The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation on proposals to reclassify codeine linctus from a pharmacy (P) medicine to a prescription-only medicine (POM), following what it said were “multiple” reports that it was being used recreationally for its opioid effects.
Codeine linctus is available as an oral solution or a syrup. It is indicated to relieve unproductive or dry cough and contains the active ingredient codeine phosphate, which is an opioid.
It is currently licensed as a P medicine, which means individuals can buy it over the counter in pharmacies without the need for a prescription.
Announcing the consultation on 18 July 2023, the MHRA said that it had received 116 Yellow Card adverse effect reports of recreational drug abuse, dependence and/or withdrawal to codeine medicines, including codeine linctus, since 2018.
The Pharmaceutical Journal reported in June 2022 that the MHRA was reviewing the impact of warning labels on sales and prescribing of codeine linctus.
Minutes from the MHRA’s Commission on Human Medicines (CHM) meeting, held in October 2022 discussed the use of codeine linctus as a primary ingredient in the product of an illegal recreational drink, known as ‘purple drank’, which has been popularised through social media and hip-hop music.
The minutes noted that codeine can be fatal “at doses between 500mg to 1,000mg” and that some music artists had died through overuse and addiction to ‘purple drank’.
The CHM meeting minutes also mentioned the “lack” of clinical evidence of codeine efficacy in acute or sub-acute cough.
Then, in January 2023, The Pharmaceutical Journal reported that the MHRA’s CHM had concluded that codeine linctus met a criterion for reclassification as a POM.
Alison Cave, chief safety officer at the MHRA, said: “Codeine linctus is an effective medicine, but as it is an opioid, its misuse and abuse can have major health consequences.
“Every response received will help us to develop a broader view on whether codeine linctus should be restricted to [POM] status.”
Claire Anderson, president of the Royal Pharmaceutical Society (RPS), said she welcomed the MHRA consultation in this area to understand the impact this reclassification could have on pharmacy and the public. “Medicines should maximise benefits to patient health with minimum risk,” she said.
“We believe there is insufficient robust evidence for the benefits of codeine linctus in treating coughs safely and appropriately. We also have significant concerns about its misuse and addictive potential, as well as the risk of overdose.
“There are many non-codeine based products available for the treatment of dry cough. With studies showing up to 60% of people are genetically predisposed to opioid dependence, the role of codeine linctus in treating what is ultimately a self-limiting condition is questionable.”
Commenting on the consultation, Roz Gittins, president of the College of Mental Health Pharmacy, said that while the classification review was appropriate, it must also consider both the risks and benefits of a change.
“For example, should the individual have a genuine clinical need or otherwise dependence on codeine linctus, to ensure that if supplies were restricted it does not have the unintended consequences of creating risk elsewhere,” she said.
“For instance, delaying timely access to medication, or if the individual resorts to sourcing illicit alternatives or products that put them at risk of other adverse events, such as combination products like co-codamol, which may place individuals at risk of a paracetamol overdose. There would need to be proactive considerations about how to mitigate such risks.
“This is not saying that the reclassification should not occur, but that there needs to be consideration of such potential issues.”
The MHRA consultation will close on 15 August 2023.