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This week has seen the ignition of another debate related to pain management medication, but this time, the unlikely culprit appears to be the household staple, paracetamol.
Paracetamol is a widely-used non-narcotic analgesic. When taken at therapeutic doses, paracetamol is considered the safest of all available analgesic agents, but in large amounts it overwhelms the body’s ability to process it safely and in severe overdose cases, liver failure means the person will need a liver transplant or they won’t survive.
There are two main types of paracetamol available in Australia, Immediate Release (IR) and Modified Release (MR). MR paracetamol tablets are constructed in two layers, an IR layer and a sustained release layer that gradually releases paracetamol over a period of 8 hours at normal doses. The only real benefit MR paracetamol offers in comparison with Immediate Release (IR) paracetamol appears to be less frequent dosing and therefore may be more convenient for longer term use in patients with chronic pain conditions. It’s easy accessibility over the counter (OTC) also means consumers do not need to visit their doctor in order to obtain a prescription.
MR paracetamol is thought to be widely used in Australia to manage chronic pain in older people, but as it is an OTC product, it is difficult to estimate the volume of usage. Overdose with paracetamol (immediate and modified release) whether intentional or accidental, is common in Australia and in many other countries. In particular, overdoses related to modified release paracetamol are more complicated, as patients are more likely to sustain liver failure despite treatment with the antidote. Gaps in patient knowledge, particularly around the perceived safety of paracetamol, are contributing factors to paracetamol misuse and accidental overdose. Paracetamol is the active ingredient in a number of pain and fever relief medicines and combination medicines (eg, for cold and flu).
New research published in the Medical Journal of Australia found that the annual number of paracetamol poisoning-related hospital admissions between 2007–08 and 2016–17 had increased by 44.3% or about 3.8% per year. The number of associated cases of toxic liver disease increased by 7.7% per year. Concerningly, the research also found that paracetamol is the number one medication Australian poisons centres receive calls about.
Based on their analysis, the researchers have called for further restrictions, including reducing pack sizes and changing the way paracetamol is sold. The researchers note that Australia’s current access to paracetamol is out of step with many other countries, especially the UK (restricted to 32 tablets in pharmacy and 16 outside) and Europe (no non-pharmacy sale allowed).
This is not the first time that Paracetamol related safety issues have been considered in Australia. After a consultation process held last year, the Therapeutic Goods Administration (TGA) announced a rescheduling of modified release tablets or capsules containing 665 mg of paracetamol or less from pharmacy-only (S2) to pharmacist-only (S3) from June 2020.
The TGA’s upscheduling decision only impacts modified release (MR) paracetamol. Painaustralia’s submission to the consultation supports the TGA’s decision and agrees that up-scheduling to S3 will provide an opportunity for pharmacists to counsel patients on the importance of not exceeding a dose of 6 tablets (with each tablet containing 665 mg or less paracetamol) per day whilst still preserving OTC access to these products. Ideally this verbal advice would go with written take-home information that can be reviewed by the consumer at their discretion.
The issue of changes to pack sizes however is a more complex one. According to the researchers, about three-quarters of cases of overdose were intentional.
As the adverse outcomes reported seem to largely relate to intentional or polypharmacy overdose, this is an issue that is unlikely to be altered by a change in scheduling or even pack sizes. Restricting access alone is a blunt tool to address the 75% of overdoses caused by the intention to self-harm.
So in this whole debate, how long can we keep ignoring the elephant in the room? Every day millions of people battle with the physical, mental and emotional toll of chronic pain impacting every facet of their lives. Nearly 1.45 million people in pain also live with depression and anxiety.
Unfortunately, a lack of pain specialist care and GPs with limited options to deal with chronic pain, means many of these Australians are falling through the cracks of the country’s health system. They are not receiving the multidisciplinary care they deserve and are inappropriately pushed towards medication that may or may not work as a way of pain management.
We must recognise that in many instances, people living with chronic pain have no option but to self-medicate their condition, so it is vital that they are able to understand the components of their medication, and the risks associated with them. When it comes to commonly used medications that are available over the counter, clear visibility of safety concerns is vital to ensure consumers are aware of the risks and in aiding consumers to comply with their treatment and avoid adverse health outcomes.
Patient education and awareness of both pharmaceutical and non-pharmaceutical pain management options are crucial in reducing all medication related harm. This is a central component of our National Pain Action Plan, which is currently being considered for approval by the Council of Australian Governments.
We have ignored the needs of people living with chronic pain for far too long. We cannot afford to keep tinkering at the edges anymore, we need to recognise the enormity of the problem at hand and commit to implementing real change that improves outcomes for the millions of people that live with chronic pain each and every day.
Carol Bennett, CEO