MHRA seek views on public consultation on reclassification of opioid-containing cough medicine


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The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation on the reclassification of codeine linctus to a prescription-only medicine after considering multiple Yellow Card reports for its opioid effects, rather than for its intended use as a cough suppressant.

This medication is currently licensed as a pharmacy medicine, which means that it is available to purchase over the counter in pharmacies. If reclassified as a prescription-only medicine, all strengths of codeine linctus will only be available upon presentation of a prescription.

Dr Alison Cave, MHRA Chief Safety Officer, 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 prescription-only status.

We want to hear from members of the public, health professionals and others who would be affected by this potential change so we can make a properly considered decision for the benefit of patients, carers, and healthcare professionals across the UK.

Professor Claire Anderson, President of the Royal Pharmaceutical Society (RPS), said: “We welcome the MHRA consulting in this area, to understand the impact of this potential change on pharmacists, pharmacy teams and the public.

Medicines should maximise benefits to patient health with minimum risk. 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.”

The MHRA welcomes views as to whether codeine linctus should become a prescription-only medicine, where access is only given based on the prescribing judgement of a GP. The MHRA is committed to ensuring the safe use of medicines, especially those that are potentially extremely addictive.

The codeine linctus consultation will run for four weeks and is open until 15 August 2023.


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