Upscheduling of Modified Release Paracetamol
New research highlighting the risk of paracetamol related harm has prompted a discussion around this widely used analgesic. 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.
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 that up-scheduling to S3 provides 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. Read our blog on the subject here.