Critics lash TGA’s move to downsize paracetamol packs

5 minute read

Experts say it will further stigmatise chronic pain patients and could promote ibuprofen misuse.

The TGA’s interim decision to slash the size of paracetamol packs available on pharmacy shelves has drawn criticism from Australian pain experts and patient advocates. 

They say it will potentially push more people to misuse ibuprofen and further stigmatise Australians suffering daily from chronic pain. 

The TGA announced last week that it would reduce the maximum size of paracetamol packs available off the shelf in pharmacies from 100 to 32 tablets or capsules as part of an interim decision aimed at reducing Australia’s incidence of serious injury and death from intentional paracetamol overdose. 

Its interim decision also proposes to amend the Poisons Standard, to reduce the maximum size of packs available for general sale (such as in supermarkets and convenience stores) from 20 to 16 tablets or capsules; make other pack sizes of up to 100 tablets or capsules only available under the supervision of a pharmacist; and ban the use of bottles for paracetamol products, meaning only blister packs will be available for sale. 

However, rehabilitation consultant and pain medicine specialist Associate Professor Michael Vagg said he was particularly concerned the move would push people to increase their use of ibuprofen, which will still be available off the shelves in packs of up to 96 tablets or capsules. 

“Ibuprofen overdoses very rarely cause sufficient gastric haemorrhage to kill you,” he said. 

“They may cause significant renal damage but that takes days to develop, and patients recover relatively well at least on the first couple of occasions.” 

Nevertheless, Professor Vagg – director of Pain Matrix in Melbourne and a conjoint clinical associate professor at Deakin University’s school of medicine – said while the lethality of an overdose was probably higher with paracetamol, the effects of ibuprofen misuse needed to be considered.

He said that in “trying to save 200 or 300 people from paracetamol overdoses … you might land 2000 or 5000 more people in hospital with ibuprofen-related bleeds”.

“I think they’re looking at the problem just in isolation. They’re applying one of the classic tried-and-true public health responses, but they’re doing it in an environment where they’re not looking at the knock-on effects – and that’s the thing that we’re disappointed about.” 

Professor Vagg, who is also director of professional affairs for the Australian and New Zealand College of Anaesthetists’ Faculty of Pain Medicine, said the faculty was not convinced that reducing pack sizes would protect people who were determined to self-harm using paracetamol. 

He said the faculty had raised this in its submission to the TGA during the consultation phase of its review. The faculty wanted to see safeguards put in place to ensure that “this is landing where it’s supposed to land, because it’s definitely going to inconvenience chronic pain patients”. 

“Getting adequate chronic pain management done in the Australian population is difficult enough without poorly thought-out changes like this, which, although they’re not intended this way, will undoubtedly impact people with chronic pain and may well not have the benefits that they’re seeking to have in that vulnerable group of patients with overdose,” said Professor Vagg. 

“Once again, we’ll stigmatise chronic pain patients who are not doing anything wrong and who are managing their pain sensibly. 

“And they already get a lot of discrimination through people not understanding what chronic pain is, how it works, as well as doctors and other health professionals blaming the victim a lot of the time.” 

He conceded that while paracetamol was not “phenomenally helpful” in treating chronic pain, it certainly had a role to play. 

“The recommendations for taking it regularly are really based on data from osteoarthritis pain, which shows that if they’re taking it regularly, and you’re monitoring people’s pain levels across a month, versus a month when they’re not taking it, is about 20% less area under the curve,” he explained. 

“So you’re not going to notice necessarily every dose making a great effect, but if you’re taking it by the clock, for your consistent pain, on the whole you’re probably going to be slightly better off and you’re not going to be at significant risk.” 

Nicolette Ellis, president of Chronic Pain Australia, echoed Professor Vagg’s concerns about the pressure the TGA’s interim decision would place on millions of people suffering from chronic pain. 

“We are not supportive of the TGA’s recommendations to put further restrictions on paracetamol,” she said. 

“We surveyed over 350 chronic pain members who would have liked to see that warning labels and an education campaign would come as a first response rather than reducing quantity sizes or up-scheduling paracetamol quantities of 100 as a pharmacist-only medicine.” 

Ms Ellis also raised concerns about the effect it would have on the cost of paracetamol, which is currently relatively inexpensive. 

“It is likely consumers will be paying the same price for less medication when they get their paracetamol from a supermarket or pharmacy now that tablet quantities have been reduced. 

“We are hopeful the TGA will listen to our members and not place further restrictions on accessing paracetamol, for example, up-scheduling paracetamol to prescription only. We will continue advocating for the chronic pain community.”

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