CHARMS - Adverse Drug Reaction Module
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
- 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
DID YOU KNOW...
- 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.