Thank you for giving the National Pharmaceutical Association (NPA) the opportunity to comment on consultation letter ARM 25 on proposals to reclassify chloramphenicol eye drops from POM to P.
The NPA represents the interests of community pharmacies. We have, in voluntary membership, around 11,000 community pharmacies, which comprises the majority of the 12,000 pharmacies in the UK, with the exception of the Boots chain. The NPA provides a representative voice for its members as well as a range of services to help them with both commercial and professional aspects of running their businesses.
The NPA welcomes extensions to the pharmacist’s armamentarium by expansion of the ‘Pharmacy’ only class with the proposed pharmacy availability of chloramphenicol eye drops. Pharmacists have been calling for chloramphenicol eye drops to be available through pharmacies for many years and will welcome the opportunity to provide patients with an effective treatment for conjunctivitis as early as possible in the disease process.
Wording of the Indication
We believe that the product should be indicated for the treatment of "infective conjunctivitis" instead of "bacterial conjunctivitis" as stated in the application. It is difficult to differentiate clinically between infections of viral and bacterial origin and therefore it is current clinical practice to treat infective conjunctivitis with chloramphenicol eye drops without attempting to confirm whether the infection is of viral or bacterial origin1.
Support for reclassification
Pharmacists frequently receive requests for advice from patients suffering from infective conjunctivitis and are familiar with its diagnosis and treatment. Pharmacists and their staff are also familiar with the warning symptoms which may indicate the presence of a more serious eye condition and will already refer patients to their practitioner if further investigation is necessary.
Safety profile
We welcome the pharmacy availability of chloramphenicol eye drops for adults and children over 2 years old. However as the cases of "grey baby" syndrome occur predominately in infants of less than 30 days old, we hope that, in future, consideration will be given to reducing the minimum age limit. Given the frequency of infective conjunctivitis in very young children, a reduced lower age limit of 18 months would allow pharmacists to treat many more patients in need and thus improve access to this medicine.
Contact lens wearers and eye surgery
1 Prodigy guidance
In our opinion it is appropriate for pharmacists to be able to supply chloramphenicol eye drops to contact lens wearers. Pharmacists are already familiar with advising contact lens wearers on the use of eye drops with contact lenses and are able to recommend appropriate measures such as removing lenses during the treatment period and referring patients to their contact lens practitioner when necessary. We agree that it is appropriate for patients who have had recent eye surgery or laser treatment to be referred to their practitioner. However in our opinion it is not necessary to exclude all patients with a history of eye surgery or laser treatment. There should be a clear definition of "recent history" as part of the marketing authorisation.
Summary
The NPA supports this proposal and believes that pharmacists are ideally placed to advise and treat patients presenting with infective conjunctivitis.
