In a special feature, Dr Des Corrigan drills into the possible demise of OTC codeine-containing medicines
These observations on the possible demise of over- the-counter (OTC) codeine- containing medicines are prompted by the knowledge that their status is under review by an independent multi-disciplinary subcommittee set up by the Health Products Regulatory Authority (HPRA).
According to Health Minister Jennifer Carroll MacNeill, in a reply to a recent Parliamentary Question, this review was expected to be finalised in early 2026. This classification review is being conducted under Article 74 of the Medicines Directive.
The criteria that the HPRA must use when deciding that a medicine can be supplied OTC or only on prescription are set out in Article 71. Several appear to me to be pertinent to low-dose codeine combinations. One refers to products that are likely to present a direct or indirect danger even when used correctly. Another reads as follows: “It is likely, if incorrectly used, to present a substantial risk of medicinal abuse, to lead to addiction, or be misused for illegal purposes.”
Non-medical use
We know from a National Drug and Alcohol Survey published by the HRB that non-medical use of codeine was reported by 1.8 per cent of the adult population, or 70,000 adults, illustrating the scale of problematic codeine use. There were 236 overdose deaths between 2013 and 2022 where codeine was implicated as a cause of death by a coroner, according to the most recent bulletin from the National Drug-Related Deaths Index.
In 2022, there were 22 such overdoses compared to 32 involving paracetamol. Codeine-based medicines were involved in 4,789 cases (8.3 per cent of the total) of Intentional Drug Overdoses recorded by the National Self-Harm Registry Ireland and published in 2021 in the European Journal of Public Health.
Apart from these fatal and non- fatal overdoses, there is a definite risk of dependence. The National Drug Treatment Reporting System for 2024 stated that codeine was the second- most common opioid (after heroin), numbering 1,611 cases, or 5.2 per cent, of all of those seeking treatment for substance dependence.
Prof Colin O’Gara of St John of God Hospital and the Department of Psychiatry at University College Dublin has referred to dependent patients consuming up to 1g of codeine a day due to the tolerance they have developed. As a result, not only do they suffer codeine- related toxicity, but their exposure to multi-gram quantities of paracetamol or ibuprofen increases the likelihood of life-threatening hepatotoxicity, gastric haemorrhage, or renal tubular acidosis.
It is a matter of debate whether the benefits to patients outweigh the well- documented risks. A series of overviews by the Canadian Agency for Drugs and Technologies in Health (CADTH) are not particularly reassuring. A 2018 overview of reviews and systematic reviews failed to identify any studies on the efficacy of low-dose — 8mg per tablet — codeine for the treatment of pain or cough. There was some evidence of a moderate benefit in osteoarthritis patients but not in acute pain due to sprains, fractures, or burns.
If or when codeine is reclassified, some patients will need empathetic counselling about its lack of availability
A 2015 Cochrane overview of 10 Cochrane reviews concerning non- prescription (OTC) oral analgesics
for acute pain, particularly after third molar extraction, which is the industry model for everyday pain, considered 21 different OTC analgesics, doses, and formulations. It did not include studies on tension headache, migraine, or period pain. Just as with the CADTH review, the influential Cochrane Collaboration found that there was no or insufficient information on many of the commonly available low-dose codeine combinations.
Overall, the lowest Number Needed to Treat was below two and was found for combinations of ibuprofen and paracetamol that did not contain codeine. The overview expressed a clear message for those tasked with responding to patient’s requests for advice on analgesia to the effect that simple non-codeine drug combinations and fast-acting formulations deliver good pain relief in many patients with acute pain. Pharmacists can thus provide good evidence-based advice on pain relief to those wishing to self- medicate according to the review.
The possible impact of reclassifying codeine
I have previously written (July 2022) about the Australian experience of moving codeine to prescription-only medicine status in 2018, noting that it appeared positive, with many studies showing significant drops in calls to poison centres, emergency department presentations, and deaths due to codeine — while there was no increase in the use of other opioids.
Australian pharmacists felt that advantages of the move included increased engagement with patients and less codeine use, leading to a better overall risk/benefit outcome. Perceived disadvantages included fewer analgesic options and an increased burden on patients, GPs, and the health system.
Not surprisingly, sales of codeine combination products dropped by 87 per cent, which would have obvious implications for the financial health of Irish pharmacies if the same happened here. We spent more on OTC codeine than any of the other 30 countries included in a 2022 study on Drug Safety. Our per capita expenditure on codeine was three times that of the UK.
The two well-known low-dose codeine products have consistently topped the OTC sales charts here for many years and, based on wholesale prices of sales to pharmacies, the market for pain relief medication stood at €161 million in the year to April 2025.
Obviously, codeine combinations constitute one element but, given their pre-eminence, they undoubtedly account for a huge chunk of overall income derived from OTC sales. Against that loss, one needs to balance gains in staff time and possibly morale in no longer having to quiz patients about their request for codeine or agonise over full compliance with the Pharmaceutical Society of Ireland’s codeine guidance. It also means worrying less about falling foul of ‘mystery shoppers’ engaged by the PSI or spending hours ensuring compliance with the two codeine-related items in its Pharmacy Inspection Checklist.
Ambiguous
But I would not advise packaging up your stocks of OTC codeine combinations for return to the wholesalers just yet, given the Department of Health’s almost institutionalised philosophy of festina lente. The Minister’s PQ answer is notably ambiguous when it commits the Department to “engage with relevant stakeholders to assess the recommendations made [and] to fully consider any policy changes that may be required regarding the regulation of codeine-containing medicinal products”.
And that is before those stakeholders engage in what is euphemistically called “liaison with Government”.
If or when codeine is reclassified, some patients will need empathetic counselling about its lack of availability, which may in turn nudge them to question the nature of their relationship with the drug. They may need referral to their GP, especially one having Level 2 status. It would therefore be helpful
to have contact details to hand for available statutory, voluntary, or private addiction treatment services either locally or nationally.
But first let us see what the HPRA decides.
