Tighter restrictions on the sale of nasal decongestants containing the agents pseudoephedrine and ephedrine will become law from April 1 this year, the Medicines and Healthcare Products Agency has confirmed.

The move is in response to growing concern about the potential for these drugs to be siphoned from over-the-counter medicines and used in the illegal manufacture of methylamphetamine, otherwise known as crystal meth.

Currently there are close to 100 authorised products containing pseudoephedrine and 17 containing ephedrine, and they are only available from a pharmacist and not general sale. Yet still there are believed to be four incidents in England and Wales of crystal meth manufacture using OTC medicines containing these agents.

Last year, the Agency initiated a public consultation on the issue, the outcome of which was recently considered by the Commission on Human Medicines. The Commission has now advised the MHRA to proceed with the amendments to the law by April 1, 2008, to cement its recommendation that large packs of pseudoephedrine and ephedrine should be replaced by smaller packs of 720mg and that customers should only be able to get one pack at a time.

Expert monitoring
“All stakeholders are working together to ensure the controls are effective and an Expert Group is carrying out a programme of work to monitor the situation,” said Dr June Raine, Director of Vigilance and Risk Management of Medicines at the MHRA.

If these new measures are unsuccessful, pseudoephedrine and ephedrine may well be reclassified to prescription-only medicines at a later stage, a spokesperson for the Agency previously told PharmaTimes UK News. But the National Pharmacy Association has voiced its opposition to a reclassification, refuting the claim that the only way to control the medicine is through prescribing.