The TGA has launched a review to find out if changes to paracetamol programming and access controls are needed.
Australia’s most commonly used over-the-counter painkiller is responsible for a steady rise in overdose rates.
Despite clear usage guidelines and most healthcare professionals assuming patients know how to use paracetamol, some misunderstandings about the drug’s safety – as well as its ease of access – contribute to misuse and accidental or intentional overdose.
In 2018-2019, non-opioid painkillers, including paracetamol, accounted for 11% of drug-related hospitalizations. Specifically, a 2019 study found that paracetamol-related hospital admissions in Australia increased by 3.8% per year between 2007-08 and 2016-17, prompting experts to call for a reduction in the size of packaging.
Although Paracetamol has dosage guidelines and restrictions from the Poisons Standard for pack sizes and strengths sold in the Australian market, there is currently no application to update these restrictions.
But the continued growth of paracetamol-related harms prompted the Therapeutic Goods Administration (TGA) to commission an independent report on the need to boost access to the drug.
The regulator cites concerns about ‘the number of poisonings and deliberate overdoses of paracetamol obtained from retail outlets’.
Supporting the review is Dr. Marguerite Tracy, member of the RACGP Expert Committee – Quality Care.
“It is appropriate for the TGA to review the timing and availability of any medicine available in Australia,” she said. newsGP.
“We have always known that paracetamol can be harmful above therapeutic/recommended doses – and rarely even at recommended doses in special circumstances, [such as] children, [people who are] very lean, or fasting.
“There is increasing complexity with paracetamol included with other painkillers – ibuprofen, caffeine, codeine – and in cold and flu preparations, which could lead to inadvertent consumption above the recommended dose. .”
“In addition, there are many unregulated sources of information available to the public that can also contribute to overuse, misuse, and deliberate overdose.”
The TGA review will cover analyzes of overdose reports, emergency room presentations, hospital admissions, adverse health effects and deaths attributable to paracetamol.
This will include a particular focus on ‘the contribution of paracetamol from general retail’ in Australia, with comparisons to other painkillers available over the counter.
A similar review of codeine led to the drug being updated in 2018, which subsequently led to a significant drop in its use and contribution to overdose rates.
Dr Tracy believes one solution to reducing the harm caused by paracetamol abuse is to follow the example of purchasing controls in parts of Europe.
“Pharmacy-only sales have proven effective in other countries [such as] Sweden and limiting the age of sale to 18 or over in Denmark have reduced paracetamol poisonings,” she said.
“Restricting package size, access points and age of purchase has been shown in other countries to reduce the rate of paracetamol poisoning presentations.”
But, like the review of codeine restriction, Dr. Tracy cautions that the harm-reduction impact of an overdose must be weighed against the potential harms in terms of pain management.
GlaxoSmithKline, the pharmaceutical supplier of Panadol in Australia, does not support a regulatory overhaul of paracetamol, citing a current lack of evidence regarding misuse, but does support a potential restriction on the number of packs that can be purchased from unregistered sites. pharmaceuticals.
The TGA review will also predict the benefits and risks of current access to paracetamol, and possible outcomes in the community of changes in access to purchase, including “deliberate self-intoxication with other medications and the impacts on access to effective pain relief”.
Since paracetamol is often recommended as a first-line treatment for pain management, Dr. Tracy said healthcare professionals have a valuable role to play in educating about the potential risks of abuse and overdose. as part of supporting patient health literacy and quality medication use.
“GPs always have a role to play in the safe use of medicines,” she said.
“GPs prescribe and recommend paracetamol, which provides an educational opportunity about recommended total daily doses, the issue of multiple preparations containing paracetamol, and encourages people to ask the pharmacist when purchasing other products from interactions with prescribed medications.
“Additionally, GPs also manage mental health issues; in-depth discussions of the risks and benefits of medications, including paracetamol, are frequently undertaken.
The review will also examine relevant international findings related to paracetamol abuse and access controls, as well as the extent to which paracetamol is used in Australia generally.
“One outcome of the review could be a change in planning or could include other recommendations to minimize accidental and deliberate doses above the recommended therapeutic dose,” Dr. Tracy said.
The TGA report will be produced by a panel of independent experts and published in July 2022.
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