§ Mr. Ashley
asked the Secretary of State for Social Services (1) if he will specify the drugs for which adverse reactions are notified; and how many have been notified for each in the last 10 years;
(2) what is the latest estimate of the Committee on Safety of Medicines of the percentage of adverse reactions which are represented by reports obtained through the yellow card system;
(3) if he will list the number of adverse reactions reported by doctors using the yellow card system for each year since it was set up;
(4) if he will list the drugs for which yellow warning notices have been issued stating whether, in each case, the first indications of the need for caution came from the yellow card system or other sources;
(5 if he will seek to introduce legislation requiring the mandatory reporting by doctors of all adverse reactions to drugs;
(6) what progress has been made with existing schemes for monitoring adverse reactions to drugs; and if he will make a statement;
(7) what steps he has taken to improve reporting of adverse reactions to drugs.
§ Sir George Young
Between January 1970 and 4 March 1980, 65,268 reports of suspected adverse reactions were received by the Committee on Safety of Medicines and its predecessor from all sources, including 47,484 through the yellow card system. These reports related to 1,777 medicinal products and it would be disproportionately costly to list the 503W products and numbers of reports received on each for each of the last 10 years. The number of reports received through the yellow card system in each year since its inception was:
1963 9 1964 1,073 1965 3,425 1966 1,936 1967 2,848 1968 2,750 1969 3,411 1970 2,824 1971 2,218 1972 3,087 1973 2,729 1974 3,288 1975 3,275 1976 4,929 1977 8,424 1978 8,488 1979 7,662 1980 (to 4 March) 560
It has been estimated that yellow card reports represent an average of about 10 per cent of suspected adverse reactions to a drug. This average, however, probably conceals a very wide variation between individual drugs.
Yellow warning notices issued by the Committee on Safety of Medicines may relate to a single drug or to a group of drugs. These are normally issued as a result of both reports on yellow cards and reports from other sources. The following notices have been issued:February 1964—Monoamine Oxidase InhibitorsAugust 1965—(1) Some anti-arthritic drugs (ie Phenylbutazone, Oxyphenbutazone, Nifenazone and Indomethacin) and(2) Mefenamic Acid (an analgesic)January 1967—ChloramphenicolJune 1967—(1) Bronchodilating Drugs for the treatment of asthma;(2) VaccinesSeptember 1967—Psychotropic DrugsMay 1967—Sequential Oral ContraceptivesDecember 1969—Oral Contraceptive containing OestrogensJune 1973—Erythromycin EstolateJanuary 1975—PractololFebruary 1975—PrazosinJune 1975 and November 1977—Hormonal Pregnancy TestsMay 1977—NeomycinJuly 1977—Perhexiline MaleateJune 1979—Antibiotic induced colitis
As my hon. Friend indicated in his reply to the right hon. Member on 27 February, he hopes to make a statement in the near future about procedures for reporting and monitoring of adverse reactions to drugs.—[Vol. 979, c. 600–1.] 504W There are no plans to require the mandatory reporting of adverse reactions to drugs.
§ 8. Mr. Ashley
asked the Secretary of State for Social Services what is the annual number of drug-induced hospital cases including in and out-patients.
§ Sir George Young
I regret that information is not available in the precise form requested. It is estimated that in England in 1977, the latest year for which figures are available, 100,070 patients were discharged from or died in non-psychiatric hospitals due to the "adverse effects of medicinal agents" and 370 patients due to drug dependency. In the same year it is estimated that 1,444 patients were admitted to mental illness hospitals and units with a primary diagnosis of drug dependence. Similar information on out-patients is not available centrally.