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Dept of Health

Answer

Mr. Burstow: To ask the Secretary of State for Health what plans he has to introduce a system of learning from the yellow card system about the correct dosage and prescribing methods for medicines for children. [194259] Ms Rosie Winterton: The yellow card scheme is not designed to enable lessons to be drawn about correct dosage or prescribing methods for medicines for children. There are no plans to introduce a system of learning in this context. Reports of suspected adverse drug reactions (ADRs) are held on a purpose designed computer database known as the adverse drug reactions on-line information tracking (ADROIT) database, which was introduced in 1991. Data held on ADROIT is dynamic and may be subject to change. The Committee on Safety of Medicines/Medicines and Healthcare products Regulatory Agency (CSM/ MHRA) request that all suspected ADRs which occur in children are reported, regardless of whether the medicine is licensed for use in children. This is because the nature and course of illness and ADRs may differ between adults and children. In general, children are not exposed to medicines in clinical trials, many drugs which are routinely used to treat children are not licensed for use in this age group. It is therefore particularly important to focus on the safety of medicines in children. We are interested in any side effects of medicines as used in clinical practice, regardless of whether they are being used according to the terms of the licence, as described in the product information. It is important that we are aware of side effects which arise when medicines are used "off label", so that we can act to warn health professionals if necessary. However, the treatment of individual patients remains the responsibility of the doctor.

Secondary information

Type

Written question

Reference

194259; 426 c319W

Session

2003-04

Subjects

Children Databases Drugs Prescription drugs Prescriptions Side effects Yellow card scheme

Link

View this Written question on www.publications.parliament.uk