Caution with the forthcoming rescheduling of over-the-counter codeine-containing analgesics

To the Editor:

After extensive public consultation, the Therapeutic Goods Administration announced that all over-the-counter codeine preparations, including over-the-counter codeine-containing analgesics (OTC CCAs) will be rescheduled as prescription only in February 2018, citing the substantial risk of drug toxicity from deliberate misuse and the relative lack of efficacy compared with safer products.

Codeine is a weak analgesic — even at doses of 60 mg — and the Australian Medicines Handbook notes that “there is no conclusive evidence that products containing 8–15 mg of codeine per tablet with paracetamol, aspirin or ibuprofen have any benefits over these non-opioids alone”.1

Misuse and harm are widespread, with people who are addicted to codeine taking 40 or more tablets a day. In 2016, more than 500 000 Australians aged 14 years or over used OTC CCAs non-medically. Despite more restrictive scheduling in 2010, a Poisons Information Centre described a 17.9% annual increase from 2004–2015 in calls concerning the misuse of ibuprofen–codeine analgesics.2 Moreover, drug clinics describe a 10-year four-fold increase in treatments where codeine was a drug of concern (Box).

Prolonged high-dose ibuprofen exposure secondary to codeine addiction may cause bleeding or perforated gastric ulcers; non-steroidal anti-inflammatory drug-induced enteropathy, with diaphragm disease and bowel obstruction; anaemia; protein-losing enteropathy; hypoalbuminaemia; renal tubular acidosis and death. Medical practitioners should consider OTC CCA misuse in patients presenting with non-steroidal anti-inflammatory drug-related or paracetamol-related morbidity, as many patients do not disclose their misuse, therefore creating a failure to recognise the underlying cause of the presenting complaint.4

Apart from the human cost of serious injury and loss of life, there is also the cost of treatment for dependence; the cost of hundreds of hospital admissions, involving avoidable surgery, intensive care and serious morbidity;4,5 and the statistical cost of lives lost.6 Practitioners need to prepare for the forthcoming rescheduling to avoid substituting OTC CCAs with either prescription opioid analgesics or prescribing a codeine–paracetamol product, which may cause paracetamol hepatotoxicity. In addition, practitioners should treat codeine dependence by referral, opioid replacement therapy or medicated withdrawal with follow-up.

The unfavourable risk–benefit profile for OTC CCAs means that the planned Australian rescheduling aligns with many other countries to minimise harm. Access to effective analgesics without a prescription is now provided by products with the non-addictive ibuprofen–paracetamol combination, which offer better analgesia than OTC CCAs.7

Box – Treatments provided for own drug use, by principal and additional drug of concern (codeine), from 2003–04 to 2013–143