§ Mr. Ashleyasked the Secretary of State for Social Services in what way, and to what extent, his Department checks the warnings given by drug manufacturers about the risk of adverse reactions.
§ Mr. NewtonAny medicinal product which is promoted to doctors must be accompanied by a data sheet, which must be consistent with the product licence and must include an accurate account of the uses of the drug and its contra-indications and warnings. Data sheets submitted with licence applications are scrutinised to ensure that they reflect the data supporting the application.
The Committee on Safety of Medicines promote and monitor the reporting of adverse drug reactions. The adverse reactions group of CSM's sub-committee on safety (ARGOS), operates a prospective monitoring scheme to look every month at recently reported adverse reactions to selected new drugs. In addition, a team of doctors in the Department with appropriate experience carries out a fortnightly surveillance of all recently-received individual patient reports. The international published literature on adverse drug reactions is scrutinised by the Department and by ARGOS. The aim in each case is to identify new or increased hazards. As fresh information about adverse reactions becomes apparent officers of the Department may discuss revisions to the data sheet with the licence holder, or the CSM may advise the licensing authority on courses of action including measures to secure compulsory variation of a data sheet.
§ Mr. Ashleyasked the Secretary of State for Social Services what severity of reaction is understood by his Department to be indicated where a pharmaceutical company warns of a mild adverse reaction; and whether such a reaction is understood to include photosensitivity;
§ Mr. NewtonIn the medical sense, mild carries the same connotations as in lay usage. It specifically excludes all reactions which are fatal, life-threatening, disabling, incapacitating or which result in or prolong hospitalisation. Photosensitivity can be mild, moderate or severe.
§ Mr. Ashleyasked the Secretary of State for Social Services what approximate period of time is understood by his Department to be referred to where a pharmaceutical company warns of a transient adverse reaction in connection with a drug.
§ Mr. NewtonIn the medical sense, transient carries the same connotations as in lay usage. However, the significance of a transient reaction can be considered only in relationship to the drug and reaction in question.