Health Canada added a potentially valuable pharmacovigilance tool to its post-market surveillance arsenal today — a web form for direct consumer reporting of adverse drug events.
Unfortunately, the implementation is terrible. The goal was “to make it even easier for consumers to report side effects to drugs and other health products,” but I doubt most consumers would make it past the first page.
Why? The form provided to consumers (direct link) is the exact same form that is provided to physicians (direct link) for voluntary reporting. It is hard to fill out. After clearing the intro screen and the privacy warning, I got stuck trying to figure out what I should use for my “Identifier,” which helpfully notes “for privacy purpose do not use the patient’s name.”
Once If you get to the second page, a note at the top informs you that not all fields are required, just the ones “that have a red asterisk displayed next to them.” Here’s an idea: how about starting with the mandatory fields on the first page?
The best advice, at this point, is in the press release:
Health Canada reminds consumers that all side effects, especially serious ones, should be reported immediately to a health professional. Consumers are encouraged to seek assistance from their health professional to report a side effect to Health Canada.
There are many ways direct reporting could work well: a useable web form, a Twitter hashtag, etc. Hopefully MedEffect will give this some more thought and help make direct reporting a viable supplement to the Canada Vigilance Program.
Re-posted from the Cross-Border Biotech Blog
Jeremy Grushcow is a Foreign Legal Consultant practising corporate law at Ogilvy Renault LLP. He has a Ph.D. in Molecular Genetics and Cell Biology. His practice focuses on life science and technology companies.