Codeine linctus (codeine oral solutions): reclassification to prescription-only medicine

Following a review of all available evidence, including the responses to the public consultation, the CHM advised that codeine linctus is likely, if incorrectly used, to present a substantial risk of medicinal abuse, to lead to addiction, or to be used for illegal purposes. Therefore, the decision was taken to reclassify codeine linctus to a POM. This is a risk minimisation measure to protect the health of patients in need of treatment, to prevent recreational use and to enable the identification of individuals who may have become unintentionally addicted to codeine.

Patients will still be able to access codeine linctus with a prescription from a qualified healthcare professional. This will ensure that the medicine is used safely and appropriately under medical supervision.

It will take time for the new labelling to appear on the products. All market authorisation holders (MAH) are in the process of updating their product licences to reflect the change to Prescription Only (POM). Once the licences have been updated the MAHs have committed to implement the changes to their product information within 3 months. During that interim period, the RPS and Pharmacy Forum NI are encouraging pharmacists to exercise professional judgement when receiving requests for over-the-counter codeine linctus and to be mindful that some individuals may stockpile codeine linctus following this update. Therefore, it would be prudent to treat existing ‘P’ products as POMs.

Further information and advice can be found on the MHRA website.