RACGP doubles down on paracetamol pack size

The college says the medication is being overused for conditions such as osteoarthritis and back pain.

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The RACGP has called on the TGA to further slash the pack size of paracetamol pills available off the shelf in pharmacies and to up-schedule modified-release paracetamol to prescription-only.

It claims modified-release paracetamol is being overused for conditions where there is “insufficient evidence of benefit, such as osteoarthritis and back pain”.

The call is opposed by the Australian and New Zealand College of Anaesthetists, which said the RACGP proposal would make chronic pain treatments less accessible and lead to “further harms” from overuse of other medications.

The news came as the TGA revealed it had received hundreds of submissions in response to its interim decision, announced in February, to reduce the maximum size of paracetamol packs available off the shelf in pharmacies from 100 to 32 tablets or capsules.

It was part of a raft of proposed amendments to the Poisons Standard, designed to reduce Australia’s incidence of serious injury and death from intentional paracetamol overdose. 

Other changes include reducing the maximum size of packs available for general sale (such as in supermarkets and convenience stores) from 20 to 16 tablets or capsules; making other pack sizes of up to 100 tablets or capsules only available under the supervision of a pharmacist; and banning the use of bottles for paracetamol products, meaning only blister packs will be available for sale. 

The TGA proposes to implement the changes from 1 June, 2024. It opened the interim decision up to community consultation for a month.

A TGA representative told The Medical Republic more than 200 submissions were received during the consultation phase and would be published along with the final decision “at a later time”.

The RACGP submission, signed by president Dr Nicole Higgins, said that while the RACGP supported the reduction of pack sizes of paracetamol available in pharmacies and supermarkets, the changes proposed in the TGA’s interim decision were unlikely to significantly impact the harms from paracetamol overdose.

“Given that overdoses mostly occur from available stockpiles in the home, the small reduction in pack size is unlikely to reduce the incidence of paracetamol overdoses in Australia,” it said.

“The RACGP recommends pack sizes be reduced further to make an impact on stockpiled medications.”

The RACGP also disagreed with allowing off-the-shelf pack sizes to be larger in pharmacies than supermarkets and convenience stores. It recommended the TGA up-schedule modified release paracetamol to Schedule 4, saying “normal paracetamol is more appropriate” for acute pain.

“There is an overuse of modified release paracetamol for conditions for which there is insufficient evidence of benefit, such as osteoarthritis and back pain.

“Additionally, treating overdose from modified release paracetamol is more difficult than normal paracetamol. This is due to the particular pharmacodynamics of modified release paracetamol.”

Professor Mark Morgan, chair of the RACGP expert committee Quality Care and professor of general practice in the Faculty of Health Sciences and Medicine at Bond University, told TMR the college had resubmitted its recommendations because most of the advice it had offered last year had not been adopted by the TGA.

He said he was more comfortable with larger pack sizes of paracetamol being available in consultation with a pharmacist, provided there was a conversation about safe use and storage.

“For somebody that is advised to take paracetamol regularly, the ability to access a larger box makes some sense and aligns with our other advocacy at the moment which is to improve convenience and access to the patient by having larger pack sizes of stable prescribed medications,” he said.

“So I don’t have a problem with a larger supply but with the proviso that it’s made as safe as possible from impulsive overdoses from stockpiles in people’s homes.”

Professor Morgan said the RACGP felt strongly about the issue of up-scheduling modified-release paracetamol, and the need for “well-funded” guidelines on the management of painful conditions like osteoarthritis.

However, Associate Professor Michael Vagg, director of professional affairs for the Faculty of Pain Medicine of the Australian and New Zealand College of Anaesthetists, said his faculty did not support this.

“The consensus of the FPM executive is that we remain concerned about the scale of changes in proportion to the risks that are purported to be mitigated,” he told TMR.

“We do not support sustained-release paracetamol being moved to prescription only but agree with it being a pharmacy-only medicine requiring pharmacist consultation for new purchases.”

He said the executive supported the reduction in pack sizes as proposed by the TGA, as it struck a balance between the needs of pain consumers and the risks of paracetamol overdose.

“We would suggest the current changes be given a trial period to assess unintended consequences before going any further,” he said.

“Hence, FPM feels the RACGP proposal tilts too much in the direction of harm minimisation and would, if implemented, have high potential for making chronic pain treatments less accessible and ibuprofen consumption increase, leading to further harms that have not been considered by RACGP.”