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MHRA mulls codeine linctus P to POM switch amid ‘recreational’ use concerns

The medicines regulator has launched a month-long public consultation on whether to make the opioid cough medicine prescription-only, it has announced.

Codeine linctus may be reclassified to a prescription-only medication (POM), as the Medicines and Healthcare products Regulatory Agency (MHRA) today (July 18) announced the launch of a month-long public consultation.

The MHRA said that the move comes “in response to multiple reports” of codeine linctus being used “recreationally for its opioid effects, rather than for its intended use as a cough suppressant”.

Read more: ‘Overwhelmed’ locum suspended for four months over codeine payment mix-up

Codeine linctus can currently be bought over the counter (OTC) at pharmacies in oral solution or syrup form to treat a dry cough.

But the MHRA said it is consulting on proposals to change its classification so that a GP prescription is required for the dispensing of all strengths of the opioid-containing medicine.

The consultation will run for four weeks from today until August 15, with members of the public and health professionals encouraged to share their views online.

Read more: P med erectile dysfunction drug to be sold from Boots pharmacies

According to the MHRA’s Yellow Card report system, since reporting began in 1964, codeine has received nearly 5,000 adverse drug reaction reports - of which 298 have been reported as fatal - up to May 31 this year.

In 2022, 35 fatal reports were received and eight fatal reports have so far been logged for 2023, according to MHRA data.

Since 2018, the MHRA has received 116 Yellow card reports for codeine medicines including codeine linctus regarding “drug abuse, dependence and/or withdrawal”, it said.


“Significant concerns”


Professor Claire Anderson, president of the Royal Pharmaceutical Society (RPS), said that the consultation was “welcome”.

There is “insufficient robust evidence” in favour of using codeine linctus to treat coughs and there are “significant concerns” about its “misuse and addictive potential as well as the risk of overdose”, she added.

Professor Anderson said that it was “questionable” to use the opioid to treat “what is ultimately a self-limiting condition”.

Read more: Maxwellia mulling 'next step' after oxybutynin drug reclassification rejected

The consultation comes as a locum pharmacist was last month suspended by the General Pharmaceutical Council’s (GPhC) fitness-to-practise (FtP) committee for four months for removing bottles of codeine linctus from two pharmacies where he was working “without paying for them”.

And in May, C+D reported that a pharmacist had been struck off the register following a conviction for fraud and the illegitimate supply of medicines after he was threatened with a gun, knives and “consequences” for his family if he did not provide codeine linctus to those threatening him.

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