Canada is one of the highest per capita consumers of opioids, second only to the United States.1 The opioid crisis has been a hot topic among healthcare professionals affecting every province from the east to west coast. According to Health Canada, there were 2,946 apparent opioid-related deaths in 2016 and at least 2,923 from January to September 2017. Of this rise, 92% were ruled as accidental or unintentional.2
The government has identified the need for intervention, and on May 2, 2018, they issued a two-step strategy: inform patients and implement risk management plans.3
- Under the Food and Drug Regulations divisions, all prescription opioids in Part A of the “List of Opioids” will require pharmacists to affix the warning sticker shown below as well as a patient information handout at the time of dispensing.
- Market authorization holders (MAH) of specific opioids will be required to submit a Canadian tailored opioid risk management plan to Health Canada. This plan will allow for categorization, monitoring, prevention and management of opioid-related adverse events.
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The mandatory bright yellow warning sticker is to be implemented in October 2018 and will be accompanied by a mandatory single page patient handout informing them about:
- The signs of opioid overdose
- The signs of withdrawal
- Warnings to not share the medication
- Store safely away from the reach of children
- Other serious warnings and potential side effects
Is this necessary?
Despite Health Canada’s initiative, many pharmacists feel that their solution is modest at best. A recent poll on the Canadian Health Care Network found that only 38% of pharmacy professionals support Health Canada’s mandated warning sticker on all opioids. Rather, pharmacists serve as the last healthcare professional that patients encounter before receiving their opioid medications, thereby providing a distinct opportunity for individualized counselling. Warning stickers can inform and remind patients of the risks associated with opioid misuse, but this could also lead to non-compliant therapy and pharmacists may be the best judge of whether or not the sticker is appropriate.4,5
"Would you attach the warning sticker for a methadone or suboxone patient who is trying to manage their addiction?"?
In addition, the CPhA has proposed that the government utilizes the clinical knowledge and accessibility of pharmacists by expanding our scope for designation as practitioners under the Controlled Drugs and Substances Act. This will allow for modifications to opioid prescriptions including:
- Dose Reductions
- Dosage form adjustment
- Substitutions for non-opioid alternatives
- Opioid tapering
Working in a community pharmacy, I know that every opioid prescription already has auxiliary warning labels affixed and each new prescription also has a patient information handout to reinforce the pharmacist’s counselling points. So, the question is, will this really make a difference?
Personally, I have mixed feelings, these stickers may be the catalyst for conversations with patients, but we shouldn’t be treating them homogeneously. Rather, we should be providing personalized care, and a regulatory change like the one above will allow for pharmacists to leverage their role and combat the crises more holistically.
Leave a comment below to let me know if you support Health Canada’s mandatory warning stickers.
Cheers,
Ingrid
References
- Special Advisory Committee on the Epidemic of Opioid Overdoses. National report: Apparent opioid-related deaths in Canada (January 2016 to September 2017) Web-based Report. Ottawa: Public Health Agency of Canada; March 2018
- Government of Canada. Health Canada. Opioid Warning Sticker and Patient Information Handout, and Risk Management Plans; May 2018. Accessed on May 30, 2018: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/policies/warning-sticker-opioid-patient-information-handout.html
- Canadian Pharmacists Association. New mandatory opioid warning stickers not sufficient to address prescription opioid misuse; May 2018
- Ubelacker, S. Health Canada mandates warning sticker for all prescription opioids. The Canadian Press; May 2018