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MHRA: Safety of OTC products containing codeine ‘under review’

MHRA: All opioid-based painkillers could be reclassified if necessary
MHRA: All opioid-based painkillers could be reclassified if necessary

The Medicines and Healthcare products Regulatory Agency (MHRA) is keeping the “safety and availability” of codeine-based products “under review”, it has told C+D.

The MHRA will consider the possibility of reclassifying all opioid-based painkillers as prescription-only medicines (POMs) “as necessary”, a spokesperson told C+D last week (March 5).

The medicines regulator was responding to C+D’s question as to whether it would consider reclassifying codeine linctus from a pharmacy (P) medicine to POM, following an increase of enforcement notices placed on pharmacies for the “high purchase numbers of codeine linctus”.

Several regulatory restrictions have already been imposed on over-the-counter (OTC) products containing codeine over the last few years, the MHRA said.

These include recommending the use of OTC painkillers containing codeine and paracetamol, ibuprofen, or aspirin for a maximum of three days.

OTC medicines containing codeine have been limited to 32-tablet pack sizes or less, and they “carry prominent label warnings to highlight the potential for addiction and the fact they contain opioids”, according to the MHRA.

The medicines regulator told C+D it has received “a very small number of queries relating to the OTC status of codeine-containing medicines and is taking these into consideration in its ongoing monitoring of these medicines”.

C+D reported last month that the GPhC had placed conditions on the practice of 38 pharmacies between April 1 last year and January 31, with the majority chastised for “the online, over-the-counter supply of codeine linctus and promethazine-containing medicines”.


Do you think codeine linctus should be reclassified from a P medicine to POM?
N/A, we don't really stock this product anymore
Total votes: 150
Do you regularly supply codeine linctus in your pharmacy?

Conor T, Community pharmacist

We do not stock the linctus for OTC sale in my Pharmacy. It should be reclassified as a POM.
It is a little extra work to sort out the abusers vs. those in genuine short term need of something a little stronger than Paracetamol, but I would like to still see Co-codamol/Solpadeine MAX etc. kept as P medicines. They shouldn't be advertised all over the place though.

Bob Dunkley, Locum pharmacist

I too would like to see codeine removed from sale - my only worry is - what is going to replace it? There exists a body of people outside of the people who frequent heroin cocaine circles, but nevertheless have a substance use disorder based exclusively on codeine, nothing stronger. These are the "Respectable Addicts" whose life revolves around codeine etc. Whilst for the greater good it is imperative that codeine is controlled, this move will cause distress to these people.

Kevin Western, Community pharmacist

The sooner its all reclassified the better. I'm tired of sorting the few genuine people needing codeine from the masses of abusers.... the marketing/advertising of this needs to be halted as a minimum.


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