April 1 cut-off for cold and flu meds

Pharmacies in the UK would indeed be foolish to ignore new restrictions on nasal decongestants that will become law as of April 1, 2008.

The Medicines and Healthcare products Regulatory Agency (MHRA) announced the final cut-off date for the sale of large packs of over-the-counter (OTC) drugs containing pseudoephedrine and ephedrine yesterday, in a move to curb the misuse of the meds in the illicit manufacture of Class A drug, methamphetamine.

As of the April 1 deadline, customers will no longer be able to buy packs of cold and flu drugs that contain more than 720mg pseudoephedrine (equivalent to 12 tablets/capsules of 60mg or 24 tablets of 30mg) or 180mg ephedrine, and there will be a limit of one pack per customer.

The products will, however, remain available over the counter for at least the next couple of years. A proposal to switch the drugs to prescription-only is only likely to be enforced if the pack size restrictions fail to deter the illegal use of the medicines.

"It's hoped [the measures] will mean it won't take hold here as it has in the US," said an MHRA spokesperson of the problem of methamphetamine production using cold and flu drugs.

However, she also pointed out that nasal decongestants are just one of several options that are regularly used in the production of crystal meth, and that these measures can only hope to cut off one route of manufacture.

The US has already enforced much more exacting restrictions on drugs containing pseudoephedrine and ephedrine, a response to the more severe methamphetamine problem over in the States. Australia and the Philippines have also taken steps to strengthen controls over these preparations.

In the UK, however, there were concerns that the April deadline was too soon, failing to give enough time for larger packs to make their way through the distribution chain and for the smaller packs to be available on the market..

The Proprietary Association of Great Britain (PAGB) for example, while "broadly supportive" of the pack size restrictions and limits on sale quantity, considered the transitional period too short, and had recommended an alternative implementation date of June 1.

"Production plans to meet forecasted needs are set in place months before the season begins and stock has already been produced…to meet the needs of this year's cold and flu season," the PAGB said in its response to the MHRA proposals.

"In addition the threat of pandemic flu and a desire to ensure continued availability of products in this event has meant that companies have maintained production schedules as originally forecast."

The association also pointed out the regulatory and manufacturing hurdles needed to be overcome in order to introduce new pack sizes, and the fact that national sales figures suggest the cold and flu season lasts well into May, meaning that the April deadline was premature.

However, despite the PAGB's concerns, the MHRA has stuck with its original plans, supported by the Commission on Human Medicines.

With the pseudoephedrine/ephedrine meds remaining OTC, at least for the time being, firms supplying the UK market should be spared the reformulation scramble that took place in the US, as companies fought to formulate versions of their drugs that were easily available to consumers.

The bulk of cold and flu products available in the UK, however, will not be affected by the restrictions as they contain different decongestants. There are currently 97 authorised products containing psuedoephedrine and 17 containing ephedrine.