TGA commissions independent report on self-harm risk of paracetamol misuse

Pharma News: Australia’s Therapeutic Goods Administration (TGA) has commissioned an independent expert report into how current access controls for paracetamol manage the risks of self-harm from intentional misuse.

While there are currently no applications to amend the Poisons Standard with respect to paracetamol, TGA wants to gather information to inform considerations about whether any changes to the scheduling, including access or purchasing controls, may be warranted. TGA’s interest in potentially making changes reflects the concerns of the families and healthcare professionals of affected consumers of paracetamol. The concerns centre on the number of poisonings and deliberate overdoses from paracetamol.

As those poisonings and overdoses involve paracetamol obtained from general retail outlets, TGA wants to assess whether current access restrictions are appropriate. The current restrictions place limits on the pack size and strengths of paracetamol that can be sold by general retail outlets, such as supermarkets and convenience stores, and through pharmacy or pharmacist-only sales.

TGA wants the panel of experts to assess the incidence of overdosing reports, emergency department presentations, hospital admissions, adverse health outcomes and deaths attributable to paracetamol in Australia. The review will place particular emphasis on events linked to paracetamol bought at general retail outlets and try to compare outcomes to other over-the-counter pain relief medicines.

The experts will also perform a systematic review of medicine overdosing behaviour, assess the balance of benefits and risks of current access to paracetamol on the Australian market and look into the possible outcomes of changes to general sale access to paracetamol. TGA has asked the panel to review access controls and paracetamol misuse outside Australia.

TGA is set to publish the report online in July. After that, the agency will hold a public consultation ahead of the Advisory Committee on Medicines Scheduling offering its take on any proposal to amend the Poisons Standard in relation to paracetamol in the second half of the year.