Nicholas Brown – 2014 Parliamentary Question to the Department of Health

The below Parliamentary question was asked by Nicholas Brown on 2014-06-05.

To ask the Secretary of State for Health, what steps his Department takes to record and identify instances where non-pharmacological treatments have caused adverse reactions in patients.

Norman Lamb

Reports of suspected adverse drug reactions (ADRs) are collected by the Medicines and Healthcare products Regulatory Agency (MHRA) and Commission for Human Medicines through the spontaneous reporting scheme; the Yellow Card Scheme. The scheme has been in place since 1964 and collects ADR reports from across the whole United Kingdom and includes all medicines, including non-pharmacological treatments such as herbal and homeopathic medicines.

Reports are received from healthcare professionals and members of the public on a voluntary basis. However there is a legal requirement for pharmaceutical companies to report suspected ADRs to their products. The MHRA receives approximately 30,000 ADR reports per year. All reports received are rapidly entered onto the MHRA’s ADR database for assessment by a team of medical, pharmaceutical and scientific assessors. The purpose of the scheme is to provide an early warning that the safety of a product may require further investigation and the scheme has a proven track record of identifying safety issues.

National Health Service organisations will also record details of adverse incidents in local risk management systems and other datasets such as the Hospital Episodes Statistics datasets. Many of these systems rely on accurate coding to enable data extract and analysis, and codes specific to non pharmacological treatments may not always be available.