Codeine linctus: reclassification to prescription-only medicine

The MHRA has written to advise healthcare professionals that codeine linctus cough medicines have been reclassified to a prescription-only medicine (POM), following a public consultation.

The communication from the MHRA has the following key points:

Advice for healthcare professionals:

• Codeine linctus is to be reclassified from a pharmacy-only medicine (P) to a prescription-only medicine (POM) owing to the risk of dependence, addiction, and overdose.
• Codeine linctus is only authorised for the treatment of dry cough.
• Codeine linctus is only considered to be effective in the treatment of chronic cough lasting over 8 weeks.
• Advise patients that those with a long-term cough should see a healthcare professional, for review of symptoms and may require medical assessments to check for other conditions which may be the cause of the cough
• We would encourage healthcare professionals to read the Summary of Product Characteristics for special warnings and contraindications for the use of codeine linctus, especially in patients with a history of substance abuse.
• Record prescription details in the patient’s summary care record (or equivalent) and encourage patients to read the Patient Information Leaflet that comes with their medicine.
• Report suspected adverse drug reactions to codeine linctus to the Yellow Card scheme

Advice for healthcare professionals to provide to patients, parents and carers:

• Codeine linctus (also known as codeine oral solution) is used in the treatment of dry cough, in adults and children aged 12 to 18 years without breathing difficulties.
• Codeine is an opioid medicine and is addictive. Codeine linctus will only be available on prescription following assessment with a healthcare professional. This action is being taken to reduce the risk of addiction or overdose
• Evidence is limited that codeine linctus is effective in the treatment of short-term cough but may be effective in the treatment of long-term cough (lasting over 8 weeks)
• Alternative non-prescription cough medicines are available for short-term cough to sooth an irritated throat, including honey and lemon mixtures and cough suppressants. You can speak to a pharmacist for advice
• If you have a long-term cough, you may be asked to attend further medical assessments to check for other conditions which could be causing the cough. This is to make sure you are on the best treatment.
• Addiction can happen gradually especially if you have been taking codeine for a long time. If you want to stop taking it and have been taking codeine linctus for a long time, then it is important to reduce the amount you take slowly with the help of your prescriber.
• If you feel that you are addicted, speak to your doctor, or if you are concerned for someone who has been using more than the prescribed amount of codeine linctus, you can also seek advice on the NHS website. Support groups and self- help groups are also available such as Talk to FRANK
• We urge you not to buy codeine linctus from an unregistered website as it could be dangerous.

Background and Comment

The communication provides some useful background information on the consultation process and the reasoning behind the reclassification. This forms the basis for our Podcast and TV episodes this week, which also look at whether this makes an impact on the average pharmacy and review the propriety of available alternatives. You may get further details of this MHRA alert here.

Other MHRA alerts of significance to primary care pharmacy professionals may be found here.