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Press release
| Date: | 08 Jun 2005 |
|---|---|
| Time: | 12:08 |
| Subject: | Prescription only medicine made available over the pharmacy counter |
| Contact: | Press Office 020 3080 7651
or press.office@mhra.gsi.gov.uk Out-of-hours 07770 446 189 |
The Medicines and Healthcare products Regulatory Agency (MHRA) today announced that Chloramphenicol Eye Drops could be safely sold through pharmacies for the treatment of acute bacterial conjunctivitis.
This move represents the first antibiotic eye treatment that can be accessed without a prescription in the UK and highlights the Government’s commitment to expand the range of medicines available for self-medication. Topical antibiotics for conjunctivitis are generally used on the grounds that they speed recovery. Being able to purchase this medicine in a pharmacy will therefore enable patients to take control of their own healthcare by accessing treatment straight away without having to spend time visiting their doctor.
"Chloramphenicol has been used in clinical practice for more than 50 years. Its safety profile and its efficacy in the topical treatment of bacterial conjunctivitis are well established. 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” says MHRA Chief Executive, Professor Kent Woods.
Chairman of the Committee on Safety of Medicines (CSM), Professor Gordon Duff 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.”
The reclassification of Chloramphenicol Eye Drops was subject to a public consultation exercise. In order to aid transparency, and for easy access the MHRA has made the responses received electronically available on their website
Notes to Editor
The CSM is an independent Committee of experts that advise Government on the safety, quality and effectiveness of medicines, including vaccines. It is also responsible for encouraging the collation and investigation of reports on suspected adverse reactions to medicines already on the market. The MHRA is the executive arm of the UK's Medicines Licensing Authority and is responsible for all aspects of the regulation of medicines in the UK.
Following a detailed public consultation exercise (ARM 25), the responses were referred to the Committee on Safety of Medicines (CSM) for advice. No new issues were raised in the responses to consultation and the CSM advised the Agency that pharmacists should be able to supply the antibiotic eye drop direct to patients.
Responses to the consultation exercise (ARM 25) can be accessed via the MHRA website (www.mhra.gov.uk) or by contacting the MHRA’s Information Centre.
