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High-strength opioid formulations meet the legal threshold for the Canadian federal minister of health to recall them from the Canadian market in order to prevent serious risk for injury to health, according to the authors of a commentary published in the Canadian Medical Association Journal.
The Protecting Canadians from Unsafe Drugs Act passed into law in 2014 empowered the minister of health to recall a drug if they “believe that a therapeutic product presents a serious or imminent risk of injury to health.” The minister’s belief must be supported by “some evidence,” and under the law the minister is not required to consult with a drug’s manufacturer. The potential harms of high-strength opioids are numerous, noted the commentary authors, and include accidental death by overdose, falls, fractures, cognitive impairment, testosterone suppression, depression, paradoxical worsening of pain, motor vehicle collisions, and physical dependence.
High-dose opioid formulations include those containing 100 mg of morphine, 80 mg of oxycodone, ≥20 mg of hydromorphone, and fentanyl patches releasing 75 or 100 μg per hour. These products gained regulatory approval despite a lack of evidence supporting their use, and dispense 200 to 400 mg morphine equivalent (MME) per day. Current evidence-based guidelines recommend that clinicians avoid prescribing daily doses that exceed 90 mg MME per day due to the high risk for net harm.
Patients are often prescribed high-strength opioids due to the failure of lower doses to relieve their pain. Few patients can stop opioid treatment without experiencing withdrawal symptoms for which they require treatment.
To mitigate any potential unintended consequences that may result from a recall of high-dose opioids, clinicians can prescribe an equivalent dose of lower-strength medications.
“Ministerial recall of the most hazardous opioid formulations is a powerful regulatory tool that should be deployed to address one aspect of the crisis: the excessive prescribing of opioids for chronic pain,” the commentary authors wrote.
Reference
Herder M, Juurlink D. High-strength opioid formulations: the case for a ministerial recall. [published online December 3, 2018]. CMAJ. doi:10.1503/cmaj.181289
