The Medicines Control Agency has started consultation on a proposal to reclassify levonorgestrel as a pharmacy medicine for emergency contraception. The consultation has been launched following an application for reclassification by the licence holder, Schering Healthcare. MLX 263, issued on May 19, says that the Committee on Safety of Medicines has advised that levonorgestrel 0.75mg for emergency contraception can safely be supplied as a pharmacy medicine to women aged 16 years and over. The CSM considered evidence for the safety of the product under the three relevant criteria for restricting medicines to prescription control (see panel). The CSM took the view that all steps necessary to supply EHC safely could be completed in pharmacies, including the provision of advice and referral to medical practitioners, where appropriate. The committee decided that the product was unlikely to present a direct or indirect danger to women's health when used without medical supervision. It recommended that women who were taking medicines with potential for interaction with levonorgestrel should be referred to a doctor and that women should be encouraged by pharmacists to see a doctor for follow-up advice. Suitable information addressing these recommendations should be included in the product's SPC (summary of product characteristics) and in patient information leaflets.

Pharmacists may soon be able to sell EHC over the counter

The consultation letter says that the change to pharmacy supply would be supported with guidance developed by a multidisciplinary working group established by the Royal Pharmaceutical Society. That group would also advise on additional training for pharmacists.
The MCA says that pharmacy supply of EHC would increase its accessibility and contribute to the Department of Health's strategy for health, one aim of which is to reduce unwanted pregnancies. The product would continue to be available as a POM through GPs, family planning clinics, youth clinics and hospital casualty departments.
Once a six-week period of statutory consultation is over, the proposal will be considered by the Medicines Commission, which will make a recommendation to Government Ministers. The final decision on whether to proceed with the reclassification lies with Ministers.
Levonorgestrel has been available for emergency contraception in Britain as Levonelle-2 since 1999. Levonorgestrel has been in use for emergency contraception in other countries since 1980.

Criteria for prescription control

The Medicines Act 1968 and European Directive 92/26/EEC set five criteria for classifying medicines as prescription-only. Prescription control is applied to products which meet any of the following criteria.

• Likely to present a direct or indirect danger to human health, even when used correctly, or if used without medical supervision
• Frequently used incorrectly and, as a result, likely to present a danger to human health
• Contains substances or presentations of substances with activity or side effects which require further investigation
• Normally prescribed for parenteral administration.

Exemptions from prescription control may be made with regard to a product's maximum dose, maximum daily dose, strength, pharmaceutical form, packaging or other circumstances specified in a decision.