Crookes Healthcare Ltd is considering applying for a POM-to-P switch for flurbiprofen
8.75mg lozenges (Strefen) which are used to treat sore throat. The company recently
completed a small study to find out whether it was possible to collect safety
data from a pharmacy base to support an over-the-counter switch application
and what methodology would be required.
Dr Ian Gibb (clinical research associate, Boots Healthcare International) told
The Journal on October 23 that he had concluded that it was possible to conduct
pharmacy-based trials within the British ethical and legal framework and that
the necessary data could be gathered. The next step would be to conduct a full
population risk trial with a view to a POM-to-P switch.
He said: “The vision we started out with was that the patient would have
to have the condition [sore throat] and, as with any OTC medicine, there would
have to be an element of decision on whether to treat themselves.”
This meant that people would be given information on Strefen in the form of
the proposed OTC labelling and pack insert. After the patient had decided to
use the product, a pharmacist would corroborate the decision and take a medical
history. Details would be sent to the trial’s supervising medical practitioner
who would authorise supply. No prescription would be needed because the trial
would be carried out under a clinical trial exemption certificate. Participants
would be interviewed by telephone after treatment to collect data on use and
adverse events.