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Register Of Adverse Reactions

Volume 982: debated on Tuesday 15 April 1980

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asked the Secretary of State for Social Services (1) when a new issue of the Register of Adverse Re actions was published; on average, how many copies are circulated; and what would be the cost of circulating it to all general practitioners;(2) pursuant to his reply of 11 March to the right hon. Member for Stoke-on-Trent, South, how many of the 1,777 medicinal products, about which 65,268 reports of suspected adverse reactions were received between January 1970 and 4 March, were, (a) cleared of suspicion of causing adverse reactions, (b) had their product licences withdrawn or (c) were voluntarily withdrawn from the market by the manufacturer respectively;(3) what is his estimate of the cost of sending annually to all medical practitioners a list of all the medical products for which the Committee on Safety of Medicines receives a suspected adverse reaction report for the first time during the preceding 12 months;(4) for each of the last five years, how many yellow cards received by the Committee on Safety of Medicines referred to medicinal products about which the committee had not previously received any reports of adverse reactions;(5) pursuant to his reply of 11 March to the right hon. Member for Stoke-on-Trent, South, for each of the 14 drugs or groups of drugs for which yellow warning notices have been issued, whether the first reports of suspected adverse reactions came from, (a) the yellow card system, (b) the manufacturing company or (c) other sources.

When reports of suspected adverse reactions are received in respect of individual patients, they are scrutinised by the professional secretariat of the Committee on Safety of Medicines (CSM) and, where appropriate, are referred to locally based medical officers for follow-up with the doctor who submitted the report. The professional secretariat then considers whether to draw the individual reports, together with any previous ones, to the attention of the CSM's sub-committee on adverse reactions; if not, the reports will none the less be included in the cumulative record which is referred to the sub-committee at each meeting, each member scrutinising a section in depth. The question which most usually concerns the CSM and the sub-committee is whether the suspected adverse reactions are of a nature and frequency to justify further investigations or action in respect of the product—for example, restricting its availability, requiring warnings to be inserted in the product literature; it is not generally a question of formally clearing a product of suspicion of causing adverse reactions.Revocation of a licence has seldom been found necessary when action to remove a product from the market has been indicated. More usually the licence holder co-operates by withdrawing it before that stage is reached. It would not be practicable, to check all voluntary withdrawals against the Adverse Reaction Register to determine the relationship between reports and withdrawals.The CSM's sub-committee is, as stated above, regularly provided with a summary of reports of all suspected adverse reactions. This includes a statement of the number of reports received by drug and suspected adverse reaction, for each of the previous five years and for the current year to date, which enables the sub-committee to evaluate recent reports against the pattern of earlier years. It is the cumulative or developing picture which is most likely to reveal the need for some action, and the register would inevitably be less helpful and informative to general practitioners and others making only occasional reference to it. It is mainly for this reason that it is not thought practicable to issue it, or annual lists of newly-reported suspected reactions, to all general practitioners on a personal basis.The seven-volume register was last issued to medical schools, postgraduate medical centres, etc., in 1977. The total number of copies issued was 2,300. The cost of distributing copies to all general practitioners would probably be in the region of £500,000. The cost of issuing an annual list has not been estimated for the reasons mentioned but would clearly be substantial. I have no knowledge of any representative medical association ever suggesting that personal copies of the register or lists should be issued.As well as referring to the points where copies of the register are held, doctors are also at liberty to make enquiries of the CSM's secretariat. In addition, medical libraries generally hold copies of publications on the side effects of drugs, based on worldwide literature searches and careful, critical examination of these reports.For each of the 14 groups of drugs for which yellow warning notices have been issued, the suspected reaction was mentioned in the medical literature before yellow cards gave adequate indication of hazard but thereafter the yellow card system provided valuable confirmatory data. Moreover, of the products referred to in "Current Problems", in seven out of 22 the CSM's reference preceded any known reference in the medical literature.