PAGB response on latest news regarding OTC codeine availability

Published on: 6 August 2020


In response to a statement by the Medicines and Healthcare products Regulatory Agency (MHRA) that the legal classification and over-the-counter availability of codeine is being considered, PAGB Chief Executive, Michelle Riddalls, said:

“Over-the-counter (OTC) products containing codeine are designed to provide symptomatic relief for people suffering from short term moderate pain. They are the only second-line treatment available without a prescription for people who experience pain that is not alleviated by paracetamol, aspirin or ibuprofen alone.

“PAGB believes these products should continue to be available to buy under the supervision of a pharmacist, to enable people to self care effectively when they experience moderate pain.

“Safety is of paramount importance to the OTC medicines industry and, as they have done in the past, PAGB member companies are keen to work with MHRA to consider additional measures which could be put in place to support the continued availability of OTC codeine.”

The measures currently in place to support the appropriate use of OTC codeine products include:
• OTC products containing codeine can only be sold under the supervision of a pharmacist
• Prominent front of pack warnings must be displayed which clearly state, “Contains opioid. Can cause addiction. Use for three days only”
• All advertising is required to contain the same warning
• Advertising for codeine containing products should not emphasise the ‘strength’ or ‘power’ of the product.

Michelle Riddalls continues:

“OTC products containing codeine are effective and appropriately safe if used in accordance with the instructions on the pack and the patient information leaflet inside. These products can only be sold under the supervision of a pharmacist and carry prominent warnings about the possible risk of addiction on the front of pack. If people adhere to the warnings and instructions on the packs and do not take the product for more than three days, they are extremely unlikely to be at risk of addiction.

“PAGB member companies provide comprehensive accessible information to support people to make responsible informed decisions, in discussion with their pharmacist, about which painkiller is right for them.

“Anyone who has concerns about taking any medicine should speak to a pharmacist for advice. Pharmacists are highly trained healthcare professionals and can provide useful information and advice on OTC medicines.”

PAGB response on latest news regarding OTC codeine availability