The UK Department of Health, the Association of British
Pharmaceutical Industry, and the British Generic Manufacturers
Association have produced joint guidelines which aim to ensure
that any unavoidable shortages in the medicines supply in England are handled in a “more collaborative” way.
“Thanks to the hard work of manufacturers, wholesalers and pharmacists, minor shortages often go unnoticed by patients and clinicians. We hope that these guidelines will help to minimise the impact of the occasional incidences that do affect patients,” said Health Minister Andy Burnham.
The guidelines call for companies to communicate with the DH as soon as possible about impending shortages that are likely to have an impact on patient care, to enable the Department and industry to work together and make contingency arrangements where necessary.
Other key recommendations are for: a designated person to deal with supply issues within companies; a designated person at the DH to deal with supply issues; each company developing its own written procedures; and companies warning the DH if they anticipate a product shortage that is likely to impact on patient care.
“Rare and unforeseen circumstances, such as raw material shortages or factory equipment failures, occasionally have the potential to disrupt the manufacture and supply of medicines. This guidance has been produced to formalise best practice and to ensure that all in the
supply chain can work together to ensure that patients continue to
receive appropriate treatments,” said Nigel Brooksby, president of the
Warwick Smith, Director of the BGMA, added that the guidelines “also
underscore the existing close cooperation between the BGMA and the
Department of Health to ensure that the industry can provide needed
healthcare at a cost that keeps the drugs bill affordable.”
To read the Best Practice Guidelines - Notification and management of
medicines shortages visit the DH website at http://www.dh.gov.uk