The federal government is considering making adverse drug reaction reporting mandatory for doctors and other health care providers.
Only 5% of suspected adverse drug reactions (ADRs) are now reported according to an estimate from the Senate Committee on Social Affairs, Science and Technology.
Underreporting reduces Health Canada’s ability to rapidly detect safety problems related to drugs or medical devices and to change labelling, warnings and advisories, Health Canada senior media officer Leslie Meerburg wrote in an email.
Health Canada will “take concrete action” to improve its ADR reporting system, said Health Minister Leona Aglukkaq.
ADR reporting is currently voluntary for everyone except pharmaceutical manufacturers and distributors. The latter two must submit all Canadian ADR reports and serious international reports to the federal government’s Canada Vigilance program. The reports are analyzed and if a problem is found, health care providers and the public are informed, and drug packaging may be changed or the drug taken off the market.
However, this process can take up to two years, states the Senate Report on Post-Approval Monitoring of Pharmaceuticals, released Mar. 26. The report also criticized Health Canada for not paying enough attention to international ADR reports; in a nation with a relatively small population, these reports provide valuable information.
Health Canada is also considering making reporting mandatory for doctors, which will flood the system with data, says Dr. Eric Wooltorton, assistant family medicine professor at Ottawa University, Ontario. And more doesn’t necessary mean better quality, he says. What’s really needed is a better system to interpret the reports.
“The issue is not just getting doctors to report,” adds Dr. David Healy, founder and CEO of RxISK, a website where patients can report ADRs and health care providers can research medications. “The issue is having a person who’s going to make sense of what the reports mean. Regulators aren’t rained for this.”
Health Canada needs to overhaul the way reports are interpreted and acted upon, he says.