§ Mr. Ashley
asked the Secretary of State for Social Services (1) what steps he proposes to take to establish a watchdog organisation to check on any inadequacies of drug monitoring;
(2) what steps he proposes to take to ensure the close involvement of patients in the checking of adverse reactions to drugs;
(3) if he will outline in the Official Report the latest proposed scheme for checking adverse reactions to drugs such as Eraldin (Practolol); and if he will give his views of the proposed scheme.
§ Dr. Vaughan
The Committee on Safety of Medicines, an independent body of experts, is responsible for promoting the collection and investigation of information relating to adverse reactions to drugs, and I see no need to establish an additional body.
It is currently in consultation with the appropriate professional organisations and the industry on proposals for the improved post-marketing surveillance of drugs to complement its present system of voluntary reporting by doctors of suspected adverse reactions to drugs. The Committee proposes that doctors would be asked to provide details of all significant clinical events occurring to a sample of monitored patients in the hope that analysis of the case histories would provide early recognition of any adverse reactions.
In the light of these proposed improvements and the difficulty a patient has in distinguishing between an adverse reaction to a drug and a spontaneously-occurring illness. I do not think it would be helpful to involve patients more directly in the monitoring of suspected adverse reactions.