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PJ Online homeThe Pharmaceutical Journal
Vol 278 No 7448 p445
21 April 2007

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NPA opposes reclassifying pseudoephedrine

Proposals to restrict pseudoephedrine and ephedrine to prescription supply in order to prevent methylamphetamine abuse becoming a problem in the UK are based on false grounds, the National Pharmacy Association has told a Parliamentary inquiry into the plan.

“Reclassification would deprive many people of a safe, effective medicine and there is no evidence that reclassification would reduce methylamphetamine use in the UK,” the NPA says in a submission to the joint inquiry of the all-party parliamentary groups on drug misuse and on primary care and public health.

It adds that having to wait for GP appointments rather than being able to buy what they need from pharmacies would inconvenience patients.

The NPA also believes that there are no effective alternative decongestants to pseudoephedrine. It says: “Professor [Ron] Eccles, of the Common Cold Centre, stated in a recent review that phenylephrine is a poor substitute for pseudoephedrine as an orally administered decongestant as it is extensively metabolised in the gut and its efficacy as a decongestant is unproven.”

In an eight-point response, the NPA addresses each of the concerns set out by the Medicines and Healthcare products Regulatory Agency in its proposal to remove the two drugs from the pharmacy category.

The association says:

• There is little evidence that pseudoephedrine and ephedrine are used in the UK to manufacture methylamphetamine

• Concern is based on events in countries where pseudoephedrine was previously available by self-selection in non-pharmacy outlets in packs of up to 250 tablets of higher strength than in the UK

• Only 10 per cent of illicit methylamphetamine manufactured in the US is sourced from OTC products, most of which are stolen

• Other countries dealt with the problem by introducing restrictions similar to pharmacy control in the UK

• Evidence from the US suggests that restricting pseudoephedrine supplies had no effect on amounts of methylamphetamine available for illicit use

Addressing other impacts, the NPA adds:

• Reclassification will reduce access to safe, effective medicines

• Many affected products are on the NHS blacklist

• Reclassification will drive up GP workload

The NPA’s preferred solution to the risk of illicit conversion of pseudoephedrine to methylamphetamine is to restrict packs available for pharmacy sale to a total of 720mg of pseudoephedrine, to ask pharmacists to sell only one pack per patient and to monitor sales more closely, supported by professional guidance from the Royal Pharmaceutical Society.

The two all-party groups launched their inquiry in the light of the MHRA’s proposal to make ephedrine and pseudoephedrine prescription products (PJ, 10 March, p269).

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