Virendra Sharma (Ealing, Southall, Labour)
To ask the Secretary of State for Health
(1) whether manufacturers have a responsibility to notify his Department of potential drug shortages; and what steps his Department takes to inform pharmacists and physicians of potential shortages;
(2) what steps his Department is taking to tackle shortages of (a) paediatric and (b) other tuberculosis drugs; and what steps it is taking to ensure that drug shortages do not occur in the future.
Simon Burns (Minister of State (Health), Health; Chelmsford, Conservative)
The Department and the pharmaceutical industry have published joint best practice guidelines, “Notification and Management of Medicines Shortages”, a copy of which has already been placed in the Library. These recommend that companies communicate with the Department as soon as possible about impending shortages that are likely to have an impact on patient care, so that the options for mitigating and managing the shortage can be explored. Marketing Authorisation Holders also have a statutory duty to inform the Medicines and Healthcare products Regulatory Agency if a product is not going to be available either temporarily or permanently. The Department expects companies to communicate directly with pharmacists and physicians where there is an interruption to the supply of a medicine.
Although there have previously been occasional shortages of tuberculosis (TB) medicines, we are not aware of any current national shortages or of patients being adversely affected. The Department is working with, a group of national health service experts to investigate what can be done to improve security of supply of TB medicines for children and others.