From Mr J. Morris, MRPharmS
SIR,-Since the coming into force of the Marketing Authorisation Regulations on January 1, 1999, pharmacists have been legally required to provide a manufacturer's patient information leaflet (PIL) each time a medicine is dispensed or sold.
This directive, enforced by the Medicines Control Agency (MCA), is intended to keep patients/consumers fully informed on the safe and effective use of medicines. However, despite my best efforts as an advocate of such measures, I have experienced considerable difficulty in adhering to the regulations.
Most manufacturers trade only partially in patient packs so there is the immediate difficulty of leaflet availability for those items dispensed from bulk packs. If additional leaflets are to be requested from the wholesaler/ manufacturer I must contact the appropriate manufacturer's medical information departments with my "order", and, after a delay of anything between two to 10 working days, will receive a limited quantity. If only I had a photocopier or free facsimile paper.
On top of this, there is the endless task of sorting, organising, and storing additional leaflets in such a way that the most recently revised and appropriate copies are held in stock.
Unsure of what to do with regard to monitored dosage systems for local nursing homes or clients holding FP10(MDA) with multiple daily instalments. I contacted the MCA in the hope that here would be some concessions. No there would not. Each dispensing must be accompanied with a PIL. This means some of my clients will receive up to 28 copies of the same leaflet against one form.
I would be glad to read of other pharmacists' approaches to the PIL problem and would appreciate a statement further to that published (PJ, March 11, p401) as to the penalties for pharmacists who fail to meet the standards set out in the directive.
Joseph Morris
Leeds