Issue 12 / 11 April 2023

New research has found poisonings from modified release paracetamol has not significantly declined, despite being up-scheduled to Schedule 3 (pharmacist-only medicine).

A research letter published in The Medical Journal of Australia explores the impact of up-scheduling modified release (MR) paracetamol to Schedule 3 (pharmacist only medicine).

Pharmacist only medicine refers to medication which can be accessed without a prescription but only from a pharmacist, as it requires professional advice.

The letter, by Rose Cairns, Firouzeh Noghrehchi and Nicholas Buckley, examined the impact of the Therapeutic Goods Administration’s (TGA) decision to up-schedule MR paracetamol, from Schedule 2 to Schedule 3, in June 2020, on the increasing number of overdoses reported nationally.

They evaluated whether the TGA re-scheduling was associated with changes in overdoses with MR paracetamol, immediate release paracetamol, and other over-the-counter analgesics reported to the New South Wales Poisons Information Centre (NSWPIC) between June 2020 and August 2022.

“[The] analysis identified no significant … change in MR paracetamol overdose number after re-scheduling, whereas the number of reports regarding other over-the-counter analgesics increased significantly,” they wrote.

“We found that poisonings with MR paracetamol did not significantly decline after its re-scheduling as a Schedule 3 medicine; the number was increasing prior to re-scheduling and continued to do so subsequently.

“The increase in overdoses with ibuprofen and other over-the-counter analgesics may indicate that people were switching analgesics; as MR paracetamol is more toxic than non-steroidal anti-inflammatory drugs, this would be consistent with harm reduction.”

Labelling changes to over-the-counter cough and cold medications

In a second research letter, also published in The Medical Journal of Australia, researchers explored whether labelling changes to over-the-counter cough and cold medications reduced reported poisoning exposure.

The TGA introduced compulsory labelling changes for non-prescription cough and cold products in 2012 (but not for herbal products), with further changes in 2020 for first generation (sedating) antihistamine-containing products.

The researchers Abrar Arbaeen and colleagues reviewed calls to the NSWPIC between January 2010 and 31 December 2021 regarding children under six years of age who were exposed to over-the-counter cough and cold medications.

They found that a total of 8327 exposures of children to non-prescription cough and cold products were reported during the study period (here), and that almost all were accidental (4264, 51.2%) or therapeutic errors (3953, 47.5%) (See Table 2). 

“We found that reported poisonings of children under six years of age with non-prescription cough and cold products have declined since the 2012 labelling changes,” they wrote.

They said that this substantial decline in the numbers of accidental ingestions and therapeutic errors in children under six years of age occurred in the United States after a similar intervention (here).

“Health care professional and public education campaigns discouraging the use of non-prescription cough and cold products may have played a role in reducing the number of poisonings in NSW children.

“Nevertheless, about 600 exposures of children under six, including 75 who require hospital management, are still reported to NSWPIC each year.”

More clinical guidance needed

“The continued off-label use of products for treating coughs and colds in young children suggests that health care professionals and the public may underappreciate their risks,” the researchers wrote.

“This indicates that further education and clinical guidance are needed.”

Read both research letters in The Medical Journal of Australia.

2 thoughts on “Paracetamol poisonings in the spotlight

  1. Anonymous says:

    There is definitely a need for more appropriate labelling of Children’s Paracetamol mixtures available OTC.
    Experience has demonsta=rated to me that parents will administer paracetamol to their infants and children for many reasons other than high fever or purported pain.
    I believe that Pracetamol use/abuse is a national epidemic with toxicity to paracetamol going largely unnoticed and under reported except in extreme cases.
    There is now also the propensity by parents and adults to use combinations of paracetamol and ibuprofen on a regular basis and for mostly minor problems ,as evidenced by the numerous national advertisements for these products.

  2. Anonymous says:

    My kids generation (15-20 yo) have no awareness of the toxicity of any over-the-counter pain medications. ‘Popping half-a-dozen paracetamol is common.
    Upscheduling removes ‘a product’ after real or perceived harm from easy access, but primarily results in diversion to a different product.
    Where is the education that would prevent or reduce this cycle before it even starts?

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