Paracetamol: ‘balance versus risk’


tablets and glass of water

It’s too early to decide whether restrictions on access to paracetamol are appropriate, says one leading pharmacist, following reports of increased hospitalisations related to the drug

New research published in this week’s MJA has found that the frequency of paracetamol overdose‐related hospital admissions has increased in Australia since 2004 – a phenomenon associated with an increase in liver injury.

Paracetamol is the medicine most frequently involved in overdoses in Australia.

The researchers conducted a retrospective analysis of data on paracetamol‐related exposures, hospital admissions, and deaths from the Australian Institute of Health and Welfare National Hospital Morbidity Database (NHMD; 2007–08 to 2016–17), the New South Wales Poisons Information Centre (NSWPIC; 2004–2017), and the National Coronial Information System (NCIS; 2007–08 to 2016–17).

Patients included in the study were those who took overdoses of paracetamol as a single ingredient formulation.

“The NHMD included 95 668 admissions with paracetamol poisoning diagnoses (2007–08 to 2016–17); the annual number of cases increased by 44.3% during the study period (3.8% per year; 95% CI, 3.2–4.6%),” the researchers wrote.

“Toxic liver disease was documented for 1816 of these patients; the annual number increased by 108% during the study period (7.7% per year; 95% CI, 6.0–9.5%).

“The NSWPIC database included 22 997 reports of intentional overdose with paracetamol (2004–2017); the annual number increased by 77.0% during the study period (3.3% per year; 95% CI, 2.5–4.2%).

“The median number of tablets taken increased from 15 (IQR, 10–24) in 2004 to 20 (IQR, 10–35) in 2017.

“Modified release paracetamol ingestion report numbers increased 38% between 2004 and 2017 (95% CI, 30–47%). 126 in‐hospital deaths were recorded in the NHMD, and 205 deaths (in‐hospital and out of hospital) in the NCIS, with no temporal trends.”

The researchers noted that paracetamol is “available outside pharmacies in packs of twenty 500mg tablets (10g), and from pharmacies as 100 × 500mg (50g) tablet packs and 96 × 665mg (about 64g) modified release (MR) tablet packs; there is no legal limit to the number of packs that can be purchased”.

“Access restrictions, including reduced pack sizes, could reduce the harm caused by paracetamol overdoses in Australia, and should be considered, together with other policy changes for curbing this growing problem,” they write.

In a related piece in MJA InSight, Dr Angela Chiew, Emergency Physician and Clinical Toxicologist at Sydney’s Prince of Wales Hospital and the NSW Poisons Information Centre, said a particular worry was the growing size of paracetamol overdoses – saying the modified release data in particular were “very telling” because packs contained 96 tablets.

Professor Andrew McLachlan, Head of School and Dean of Pharmacy at the University of Sydney’s School of Pharmacy, said the pain management context was important, but that pharmacy as a sector was not entirely innocent in the matter.

“I wouldn’t let my pharmacy colleagues off the hook,” he said. “I know that some discount pharmacy chains do provide large packets of paracetamol – 100 tablets—often at very low prices, as loss leaders. Medicines are not normal items of commerce and they should not be promoted in that way, but I think that certainly has been changing.”

In response to the data, pharmacy owner and national president of Chronic Pain Australia Jarrod McMaugh told the AJP that he believes it is “too soon to determine if a decision to restrict access is in the best interests of people who experience chronic pain”.

“There are definitely risks associated with use of paracetamol, but there needs to be a balance of access versus risk,” he explained.

“Paracetamol is a very common medicine, and is found in a lot of products.

The greatest risks are with inadvertent overdose (from taking multiple sources of paracetamol). When this happens, SR forms of Paracetamol are definitely more toxic. For this reason, making these products Schedule 3 seems to fit with the scheduling rules.

“When it comes to intentional overdose, that’s a different matter—a person can easily access multiple packs of paracetamol at any time they want just from visiting multiple outlets. There have been documented cases in the past of people purchasing multiple boxes in one transaction from supermarkets, for instance.”

Mr McMaugh said that the role for pharmacists “is as it has always been–but there is an important role here for people who use paracetamol too… that is, people become complacent about the risks of medicines because they are so readily available.

“People should have a healthy respect for the risks that paracetamol can carry; listen to your health professional’s advice. There is a reason that ‘always read the label’ is such a well-known term, but people actually need to do it!”

Mr McMaugh said that the issue of pharmacy promotions raised by Prof McLachlan mentions is significant.

“it has always been understood that medicines are not ordinary items of commerce, therefore price promotions should be weighed against public good,” he said.

“If people are being encouraged to stockpile due to a sale—for instance—this is a poor outcome. It’s also worth noting that as a prescription item, paracetamol is provided in very high volumes for a very low price (for instance, 300 tablets of Immediate Release 500mg tablets on PBS, 192 x 665mg SR tablets on PBS).

“If we just look at volume and price, then it can be tempting to say that there is a risk of stockpiling and inadvertent poisoning, but at the same time if the cost of this medicine is low, then this should be reflected in the price to a person in pain.

“At this point, there is very little to suggest that the change to schedule 3 will result in a price rise.

“In recent times when codeine-containing products changed price after schedule change, this was driven by manufacturer wholesale prices. I don’t [believe] this would happen this time.”

The main thing to keep in mind, he said, is that overdose (accidental and intentional) with paracetamol is relatively common, while the presence of Sustained Release paracetamol in recent years has made the treatment of this very difficult and much less likely to be reversed.

“Changing the availability of this particular version to Schedule 3 as a result may well be a good idea, but as with all things, the data needs to support this.

“SR paracetamol is in the top 40 most commonly prescribed medicines on the PBS from most recent data—if this is in fact the primary source, then a change to schedule 3 will have little impact on poisonings, and will also be unlikely to inconvenience anyone.”

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