links below for examples of such guidance.
- https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada.html then scroll down to Guidance Documents and Guidelines.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements-advertising/policies-guidance-documents.html for examples of advertising regulations.
#'''Risk communications'''
Risk Communication tools may also be familiar to healthcare professionals:
'''Canadian Medical Devices Sentinel Network Bulletin (CMDSNet)'''
* The CMDSNet issues a monthly bulletin to keep the members of the network aware of a number of items related to adverse events associated with medical devices. For instance: updates to the program, recent reports of adverse events, recent regulatory actions and outcomes which have resulted from their reports, lessons learned, highlighted issues, recently completed and upcoming safety reviews, and educational opportunities. A list of all reports submitted to the Network is also included with the monthly bulletin. '''The distribution of the bulletin and list of reports is limited to Health Canada and those in the CMDSNet, and are not to be distributed beyond the Network, and therefore, no example is provided.'''
* For more information:
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/medeffect-canada-canadian-medical-devices-sentinel-network-pilot-project.html

'''Annual Trends Report'''
* The primary objective of the Annual Trends Report is to provide the numbers and trends of adverse drug reaction case reports and medical device incident reports to Health Canada on an annual basis. The data are based on reports submitted to Health Canada through the Canada Vigilance Adverse Reaction Online Database (more below) for reporting adverse reactions to drugs, the CV-MDS (where people report problems with medical devices), and CMDSNet.

- https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/annual-trends-adverse-reaction-case-reports-health-products-medical-device-problem-incidents.html

'''Health Product InfoWatch'''
This is a Health Canada monthly publication to raise awareness and to provide clinically relevant information to healthcare professionals concerning marketed health products and their safety. In some cases, information is intended to stimulate reporting of similar adverse reactions.

-https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/health-product-infowatch.html

'''Recalls and Safety Alerts'''

* Health Canada sometimes needs to recall a product that is on the market, or issue a safety alert. There are several ways these recalls and safety notices are communicated. These are detailed below.
a) Health Product Risk Communications (HPRC’s): Includes three types of communications
o Dear Healthcare Professional Letter (DHCPL);
o Public communication; and,
o Notice to hospitals. (Type I risk: 48 hours - Type II risk 2-10 days). Communications are targeted to healthcare professionals, mainly written by industry and endorsed by Health Canada.
b) Information Updates: Health Canada’s communication for less urgent risk issues, e.g., some labelling updates, can take anywhere from 2-3 days to a week or more.
c) Public advisory: Health Canada’s communication to warn the public of a potential hazard.
d) Recall notice: This communication is written and distributed by Industry. An “extract” of the information is posted by Health Canada at regular intervals on Health Canada’s Recalls and Safety Alerts website link (see below).
e) Foreign product alert: Health Canada’s communication related to unauthorized products from other countries which may have been brought into the country by travellers or purchased online.

* You can search for recalls and safety alerts through this link:

- http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php?cat=3

#'''Health Product Safety Information'''
* Health Product Safety Information tools may also be familiar to healthcare professionals and industry:

* Health-related products in Canada must be safe and effective. Each drug product has information associated with it, and this information is easily accessible through the drugs and health products portion of the Health Canada website. In addition, Health Canada has specific guidelines for each product that includes providing clear directions and ensuring the proper labelling of products.

'''Product Monographs'''

*A Product Monograph is a factual, scientific document on a drug product that describes the properties, claims, indications, and conditions of use of the drug, and contains any other information that may be required for optimal, safe and effective use of the drug.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html

'''Directions for use/Product Labelling'''

*These are the directions and labels on each product.

'''The Drug and Health Product Register (DHPR)'''

*The DHPR was created to make information on health products available to Canadians.

- https://hpr-rps.hres.ca/index.php?lang=en

#'''Communications around Transparency/Transparency Initiatives for the Public'''

* Transparency tools may also be familiar to healthcare professionals and industry:

*'''Summary Safety Reviews (SSRs)'''

*SSRs are Health Canada’s summaries of its safety reviews of products and drugs on the market. These are intended to provide greater transparency to Canadians. They are brief 3-page summaries that outline what was assessed, what was found and what action was taken by Health Canada, if any. These are found in the DHPR. Here is the link:

- https://hpr-rps.hres.ca/reg-content/summary-safety-review-result.php?lang=en&term=

'''New Safety and Effectiveness Reviews'''

*Health Canada posts lists of new safety reviews to increase transparency with Canadians and inform them of the products and risks that Health Canada is assessing. Once a new safety and effectiveness review is completed, an SSR (see above) is published to inform Canadians of what was found and what action was taken by Health Canada, if any.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/safety-reviews/new.html

Medical Devices Online Incidents Database
The Medical Device Online Incidents Database is an online initiative for reporting adverse reactions to medical devices. It contains medical device incident reports and information regarding recalls in a user-friendly, searchable, online format. There is also a full data extract available for download.
https://hpr-rps.hres.ca/mdi_landing.php
MedEffect Canada
MedEffect Canada provides consumers, patients, and health professionals with an easy way to: report an adverse reaction or side effect; obtain new safety information on drugs and other health products; and, learn and better understand the importance of reporting side effects.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html
Canada Vigilance Adverse Reaction Online Database
The Canada Vigilance Adverse Reaction Online Database contains information about suspected adverse drug reactions reported to Health Canada by consumers, health professionals and market authorization holders.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-database.html

Purchasing:Health Canada Communication Tools

2019-08-07T18:52:59Z

Johnt:

'''Health Canada Communication Tools'''
''These four categories of communication tools include a few documents that may or may not be familiar to you. If the document is unfamiliar, you will have an opportunity to share this with the interviewer. We have provided links and descriptions for your reference.''
#'''Guidance and regulations (Guidance Documents, guidelines and all regulation-related communications)'''
* Industry and other healthcare professionals have specific guidance and regulations they must adhere to in order to meet Health Canada’s requirements. If you are a healthcare professional, or represent industry, these may be familiar to you. Please see the links below for examples of such guidance.
- https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada.html then scroll down to Guidance Documents and Guidelines.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements-advertising/policies-guidance-documents.html for examples of advertising regulations.
#'''Risk communications'''
Risk Communication tools may also be familiar to healthcare professionals:
'''Canadian Medical Devices Sentinel Network Bulletin (CMDSNet)'''
* The CMDSNet issues a monthly bulletin to keep the members of the network aware of a number of items related to adverse events associated with medical devices. For instance: updates to the program, recent reports of adverse events, recent regulatory actions and outcomes which have resulted from their reports, lessons learned, highlighted issues, recently completed and upcoming safety reviews, and educational opportunities. A list of all reports submitted to the Network is also included with the monthly bulletin. '''The distribution of the bulletin and list of reports is limited to Health Canada and those in the CMDSNet, and are not to be distributed beyond the Network, and therefore, no example is provided.'''
* For more information:
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/medeffect-canada-canadian-medical-devices-sentinel-network-pilot-project.html

'''Annual Trends Report'''
* The primary objective of the Annual Trends Report is to provide the numbers and trends of adverse drug reaction case reports and medical device incident reports to Health Canada on an annual basis. The data are based on reports submitted to Health Canada through the Canada Vigilance Adverse Reaction Online Database (more below) for reporting adverse reactions to drugs, the CV-MDS (where people report problems with medical devices), and CMDSNet.

- https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/annual-trends-adverse-reaction-case-reports-health-products-medical-device-problem-incidents.html

#'''Health Product InfoWatch'''
This is a Health Canada monthly publication to raise awareness and to provide clinically relevant information to healthcare professionals concerning marketed health products and their safety. In some cases, information is intended to stimulate reporting of similar adverse reactions.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/health-product-infowatch.html
Recalls and Safety Alerts
Health Canada sometimes needs to recall a product that is on the market, or issue a safety alert. There are several ways these recalls and safety notices are communicated. These are detailed below.
a) Health Product Risk Communications (HPRC’s): Includes three types of communications
o Dear Healthcare Professional Letter (DHCPL);
o Public communication; and,
o Notice to hospitals. (Type I risk: 48 hours - Type II risk 2-10 days). Communications are targeted to healthcare professionals, mainly written by industry and endorsed by Health Canada.
b) Information Updates: Health Canada’s communication for less urgent risk issues, e.g., some labelling updates, can take anywhere from 2-3 days to a week or more.
c) Public advisory: Health Canada’s communication to warn the public of a potential hazard.
d) Recall notice: This communication is written and distributed by Industry. An “extract” of the information is posted by Health Canada at regular intervals on Health Canada’s Recalls and Safety Alerts website link (see below).
e) Foreign product alert: Health Canada’s communication related to unauthorized products from other countries which may have been brought into the country by travellers or purchased online.
You can search for recalls and safety alerts through this link:
http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php?cat=3 3. Health Product Safety Information
Health Product Safety Information tools may also be familiar to healthcare professionals and industry:
Health-related products in Canada must be safe and effective. Each drug product has information associated with it, and this information is easily accessible through the drugs and health products portion of the Health Canada website. In addition, Health Canada has specific guidelines for each product that includes providing clear directions and ensuring the proper labelling of products.
Product Monographs
A Product Monograph is a factual, scientific document on a drug product that describes the properties, claims, indications, and conditions of use of the drug, and contains any other information that may be required for optimal, safe and effective use of the drug.
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html
List and Links for Pollara Interviews
3
Directions for use/Product Labelling
These are the directions and labels on each product.
The Drug and Health Product Register (DHPR)
The DHPR was created to make information on health products available to Canadians.
https://hpr-rps.hres.ca/index.php?lang=en 4. Communications around Transparency/Transparency Initiatives for the Public
Transparency tools may also be familiar to healthcare professionals and industry:
Summary Safety Reviews (SSRs)
SSRs are Health Canada’s summaries of its safety reviews of products and drugs on the market. These are intended to provide greater transparency to Canadians. They are brief 3-page summaries that outline what was assessed, what was found and what action was taken by Health Canada, if any. These are found in the DHPR. Here is the link:
https://hpr-rps.hres.ca/reg-content/summary-safety-review-result.php?lang=en&term=
New Safety and Effectiveness Reviews
Health Canada posts lists of new safety reviews to increase transparency with Canadians and inform them of the products and risks that Health Canada is assessing. Once a new safety and effectiveness review is completed, an SSR (see above) is published to inform Canadians of what was found and what action was taken by Health Canada, if any.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/safety-reviews/new.html
Medical Devices Online Incidents Database
The Medical Device Online Incidents Database is an online initiative for reporting adverse reactions to medical devices. It contains medical device incident reports and information regarding recalls in a user-friendly, searchable, online format. There is also a full data extract available for download.
https://hpr-rps.hres.ca/mdi_landing.php
MedEffect Canada
MedEffect Canada provides consumers, patients, and health professionals with an easy way to: report an adverse reaction or side effect; obtain new safety information on drugs and other health products; and, learn and better understand the importance of reporting side effects.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html
Canada Vigilance Adverse Reaction Online Database
The Canada Vigilance Adverse Reaction Online Database contains information about suspected adverse drug reactions reported to Health Canada by consumers, health professionals and market authorization holders.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-database.html

Purchasing:Health Canada Communication Tools

2019-08-07T18:51:35Z

Johnt:

'''Health Canada Communication Tools'''
''These four categories of communication tools include a few documents that may or may not be familiar to you. If the document is unfamiliar, you will have an opportunity to share this with the interviewer. We have provided links and descriptions for your reference.''
# '''Guidance and regulations (Guidance Documents, guidelines and all regulation-related communications)'''
* Industry and other healthcare professionals have specific guidance and regulations they must adhere to in order to meet Health Canada’s requirements. If you are a healthcare professional, or represent industry, these may be familiar to you. Please see the links below for examples of such guidance.
- https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada.html then scroll down to Guidance Documents and Guidelines.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements-advertising/policies-guidance-documents.html for examples of advertising regulations.
## '''Risk communications'''
Risk Communication tools may also be familiar to healthcare professionals:
'''Canadian Medical Devices Sentinel Network Bulletin (CMDSNet)'''
* The CMDSNet issues a monthly bulletin to keep the members of the network aware of a number of items related to adverse events associated with medical devices. For instance: updates to the program, recent reports of adverse events, recent regulatory actions and outcomes which have resulted from their reports, lessons learned, highlighted issues, recently completed and upcoming safety reviews, and educational opportunities. A list of all reports submitted to the Network is also included with the monthly bulletin. '''The distribution of the bulletin and list of reports is limited to Health Canada and those in the CMDSNet, and are not to be distributed beyond the Network, and therefore, no example is provided.'''
* For more information:
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/medeffect-canada-canadian-medical-devices-sentinel-network-pilot-project.html

'''Annual Trends Report'''
The primary objective of the Annual Trends Report is to provide the numbers and trends of adverse drug reaction case reports and medical device incident reports to Health Canada on an annual basis. The data are based on reports submitted to Health Canada through the Canada Vigilance Adverse Reaction Online Database (more below) for reporting adverse reactions to drugs, the CV-MDS (where people report problems with medical devices), and CMDSNet.
https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/annual-trends-adverse-reaction-case-reports-health-products-medical-device-problem-incidents.html
'''Health Product InfoWatch
'''This is a Health Canada monthly publication to raise awareness and to provide clinically relevant information to healthcare professionals concerning marketed health products and their safety. In some cases, information is intended to stimulate reporting of similar adverse reactions.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/health-product-infowatch.html
Recalls and Safety Alerts
Health Canada sometimes needs to recall a product that is on the market, or issue a safety alert. There are several ways these recalls and safety notices are communicated. These are detailed below.
a) Health Product Risk Communications (HPRC’s): Includes three types of communications
o Dear Healthcare Professional Letter (DHCPL);
o Public communication; and,
o Notice to hospitals. (Type I risk: 48 hours - Type II risk 2-10 days). Communications are targeted to healthcare professionals, mainly written by industry and endorsed by Health Canada.
b) Information Updates: Health Canada’s communication for less urgent risk issues, e.g., some labelling updates, can take anywhere from 2-3 days to a week or more.
c) Public advisory: Health Canada’s communication to warn the public of a potential hazard.
d) Recall notice: This communication is written and distributed by Industry. An “extract” of the information is posted by Health Canada at regular intervals on Health Canada’s Recalls and Safety Alerts website link (see below).
e) Foreign product alert: Health Canada’s communication related to unauthorized products from other countries which may have been brought into the country by travellers or purchased online.
You can search for recalls and safety alerts through this link:
http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php?cat=3 3. Health Product Safety Information
Health Product Safety Information tools may also be familiar to healthcare professionals and industry:
Health-related products in Canada must be safe and effective. Each drug product has information associated with it, and this information is easily accessible through the drugs and health products portion of the Health Canada website. In addition, Health Canada has specific guidelines for each product that includes providing clear directions and ensuring the proper labelling of products.
Product Monographs
A Product Monograph is a factual, scientific document on a drug product that describes the properties, claims, indications, and conditions of use of the drug, and contains any other information that may be required for optimal, safe and effective use of the drug.
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html
List and Links for Pollara Interviews
3
Directions for use/Product Labelling
These are the directions and labels on each product.
The Drug and Health Product Register (DHPR)
The DHPR was created to make information on health products available to Canadians.
https://hpr-rps.hres.ca/index.php?lang=en 4. Communications around Transparency/Transparency Initiatives for the Public
Transparency tools may also be familiar to healthcare professionals and industry:
Summary Safety Reviews (SSRs)
SSRs are Health Canada’s summaries of its safety reviews of products and drugs on the market. These are intended to provide greater transparency to Canadians. They are brief 3-page summaries that outline what was assessed, what was found and what action was taken by Health Canada, if any. These are found in the DHPR. Here is the link:
https://hpr-rps.hres.ca/reg-content/summary-safety-review-result.php?lang=en&term=
New Safety and Effectiveness Reviews
Health Canada posts lists of new safety reviews to increase transparency with Canadians and inform them of the products and risks that Health Canada is assessing. Once a new safety and effectiveness review is completed, an SSR (see above) is published to inform Canadians of what was found and what action was taken by Health Canada, if any.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/safety-reviews/new.html
Medical Devices Online Incidents Database
The Medical Device Online Incidents Database is an online initiative for reporting adverse reactions to medical devices. It contains medical device incident reports and information regarding recalls in a user-friendly, searchable, online format. There is also a full data extract available for download.
https://hpr-rps.hres.ca/mdi_landing.php
MedEffect Canada
MedEffect Canada provides consumers, patients, and health professionals with an easy way to: report an adverse reaction or side effect; obtain new safety information on drugs and other health products; and, learn and better understand the importance of reporting side effects.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html
Canada Vigilance Adverse Reaction Online Database
The Canada Vigilance Adverse Reaction Online Database contains information about suspected adverse drug reactions reported to Health Canada by consumers, health professionals and market authorization holders.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-database.html

Purchasing:Health Canada Communication Tools

2019-08-07T18:40:51Z

Johnt:

'''Health Canada Communication Tools'''
''These four categories of communication tools include a few documents that may or may not be familiar to you. If the document is unfamiliar, you will have an opportunity to share this with the interviewer. We have provided links and descriptions for your reference.''
# '''Guidance and regulations (Guidance Documents, guidelines and all regulation-related communications)'''
* Industry and other healthcare professionals have specific guidance and regulations they must adhere to in order to meet Health Canada’s requirements. If you are a healthcare professional, or represent industry, these may be familiar to you. Please see the links below for examples of such guidance.
- https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada.html then scroll down to Guidance Documents and Guidelines.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements-advertising/policies-guidance-documents.html for examples of advertising regulations.
# '''Risk communications'''
Risk Communication tools may also be familiar to healthcare professionals:
'''Canadian Medical Devices Sentinel Network Bulletin (CMDSNet)'''
* The CMDSNet issues a monthly bulletin to keep the members of the network aware of a number of items related to adverse events associated with medical devices. For instance: updates to the program, recent reports of adverse events, recent regulatory actions and outcomes which have resulted from their reports, lessons learned, highlighted issues, recently completed and upcoming safety reviews, and educational opportunities. A list of all reports submitted to the Network is also included with the monthly bulletin. '''The distribution of the bulletin and list of reports is limited to Health Canada and those in the CMDSNet, and are not to be distributed beyond the Network, and therefore, no example is provided.'''
* For more information:
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/medeffect-canada-canadian-medical-devices-sentinel-network-pilot-project.html

'''Annual Trends Report'''
The primary objective of the Annual Trends Report is to provide the numbers and trends of adverse drug reaction case reports and medical device incident reports to Health Canada on an annual basis. The data are based on reports submitted to Health Canada through the Canada Vigilance Adverse Reaction Online Database (more below) for reporting adverse reactions to drugs, the CV-MDS (where people report problems with medical devices), and CMDSNet.
https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/annual-trends-adverse-reaction-case-reports-health-products-medical-device-problem-incidents.html
'''Health Product InfoWatch
'''This is a Health Canada monthly publication to raise awareness and to provide clinically relevant information to healthcare professionals concerning marketed health products and their safety. In some cases, information is intended to stimulate reporting of similar adverse reactions.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/health-product-infowatch.html
Recalls and Safety Alerts
Health Canada sometimes needs to recall a product that is on the market, or issue a safety alert. There are several ways these recalls and safety notices are communicated. These are detailed below.
a) Health Product Risk Communications (HPRC’s): Includes three types of communications
o Dear Healthcare Professional Letter (DHCPL);
o Public communication; and,
o Notice to hospitals. (Type I risk: 48 hours - Type II risk 2-10 days). Communications are targeted to healthcare professionals, mainly written by industry and endorsed by Health Canada.
b) Information Updates: Health Canada’s communication for less urgent risk issues, e.g., some labelling updates, can take anywhere from 2-3 days to a week or more.
c) Public advisory: Health Canada’s communication to warn the public of a potential hazard.
d) Recall notice: This communication is written and distributed by Industry. An “extract” of the information is posted by Health Canada at regular intervals on Health Canada’s Recalls and Safety Alerts website link (see below).
e) Foreign product alert: Health Canada’s communication related to unauthorized products from other countries which may have been brought into the country by travellers or purchased online.
You can search for recalls and safety alerts through this link:
http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php?cat=3 3. Health Product Safety Information
Health Product Safety Information tools may also be familiar to healthcare professionals and industry:
Health-related products in Canada must be safe and effective. Each drug product has information associated with it, and this information is easily accessible through the drugs and health products portion of the Health Canada website. In addition, Health Canada has specific guidelines for each product that includes providing clear directions and ensuring the proper labelling of products.
Product Monographs
A Product Monograph is a factual, scientific document on a drug product that describes the properties, claims, indications, and conditions of use of the drug, and contains any other information that may be required for optimal, safe and effective use of the drug.
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html
List and Links for Pollara Interviews
3
Directions for use/Product Labelling
These are the directions and labels on each product.
The Drug and Health Product Register (DHPR)
The DHPR was created to make information on health products available to Canadians.
https://hpr-rps.hres.ca/index.php?lang=en 4. Communications around Transparency/Transparency Initiatives for the Public
Transparency tools may also be familiar to healthcare professionals and industry:
Summary Safety Reviews (SSRs)
SSRs are Health Canada’s summaries of its safety reviews of products and drugs on the market. These are intended to provide greater transparency to Canadians. They are brief 3-page summaries that outline what was assessed, what was found and what action was taken by Health Canada, if any. These are found in the DHPR. Here is the link:
https://hpr-rps.hres.ca/reg-content/summary-safety-review-result.php?lang=en&term=
New Safety and Effectiveness Reviews
Health Canada posts lists of new safety reviews to increase transparency with Canadians and inform them of the products and risks that Health Canada is assessing. Once a new safety and effectiveness review is completed, an SSR (see above) is published to inform Canadians of what was found and what action was taken by Health Canada, if any.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/safety-reviews/new.html
Medical Devices Online Incidents Database
The Medical Device Online Incidents Database is an online initiative for reporting adverse reactions to medical devices. It contains medical device incident reports and information regarding recalls in a user-friendly, searchable, online format. There is also a full data extract available for download.
https://hpr-rps.hres.ca/mdi_landing.php
MedEffect Canada
MedEffect Canada provides consumers, patients, and health professionals with an easy way to: report an adverse reaction or side effect; obtain new safety information on drugs and other health products; and, learn and better understand the importance of reporting side effects.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html
Canada Vigilance Adverse Reaction Online Database
The Canada Vigilance Adverse Reaction Online Database contains information about suspected adverse drug reactions reported to Health Canada by consumers, health professionals and market authorization holders.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-database.html

Purchasing:Health Canada Communication Tools

2019-08-07T18:39:06Z

Johnt:

'''Health Canada Communication Tools'''
''These four categories of communication tools include a few documents that may or may not be familiar to you. If the document is unfamiliar, you will have an opportunity to share this with the interviewer. We have provided links and descriptions for your reference.''
# '''Guidance and regulations (Guidance Documents, guidelines and all regulation-related communications)'''
* Industry and other healthcare professionals have specific guidance and regulations they must adhere to in order to meet Health Canada’s requirements. If you are a healthcare professional, or represent industry, these may be familiar to you. Please see the links below for examples of such guidance.
- https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada.html then scroll down to Guidance Documents and Guidelines.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements-advertising/policies-guidance-documents.html for examples of advertising regulations.
# '''Risk communications'''
Risk Communication tools may also be familiar to healthcare professionals:
Canadian Medical Devices Sentinel Network Bulletin (CMDSNet)
The CMDSNet issues a monthly bulletin to keep the members of the network aware of a number of items related to adverse events associated with medical devices. For instance: updates to the program, recent reports of adverse events, recent regulatory actions and outcomes which have resulted from their reports, lessons learned, highlighted issues, recently completed and upcoming safety reviews, and educational opportunities. A list of all reports submitted to the Network is also included with the monthly bulletin. The distribution of the bulletin and list of reports is limited to Health Canada and those in the CMDSNet, and are not to be distributed beyond the Network, and therefore, no example is provided.
For more information:
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/medeffect-canada-canadian-medical-devices-sentinel-network-pilot-project.html
Annual Trends Report
The primary objective of the Annual Trends Report is to provide the numbers and trends of adverse drug reaction case reports and medical device incident reports to Health Canada on an annual basis. The data are based on reports submitted to Health Canada through the Canada Vigilance Adverse Reaction Online Database (more below) for reporting adverse reactions to drugs, the CV-MDS (where people report problems with medical devices), and CMDSNet.
https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/annual-trends-adverse-reaction-case-reports-health-products-medical-device-problem-incidents.html
'''Health Product InfoWatch
'''This is a Health Canada monthly publication to raise awareness and to provide clinically relevant information to healthcare professionals concerning marketed health products and their safety. In some cases, information is intended to stimulate reporting of similar adverse reactions.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/health-product-infowatch.html
Recalls and Safety Alerts
Health Canada sometimes needs to recall a product that is on the market, or issue a safety alert. There are several ways these recalls and safety notices are communicated. These are detailed below.
a) Health Product Risk Communications (HPRC’s): Includes three types of communications
o Dear Healthcare Professional Letter (DHCPL);
o Public communication; and,
o Notice to hospitals. (Type I risk: 48 hours - Type II risk 2-10 days). Communications are targeted to healthcare professionals, mainly written by industry and endorsed by Health Canada.
b) Information Updates: Health Canada’s communication for less urgent risk issues, e.g., some labelling updates, can take anywhere from 2-3 days to a week or more.
c) Public advisory: Health Canada’s communication to warn the public of a potential hazard.
d) Recall notice: This communication is written and distributed by Industry. An “extract” of the information is posted by Health Canada at regular intervals on Health Canada’s Recalls and Safety Alerts website link (see below).
e) Foreign product alert: Health Canada’s communication related to unauthorized products from other countries which may have been brought into the country by travellers or purchased online.
You can search for recalls and safety alerts through this link:
http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php?cat=3 3. Health Product Safety Information
Health Product Safety Information tools may also be familiar to healthcare professionals and industry:
Health-related products in Canada must be safe and effective. Each drug product has information associated with it, and this information is easily accessible through the drugs and health products portion of the Health Canada website. In addition, Health Canada has specific guidelines for each product that includes providing clear directions and ensuring the proper labelling of products.
Product Monographs
A Product Monograph is a factual, scientific document on a drug product that describes the properties, claims, indications, and conditions of use of the drug, and contains any other information that may be required for optimal, safe and effective use of the drug.
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html
List and Links for Pollara Interviews
3
Directions for use/Product Labelling
These are the directions and labels on each product.
The Drug and Health Product Register (DHPR)
The DHPR was created to make information on health products available to Canadians.
https://hpr-rps.hres.ca/index.php?lang=en 4. Communications around Transparency/Transparency Initiatives for the Public
Transparency tools may also be familiar to healthcare professionals and industry:
Summary Safety Reviews (SSRs)
SSRs are Health Canada’s summaries of its safety reviews of products and drugs on the market. These are intended to provide greater transparency to Canadians. They are brief 3-page summaries that outline what was assessed, what was found and what action was taken by Health Canada, if any. These are found in the DHPR. Here is the link:
https://hpr-rps.hres.ca/reg-content/summary-safety-review-result.php?lang=en&term=
New Safety and Effectiveness Reviews
Health Canada posts lists of new safety reviews to increase transparency with Canadians and inform them of the products and risks that Health Canada is assessing. Once a new safety and effectiveness review is completed, an SSR (see above) is published to inform Canadians of what was found and what action was taken by Health Canada, if any.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/safety-reviews/new.html
Medical Devices Online Incidents Database
The Medical Device Online Incidents Database is an online initiative for reporting adverse reactions to medical devices. It contains medical device incident reports and information regarding recalls in a user-friendly, searchable, online format. There is also a full data extract available for download.
https://hpr-rps.hres.ca/mdi_landing.php
MedEffect Canada
MedEffect Canada provides consumers, patients, and health professionals with an easy way to: report an adverse reaction or side effect; obtain new safety information on drugs and other health products; and, learn and better understand the importance of reporting side effects.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html
Canada Vigilance Adverse Reaction Online Database
The Canada Vigilance Adverse Reaction Online Database contains information about suspected adverse drug reactions reported to Health Canada by consumers, health professionals and market authorization holders.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-database.html

Purchasing:Health Canada Communication Tools

2019-08-07T18:38:03Z

Johnt:

'''Health Canada Communication Tools'''
''These four categories of communication tools include a few documents that may or may not be familiar to you. If the document is unfamiliar, you will have an opportunity to share this with the interviewer. We have provided links and descriptions for your reference.''
# '''Guidance and regulations (Guidance Documents, guidelines and all regulation-related communications)'''
* Industry and other healthcare professionals have specific guidance and regulations they must adhere to in order to meet Health Canada’s requirements. If you are a healthcare professional, or represent industry, these may be familiar to you. Please see the links below for examples of such guidance.
- https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada.html then scroll down to Guidance Documents and Guidelines.
- https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements-advertising/policies-guidance-documents.html for examples of advertising regulations.
# '''Risk communications'''
Risk Communication tools may also be familiar to healthcare professionals:
Canadian Medical Devices Sentinel Network Bulletin (CMDSNet)
The CMDSNet issues a monthly bulletin to keep the members of the network aware of a number of items related to adverse events associated with medical devices. For instance: updates to the program, recent reports of adverse events, recent regulatory actions and outcomes which have resulted from their reports, lessons learned, highlighted issues, recently completed and upcoming safety reviews, and educational opportunities. A list of all reports submitted to the Network is also included with the monthly bulletin. The distribution of the bulletin and list of reports is limited to Health Canada and those in the CMDSNet, and are not to be distributed beyond the Network, and therefore, no example is provided.
For more information:
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/medeffect-canada-canadian-medical-devices-sentinel-network-pilot-project.html
Annual Trends Report
The primary objective of the Annual Trends Report is to provide the numbers and trends of adverse drug reaction case reports and medical device incident reports to Health Canada on an annual basis. The data are based on reports submitted to Health Canada through the Canada Vigilance Adverse Reaction Online Database (more below) for reporting adverse reactions to drugs, the CV-MDS (where people report problems with medical devices), and CMDSNet.
https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/annual-trends-adverse-reaction-case-reports-health-products-medical-device-problem-incidents.html
'''Health Product InfoWatch
'''This is a Health Canada monthly publication to raise awareness and to provide clinically relevant information to healthcare professionals concerning marketed health products and their safety. In some cases, information is intended to stimulate reporting of similar adverse reactions.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/health-product-infowatch.html
Recalls and Safety Alerts
Health Canada sometimes needs to recall a product that is on the market, or issue a safety alert. There are several ways these recalls and safety notices are communicated. These are detailed below.
a) Health Product Risk Communications (HPRC’s): Includes three types of communications
o Dear Healthcare Professional Letter (DHCPL);
o Public communication; and,
o Notice to hospitals. (Type I risk: 48 hours - Type II risk 2-10 days). Communications are targeted to healthcare professionals, mainly written by industry and endorsed by Health Canada.
b) Information Updates: Health Canada’s communication for less urgent risk issues, e.g., some labelling updates, can take anywhere from 2-3 days to a week or more.
c) Public advisory: Health Canada’s communication to warn the public of a potential hazard.
d) Recall notice: This communication is written and distributed by Industry. An “extract” of the information is posted by Health Canada at regular intervals on Health Canada’s Recalls and Safety Alerts website link (see below).
e) Foreign product alert: Health Canada’s communication related to unauthorized products from other countries which may have been brought into the country by travellers or purchased online.
You can search for recalls and safety alerts through this link:
http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php?cat=3 3. Health Product Safety Information
Health Product Safety Information tools may also be familiar to healthcare professionals and industry:
Health-related products in Canada must be safe and effective. Each drug product has information associated with it, and this information is easily accessible through the drugs and health products portion of the Health Canada website. In addition, Health Canada has specific guidelines for each product that includes providing clear directions and ensuring the proper labelling of products.
Product Monographs
A Product Monograph is a factual, scientific document on a drug product that describes the properties, claims, indications, and conditions of use of the drug, and contains any other information that may be required for optimal, safe and effective use of the drug.
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html
List and Links for Pollara Interviews
3
Directions for use/Product Labelling
These are the directions and labels on each product.
The Drug and Health Product Register (DHPR)
The DHPR was created to make information on health products available to Canadians.
https://hpr-rps.hres.ca/index.php?lang=en 4. Communications around Transparency/Transparency Initiatives for the Public
Transparency tools may also be familiar to healthcare professionals and industry:
Summary Safety Reviews (SSRs)
SSRs are Health Canada’s summaries of its safety reviews of products and drugs on the market. These are intended to provide greater transparency to Canadians. They are brief 3-page summaries that outline what was assessed, what was found and what action was taken by Health Canada, if any. These are found in the DHPR. Here is the link:
https://hpr-rps.hres.ca/reg-content/summary-safety-review-result.php?lang=en&term=
New Safety and Effectiveness Reviews
Health Canada posts lists of new safety reviews to increase transparency with Canadians and inform them of the products and risks that Health Canada is assessing. Once a new safety and effectiveness review is completed, an SSR (see above) is published to inform Canadians of what was found and what action was taken by Health Canada, if any.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/safety-reviews/new.html
Medical Devices Online Incidents Database
The Medical Device Online Incidents Database is an online initiative for reporting adverse reactions to medical devices. It contains medical device incident reports and information regarding recalls in a user-friendly, searchable, online format. There is also a full data extract available for download.
https://hpr-rps.hres.ca/mdi_landing.php
MedEffect Canada
MedEffect Canada provides consumers, patients, and health professionals with an easy way to: report an adverse reaction or side effect; obtain new safety information on drugs and other health products; and, learn and better understand the importance of reporting side effects.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html
Canada Vigilance Adverse Reaction Online Database
The Canada Vigilance Adverse Reaction Online Database contains information about suspected adverse drug reactions reported to Health Canada by consumers, health professionals and market authorization holders.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-database.html

Purchasing:Health Canada Communication Tools

2019-08-07T18:36:14Z

Johnt:

'''Health Canada Communication Tools'''
''These four categories of communication tools include a few documents that may or may not be familiar to you. If the document is unfamiliar, you will have an opportunity to share this with the interviewer. We have provided links and descriptions for your reference.''
# Guidance and regulations (Guidance Documents, guidelines and all regulation-related communications)
- Industry and other healthcare professionals have specific guidance and regulations they must adhere to in order to meet Health Canada’s requirements. If you are a healthcare professional, or represent industry, these may be familiar to you. Please see the links below for examples of such guidance.
https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada.html then scroll down to Guidance Documents and Guidelines.
https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements-advertising/policies-guidance-documents.html for examples of advertising regulations. 2. Risk communications
Risk Communication tools may also be familiar to healthcare professionals:
Canadian Medical Devices Sentinel Network Bulletin (CMDSNet)
The CMDSNet issues a monthly bulletin to keep the members of the network aware of a number of items related to adverse events associated with medical devices. For instance: updates to the program, recent reports of adverse events, recent regulatory actions and outcomes which have resulted from their reports, lessons learned, highlighted issues, recently completed and upcoming safety reviews, and educational opportunities. A list of all reports submitted to the Network is also included with the monthly bulletin. The distribution of the bulletin and list of reports is limited to Health Canada and those in the CMDSNet, and are not to be distributed beyond the Network, and therefore, no example is provided.
For more information:
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/medeffect-canada-canadian-medical-devices-sentinel-network-pilot-project.html
Annual Trends Report
The primary objective of the Annual Trends Report is to provide the numbers and trends of adverse drug reaction case reports and medical device incident reports to Health Canada on an annual basis. The data are based on reports submitted to Health Canada through the Canada Vigilance Adverse Reaction Online Database (more below) for reporting adverse reactions to drugs, the CV-MDS (where people report problems with medical devices), and CMDSNet.
https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/annual-trends-adverse-reaction-case-reports-health-products-medical-device-problem-incidents.html
List and Links for Pollara Interviews
2
Health Product InfoWatch
This is a Health Canada monthly publication to raise awareness and to provide clinically relevant information to healthcare professionals concerning marketed health products and their safety. In some cases, information is intended to stimulate reporting of similar adverse reactions.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/health-product-infowatch.html
Recalls and Safety Alerts
Health Canada sometimes needs to recall a product that is on the market, or issue a safety alert. There are several ways these recalls and safety notices are communicated. These are detailed below.
a) Health Product Risk Communications (HPRC’s): Includes three types of communications
o Dear Healthcare Professional Letter (DHCPL);
o Public communication; and,
o Notice to hospitals. (Type I risk: 48 hours - Type II risk 2-10 days). Communications are targeted to healthcare professionals, mainly written by industry and endorsed by Health Canada.
b) Information Updates: Health Canada’s communication for less urgent risk issues, e.g., some labelling updates, can take anywhere from 2-3 days to a week or more.
c) Public advisory: Health Canada’s communication to warn the public of a potential hazard.
d) Recall notice: This communication is written and distributed by Industry. An “extract” of the information is posted by Health Canada at regular intervals on Health Canada’s Recalls and Safety Alerts website link (see below).
e) Foreign product alert: Health Canada’s communication related to unauthorized products from other countries which may have been brought into the country by travellers or purchased online.
You can search for recalls and safety alerts through this link:
http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php?cat=3 3. Health Product Safety Information
Health Product Safety Information tools may also be familiar to healthcare professionals and industry:
Health-related products in Canada must be safe and effective. Each drug product has information associated with it, and this information is easily accessible through the drugs and health products portion of the Health Canada website. In addition, Health Canada has specific guidelines for each product that includes providing clear directions and ensuring the proper labelling of products.
Product Monographs
A Product Monograph is a factual, scientific document on a drug product that describes the properties, claims, indications, and conditions of use of the drug, and contains any other information that may be required for optimal, safe and effective use of the drug.
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html
List and Links for Pollara Interviews
3
Directions for use/Product Labelling
These are the directions and labels on each product.
The Drug and Health Product Register (DHPR)
The DHPR was created to make information on health products available to Canadians.
https://hpr-rps.hres.ca/index.php?lang=en 4. Communications around Transparency/Transparency Initiatives for the Public
Transparency tools may also be familiar to healthcare professionals and industry:
Summary Safety Reviews (SSRs)
SSRs are Health Canada’s summaries of its safety reviews of products and drugs on the market. These are intended to provide greater transparency to Canadians. They are brief 3-page summaries that outline what was assessed, what was found and what action was taken by Health Canada, if any. These are found in the DHPR. Here is the link:
https://hpr-rps.hres.ca/reg-content/summary-safety-review-result.php?lang=en&term=
New Safety and Effectiveness Reviews
Health Canada posts lists of new safety reviews to increase transparency with Canadians and inform them of the products and risks that Health Canada is assessing. Once a new safety and effectiveness review is completed, an SSR (see above) is published to inform Canadians of what was found and what action was taken by Health Canada, if any.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/safety-reviews/new.html
Medical Devices Online Incidents Database
The Medical Device Online Incidents Database is an online initiative for reporting adverse reactions to medical devices. It contains medical device incident reports and information regarding recalls in a user-friendly, searchable, online format. There is also a full data extract available for download.
https://hpr-rps.hres.ca/mdi_landing.php
MedEffect Canada
MedEffect Canada provides consumers, patients, and health professionals with an easy way to: report an adverse reaction or side effect; obtain new safety information on drugs and other health products; and, learn and better understand the importance of reporting side effects.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html
Canada Vigilance Adverse Reaction Online Database
The Canada Vigilance Adverse Reaction Online Database contains information about suspected adverse drug reactions reported to Health Canada by consumers, health professionals and market authorization holders.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-database.html

Purchasing:Health Canada Communication Tools

2019-08-07T18:35:57Z

Johnt:

'''Health Canada Communication Tools'''
''These four categories of communication tools include a few documents that may or may not be familiar to you. If the document is unfamiliar, you will have an opportunity to share this with the interviewer. We have provided links and descriptions for your reference.''
1. Guidance and regulations (Guidance Documents, guidelines and all regulation-related communications)
- Industry and other healthcare professionals have specific guidance and regulations they must adhere to in order to meet Health Canada’s requirements. If you are a healthcare professional, or represent industry, these may be familiar to you. Please see the links below for examples of such guidance.
https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada.html then scroll down to Guidance Documents and Guidelines.
https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements-advertising/policies-guidance-documents.html for examples of advertising regulations. 2. Risk communications
Risk Communication tools may also be familiar to healthcare professionals:
Canadian Medical Devices Sentinel Network Bulletin (CMDSNet)
The CMDSNet issues a monthly bulletin to keep the members of the network aware of a number of items related to adverse events associated with medical devices. For instance: updates to the program, recent reports of adverse events, recent regulatory actions and outcomes which have resulted from their reports, lessons learned, highlighted issues, recently completed and upcoming safety reviews, and educational opportunities. A list of all reports submitted to the Network is also included with the monthly bulletin. The distribution of the bulletin and list of reports is limited to Health Canada and those in the CMDSNet, and are not to be distributed beyond the Network, and therefore, no example is provided.
For more information:
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/medeffect-canada-canadian-medical-devices-sentinel-network-pilot-project.html
Annual Trends Report
The primary objective of the Annual Trends Report is to provide the numbers and trends of adverse drug reaction case reports and medical device incident reports to Health Canada on an annual basis. The data are based on reports submitted to Health Canada through the Canada Vigilance Adverse Reaction Online Database (more below) for reporting adverse reactions to drugs, the CV-MDS (where people report problems with medical devices), and CMDSNet.
https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/annual-trends-adverse-reaction-case-reports-health-products-medical-device-problem-incidents.html
List and Links for Pollara Interviews
2
Health Product InfoWatch
This is a Health Canada monthly publication to raise awareness and to provide clinically relevant information to healthcare professionals concerning marketed health products and their safety. In some cases, information is intended to stimulate reporting of similar adverse reactions.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/health-product-infowatch.html
Recalls and Safety Alerts
Health Canada sometimes needs to recall a product that is on the market, or issue a safety alert. There are several ways these recalls and safety notices are communicated. These are detailed below.
a) Health Product Risk Communications (HPRC’s): Includes three types of communications
o Dear Healthcare Professional Letter (DHCPL);
o Public communication; and,
o Notice to hospitals. (Type I risk: 48 hours - Type II risk 2-10 days). Communications are targeted to healthcare professionals, mainly written by industry and endorsed by Health Canada.
b) Information Updates: Health Canada’s communication for less urgent risk issues, e.g., some labelling updates, can take anywhere from 2-3 days to a week or more.
c) Public advisory: Health Canada’s communication to warn the public of a potential hazard.
d) Recall notice: This communication is written and distributed by Industry. An “extract” of the information is posted by Health Canada at regular intervals on Health Canada’s Recalls and Safety Alerts website link (see below).
e) Foreign product alert: Health Canada’s communication related to unauthorized products from other countries which may have been brought into the country by travellers or purchased online.
You can search for recalls and safety alerts through this link:
http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php?cat=3 3. Health Product Safety Information
Health Product Safety Information tools may also be familiar to healthcare professionals and industry:
Health-related products in Canada must be safe and effective. Each drug product has information associated with it, and this information is easily accessible through the drugs and health products portion of the Health Canada website. In addition, Health Canada has specific guidelines for each product that includes providing clear directions and ensuring the proper labelling of products.
Product Monographs
A Product Monograph is a factual, scientific document on a drug product that describes the properties, claims, indications, and conditions of use of the drug, and contains any other information that may be required for optimal, safe and effective use of the drug.
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html
List and Links for Pollara Interviews
3
Directions for use/Product Labelling
These are the directions and labels on each product.
The Drug and Health Product Register (DHPR)
The DHPR was created to make information on health products available to Canadians.
https://hpr-rps.hres.ca/index.php?lang=en 4. Communications around Transparency/Transparency Initiatives for the Public
Transparency tools may also be familiar to healthcare professionals and industry:
Summary Safety Reviews (SSRs)
SSRs are Health Canada’s summaries of its safety reviews of products and drugs on the market. These are intended to provide greater transparency to Canadians. They are brief 3-page summaries that outline what was assessed, what was found and what action was taken by Health Canada, if any. These are found in the DHPR. Here is the link:
https://hpr-rps.hres.ca/reg-content/summary-safety-review-result.php?lang=en&term=
New Safety and Effectiveness Reviews
Health Canada posts lists of new safety reviews to increase transparency with Canadians and inform them of the products and risks that Health Canada is assessing. Once a new safety and effectiveness review is completed, an SSR (see above) is published to inform Canadians of what was found and what action was taken by Health Canada, if any.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/safety-reviews/new.html
Medical Devices Online Incidents Database
The Medical Device Online Incidents Database is an online initiative for reporting adverse reactions to medical devices. It contains medical device incident reports and information regarding recalls in a user-friendly, searchable, online format. There is also a full data extract available for download.
https://hpr-rps.hres.ca/mdi_landing.php
MedEffect Canada
MedEffect Canada provides consumers, patients, and health professionals with an easy way to: report an adverse reaction or side effect; obtain new safety information on drugs and other health products; and, learn and better understand the importance of reporting side effects.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html
Canada Vigilance Adverse Reaction Online Database
The Canada Vigilance Adverse Reaction Online Database contains information about suspected adverse drug reactions reported to Health Canada by consumers, health professionals and market authorization holders.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-database.html

Purchasing:Health Canada Communication Tools

2019-08-07T18:34:38Z

Johnt: Created page with "Health Canada Communication Tools These four categories of communication tools include a few documents that may or may not be familiar to you. If the document is unfamiliar, y..."

Health Canada Communication Tools
These four categories of communication tools include a few documents that may or may not be familiar to you. If the document is unfamiliar, you will have an opportunity to share this with the interviewer. We have provided links and descriptions for your reference. You are not expected to be knowledgeable on any of the communication tools used by Health Canada. 1. Guidance and regulations (Guidance Documents, guidelines and all regulation-related communications)
Industry and other healthcare professionals have specific guidance and regulations they must adhere to in order to meet Health Canada’s requirements. If you are a healthcare professional, or represent industry, these may be familiar to you. Please see the links below for examples of such guidance.
https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada.html then scroll down to Guidance Documents and Guidelines.
https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements-advertising/policies-guidance-documents.html for examples of advertising regulations. 2. Risk communications
Risk Communication tools may also be familiar to healthcare professionals:
Canadian Medical Devices Sentinel Network Bulletin (CMDSNet)
The CMDSNet issues a monthly bulletin to keep the members of the network aware of a number of items related to adverse events associated with medical devices. For instance: updates to the program, recent reports of adverse events, recent regulatory actions and outcomes which have resulted from their reports, lessons learned, highlighted issues, recently completed and upcoming safety reviews, and educational opportunities. A list of all reports submitted to the Network is also included with the monthly bulletin. The distribution of the bulletin and list of reports is limited to Health Canada and those in the CMDSNet, and are not to be distributed beyond the Network, and therefore, no example is provided.
For more information:
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/medeffect-canada-canadian-medical-devices-sentinel-network-pilot-project.html
Annual Trends Report
The primary objective of the Annual Trends Report is to provide the numbers and trends of adverse drug reaction case reports and medical device incident reports to Health Canada on an annual basis. The data are based on reports submitted to Health Canada through the Canada Vigilance Adverse Reaction Online Database (more below) for reporting adverse reactions to drugs, the CV-MDS (where people report problems with medical devices), and CMDSNet.
https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/annual-trends-adverse-reaction-case-reports-health-products-medical-device-problem-incidents.html
List and Links for Pollara Interviews
2
Health Product InfoWatch
This is a Health Canada monthly publication to raise awareness and to provide clinically relevant information to healthcare professionals concerning marketed health products and their safety. In some cases, information is intended to stimulate reporting of similar adverse reactions.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/health-product-infowatch.html
Recalls and Safety Alerts
Health Canada sometimes needs to recall a product that is on the market, or issue a safety alert. There are several ways these recalls and safety notices are communicated. These are detailed below.
a) Health Product Risk Communications (HPRC’s): Includes three types of communications
o Dear Healthcare Professional Letter (DHCPL);
o Public communication; and,
o Notice to hospitals. (Type I risk: 48 hours - Type II risk 2-10 days). Communications are targeted to healthcare professionals, mainly written by industry and endorsed by Health Canada.
b) Information Updates: Health Canada’s communication for less urgent risk issues, e.g., some labelling updates, can take anywhere from 2-3 days to a week or more.
c) Public advisory: Health Canada’s communication to warn the public of a potential hazard.
d) Recall notice: This communication is written and distributed by Industry. An “extract” of the information is posted by Health Canada at regular intervals on Health Canada’s Recalls and Safety Alerts website link (see below).
e) Foreign product alert: Health Canada’s communication related to unauthorized products from other countries which may have been brought into the country by travellers or purchased online.
You can search for recalls and safety alerts through this link:
http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php?cat=3 3. Health Product Safety Information
Health Product Safety Information tools may also be familiar to healthcare professionals and industry:
Health-related products in Canada must be safe and effective. Each drug product has information associated with it, and this information is easily accessible through the drugs and health products portion of the Health Canada website. In addition, Health Canada has specific guidelines for each product that includes providing clear directions and ensuring the proper labelling of products.
Product Monographs
A Product Monograph is a factual, scientific document on a drug product that describes the properties, claims, indications, and conditions of use of the drug, and contains any other information that may be required for optimal, safe and effective use of the drug.
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html
List and Links for Pollara Interviews
3
Directions for use/Product Labelling
These are the directions and labels on each product.
The Drug and Health Product Register (DHPR)
The DHPR was created to make information on health products available to Canadians.
https://hpr-rps.hres.ca/index.php?lang=en 4. Communications around Transparency/Transparency Initiatives for the Public
Transparency tools may also be familiar to healthcare professionals and industry:
Summary Safety Reviews (SSRs)
SSRs are Health Canada’s summaries of its safety reviews of products and drugs on the market. These are intended to provide greater transparency to Canadians. They are brief 3-page summaries that outline what was assessed, what was found and what action was taken by Health Canada, if any. These are found in the DHPR. Here is the link:
https://hpr-rps.hres.ca/reg-content/summary-safety-review-result.php?lang=en&term=
New Safety and Effectiveness Reviews
Health Canada posts lists of new safety reviews to increase transparency with Canadians and inform them of the products and risks that Health Canada is assessing. Once a new safety and effectiveness review is completed, an SSR (see above) is published to inform Canadians of what was found and what action was taken by Health Canada, if any.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/safety-reviews/new.html
Medical Devices Online Incidents Database
The Medical Device Online Incidents Database is an online initiative for reporting adverse reactions to medical devices. It contains medical device incident reports and information regarding recalls in a user-friendly, searchable, online format. There is also a full data extract available for download.
https://hpr-rps.hres.ca/mdi_landing.php
MedEffect Canada
MedEffect Canada provides consumers, patients, and health professionals with an easy way to: report an adverse reaction or side effect; obtain new safety information on drugs and other health products; and, learn and better understand the importance of reporting side effects.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html
Canada Vigilance Adverse Reaction Online Database
The Canada Vigilance Adverse Reaction Online Database contains information about suspected adverse drug reactions reported to Health Canada by consumers, health professionals and market authorization holders.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-database.html

Information Systems:Updating MMBC

2019-07-11T20:49:29Z

Johnt:

=Overview=
This is a non-profit organization that is fully financed by industry to manage residential packaging and printed paper recycling programs in BC, either directly or by working with local governments, First Nations, private companies, and other non-profit organizations. (https://recyclebc.ca/)
*Notes: The goal is to have the manufacturer of a specific item be responsible for any packaging material and register/pay to MMBC the costs of recycling this material. For any manufacturer that is not registered with MMBC, the obligation falls to the distributor or retailer. uniPHARM has decided that we will pay (if needed) based on the sale of the item(s) to the retailers.
MMBC has developed volume thresholds that have changed since the program was first introduced. These can be found on the website below.
*https://recyclebc.ca/wp-content/uploads/2018/10/Recycle-BC-Low-Volume-Flat-Fees_2019.jpg

=Instructions=
* Typically this work would be done at the beginning of a year - looking at the data from the past year.

==Download File to Excel==

To generate the data file from the previous years sales information;
In InfoNet, go to UniView / Sales Statistics / Summarized Item Sales. Set ‘From Year/Month’ and ‘To Year/Month’ so that the entire year is included, and click on ‘Search’. Then click on ‘MMBC to Excel’.

This will create an Excel file of item information, sales, and MMBC rates that have been previously uploaded. Items with main suppliers that are registered with MMBC are not included.

#The file is saved on superserver/buying/common/Multi Material BC (example: sls2018.xlsx)
#Open the previous years spreadsheet. Copy columns BN1:DR2 (headers) and past into current years spreadsheet.
#Copy formulas from BO3:DQ3 and paste into current spreadsheet.
#Copy formulas down to bottom of data records and paste on current spreadsheet.
#Copy from column BO (go to the very bottom) and now copy the remaining rows that contain all the totals into the new spreadsheet. Note: you will probably have to edit the formulas to account for new data records.
#Sort all the records by vendor name, item description
#Apply filter to the column headers
#On the website indicated above, obtain a current list of the stewards that are registered in BC. Suggestion is to print this list off (in 2019 this was 27 pages).
#Based on the vendor name column, check on the print out to determine if any new vendors have registered in the past year. Keep track of vendors in our system that will need to have their business partner information updated.
## Update any changed vendors in Business Partner maintenance - user defined - MMBC registered - if registered select "Vendor registered with MMBC" OR if Resident Steward select "BC Resident"
#On spreadsheet indicate these changes in Vendor Status column.
#Fictitious items (Nancy) can be removed from spreadsheet.
#Internal supply items can be removed from spreadsheet.
#For the remaining item records - need to determine the various column weights (grams) as needed - this can be obtained by contacting the manufacturer for the information OR physically inspecting and weighing the packaging material OR by estimation based on a similar item from the same manufacturer. NOTE: This step will take HOURS/DAYS/WEEKS to complete.
#The spreadsheet will update/calculate the units sold times the various weights columns and provide totals at the bottom and far right columns. These totals at the bottom will be what is used when logging into the recyclebc website and completing our annual activity report.
#Once all items have been reviewed & checked it is time to upload this spreadsheet back into the item master. Steps below.

==Upload File from Excel==

#Save the updated file (the spreadsheet that you have been working on above) as CSV. This must be in the same format as was previously downloaded – you cannot insert or remove columns (however, you can add columns to the end; they will be ignored in the upload).
#In InfoNet, go to Maintenance & Lists / MMBC / Upload CSV File. After it has been uploaded, the first 50 records of the file will be displayed. If they look correct – like, for example, everything is in the correct column – click on ‘Update’.

The upload runs WebSmart program IN_MMBC01, which calls CL program MMBC01 to copy the file from the IFS to the data base file MMBCINTF.

The update function in IN_MMBC02 calls CL program MMBC02, which calls RPG program MMBC03.

==MMBC in InfoNet Partner Maintenance==

A 'user defined field can be added to indicate whether or not the vendor is registered with MMBC. The options are -

In Progress
No uniPHARM brings the product into BC, and is responsible
BC Resident vendor that creates the paper and packaging is responsible
Yes vendor is responsible

==MMBC in InfoNet Item Maintenance==

If the main supplier is registered, the MMBC source is changed to 'Vendor Registered with MMBC', and not changes are allowed.

When changing the MMBC manually, the options are -

Averaged
BC Resident
Estimated
Manually Weighed
N/A
Vendor Registered with MMBC
Vendor Supplied
Yes

[[Category: Infonet Programs]]

Information Systems:Updating MMBC

2019-07-11T20:48:09Z

Johnt:

=Overview=
This is a non-profit organization that is fully financed by industry to manage residential packaging and printed paper recycling programs in BC, either directly or by working with local governments, First Nations, private companies, and other non-profit organizations. (https://recyclebc.ca/)
*Notes: The goal is to have the manufacturer of a specific item be responsible for any packaging material and register/pay to MMBC the costs of recycling this material. For any manufacturer that is not registered with MMBC, the obligation falls to the distributor or retailer. uniPHARM has decided that we will pay (if needed) based on the sale of the item(s) to the retailers.
MMBC has developed volume thresholds that have changed since the program was first introduced. These can be found on the website below.
*https://recyclebc.ca/wp-content/uploads/2018/10/Recycle-BC-Low-Volume-Flat-Fees_2019.jpg

=Instructions=
* Typically this work would be done at the beginning of a year - looking at the data from the past year.

==Download File to Excel==

To generate the data file from the previous years sales information;
In InfoNet, go to UniView / Sales Statistics / Summarized Item Sales. Set ‘From Year/Month’ and ‘To Year/Month’ so that the entire year is included, and click on ‘Search’. Then click on ‘MMBC to Excel’.

This will create an Excel file of item information, sales, and MMBC rates that have been previously uploaded. Items with main suppliers that are registered with MMBC are not included.

#The file is saved on superserver/buying/common/Multi Material BC (example: sls2018.xlsx)
#Open the previous years spreadsheet. Copy columns BN1:DR2 (headers) and past into current years spreadsheet.
#Copy formulas from BO3:DQ3 and paste into current spreadsheet.
#Copy formulas down to bottom of data records and paste on current spreadsheet.
#Copy from column BO (go to the very bottom) and now copy the remaining rows that contain all the totals into the new spreadsheet. Note: you will probably have to edit the formulas to account for new data records.
#Sort all the records by vendor name, item description
#Apply filter to the column headers
#On the website indicated above, obtain a current list of the stewards that are registered in BC. Suggestion is to print this list off (in 2019 this was 27 pages).
#Based on the vendor name column, check on the print out to determine if any new vendors have registered in the past year. Keep track of vendors in our system that will need to have their business partner information updated.
## Update any new vendors in Business Partner maintenance - user defined - MMBC registered - if registered select "Vendor registered with MMBC" OR if Resident Steward select "BC Resident"
#On spreadsheet indicate these changes in Vendor Status column.
#Fictitious items (Nancy) can be removed from spreadsheet.
#Internal supply items can be removed from spreadsheet.
#For the remaining item records - need to determine the various column weights (grams) as needed - this can be obtained by contacting the manufacturer for the information OR physically inspecting and weighing the packaging material OR by estimation based on a similar item from the same manufacturer. NOTE: This step will take HOURS/DAYS/WEEKS to complete.
#The spreadsheet will update/calculate the units sold times the various weights columns and provide totals at the bottom and far right columns. These totals at the bottom will be what is used when logging into the recyclebc website and completing our annual activity report.
#Once all items have been reviewed & checked it is time to upload this spreadsheet back into the item master. Steps below.

==Upload File from Excel==

#Save the updated file (the spreadsheet that you have been working on above) as CSV. This must be in the same format as was previously downloaded – you cannot insert or remove columns (however, you can add columns to the end; they will be ignored in the upload).
#In InfoNet, go to Maintenance & Lists / MMBC / Upload CSV File. After it has been uploaded, the first 50 records of the file will be displayed. If they look correct – like, for example, everything is in the correct column – click on ‘Update’.

The upload runs WebSmart program IN_MMBC01, which calls CL program MMBC01 to copy the file from the IFS to the data base file MMBCINTF.

The update function in IN_MMBC02 calls CL program MMBC02, which calls RPG program MMBC03.

==MMBC in InfoNet Partner Maintenance==

A 'user defined field can be added to indicate whether or not the vendor is registered with MMBC. The options are -

In Progress
No uniPHARM brings the product into BC, and is responsible
BC Resident vendor that creates the paper and packaging is responsible
Yes vendor is responsible

==MMBC in InfoNet Item Maintenance==

If the main supplier is registered, the MMBC source is changed to 'Vendor Registered with MMBC', and not changes are allowed.

When changing the MMBC manually, the options are -

Averaged
BC Resident
Estimated
Manually Weighed
N/A
Vendor Registered with MMBC
Vendor Supplied
Yes

[[Category: Infonet Programs]]