Today, the Department has issued joint guidelines with the Association of British Pharmaceutical Industry (ABPI) and British Generic Manufacturers Association (BGMA). These guidelines will give guidance to companies on how to communicate and manage potential shortages of a particular medicine and will mean better and more effective working between the Government and industry in this area.
Shortages of medicines are caused by a number of factors:
manufacturing problems;
supply and demand imbalance;
raw material problems; and
regulatory problems.
When there is a shortage of a particular medicine, this new guidance will encourage companies to give early notice to the Department in cases that patient care will be adversely affected. This will enable a contingency plan to be formed and will give time for alternative suppliers or medicines to be found when possible or for options to be found for managing the shortage. This will help reduce the effect of any shortage on the National Health Service and patient care.
These guidelines follow the successful guidelines between Government and the ABPI on the discontinuation of medicines. Those guidelines have meant that on several occasions, the effect of discontinuations on patients has been minimised.
The new guidelines have been placed in the Library and are available on the Department’s website at: www.dh.gov.uk/medicinesupply.