High-Strength Opioid Formulations: The Case for a Ministerial Recall

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Canadian Government, Drug Regulation, Drugs: Pain (Including Opioids), Family Medicine, General Practice, Primary Care, Health Policy, Medicine & the Law (Including Forensic Medicine), Vulnerable Populations


Until recently, the power to recall pharmaceuticals from the market was absent from Canadian law. In November 2014, this deficiency was remedied with the passage of the Protecting Canadians from Unsafe Drugs Act, widely known as Vanessa’s Law, which empowers the minister of health to recall a drug when he or she “believes that a therapeutic product presents a serious or imminent risk of injury to health.” We contend that a strong case can be made for recall from the Canadian market of high-dose opioid formulations: those containing 100 mg of morphine, 80 mg of oxycodone or 20 mg or more of hydromorphone, and fentanyl patches releasing 75 or 100 μg per hour. We explain why the legal requirements of section 21.3(1) of this act are met and highlight challenges to exercising this regulatory power responsibly.

In the early 1960s, thalidomide remained on the Canadian market even after its profound teratogenicity became apparent. After initially downplaying the harms of the drug, Canada’s Food and Drug Directorate eventually had to negotiate a voluntary withdrawal by the manufacturer in March 1962, 3 months after its withdrawal elsewhere. Lacking the legal authority to recall the drug from the market unilaterally, the Parliament of Canada finally prohibited its sale in December 1962, in an effort to eliminate thalidomide from pharmacy shelves.