Canadian regulators don’t declare all drug side effects before they are dispensed, says UBC researcher

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      According to a recent international study co-authored by UBC researchers, Health Canada fails to issue drug safety warnings put out by its counterparts in three other countries: the U.S., the U.K., and Australia.

      In a study published in JAMA Internal Medicine, researchers analyzed how often drug regulators issued safety advisories about the potential health risks of prescriptions, and found significant variation across the four nations.

      Typically when new medicines become available to consumers, a country’s regulator will approve them for use based on the data gathered during clinical trials and development. Often when a drug enters common circulation, more information becomes available about the effects of long-term use, and physicians discover side effects that occur more rarely in individuals.  The study determined that warnings were not issued consistently across all four countries, with many regulators failing to declare the new findings until sometimes years after each other.

      “Clearly if a drug has a safety advisory issued in one country, the same drug sold in another country should also come with similar warnings,” says the study’s primary investigator Barbara Mintzes, affiliate associate professor at UBC’s School of Population and Public Health and associate professor at the University of Sydney in Australia. “We really need better understanding of how decisions to issue safety warnings are made, to ensure emerging risks of medicines are effectively communicated to doctors and other prescribers as well as the public.”

      The study took place over a 10 year period, analyzing 1,441 advisories and 680 drug safety concerns. Researchers found that the country’s regulators were only consistent in the decision to warn the public about any additional side effects 10 percent of the time—implying that, more often than not, important drug information had been omitted.

      “Between 2007 and 2016, Health Canada issued safety warnings for only 50 per cent of the drug safety issues identified by regulators in Australia, the United States, and the United Kingdom,” said Mintzes. “While Australia’s regulator issued the fewest warnings of the four countries, it’s concerning that there is so little consistency between countries regarding how they communicated emerging health risks of medicines.”

      Having more complete information about drugs can save lives and taxpayer dollars. Bad reactions to prescriptions are estimated to be responsible for up to two-thirds of drug-related emergency department visits and hospital admissions, according to the Canadian Institute for Health Information.

      Kate Wilson is the Technology Editor at the Georgia Straight. Follow her on Twitter @KateWilsonSays