§ Sir Michael McNair-WilsonTo ask the Secretary of State for Health whether his Department monitors the number of persons who show serious side-effects after a long period of drug therapy; and what action is taken both in informing manufacturers and advising the medical profession.
§ Mrs. Virginia BottomleyThe Committee on Safety of Medicines (CSM) carefully monitors all issues of drug safety. Suspected adverse reactions to medical products are reported on a voluntary basis by doctors and dentists under the yellow card scheme, and there is a statutory requirement for pharmaceutical companies to submit reports. This applies to patients receiving treatment over short and long periods. The CSM recommends that manufacturers carry out post marketing surveillance studies for new drugs likely to be used for widespread long-term use, in order to identify any side-effects associated with treatment. In addition the CSM closely monitors worldwide epidemiological studies investigating the long-term effects of medicines.
Information on potential problems is sent regularly to all prescribers by means of CSM's "Current Problems" bulletin; in the case of major drug safety hazards the professions are alerted by means of a letter from the chairman. Drug prescribing information and guidance is also available from a number of other sources, for example the British National Formulary, which the Department issues free to all doctors twice yearly.
The pharmaceutical industry is regularly supplied with information on adverse reactions received by the CSM. In addition it is involved in receiving and providing information in relation to drug safety problems for its licensed products.