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08 Jun 05 10:35 11:35 UK |
An antibiotic is to be sold by pharmacists without a prescription for the first time, the drugs regulator has announced.
The Medicine and Healthcare products Regulatory Agency has said chloramphenicol eye drops should be available over-the-counter.
It said the antibiotic, used to treat bacterial conjunctivitis, could be safely sold to the public.
However doctors fear widespread use of antibiotics could increase resistance.
The decision to reclassify chloramphenicol was made after holding a consultation period during which health professionals and the public could offer their views on the proposed change.
The drug, sold as Optrex Infected Eye Drops, will be available from chemists later this month.
The MHRA said making the drug directly available to those affected would speed up recovery because people would be able to access treatment without having to go to their doctor.
Up to 2% of primary care consultations are for bacterial conjunctivitis.
'Lower risk'
Professor Kent Woods, MHRA Chief Executive, said chloramphenicol had been safely and effectively used for more than 50 years.
"The case for making this medicine available over the counter, both in terms of patient safety and the risk of emergent bacterial resistance, has been debated thoroughly.
"We are convinced that the potential health benefits outweigh any risks to patients, or to the community at large."
Professor Gordon Duff, chairman of the Committee on Safety of Medicines, said: "Allowing patients quick access to this treatment will help to speed their recovery, lower the risk of spreading infections, of infection returning or of further complications developing.
"As such, I welcome this move and believe there is a clear public health benefit to be gained from making this important medicine available through pharmacies for the topical treatment of bacterial conjunctivitis."
Concerns had been raised that making chloramphenicol more widely available would increase resistance to the antibiotic.
In addition to being used to treat conjunctivitis, it is also used in hospitals to treat life-threatening illnesses such as typhoid.
Antibiotic resistance has helped fuel rising rates of superbugs in hospitals, including MRSA, which kills thousands of patients each year.
The MHRA said there was no evidence that making chloramphenicol available over-the-counter would lead to more antibiotic resistance but promised resistance patterns would be monitored.
David Pruce, Director of Practice and Quality Improvement for the Royal Pharmaceutical Society, said: "Pharmacists are experts in medicines and have long believed that making chloramphenicol eye drops available without a prescription is a safe, effective and far more convenient route to treatment for the many patients who visit pharmacies every day with bacterial conjunctivitis."
Dr Hamish Meldrum, chairman of the British Medical Association's GP Committee, said: "Making prescription drugs available over-the-counter is not as simple as it sounds.
"To safeguard patients, pharmacists must have a complete picture of a patient's health before dispensing powerful drugs.
"Yet the system giving pharmacists access to patient records is far from in place. Until it is, freeing up access to more drugs should be approached with caution.
"With increasing problems of antibiotic resistance we would also be concerned about moves to make them even more freely available in the community."