Policy responses and statements

Name of organisation:

Medicines and Healthcare Products Regulatory Agency (MHRA)

Name of policy document:

ARM 37 - Request to reclassify a product from POM to P - Chloramphenicol Eye

Deadline for response:

4 January 2007

Background: The consultation seeks views on the reclassification from POM TO P Chloramphenicol Eye Ointment 1%. The active ingredient is chloramphenicol 1%, which is indicated for treatment of acute bacterial conjunctivitis.

The dose for adults (including elderly people) and for children aged 2 years and older is application of the ointment to the affected eye either at night if chloramphenicol eye drops are used during the day, or 3 to 4 times a day if the ointment is being used alone. The course of treatment should be limited to 5 days. The maximum pack size is 4 g.

COMMENTS ON
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA) ARM 37: REQUEST TO RECLASSIFY A PRODUCT FROM POM TO P - CHLORAMPHENICOL EYE OINTMENT 1%

The Royal College of Physicians of Edinburgh is pleased to respond to the Medicines and Healthcare Products Regulatory Agency on consultation ARM 37: Request to reclassify a product from POM to P in relation to Chloramphenicol Eye Ointment 1%. 

The proposal is to reclassify chloramphenicol eye ointment 1% from POM to P.  This follows a similar reclassification for chloramphenicol eye drops for which there is now good safety data.

There appears to be good support for this further change.  This is a common condition which is easily diagnosable.  There are appropriate safeguards for its use in higher risk situations such as contact lens wearers, and appropriate advice regarding the purported rare association with bone marrow suppression.  The only suggestion is that some advice might be included about viral conjunctivitis similar to the use of oral antibiotics for viral respiratory infections along the lines of: “Conjunctivitis is commonly caused by respiratory tract viruses and will usually settle without any treatment in 7-10 days”.

Copies of this response are available from:

Lesley Lockhart,
Royal College of Physicians of Edinburgh,
9 Queen Street,
Edinburgh,
EH2 1JQ.

Tel: 0131 225 7324    ext 608
Fax: 0131 220 3939

[21 December 2006]