DoH and ABPI collaborate to produce medicines shortages advice
Guidelines on how best to manage medicines' shortages have been developed by the Department of Health and the Association of the British Pharmaceutical Industry. “Notification
and management of medicines shortages” represents the first set of recommendations to be drawn
up on tackling medicines shortages.
Companies should communicate early with the DoH about impending shortages,
the guidelines say. “This early exchange of information will enable
the DoH and the industry to work together to explore the options for
managing the shortage and will allow time to make contingency arrangements
where necessary,” Andy Burnham, Minister of State for Delivery
and Quality, and Nigel Brooksby, president of the ABPI say in the foreword.
The document suggests that each company should nominate a senior member
of staff as a contact point for supply issues and develop internal written
procedures for avoiding, identifying and dealing with product shortages,
and for communicating with the DoH and the NHS Purchasing and Supply
Agency about them. To assist this communication, a pro-forma has also
developed for companies to use to notify the DoH and NHS PASA of shortages.
The management of shortages demands work from Government as well as from
pharmaceutical companies. For instance, the DoH will, the guidelines
say, inform companies if it becomes aware of supply problems relating
to their products that may have an impact on patient care. In addition,
the DoH, the NHS PASA, and the Medicines and Healthcare products Regulatory
Agency can assist this process by expediting regulatory procedures for
products deemed critical, providing information to help companies manage
supplies of existing stocks, identifying sources of products from abroad
and expediting their import, identifying NHS manufacturing units capable
of meeting demand and facilitating communication with the NHS. |