The Pharmaceutical Journal Vol 267 No 7176 p767-773
1 December 2001

This article
Reprint
Photocopy

News summary

Study smoothes POM to P switch

The first pharmacy-based actual-use trial to be conducted in Europe (designed to support the deregulation of a prescription-only medicine to pharmacy status) was described this week by Dr Joseph Veltri, chairman, Pegus Research Inc, Utah, at the United Kingdom Clinical Pharmacy Association autumn symposium in Blackpool.

The trial was conducted on behalf of Boots Healthcare International and assessed over-the-counter use of flurbiprofen (Froben). The ethical considerations of this trial (PDF* 55K) were discussed previously (PJ, 10 November, p693).

Dr Veltri explained that for the trial flurbiprofen was packaged for over-the-counter supply. Trial participants had sore throat and were able to read the package and decide if the product was suitable. At this point a pharmacist intervened to take a brief medical and drug history and confirm that the subject could take part in the study. Details were then faxed to a study doctor for review who would fax back an agreement for the pharmacist to supply the medicine or intervene if appropriate.

Customers took the medicine as they wanted and were followed-up by telephone to assess the safety profile and identify those who did not use the product as per the label.

Dr Iain Gibb, BHI, told audience members that following the trial, the Medicines Control Agency has indicated that the product would be appropriate for pharmacy status. This was expected to come at the end of December, he said.

A report of the UKCPA symposium will be published in 7 December 2001 Journal.

Back to Top