Painkillers containing codeine, such as Panadeine and Nurofen Plus, will require a prescription from 2018 to help prevent Australians getting addicted to the drug.
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In response to growing concerns about addiction, overdoses and other harm caused by codeine, the Therapeutic Goods Administration has decided to re-schedule the drugs so people cannot buy them over the counter in a pharmacy from February 2018.
The controversial decision, which will anger drug companies and pharmacies that sell the products, is being introduced with a year-long lead time so people with chronic pain conditions can adjust their pain management plans with doctors.
While an original decision on the re-scheduling of codeine products was meant to be made by November last year, Fairfax Media has previously reported on a quiet push by three large pharmaceutical lobby groups for a regulatory impact statement, which delayed the decision for 12 months.
A TGA statement released on Tuesday morning said there was evidence that misuse of codeine contributes to liver damage; stomach ulceration and perforations; low blood potassium levels; respiratory depression and death.
"Low-dose codeine-containing medicines are not intended to treat long-term conditions, however public consultation indicated that many consumers used these products to self-treat chronic pain. This meant that consumers frequently became addicted to codeine," the TGA statement said.
The regulator said there was also little evidence that low-dose codeine medicines were any more effective for pain relief or coughs than similar medicines without codeine.
The decision comes after reports of codeine addicts swallowing up to 100 tablets a day, and people "pharmacist shopping" to get around rules introduced in 2010 that restrict purchases of more than five days' supply of the drug at one time.
In 2013, Monash University researchers reported nine deaths over a decade linked to toxicity from codeine-ibuprofen medicines such as Nurofen Plus.
Government agency data also shows the number of Australians being treated for codeine addiction more than tripled over the decade to 2012-13, from 318 to more than 1000 a year.
Matthew Frei, an addiction-medicine specialist and clinical director of Turning Point Alcohol & Drug Centre, told Fairfax Media last year that this figure probably vastly underestimates the number of problem users as many patients who abused drugs were not detected.
Other countries including the US, Japan and most of Europe have already stopped codeine-containing products from being sold without prescription.
Despite the international trend towards removing codeine from chemist's shelves, Pharmacy Guild national president George Tambassis said the final decision was "short-sighted" and could limit access to the medicines for people with "genuine medical needs".
"The decision has purportedly been made to help stamp out abuse of these medicines by some people, but in reality this measure will only encourage vulnerable patients to doctor shop and try to find ways around the system," he said.
"Shifting it to prescription only without a mandated real time recording system or any screening program will simply bury the problem even deeper in the overwhelmed system and cost shift it to an already bursting MBS [Medicare Benefits Schedule]."
With Daniel Burdon
