Hospital Pharmacist
Vol 9 No 8 p215
September 2002

News summary

Related websites
Medicines Control Agency (www.mca.gov.uk)

Pharmacists could be allowed to make copies of patient information leaflets

The Medicines Control Agency has proposed that pharmacists should be able to copy or download patient information leaflets (PILs) without being liable for breach of copyright.

European rules require pharmaceutical products to be packaged with an approved PIL, and United Kingdom laws require that medicines should be supplied with such leaflets. However, pharmacy staff in hospitals sometimes have to dispense from bulk packs and therefore may not always be able to supply a PIL with each dispensed item.

The MCA, in a consultation letter issued on 1 August, suggested that pharmacists could be allowed to photocopy PILs or to download them from an approved website such as the Electronic Medicines Compendium (www.emc.vhn.net). The MCA is proposing that a new statutory defence against breach of copyright when leaflets are copied in this way should be established.

Darren Leech, vice president of the Association of Pharmacy Technicians UK, stated: "The association supports the MCA proposal, as it would allow the profession to meet the legal requirements relating to PILs and also increase patient access to bona fide information about medicines." Mr Leech, however, stressed that there was still a need for pharmacy staff to interpret and communicate the contents of PILs to patients.

On the other hand, David Miller, chief pharmacist, City Hospitals Sunderland NHS Trust, said that implementation of the proposal would be a "bureaucratic nightmare." He maintained that the only way forward was for the Government to implement the original pack dispensing initiative.

The consultation document "Provision of patient information with dispensed medicines: guidance note" is reviewed in this issue of Hospital Pharmacist (p248).

Back to Top