The Pharmaceutical Journal
Vol 275 No 7363 p215
20 August 2005

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Consultation on triptan POM to P switch starts

Consultation has begun on the reclassification of sumatriptan and zolmitriptan from prescription-only to pharmacy medicines for acute relief of migraine attacks.

The Medicines and Healthcare products Regulatory Agency announced the start of the eight-week public consultation last week (PDF 110K). “As triptans should be taken as early as possible in a migraine attack the pharmacy availability of these important medicines would be beneficial to patients who suffer from migraines, especially those who have infrequent attacks and may not always have prescription medicines to hand,” said Kent Woods, chief executive of the MHRA.

The consultation proposes a checklist style questionnaire to assist pharmacists in identifying patients who are suitable for all over-the-counter triptans, those who require referral to a doctor and those who can be offered alternative OTC treatment. Concerns over cardiovascular and other adverse events would be addressed in the questionnaire, which the pharmacist and patient would complete together.

To reduce the risk of overdose and masking of serious underlying disease, it is proposed that the pack size of triptans will be limited to two tablets with a maximum of four packs per month to be sold to one individual.

Commenting on the consultation, Sue Kilby, head of practice at the Royal Pharmaceutical Society, said: “Pharmacists are already familiar with the diagnosis and treatment of migraine. Proposals such as this provide significant opportunities for greater patient choice and recognise the important role pharmacists play in helping people to access advice and treatment in a safe, effective and convenient way.”

Clive Edwards, prescribing adviser at North Tyneside Primary Care Trust, said that although he does not foresee any particular problems with OTC triptans, difficulties with diagnosing migraine without aura could arise. He pointed out that the London Migraine Clinic once reported that only a third of its referrals from GPs had migraine, a third had migraine complicated by other headaches and a third did not have migraine. “Thus, if GPs are having problems diagnosing it, there may be a problem with pharmacists trying to do so,” he said. A previous definitive diagnosis by a doctor might be a mandatory criterion before a pharmacist can sell a triptan, he suggested.

Comments on the proposal can be sent to Amanda Lawrence, Medicines and Healthcare products Regulatory Agency, Room 14–110, Market Towers, 1 Nine Elms Lane, London SW8 5NQ until 6 October.

GlaxoSmithKline Consumer Healthcare has made the application to reclassify sumatriptan, which was first licensed as a POM in 1991 and AstraZeneca has applied to reclassify zolmitriptan, first licensed in 1997.