UK CONSIDERING RESTRICTIONS ON PSEUDOEPHEDRINE

The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a public consultation letter seeking proposals on restricting sales of cold medicines containing pseudoephedrine and ephedrine. In addition, the Commission on Human Medicines has recommended limiting the amount of the active ingredient in one pack.

The action is in response to reports of use of these ingredients to manufacture the controlled substance methamphetamine. The commission has advised the MHRA to reclassify all drugs containing pseudoephedrine and ephedrine from OTC to prescription-only status and to set maximum pack size at 720 mg of either drug.

There has been increasing concern among law enforcement agencies that pseudoephedrine and ephedrine can be easily extracted from OTC cold remedies and used in the manufacture of methamphetamine, a highly addictive stimulant. "Although the prevalence of misuse of methamphetamine is currently comparatively low in the UK, its use and availability is thought to be increasing," the MHRA said.

The agency points out that regulators in other countries, including the U.S. and Australia, have taken actions restrict products containing pseudoephedrine. In the U.S., drugs containing pseudoephedrine must be kept behind the pharmacy counter, and the ingredient has been replaced with phenylephrine in many OTC cold medicines.

"Strategies to maintain consumer access to alternative OTC therapies, such as reformulation of pseudoephedrine/ephedrine-containing products to include ingredients such as phenylephrine, are being discussed with industry," the MHRA said.

To view the draft proposal or to submit a comment, go to www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2030434&ssTargetNodeId=373.