§ Dr. Twinnasked the Secretary of State for Social Services whether he has received the second report of the Committee on Safety of Medicines working party on adverse reactions.
§ Mr. HayhoeYes. The working party has reviewed the arrangements by which the Committee on Safety of Medicines (CSM) obtains information on the adverse effects of medicinal products and has considered whether any changes are needed in these arrangements.
The working party recommends that for the foreseeable future the CSM should continue to operate its existing voluntary adverse effects reporting procedure, based on the yellow card report form. It also recommends that additional arrangements should be introduced for providing post-marketing surveillance studies on new medicines, particularly those intended for widespread long-term use. The working party has discussed this matter with the Association of the British Pharmaceutical Industry which has advised that pharmaceutical companies would be prepared to agree with the CSM arrangements for mounting such studies. I understand that the committee and the association are to hold formal discussion, on the arrangements governing the studies.
The working party concludes that the CSM may also need to commission studies on specific problems, for example, to obtain data to help in establishing the comparative risks of medicines within the same therapeutic group.
Among its other conclusions, the working party considers that none of the surveillance techniques so far developed offers immediate prospects of improvements in the monitoring of very rare or long-latency adverse drug effects. In the future, schemes which link patients' hospital discharge diagnoses with their prescribing histories might be of value, provided acceptable arrangements for the identification of patients can be developed. It recommends that current research into such record linkage schemes should be continued.
The report has been approved by the Committee on Safety of Medicines. Copies are available in the Library.