The Pharmaceutical Journal
Vol 278 No 7438 p153
10 February 2007

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Tranexamic acid proposed as next POM-to-P switch

The first steps to making tranexamic acid available as a pharmacy medicine were taken this week with the launch of a consultation on its switch from POM to P status.

The Medicines and Healthcare products Regulatory Agency published details of the proposed reclassification, sought by Meda Pharmaceuticals for its product Cyklo-f 500mg tablets. The company wants tranexamic acid to be available over the counter in a pack of 18 tablets for the treatment of heavy menstrual bleeding. Consultation on the application closes on 19 March 2007.

Coinciding with the consultation’s launch, the pros and cons of pharmacy availability for treatments for heavy menstrual bleeding (HMB) were discussed at an MHRA conference in London entitled “Widening access to medicines — focus on women’s health”.

Mary Ann Lumsden, professor of medical education and gynaecology at the University of Glasgow, argued that there are two treatments that have considerable potential as candidates for POM-to-P switches — tranexamic acid and non-steroidal anti-inflammatory drugs (mefenamic acid and ibuprofen). In determining their suitability for pharmacy supply for this condition, Professor Lumsden said that one concern could be that gynaecological diseases such as endometrial cancer might be missed if a doctor is not consulted.

However, she cited statistics used during the development of recent National Institute for Health and Clinical Excellence guidance, for which she acted as chairman of the guideline development group. “On average a GP will see a case of endometrial cancer in a woman under 45 years every 250 years and a death from the disease in this age group every 1,900 years. This communicates rarity,” she stressed. “We don’t need to get too hung up about this provided pharmacists ask the right questions,” she said.

There are certain symptoms that might indicate significant disease, such as intermenstrual bleeding, postcoital bleeding, pelvic pain (between periods) and “pressure symptoms”. However, she pointed out that GPs are advised only to question patients before starting treatment and that they are not likely to examine the patient if they have HMB alone. “Can pharmacists not do the same thing,” she asked. “This is certainly an area where we can usefully move from POM to P quite soon,” she concluded.