An occasional feature, prepared in the Royal Pharmaceutical Society's Professional Standards Directorate, to highlight problems and inquiries currently being handled
Pharmacists are reminded that since the coming into force of the Marketing Authorisation Regulations on January 1, 1999, there has been a legal requirement to provide a manufacturer's patient information leaflet each time a medicine is sold or dispensed. If a leaflet is not supplied, then an offence is committed under the regulations.
The Royal Pharmaceutical Society's Professional Standards Directorate is aware that at present there is considerable variation in the availability of patient information leaflets with manufacturers' packs. The principal reason for supplying a leaflet is to ensure all the information required for safe and effective use of the medicine is conveyed to the patient. Therefore, where insufficient leaflets have been supplied, pharmacists must use their best endeavours to obtain extra supplies.
Before producing their own leaflets, pharmacists should exercise caution to ensure that they do not contravene the Medicines Advertising Regulations.
So far as the hospital setting is concerned, the Department of Health has stated that it is not necessary to provide a leaflet in the packaging of dispensed products for inpatient use. However, leaflets should be kept in the pharmacy or on the ward and be accessible to prescribers and patients should they wish to consult them. For outpatients a leaflet should be provided in each instance.