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Medical Treatments: Safety

Question for Department of Health and Social Care

UIN 132337, tabled on 13 March 2018

To ask the Secretary of State for Health and Social Care, what the reasons are for the yellow card system for reporting medical harms not including psycho-social therapies including (a) graded exercise and (b) cognitive behaviour therapy.

Answered on

21 March 2018

The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion within the United Kingdom. The MHRA runs the Yellow Card Scheme on behalf of the Commission on Human Medicines.

The Yellow Card Scheme is the UK system for collecting and monitoring information on suspected Adverse Drug Reactions (ADRs). The Yellow Card scheme was introduced in 1964 with the aim of collecting suspected ADR reports from the whole of the United Kingdom in relation to all medicines and vaccines. In addition to the collection of suspected ADR reports for medicines and vaccines, the remit of the Yellow Card Scheme also covers the collection of suspected adverse incidents related to medical devices.

As cognitive behaviour therapy and graded exercise therapy are both non-pharmaceutical or medical device treatments, they do not fall under the remit of the MHRA or the Yellow Card Scheme. Therefore, any harms associated with them would not be reported to the Yellow Card Scheme.

Answered by

Department of Health and Social Care