Medicines

Outcry prompts TGA backflip on opioid prescribing restrictions


The TGA appears to have backpedalled on a proposal to restrict prescribing of strong opioids to clinicians in specialties such as pain medicine and palliative care.

The idea to limit prescribing of S8 opioids to certain “classes of medical practitioners” – much in the same way as the acne drug isotretinoin can only be prescribed by a dermatologist – is one of several options touted by the regulator in a consultation paper released on 19 January that aims to tackle Australia’s growing problem of prescription opioid misuse.

Reports of the proposal triggered an immediate outcry from GPs, prompting the TGA to issue a new statement on 27 January claiming the news stories were “totally wrong” and the proposal would not ban GPs from prescribing high dose opioids.

“The medicines’ regulator is not proposing and will not be stopping GPs from prescribing high dose opioids,” the TGA said. “As part of the discussion paper the TGA has issued on the use and misuse of opioids, there is an option about the level of training for potentially dangerous drugs which is being discussed in consultation with the AMA, the RACGP and other appropriate bodies.”

Despite these strong words, Option 7 in the consultation paper Prescription strong (Schedule 8) opioid use and misuse in Australia – options for a regulatory response unambiguously puts forward a regulatory option to limit the prescribing of S8 opioids to particular populations or “classes of medical practitioners” via amendment to the Poisons Standard appendices.

“While the TGA would have to seek legal advice on the potential to ability of amendments to the Poisons Standard to limit prescribing of s8 opioids to certain medical practitioners (such as palliative care physicians for high-dose opioids in patients with cancer pain and specialist pain medicine physicians for high-dose opioids in patients with chronic non-cancer pain), allowing access for GPs in remote areas would seem possible,” the paper says.

“The extent of regulatory powers under appendices to the Poisons Standard is generally untested by law and would in many cases changes would need to be adopted by the states and territories to have effect”.

Mandatory education for doctors on best practice prescribing could also be enforced via changes to the Poisons Standard, as part of this option, and the move should only be considered after consultation with the public and advice from the TGA’s Advisory Committee on Medicines Scheduling, the consultation document says.

The paper stresses the urgent need to address the problem with prescription opioid overdose levels at “record highs”.

This trend is partly driven by “indication creep” with some 1.1 million PBS opioid prescriptions dispensed for managing osteoarthritis–related pain in 2015-16, despite limited evidence for safety and efficacy. This figure is forecast to grow approximately 3 million by 2030. Approximately 2.1 million Australians (one in 11) have OA, based on 2014-15 figures.

Meanwhile, prescription opioids were implicated in 2975 deaths between 2007 and 2011.

Other options put forward in the TGA proposal include introducing specialist-only/authority prescribing for PBS reimbursement, aligning the indications for S8 opioids to clinical guidelines, mandating sponsors offer smaller pack sizes (e.g. 3 day supply) and introduce new product warnings and incentives to bring new alternative analgesics to market.

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