Dáil Éireann - Volume 540 - 04 July, 2001

Written Answers. - Adverse Vaccine Reactions.

183. Mr. Naughten asked the Minister for Health and Children the actions he has taken to resolve the difference between adverse reactions reported to the National Drugs Advisory Board in 1973 and those reported to a foundation (details supplied) by the Eastern Health Board with regard to a vaccine; and if he will make a statement on the matter. [20394/01]

Minister for Health and Children (Mr. Martin): I have made inquiries of the Irish Medicines Board about this matter. It has indicated that arrangements for the reporting of suspected adverse reactions to medicinal products began in 1968 and that, in the early years of this system, the level of reporting was relatively low in general. In the case of Trivax, four suspected adverse reactions to it were reported to the National Drugs Advisory Board, the predecessor of the IMB, in 1972 and 1973.

In 1972/3 the Eastern Health Board recorded 100 suspected adverse reactions to Trivax. These were the subject of correspondence with Wellcome and were jointly investigated by the EHB and the company.

The Eastern Regional Health Authority has not succeeded in tracing any records in relation to whether these suspected adverse reactions were notified to the NDAB. The IMB has no record of having received reports from the health board about these cases. It should be noted that while there were no formal procedures-guidelines in place for reporting of suspected adverse reactions by companies at that time, there was an informal agreement with companies to periodically provide the NDAB with information on suspected adverse reactions. This is among a number of issues which the IMB has recently raised with the GlaxoSmithKline. The company's response is at present awaited by the IMB.

As regards present-day arrangements for reporting of adverse reactions, one of the conditions of the product authorisations granted by the IMB, in respect of medicinal products being placed on the market here, is that the authorisation holder shall furnish to the board a copy of any report of adverse reactions associated with the use of the preparation to which the authorisation relates of which he has a record or of which he is aware. In addition, reports of suspected adverse drug reactions are received on a voluntary basis from healthcare professionals.

Report details are included by the IMB on a [665] computerised database to facilitate processing and evaluation of reports.