HC Deb 25 March 2004 vol 419 cc1059-60W
Tim Loughton

To ask the Secretary of State for Health how the information from the Yellow Card system is used by the Medicines and Healthcare Products Regulatory Agency. [162489]

Miss Melanie Johnson

The Committee on Safety of Medicines (CSM) and the Medicines and Healthcare products Regulatory Agency (MHRA) are responsible for monitoring the safety of medicines in the United Kingdom. Reports of suspected adverse drug reactions (ADRs) submitted by health professionals through the Yellow Card scheme are an important source of information regarding the safety of medicines in normal clinical practice.

The table shows the count of finished admission episodes for national health service hospitals in London over the last five years where the primary diagnosis is malnutrition and the age of admission was 65 plus. Data is available only by health authority of residence.

The Yellow Card scheme primarily acts as an early warning system for the identification of previously unrecognised adverse reactions and also provides valuable information on recognised adverse drug reactions, allowing the MHRA/CSM to identify and refine the understanding of risk factors that may affect the clinical management of patients. The value of the scheme has been demonstrated many times and it has helped to identify numerous important safety issues. To date the MHRA/CSM has received more than 450,000 ADRs reports from the Yellow Card scheme.

In evaluating a possible drug safety issue, the Yellow Card data is typically considered in conjunction with relevant information from other sources such as clinical trial data, published studies, adverse drug reaction reports received from the pharmaceutical industry and data from other Regulatory Authorities.

Where necessary, to protect public health, the MHRA on the advice of CSM may take regulatory action to ensure the medicine is used in a way which minimises risk and maximises benefits to the patient. Possible actions include addition of a new side effect to the product information provided to prescribers and patients, and issuing warnings about groups of patients who should not be given the medicine. In rare circumstances, the MHRA may withdraw a medicine from the market, if the risks of a medicine in clinical use are greater than its potential benefits.

Information on adverse drug reactions is communicated to health professionals and patients by the MHRA/CSM through various routes including patient information leaflets and regular safety bulletins.

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