The pharmacy owners’ industry body is calling for people in acute pain to be exempted from tough new rules for obtaining codeine-containing medicines.
The TGA will move over-the-counter (OTC) codeine medicines to prescription-only (s4) from February 2018, in a bid to curb misuse.
The Pharmacy Guild – which represents community pharmacy owners – opposes the move, arguing its MedsASSIST software, which enables pharmacies to share records of sales of OTC codeine in real time, is a more effective way to combat the problem.
But following the TGA’s January decision, the Guild is now lobbying state and territory health ministers to create an exemption for customers with acute pain.
In an open letter, Pharmacy Guild executive director David Quilty argues pharmacists who have completed codeine-related training should be allowed “in defined circumstances” to supply “up to an agreed quantity of these medicines to patients for the temporary relief of acute pain”.
These pharmacists would have to adhere to a strict protocol and “use a mandatory national real-time monitoring system like MedsASSIST”, he wrote.
Mr Quilty argued that the majority of codeine-related fatalities stem from prescriptions rather than OTC medicines.
The Guild also believes the changes may exacerbate, rather than solve, the problem of codeine misuse, particularly as the absence of a national real time monitoring system will mean GPs won’t know if patients have sought scripts elsewhere.
“To the Guild’s knowledge, there has been no proactive action taken by any doctor groups to put in place a real time recording and monitoring tool to help identify patient misuse when codeine is up-scheduled (due 1 February 2018),” he wrote.
At the same time, the “80 per cent of the more than one million patients who use these medicines annually do so on an occasional basis for the temporary treatment of acute pain” will be inconvenienced, he claimed, with some having to visit emergency departments or an after-hours home doctor service to obtain a script.
A spokesperson for the TGA said each state and territory is empowered to implement such an exemption.
But the AMA has hit out at the proposal and is urging health ministers to “not deviate from the TGA decision which was made with open and transparent consultation”.
“At this stage, we do not want to see the peddling of alternative models, dressed up as ‘patient concern’, which undermine the TGA position,” AMA president Dr Michael Gannon said.
“We are extremely concerned at recent reports of some groups endeavouring to influence or coerce State governments to change, delay, or dilute the impact of the TGA decision.
“This is not in a patient’s best interest. It goes against the decision made by the independent regulator.”
Dr Gannon said there was no evidence that low-dose codeine provides any benefit beyond placebo.
“Patients who have short term pain will still have access to alternative over-the-counter painkillers, which are more effective than low-dose codeine, but without codeine-associated risks.”