Health Canada is moving to ban non-prescription sales of codeine, a widely used opioid that has been linked to abuse and dependency.
The department is proposing to make pain pills, cough syrups and other familiar medications that contain codeine available only with a doctor's prescription.
The regulatory notice says about 600 million low-dose codeine tablets, or about 20 for every person in the country, were sold across Canada in 2015. It notes that more than 500 people entered addiction treatment centres in Ontario alone between 2007 and 2015, with non-prescription codeine as their only problem substance.
Then Health Minister Jane Philpott warned last year she would tighten the rules on over-the-counter codeine.
"While a prescription may not be needed today, codeine can produce drug dependence and has the potential for being abused," she told a Toronto conference in June 2016.
"This practice must be stopped, and so I will also introduce regulatory changes that will propose requiring a prescription for low-dose codeine products."
Canadians have until Nov. 8 to comment on Health Canada's proposed regulations.
Currently, Canadians can buy medications with low doses of codeine — for example, a maximum of 8 mg in a single pill — as long as two other medications are present, normally caffeine and a painkiller such as acetaminophen.
The medication must be kept behind the counter at drugstores, where pharmacists are supposed to carefully monitor individual sales to watch for abuse.
But the pharmacists' checks are often cursory, sometimes merely asking the customer whether they've used the medication previously, because clinical and prescription histories are rarely available.
A Toronto Star investigation in 2015 found frequent abuse of the medication, despite warnings from medical experts for decades about the potential for harm. The newspaper's investigation counted more than 100 codeine products sold in Canada, and about half of them did not require a prescription.
At least two drug manufacturers have ceased providing low-dose codeine products in recent years, and Manitoba last year ended over-the-counter sale of the products. Such products have been among the top-selling medications in Canada.
'A no-brainer.' - Drug safety researcher Dr. David Juurlink on Health Canada aiming to ban non-prescription sales of codeine
The body metabolizes codeine into morphine, a drug that can cause dependency. If taken in quantity, the pills' and syrups' content of other painkillers can also cause harmful side-effects, such as liver damage from acetaminophen.
Better medical advice in order
Australia is also joining a growing list of jurisdictions to announce a ban on over-the-counter sales of products containing codeine. It's set to begin in February.
"Evidence of problematic use of and dependence on non-prescription codeine products has also been documented in other countries where these preparations are available," says the Health Canada notice published Saturday.
"Potential changes to Canada's regulations to require all codeine products to be sold by prescription would be in line with those already in place in many countries, including Belgium, Czech Republic, Finland, France, Greece, Iceland, India, Italy, Norway, Russia and Sweden.
"Currently in the United States, the availability of low-dose codeine products without a prescription varies from state to state."
Health Canada acknowledges that although the prescription-only move could place a greater burden on the health-care system, patients would also be getting better medical advice about using codeine.
The notice also raises the possibility that reducing codeine availability would push more users to illicit markets.
Toronto-based drug safety researcher Dr. David Juurlink called Health Canada's move "a no-brainer" that is long overdue.
Juurlink said such codeine-containing products have little medical purpose, and the other ingredients can often damage the body if the medications are abused.
The Canadian Pharmacists Association wrote to Philpott last November, calling on the government to make all codeine products available by prescription only.
"Patients can form dependence to codeine pretty easily, and even with lower doses," spokesperson Shelita Dattani said in an interview, welcoming the new measure.
She said the association also wants Ottawa to designate pharmacists as practitioners who can prescribe drugs listed under the Controlled Drugs and Substances Act, with the power to adjust or amend dosages and quantities of prescribed opioids, including codeine.
"Pharmacists aren't looking to initiate opioids in patients," said Dattani, who is an Ottawa-area pharmacist. "But pharmacists have a lot of face time with patients."
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A photo in a previous version of this story displayed bottles of 30 mg codeine. In fact, that dose already requires a prescription. The proposed changes would require a prescription for lower-dose pills and cough syrups that are currently available over the counter.Sep 11, 2017 4:20 PM ET