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e-Panel Survey Summary

Post-Approval Surveillance of Drugs and Medical Devices

Synopsis

The CMA surveyed e-Panel members to learn more about their experience and satisfaction with reporting Adverse Drug Reactions (ADRs) and Medical Device Problems (MDPs). The results provide a picture of the factors that influence reporting, as well as how the reporting process could be improved. A summary of the results of the e-Panel survey is presented below.

Survey – March 2015

The survey was sent to 3,128 practising e-Panel members; 471 responded, for a response rate of 15%.

Results

Survey results indicate that reporting of ADRs and MDPs to Health Canada is inconsistent; only 35% of respondents have ever reported one. As well, almost 50% of respondents did not report any of the ADRs or MDPs to Health Canada that they saw in the past year. Respondents cited a variety of reasons for not reporting, as well as views on what could be done to improve this process.

Experience with reporting Adverse Drug Reactions or Medical Device Problems

The majority of respondents (65%) have never reported an ADR or MDP to Health Canada. Of those who have reported, the most popular method of reporting was by fax (57%), followed by mail (23%), online (12%), and phone (11%). The majority of respondents were satisfied with their latest experience reporting to Health Canada, with only 18% rating it as poor. Only 12% of respondents have used other surveillance systems to report ADRs or MDPs.

Factors influencing likelihood of reporting

When asked about the factors that contribute to not reporting ADRs and MDPs to Health Canada, the most popular responses 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 following were the most commonly cited factors that would make respondents more likely to report to Health Canada:

  • 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 (e.g., for 5 years) (49%)
  • Integration of an ADR/MDP functionality into the electronic medical record (49%)
  • Payment for time preparing reports (41%)

Reporting Process

Respondents were divided on what the reporting process for ADRs and MDPs should look like. Results indicate that 25% think that reporting should be voluntary; 26% think that it should be a professional obligation through provincial/territorial medical colleges; over 25% think it should be both a professional obligation and a legal requirement; and less than 6% think it should be a legal obligation only.

Notification about Adverse Drug Reactions and Medical Device Problems

Most respondents (66%) are notified about ADRs and MDPs through Health Canada notices or newsletters, while some are notified by their Hospitals, Pharmacists, Specialty Societies, and the Health Canada online database. Over 60% of respondents receive Health Canada’s products related to ADRs and MDPs; most (63%) are satisfied with these products. When asked about how they want to receive ADR and MDP information, the majority of respondents (65%) preferred email.

Respondents told us

“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?”

“Very complex system and little information immediately available about the process of reporting and 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 it should not need to be the case.”

“ADR/MDP reporting systems should be individualized to a physician's area of practice; e.g., as a pediatrician I am not involved in prescribing statins. Receiving too many notices about drugs outside my area of practice reduces the ability to focus on relevant problems. This is one reason the Canadian Pediatric Society program is useful. A similar approach should be followed for specialities and FPs.”

“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.”