The ADR (Adverse Drug Reaction) Module is a program within the CHARMS system. 

If your centre experiences an ADR, you/your data entry clerk would enter the information into the module.  When an ADR is completed in CHARMS it automatically fills out and sends the Health Canada Adverse Event Report Form to the following:

• Health Canada / Public Health Agency of Canada
• CBS
• Quebec Blood Services & Blood Secretariat
• the manufacturer of the product.

• A harmful and unintended response to a health product. This includes any undesirable patient effect suspected to be associated with health product use.
• Includes: Unintended effect, product abuse, overdose, drug interaction, unusual efficacy, pregnancy exposure.
• Suspected association, not necessarily caused by the drug ­, but an association in time is all that is necessary

• Anyone can complete an ADR, but under­reporting means problem drugs are not caught
• Hardly anyone does it ­ only drug manufacturer has a legal obligation to report. Pending reforms to the 'Marketed Health Products' law will make it mandatory for institutions to report
• This reform will improve post­marketing surveillance, increasing the requirements for Pharma

• Make it easier to report ADRs
• Make sure all appropriate people receive notice of an ADR: Health Canada, the company who made the product, CBS, HQ, Public Health Agency of Canada, the rest of the clinic.
• Keep a record of what was reported, to who and when.
• Keep a record of when various groups looked at the ADR report.

• Fill in the report in CHARMS
• When the report is ready, submit to the central server.
• Arrival on the server triggers an email to all concerned groups.  Only the product manufacturer is the company contacted and able to review the report.
• On receiving a CHARMS Web Notifier email, the recipient of the email signs on to the website to look at the report ­ that is recorded.
• View the current list of all recipients

Log into CHARMS

01) Upon logging into CHARMs, use the Infusion Diary and locate the infusion episode

02) Select the line item of product infused prior to the reaction reported by the patient.

03)  Click on the Reaction button and proceed to fill in the Adverse Event report.

     A. Some cells may be pre-populated with existing data (ie UI#, last recorded weight, age, date of birth).  Please review to ensure all is correct.

     B.  ‘Primary’ product tab.  This tab records the product infused as selected from the Infusion Diary to initiate the report.  If there is a need to report a secondary product infused, enter the details by selecting the ‘Secondary’ tab.

04)  Complete ‘Section C’ sub-tabs (B4. Reaction, B5. Tests, B6. History, C9. Drugs, C10. Treatment).
Note: Most information is to be entered manually with the exception of B5. Tests where you can select the applicable test results as well as add text.  All information inputted in each section will be added on the Health Canada ‘Adverse Reaction Form’

It is recommended that the report be reviewed by the Clinic Director or reporting Health Professional before it is submitted.  To preview the report, click on the magnifying glass.  Make any revisions to the form as required.

06)  Submitting the Adverse Event

Click on the Save button to submit the ADR.  Click ‘Yes’ on the popup box to finalize the submission.

DOWNLOAD AND VIEW THE COMPLETE S.O.P.

01)Upon final logging of an ADR by the clinic, the following email (sample) will be sent out to the intended recipients notifying them that an ADR has been submitted.

03)  This will launch your web-browser (ie. Internet Explorer, Firefox, Safari) taking you to the CHARMS Data-web login (https://charms.ahcdc.ca/login.asp)

If you have previously entered into this system, you may be directed to re-login.  Follow the ‘Click here to Login’ which takes you back to the main log-in screen.

04)  Enter your Username and Password and click ‘Login’

Don't have your username/password?  Contact us today

05) The ADR data will be downloaded to your computer and your Adobe Reader program will open showing the completed Health Canada Adverse Reaction Reporting Form