Azithromycin is to be made available over the counter to treat asymptomatic chlamydia infection, the Medicines and Healthcare products Regulatory Agency announced today (6 August 2008). It is the first oral antibiotic to be switched from prescription-only to pharmacy medicine status.
The drug will be available as Clamelle for people over 16 years of age who have tested positive for chlamydia but have no symptoms, and for their sexual partners.
June Raine, director of vigilance and risk management of medicines at the MHRA, said: “The MHRA is keen to support the availability of more medicines over the counter where it is safe to do so, and we wish to move on to new areas, such as prevention and chronic disease management. We know many pharmacists are ready for this too.
“Making this medicine available from a pharmacy is a real example of how we are progressing, and enabling people to play an active role in taking charge of their own healthcare.”
Howard Duff, the Royal Pharmaceutical Society’s director for England, said that the decision would mean convenient and effective care for patients. “Pharmacists already play an important role in the provision of sexual health services, and have done so for many years. Reclassifying azithromycin will expand on existing services and improve access to chlamydia screening and treatment for patients.”
The FPA also welcomed the decision. Natika Halil, director of information at the FPA, said: “For people who are already testing themselves at home it is a really positive step forward that the treatment can now also be bought from pharmacies. This will ensure fast and effective access to treatment. This service has the potential to play an important part in reducing rates of chlamydia.”
Colette McCreedy, chief pharmacist at the National Pharmacy Association, said: “The MHRA has demonstrated great confidence in pharmacy by bringing an antibiotic to the P market. This will, we hope, mark the beginning of a new phase of POM-to-P switches.”
Who may buy azithromycin?
Pharmacists will be able to sell azithromycin only to individuals with a positive NAAT (nucleic acid amplification test) result and to their sexual partners. Partner notification contact slips will be used to obtain a supply; partners will not need to have a positive test. A database of test results will be held, which pharmacists will need to access to confirm the results for index cases.
Manufacturer Actavis is working with the NPA on training materials for pharmacists and medicines counter assistants as well as a Clamelle-branded chlamydia test kit. The NPA has developed a chlamydia screening service package, which is due to be launched on 11 August 2008. Clamelle is expected to be available in late October 2008.