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Vol 278 No 7458 p759
30 June 2007

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Chlamydia treatment could soon be available OTC

Consultation with a pharmacist

Azithromycin would be supplied after consultation with a pharmacist

People with asymptomatic chlamydia infection could soon buy treatment for the condition over the counter at community pharmacies. The Medicines and Healthcare products Regulatory Agency is consulting on a request from Actavis to reclassify azithromycin 500mg tablets (Clamelle) from a prescription-only medicine to a pharmacy medicine.

Azithromycin would be supplied according to a protocol after consultation with a pharmacist. Although licensed as a single 1g dose for individuals aged 16 years and over, the target group for this medicine would be those over 25 years old. Young people aged 16 to 24 years are eligible for free treatment under the national chlamydia screening programme.

Only individuals with a positive chlamydia test result would be considered for supply and the test must be a recognised NAAT (nucleic acid amplification test), either purchased privately or provided through the NHS. Linked IT technology must be in place so that pharmacists can check test results at the point of sale, says the consultation document.

It is thought that OTC supply will help genito-urinary medicine clinics to prioritise their waiting lists so that symptomatic cases can be treated more quickly. The consultation document emphasises that the reclassification will not replace existing services — NHS supply of the medicine on a prescription or via an NHS or private patient group direction — but will complement them, allowing individuals an alternative choice of how to access treatment.

“The option of purchasing azithromycin through a pharmacy offers individuals the opportunity to access rapidly treatment from a convenient location as soon as they have been notified of a positive test result,” the consultation says.

The consultation also seeks views on whether partners of patients should be able to purchase treatment over the counter without a positive test result, or whether azithromycin should be sold only to partners who have a positive result.

As a P medicine, azithromycin would be available over the counter only from pharmacies in which the staff had completed validated training. Two sets of training materials will be developed — one for pharmacists and one for medicines counter assistants. The pharmacy training package will encourage liaison with the local sexual health lead, GUM clinician and chlamydia co-ordinator. Pharmacists will refer customers to the GUM clinic and to the national chlamydia screening programme where appropriate.

Comments on the proposed reclassification should be sent to Veronica Popo in Room 14–138, Market Towers, 1 Nine Elms Lane, London SW8 5NQ (e-mail veronica.popo@mhra.gsi.gov.uk) by 2 August 2007.

Loperamide reclassification The MHRA is also consulting on a request to reclassify Imodium (loperamide) capsules and Imodium Instants from a pharmacy medicine to a general sale list medicine for the symptomatic treatment of acute episodes of diarrhoea associated with irritable bowel syndrome in adults aged 18 years and over following initial diagnosis by a doctor. The maximum pack size would be six dosage forms, equivalent to one day’s treatment. Comments on the request should be sent to Veronica Popo (as above) by 13 July 2007.

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