Ottawa offers to make over-the-counter codeine pills only after years of pressure


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According to Health Canada, 1,300 people are admitted to treatment each year for dependence on over-the-counter codeine alone or with other drugs

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The federal government is proposing to end what a pharmacist has called the “dirty little secret” of Canada’s drug policy, requiring prescriptions for drugs containing codeine that are now available free over the counter.

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The suggested change would put a damper on products with sales of 600 million tablets per year – 20 tablets for every Canadian – and an over-the-counter status virtually unique in the industrialized world.

In a notice of possible new rules , the government cites the surprising addiction toll imposed by low doses of codeine in drugs that combine the opioid with acetaminophen or other pain relievers.

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About 500 people per year are admitted only to publicly funded drug treatment centers because they are addicted to over-the-counter codeine alone, and another 800 due to low-dose codeine addiction and to other drugs, depending on the department.

Leading Canadian drug policy scholar says pills are almost as dangerous for another reason: People who take them for high consume large amounts of acetaminophen or ASA, two drugs that can be very toxic in bulk .

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Pharmacists and other experts have called for the change long before the current epidemic of opioid addiction – with little effect so far, said Dr David Juurlink, a physician and toxicologist at Sunnybrook Health Sciences Center in Toronto.

“It is obvious, and it should have been done years ago,” he said. “It is an utterly reckless and inadvisable thing to allow. “

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Juurlink bluntly assesses why the ministry has taken so long to act: “Inertia and bureaucratic incompetence, the two things Health Canada does best.

The proposal has been published in the Canada Gazette and is open for a 60-day comment period, after which the government will decide whether to pass regulations implementing the change.

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The most common targeted products are the generic versions of Tylenol 1 – codeine and acetaminophen – and “222s” – codeine and aspirin – which are no longer available as a branded original.

Canada is close to world leader when it comes to codeine use, its consumption is several times that of most other Western countries, with only Iceland reporting a higher per capita habit.

For those who have an addiction problem and really want to get the maximum benefit from it, there are many websites that explain in detail how to extract codeine.

Health Canada says that making low-dose codeine drugs only on prescription could lead to greater utilization of the healthcare system, as patients who so wish should see a doctor. It could also lead abusers to more dangerous alternatives.

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But it would also ensure that Canadians carefully review with their doctors the best drug for their needs, according to the advisory. He noted, in fact, that over-the-counter codeine pills are questionably effective, with a 2010 study finding that non-opioid alternatives worked better than codeine.

In fact, the dose in these tablets is virtually non-therapeutic, Juurlink said. Although it is derived from opium, codeine must be converted into morphine by the liver, so the resulting concentration also differs from person to person, he said.

Benedikt Fischer, an addictions scientist at the Center for Addiction and Mental Health in Toronto, agreed the proposed change was long overdue.

But he warned that the risk of “displacement” – users switching to a more powerful alternative – is real and has recent precedent. When OxyContin was essentially taken off the market in Canada, many prescribers, patients and addicts switched to the much more potent and perilous Fentanyl, he said.

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If codeine pills are only prescription-only, authorities should make sure to educate people about less harmful pain relief options, he said.

“There are potential hidden and unintended side effects of such a restriction that we need to watch out for,” Fischer said.

Experts say the proposal would almost certainly shrink the pill market, but the trade group of brand-name drugmakers in Canada gave its approval on Monday.

Innovative Medicines Canada is supporting the government’s consultation on low-dose codeine and other efforts to address the opioid crisis, Pamela Fralick, chair of the group, said in a statement.

In fact, most of the over-the-counter codeine pills currently sold are generics, Juurlink said, so the branding industry has little to lose.

One of the most recent attempts to change the rules was a petition started by pharmacists earlier this year. One of his supporters, a former pharmacist at the Edmonton hospital Joe blais , called the policy a dirty secret. “It’s time for our love affair with readily available codeine to end,” he argued in a January blog post.

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