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Mandatory stickers and brochures when dispensing opioids

October 3, 2018

New Health Canada regulations come into effect October 20, 2018.

Starting on October 20, 2018, Health Canada will require pharmacists to provide an information handout to individuals and put warning stickers on some opioids dispensed at pharmacies.

The yellow sticker will warn that opioids can cause dependence and addictions, and that overdoses can be fatal. The handout will expand on the warnings, detail the signs of an overdose, explain possible side effects, and offer advice on safe storage and disposal.

Opioids listed on Health Canada’s schedule “A” must have the sticker. Over-the-counter opioid preparations with a low dose of codeine are exempt.

Health Canada believes the warning sticker and information handout will ensure that Canadians receiving prescription opioids have consistent and relevant information to try to reduce the risks associated with opioid use.

“Pharmacists are reminded that the labels and brochures do not replace the requirements for and importance of conversations with every individual receiving an opiate,” said Greg Eberhart, ACP’s Registrar.

Greg believes a single message for all individuals with an opioid prescription isn’t the answer. An assessment with an individual experiencing chronic pain should be different than an assessment for an individual receiving a prescription for an opioid prescription for the first time.

“How we address each one of these populations needs to be significantly different,” explained Greg.

The content for the handout and sticker is based on the recommendations of an advisory panel on opioids, while subject matter experts reviewed the material for accuracy and ensured the language is easy to understand.

The new handout is not interchangeable with the patient information section of a product monograph. While the handout may supplement existing educational resources, such as ACP’s opioid brochure, Health Canada states that it cannot be replaced with any other material.

Pharmacies will have to obtain or produce copies of the sticker and handout which meet the specifications of the source document. Digital copies of the warning sticker and patient information handout are on Health Canada’s website.

Any questions can be directed to HC.bcans.enquiries.SC@canada.ca.

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