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News & Trends - Pharmaceuticals

Aussies with chronic pain saved from “detrimental impacts” of limiting paracetamol access – for now

Health Industry Hub | February 6, 2023 |

Pharma News: The Therapeutic Goods Administration (TGA) has published an interim decision to reduce the maximum pack sizes for various paracetamol products. 

Friday’s interim decision by the TGA delegate not to recommend the upscheduling of paracetamol and to not restrict purchases based on age is a sensible decision for consumers who live with chronic pain, said Painaustralia CEO Giulia Jones.

The decision follows an independent expert report commissioned by the TGA that examined the incidence of serious injury and death from intentional paracetamol overdose. Each year in Australia around 225 people are hospitalised and 50 Australians die from paracetamol overdose, with rates of intentional overdose highest among adolescents and young adults. 

“Painaustralia’s concerns about the detrimental impacts limiting paracetamol access to people who live with chronic pain and rely on paracetamol to self-manage their day to day lives have been taken seriously by the delegate,” Ms Jones said.

“If the original proposals had been accepted, people in chronic pain would have been significantly detrimentally affected, having to pay more and go to the doctor more often. Life would have been much harder for those on low incomes, in regional and rural areas who work to self-manage their pain without the same access that people in the cities and with higher incomes can afford.”

Ms Jones said the interim decision not to upschedule modified release paracetamol is particularly sensible as the nation faces a GP access crisis, compounding the problems people in pain face.

“On every bus, in every office and across every suburb of Australia pain does not discriminate. One in five Australians live with pain. These people already suffer from discrimination, being mocked, and belittled when they seek help and often are not believed,” she said.

Packs of paracetamol on General Sale and Pharmacy Only sale would also be required to be in blister packaging to deter overdose from ingesting large numbers of tablets or capsules. 

The decision took into account responses to the initial public consultation in September-October 2022 and advice from the Advisory Committee on Medicines Scheduling. It intends to strike a balance between minimising the incidence and harm from intentional self-poisoning and access to paracetamol for the treatment of acute and chronic pain. 

To further minimise the harm from paracetamol overdose, the TGA is encouraging retailers such as supermarkets to restrict sales to a single pack at a time. The TGA is also encouraging consumers to not stockpile paracetamol in the home and to appropriately store paracetamol and other medicines. 

The interim decision acknowledged how people in pain would be affected by further restrictions to paracetamol with the delegate noting Painaustralia’s advocacy.

The delegate said “I note the considerable concerns raised regarding the impacts this would have on the consumers ability to self-manage chronic pain, particularly regarding those living in rural and remote areas…I make particular note of Painaustralia’s concerns regarding the significant psychological effects of chronic pain sufferers regarding limitations on access to analgesics.”

The delegate also noted there had been insufficient time to analyse what impact having modified release paracetamol behind the counter has made.

“Modified release paracetamol was only put behind the counter in pharmacies less than 2 years ago and the effect of this change has not yet been analysed” Ms Jones said.

Ms Jones said the interim decision was not perfect, as the recommendation to reduce the size of packs available for purchase in supermarkets would still impact consumers who live in pain.

“This will still affect low-income earners and those struggling the most with day-to-day life as they will need to return time and again to the supermarket to maintain supply if they do not have easy access to a pharmacy. However, on balance this is a sensible outcome for consumers,” she said.

Painaustralia would also welcome a discussion about safe storage of medicines at home, going to the original stated intention of keeping young people safe from overdose using paracetamol.

The decision is an interim one, and is open to further public consultation until 3 March 2023.

Painaustralia urges the TGA to adopt the delegate’s interim decision when it is considered in April this year.

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