Policy responses and statements

Name of organisation:

Medicines and Healthcare Products Regulatory Agency (MHRA)

Name of policy document:

Consultation ARM 39 - Request to reclassify Cyklo-f 500mg tablets (tranexamic acid) from prescription only medicine (POM) to pharmacy availability (P)

Deadline for response:

6 March 2007

Background: Consultation ARM 39 sought views on the reclassification of Cyklo-f 500mg tablets (tranexamic acid) from prescription only medicine (POM) to pharmacy availability (P).

The active ingredient of Cyklo-f Tablets is tranexamic acid, which is indicated for the reduction of heavy menstrual bleeding experienced over several cycles by women with regular (21-35 day) cycles with no more than 3 days individual variability in cycle duration.

COMMENTS ON
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA)
CONSULTATION ARM 39: REQUEST TO RECLASSIFY CYKLO-F 500MG TABLETS (TRANEXAMIC ACID) FROM PRESCRIPTION ONLY MEDICINE (POM) TO PHARMACY AVAILABILITY (P)

The Royal College of Physicians of Edinburgh is pleased to respond to the Medicines and Healthcare Products Regulatory Agency on public consultation ARM 39.

The request is to reclassify Cyclo-F 500mg tablets from POM to P.  Cyclo-F is tranexamic acid, which is used to treat heavy menstrual bleeding.  It has been used as a POM medicine in the UK for more than 30 years and it has been available in Sweden without prescription since 1997.

The College has two main concerns.  Firstly that, in theory, tranexamic acid might cause thrombosis.  In practice, this has not been borne out by experience but there is a suggestion that studies of this problem might have excluded those patients who were most at risk.  This raises the question as to whether the use of this medication in a less controlled manner could result in increased risk.

The second, and more important, concern is the risk of masking symptoms of an underlying endometrial, tubal or cervical cancer.  The application seeks to minimise this problem by a comprehensive patient information leaflet and by a very extensive check list to be used by the prescribing pharmacist.  There is no doubt that, if properly implemented, these measures would go a long way towards dealing with this risk.  However, in areas with many ethnic minority patients, many patients do not speak or read English.  They would also potentially be embarrassed to discuss gynaecological issues with a pharmacist, particularly if male.  In this context, there is the possibility that women might ask a family member or friend to buy the medication for them.

The College has concerns about the extensive check list that the pharmacist will be required to go through with the patient.  Within the business of the average pharmacy, lack of time and lack of privacy may result in the procedure being conducted in a less than comprehensive manner.

Against this background, the College feels that the current trends are in favour of de-medicalising these drugs in the name of convenience and patient power, but we feel that, once these drugs become generally available, the risks may begin to accumulate as less attention is given to red flags.  Doctors spend years learning the art of good history taking and GPs hold detailed records of previous medical and family histories which may raise more red flags.  So we sacrifice a bit of safety round the margins for the sake of convenience and empowerment of patients: the College is not sure that this is right but can see the arguments either way.

This appears to be a matter that gynaecologists have discussed for some time.  Despite this, it would seem that uncertainty persists.

In conclusion, while the College recognises that vaginal bleeding is a common, distressing and embarrassing condition it may, however, be a vital "tell-tale" sign: in the light of the above concerns and the importance of  making an accurate diagnosis (not always satisfactorily from a questionnaire), the College cannot support the change of status of this drug from POM. 

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

[27 February 2007]