The Medicines and Healthcare products Regulatory Agency has put in place moves to tighten control of the sale of products containing the nasal decongestants pseudoephedrine and ephedrine, but stopped short of reclassifying the drugs as prescription-only medicines at this time.
This follows a public consultation initiated by the MHRA, 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.
There are 97 authorised products containing pseudoephedrine and 17 containing ephedrine, and they are only available from a pharmacist and not general sale. Under the recommendations made by the Commission, large packs of these drugs will now be replaced by smaller ones of 720mg (the equivalent of 12 tablets or capsules of 60mg or 24 tablets or capsules of 30mg). In addition, supply will be limited to one pack per customer, and only pharmacists are allowed products containing these drugs, the MHRA said.
A spokesperson for the Agency told PharmaTimes UK News that pharmacists are required to “look out for and monitor the control of any products containing these drugs,” and that a “rolling programme is in place to see whether the news controls deter away from the potential risk of their misuse.”
If these new measures are unsuccessful, pseudoephedrine and ephedrine may well be reclassified to prescription-only medicines at a later stage, the spokesperson said. But, earlier this year, the National Pharmacy Association voiced its opposition to the proposed reclassification, refuting the claim that the only way to control the medicine is through prescribing.
An expert panel will also carry out a full review of all decongestants in this class, focusing on their effectiveness and potential safety concerns.