Only days after the Federal Government announced plans to allow double-dispensing of hundreds of pills used to treat chronic disease, its medicines regulator has made a final ruling to cut pack sizes of paracetamol.
The Therapeutic Goods Administration confirmed this week that it will reduce the maximum size of paracetamol packs available in pharmacies, supermarkets and convenience stores.
The changes, due to come into effect from February 2025, are aimed at reducing Australian overdose and death numbers due to intentional paracetamol.
The TGA said 225 people were hospitalised and 50 Australians died from paracetamol overdose every year, with the highest rates of intentional overdose among teenagers and young adults.
New rules
The new restrictions will see the maximum size of paracetamol packs that can be purchased in supermarkets and convenience stores shrink from 20 to 16 tablets, while packet sizes of the popular painkiller on pharmacy shelves will halve, from 100 to 50 tablets.
Packs of up to 100 paracetamol tablets will still be available, but only under the supervision of a pharmacist.
Access to liquid, modified-release and Schedule 4 (Prescription Only) paracetamol is not affected by the changes.
In addition to smaller maximum pack sizes, paracetamol tablets and capsules for both general and pharmacy-only sale will now also be required to be in blister packaging.
Likewise, the maximum size of pharmacy-only packs of individually wrapped powders or sachets of granules containing paracetamol will be reduced in line with tablet and capsule packs.
The TGA said the regulation would take effect in 2025 to give manufacturers and retail outlets time to adjust.
To further minimise the harm from paracetamol overdose, the TGA is encouraging retailers to restrict sales to a single pack at a time, and has asked consumers to appropriately store the medication in their home and not stockpile large quantities.
Support for limits
Chronic pain advocates have argued the changes will adversely affect many disadvantaged people, but mental health groups, GPs and pharmacists have been broadly supportive of the changes since they were first mooted.
The Royal Australian College of GPs backed the proposals but also maintained there should be no difference between regulations on packs in supermarkets and those in pharmacies, except when sold under the supervision of a pharmacist.
Dr Tin Fei Sim, a senior lecturer at the Curtin Medical School and national president of the Pharmaceutical Society of Australia, said this week that a multifaceted approach was needed to ensure that patients had access to paracetamol to treat acute pain, while also ensuring medicines were safe.
“Health professionals, including doctors and pharmacists, must be the champions for medicine safety and reducing the amount of paracetamol kept in the home for possible misadventure,” she said.
“The need to achieve a balance between minimising incidence and harm from intentional and unintentional self-poisoning, and maintaining appropriate access to paracetamol – a safe and widely used analgesic.
Could help prevent shortages
“During the pandemic, we also noticed a shortage of paracetamol, and a reduction in pack size or the amount that any person will have on hand at one time, will go a long way to avoid medicine shortages enabling everyone who needs paracetamol to have access to it when they need it.” Dr Elena Schneider-Futschik, a senior research fellow in the Department of Biochemistry and Pharmacology at the University of Melbourne, said she strongly supported the TGA decision, arguing that the use of paracetamol was often underestimated because it was easily accessible in such large quantities.
“When used as directed, paracetamol is safe and effective, however higher doses lead to toxicity, including liver failure which could even result in the need for a liver transplant,” she said.
“In countries where paracetamol access is not restricted, paracetamol poisonings is the foremost cause of acute liver failure. Overdose is often related to high-dose recreational use or in consumption with alcohol.
“When the body breaks down paracetamol, it does via liver enzymes and produces a toxic intermediate metabolite…overdosing will cause over-production of the toxic intermediate. But also, alcohol interferes with this pathway, exposing the liver to this toxic intermediate causing permanent liver damage.”