Health Canada's prescription opioid stickers and leaflets get a qualified welcome
Prescription opioids will come with a warning sticker and handout as industry regulations change
Will putting warning stickers on opioid medications and giving patients leaflets each time they get a prescription filled make a difference in overdose prevention? There's research suggesting it may, but the rollout could be an experiment in the midst of a crisis.
Opioid pain relievers include oxycodone, morphine, hydromorphone, fentanyl and codeine. Canadians are increasingly using both prescription and illegal versions, Health Canada says, which has contributed to opioid addiction and deaths.
Starting in October, Health Canada's new regulations will include three main changes:
- Require prescription opioids to come with a yellow, rectangular warning sticker saying opioids can cause dependence, addiction and overdose.
- Add a one-page handout that aims to provide concise and consistent information on the risks of opoids.
- Require drug companies to make risk-management plans.
Petra Schulz, co-founder of Moms Stop The Harm, a coalition of Canadian mothers who have children affected by addiction, applauded the warning stickers and information handout, but said she'd like an extra step: a sheet highlighting how to respond to overdoses to help save lives.
Part of the problem is that first aid courses don't show you what an overdose looks like, Schulz said.
"So many times I hear, 'I thought he was sleeping it off. He was snoring. She was sleeping," said Schulz, who lost her 25-year-old son Danny to a fentanyl overdose in 2014. "If you don't get the information in the hands of people, you're leaving them at risk."
Too many loved ones are started on an opioid prescription without being aware of the harms the drugs can caused if not used correctly, Schulz said. What's more, every individual responds differently. An opioid overdose suppresses breathing, and the longer the brain lacks adequate oxygen, the greater the risk of suffering damage.
"I feel that everyone who receives opioid pain medication for any reason, especially those who get long-term prescriptions should be made aware of all risks, including drug dependence and overdose risks, so the patient can make an informed decision and explore alternate pain relief whenever possible."
The stickers will act as reminder of the risks to patients every time they go to use the drugs, said Dr. Supriya Sharma, Health Canada's chief medical adviser in Ottawa.
"We want patients to have ongoing conversations with their health-care providers and pharmacists about the risks and the benefits of prescription opioids," Sharma told reporters on Wednesday. "These stickers and handouts will help continue those conversations."
Leaflets promote dialogue
Prescribed medications in Canada carry several warning stickers and most are unregulated, Sharma said, making it difficult to have information on their effectiveness.
"But there are a number of studies showing how provision of information at point of sale in the form of a patient leaflet actually helps both the dialogue that the patients have with the pharmacists as well as provide consistent information. There's some studies that were done in the U.K. that talk about the effectiveness of that practice as well as in the United States."
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The other new aspect places conditions on drug makers, such as requiring and detailing how they need to monitor for adverse events.
Watch for vested interests
"Practically all of the opioids were actually approved at a time when we didn't have risk-management plans, so this is a way to have manufacturers have the obligation that they put these plans in place," Sharma said.
Dr. Abhimanyu Sud is director of the Safer Opioid Prescribing Program and a family physician in Toronto. He's one of many physicians Health Canada canvassed about the opioid stickers, which he called a no-brainer to help patients.
But Sud is weary of the pharmaceutical industry developing and delivering risk management plans, because he says they have a vested interest in manufacturing, distributing and profiting off the use of the drugs.
"If Health Canada believes opioid prescribing education is wanting in Canada and in the public interest, they should fund development of high quality programs using taxpayer dollars, rather than looping in the pharmaceutical industry," Sud said in an email on Thursday.
Alberta's College of Pharmacists said it supports the need for individuals who use opioid medications to be informed, monitored and supported.
"Our college is developing our own opioid information pamphlet to be available through pharmacies. That said, discussions about the risks and benefits of using opioid medications must start at the point of prescribing."
In a statement, the Ordre des pharmaciens du Québec, which includes pharmacists in that province, said patients who use opioids need support and follow-up on their drug therapy "that is adapted to their needs." For instance, people taking opioids such as methadone or Suboxone to manage an addiction may need different information.