§ Mr. Ashleyasked the Secretary of State for Social Services (1) what information his Department requires doctors to provide in connection with adverse reactions to drugs either to his Department or to the monitoring bodies;
(2) how many times in each year doctors have been reminded of the importance of reporting adverse reactions since the yellow card system was established; what form the reminder takes; and if there is any evidence as to its effectiveness;
(3) what proportion of the information on adverse reactions to drugs received by the Committee on Safety of Medicines is derived from the yellow card system of reporting;
(4) what is his estimate of the percentage of the reported incidence of adverse 285W reactions to drugs provided by pharmaceutical companies compared with the true incidence.
§ Dr. VaughanDoctors are not "required" to provide information on adverse reactions to drugs, They are, however, encouraged to report suspected adverse reactions voluntarily through the "yellow card" system to the Committee on Safety of Medicines. Yellow card reports include the following information about each case
Patient's name, sex, age and weight;Drugs used and the indications for which they were prescribed, routes of administration, dose, dates of commencement and termination of treatment with each;Suspeted reactions noted, the dates they began and ended, and the outcome;Any additional notes;Particulars of the reporting doctor.It is estimated that about 10 per cent. of total adverse reactions to drugs are reported to the Committee on Safety of Medicines. About 70 per cent. are received through the yellow card system and about 20 per cent. from pharmaceutical companies, the remainder from publications in the literature and other sources. It is not possible to produce any very reliable estimates of reports from the industry as a percentage of total actual reactions from these figures.
Since 1963, when the yellow card system was established, doctors have been reminded by letters issued in 1964, 1965, 1972 and 1973 of the importance of reporting suspected adverse reactions. Additionally, reminders were included in yellow warning leaflets sent to all doctors in 1965 and 1968. A reminder has also been printed at the back of every prescription pad since July 1976 and in the "Blue Book" of forms used by general practitioners published by "Pulse" Magazine in October 1979. Reminders issued in these ways appear to result in an increase in the reports received from doctors and the number of reports received has increased significantly since 1963.
§ Mr. Ashleyasked 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 286W 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.
§ Dr. Vaughan[pursuant to his reply, 19 March 1980]; The schemes which the Committee on Safety of Medicines, at its meeting in December 1979, advised the licensing authority to consider, are known as "Record Linkage" and "Retrospective Assessment of Drug Safety" (RADS). RADS and an earlier, similar scheme have been the subject to wide-ranging consultation during the last two years. The bodies consulted on the current proposals, in June 1979, included the Royal Colleges, the British Medical Association, the British Dental Association, the Pharmaceutical Society and the Association of the British Pharmaceutical Industry. No consultations have yet been held on "record linkage". Consideration is at present being given to the whole issue of post marketing surveillance including the schemes mentioned and I expect to be able to make an announcement in the near future.