Thank you for giving the National Pharmacy Association (NPA) the opportunity to comment on consultation letter ARM 37 on proposals to reclassify chloramphenicol eye ointment 1% from POM to P.
The NPA welcomes expansion of the ‘Pharmacy’ only class with the proposed addition of chloramphenicol eye ointment 1%. In 2005, pharmacists welcomed the reclassification of chloramphenicol eye drops from POM to P. The reclassification provided an effective treatment which community pharmacists could supply for conjunctivitis and enabled patients to access safe and effective treatment more conveniently and without the need to consult their general practitioner (GP).
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. We believe that pharmacists have been supplying chloramphenicol eye drops as a P product safely, effectively and appropriately for over 12 months and will welcome the opportunity to be able to supply an alternative formulation which may be more appropriate for some patients.
Safety profile
We welcome the pharmacy availability of chloramphenicol eye ointment 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 consideration will be given to reducing the minimum age limit. Given the frequency of infective conjunctivitis in young children, especially those attending day care, a reduced lower age limit of 12 months would allow pharmacists to treat many more patients in need and thus improve access to this medicine.
Contact lens wearers
In our opinion it is appropriate for pharmacists to be able to supply chloramphenicol eye ointment to contact lens wearers. Pharmacists are already familiar with advising contact lens wearers on the use of eye drops and ointments 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. The application states that people who wear contact lenses will only be advised to use the ointment after seeking advice from a doctor or contact-lens practitioner. However the proposed patient information leaflet (PIL) states that patients must consult their doctor if they wear contact lenses. This may cause confusion and we believe that the PIL must be consistent with 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 with chloramphenicol eye ointment 1%.
