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Drugs (Adverse Reactions)

Volume 981: debated on Wednesday 19 March 1980

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asked the Secretary of State for Social Services if he will list the schemes that have been proposed by the Committee on Safety of Medicines to detect adverse reaction to drugs by post-marketing surveillance, giving the dates at which they were proposed; if he will list the official bodies with whom the schemes have been discussed; and if he will make a statement on the progress of each scheme and on the present position.

asked the Secretary of State for Social Services if the total use of drugs is so extensive that their adverse effects present a major health problem; and if he is satisfied with the amount of money and facilities used to gain an understanding of the dangers of treatment.

Accurate figures are not available for the total incidence of morbidity as a result of adverse effects of licensed drugs in the United Kingdom. It is, however, clear from surveys that have been conducted that the benefits of modern drugs used in accordance with the terms of the licence far outweigh the risks associated with their use.Substantial resources are devoted to ensuring that as much as possible is known about new drugs before they are licensed, though improvements are desirable in the procedures for monitoring the effects of drugs on patients thereafter.

asked the Secretary of State for Social Services to what extent drug companies insert patient information leaflets into their drug packaging; if the Department of Health and Social Security is encouraging such action; and if it will consider making it mandatory.

Although statistics are not available, it is clear that only a comparatively small number of packaged medicinal products contain patient information leaflets.Whilst I approve of the provision of such leaflets I have no plans to make it compulsory.

asked the Secretary of State for Social Services if the Committee on Safety of Medicines passes on to doctors none, some or all of the information it receives concerning adverse reactions to drugs, prior to the issue, where appropriate, of a yellow warning notice.

Information about reports of suspected adverse reactions received by the Committee on Safety of Medicines is not routinely sent to doctors. However, information about individual drugs or groups of drugs is available on request and doctors submitting adverse reaction reports are normally offered further information about the drugs on which they have reported. Copies of the register of adverse reactions compiled from reports have been issued to medical schools. post-graduate medical centres, regional and area pharmaceutical officers and hospital principal pharmacists; the last such issue was in 1977.