Canadian Medical Association

We surveyed members to learn about their experiences reporting adverse drug reactions (ADRs) and medical device problems (MDPs) — and their satisfaction with the reporting process. The results offer valuable insight into the factors that influence reporting and how the process can be improved.

Completed:
March 2015

Distributed to:
3,128 e-Panel members

Responses:
471

Response rate:
15%

Want to share your perspective? Visit the CMA Member Voice e-Panel page for more information on  how to participate in future surveys.

Aside from being informed that the complaint was received, I would have liked to have more feedback. What was done about it? Has anyone else experienced this?

- Member Voice e-Panel respondent

What members said

Frequency of ADR and MDP reporting

Only 35% of respondents have ever reported an ADR or MDPs to Health Canada. Nearly 50% of respondents didn’t report any ADRs or MDPs to Health Canada in the past year.

Among those who have reported ADRs or MDPs to Health Canada, the most popular methods were:

  • Fax (57%)
  • Mail (23%)
  • Online (12%)
  • Phone (11%)

Most respondents were satisfied with their latest reporting experience to Health Canada. Only 18% rated the reporting experience as poor.

Just 12% of respondents used surveillance systems other than Health Canada’s to report ADRs or MDPs.

Factors influencing likelihood to report

The most commonly identified factors that contribute to not reporting ADRs and MDPs to Health Canada were:

  • Nearly impossible to determine if a drug is responsible for a particular reaction (45%)
  • Little time to complete a report form (36%)
  • Not aware of the reporting system for ADR/MDPs (35%)
  • Only report serious reactions or problems (31%)
  • Only report unexpected reactions or problems (30%)
  • Existing reporting options are too cumbersome (27%)
  • No idea how information reported is used (24%)
  • ADR/MDPs are already well documented by the time a drug or device is marketed (22%)

The most commonly cited factors that would make respondents more likely to report to Health Canada were:

  • Reporting systems that optimize use of my time (65%)
  • Feedback on cases reported (61%)
  • Acknowledgement of submission (50%)
  • Receiving alerts of excess adverse events for certain drugs or medical devices (50%)
  • Clear indication of newer drugs and medical devices that require closer monitoring (49%)
  • Integration of an ADR/MDP functionality into the electronic medical record (49%)
  • Payment for time preparing reports (41%)

It’s a very complex system, little information is immediately available about the reporting process and you get no response back about the results of the investigation surrounding the report. The product was subsequently removed from the market, however. I find myself teaming with a pharmacist to help send the info in and this should not need to be the case.

-Member Voice e-Panel respondent

Obligation to report

Respondents were divided on whether reporting ADRs and MDPs to Health Canada should be:

  • Voluntary (25%)
  • A professional obligation through provincial/territorial medical colleges (26%)
  • Both a professional and legal obligation (over 25%)
  • A legal obligation only (less than 6%)

Health Canada notifications about ADRs and MDPs

Health Canada notices or newsletters alert most respondents (66%) to ADRs and MDPs. Others get notifications from hospitals, pharmacists, specialty societies and the Health Canada online database.

Most respondents (60%) get Health Canada’s communications about ADRs and MDPs. Among those who do, 63% are satisfied with these communications. The majority of respondents (65%) said they preferred to get these messages by email.

I think I maybe have received some faxes or mailed documents but these end up in the junk pile due to the overwhelming amount of junk mail crossing my desk each day.

-Member Voice e-Panel respondent

What’s next

The results from this e-Panel helped inform our response to Health Canada’s consultations on Bill C-17 (Protecting Canadians from Unsafe Drugs Act – also known as Vanessa’s Law). The CMA will continue to work with Health Canada on addressing the different facets of this bill, and on addressing patient safety related to pharmaceuticals.

Other e-Panel survey summaries

See what CMA members had to say about other health topics: