Nasal decongestants get new sales restrictions

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that pseudoephedrine and ephedrine contained in nasal decongestants in cold and flu remedies are to have tighter controls.

This follows a public consultation initiated by the MHRA as there has been an increasing concern about the potential for pseudoephedrine and ephedrine to be extracted from over-the-counter (OTC) medicines and used in the illegal manufacture of methylamphetamine (crystal meth).

The MHRA received views from industry, other organisations and public bodies about the continuing availability of pseudoephedrine and ephedrine. The Commission on Human Medicines (CHM) considered the responses to the consultation and proposals from interested parties.

The Commission recommended that large packs of pseudoephedrine and ephedrine will be replaced by smaller packs of 720mg (the equivalent of 12 tablets or capsules of 60 mg or 24 tablets or capsules of 30mg) and there will be a limit to one pack per customer. It also recommended to the pharmacy professions that the sale should be carried out by a pharmacist.

An expert group of CHM is to be set up to advise on the practical aspects of the measures proposed. The impact of the strengthened pharmacy controls will be regularly monitored and evaluated by this group. The group will also carry out a full review of all decongestants in this class, looking at the effectiveness and potential safety concerns of these medicines and their alternatives.

The legal status of products containing pseudoephedrine and ephedrine should be reclassified from pharmacy only to prescription only in 24 months time (2009) or earlier if necessary, unless the risk of the misuse of these OTC medicines in the illicit manufacture of methylamphetamine is contained by the measures outlined.