Dáil Éireann díospóireacht -
Tuesday, 30 Jan 2001

Vol. 529 No. 1

Written Answers. - Drug Treatment Services.

Denis Naughten

Ceist:

537 Mr. Naughten asked the Minister for Health and Children the explanation for the contradiction in the figures supplied in replies to Parliamentary Question No. 177 of 20 June 2000, No. 136 of 28 June 2000 and No. 134 of 18 October 2000; if he will amend any of these replies; and the action he will take to resolve the variation in the figures supplied. [1101/01]

Denis Naughten

Ceist:

538 Mr. Naughten asked the Minister for Health and Children if he will explain the variation in figures supplied by the Irish Medicines Board in replies to Parliamentary Question No. 177 of 20 June 2000 and No. 134 of 18 October 2000; and if he will make a statement on the matter. [1102/01]

Minister for Health and Children (Mr. Martin)

I propose to take Questions Nos. 537 and 538 together.

The information given in my reply to Parliamentary Question No. 136 of 28 June 2000 was in respect of the number of adverse reactions to Trivax vaccine recorded by each health board in the years 1972 to 1996, in so far as it was available at the time.

With regard to Parliamentary Question No. 177 of 20 June and No. 134 of 18 October 2000, the information given in my replies was based on information provided by the Irish Medicines Board, IMB. The 91 suspected adverse drug reaction reports referred to in Parliamentary Question No. 134 is the overall number of reports received by the IMB whereas the information given in Parliamentary Question No. 177 refers to the individual suspected reactions recorded.

Adverse drug reaction reports may include more than one suspected adverse reaction. On receipt of the Deputy's question my Department sought clarification from the IMB. The IMB has indicated that there were 198 reactions specified in respect of the 91 adverse reaction reports it received. This updates the figure of 120 reactions referred to in Parliamentary Question No. 177. The Deputy will be aware that there was some delay in compiling the information given in my reply to Parliamentary Question No. 134 as the IMB had to obtain the original records from the archives in order to ensure that the information provided was as complete and comprehensive as possible. The IMB has indicated that this reflects the most complete information available to it. I hope I have clarified the situation for the Deputy and I apologise for any confusion which my earlier replies may have caused.

It is important to recognise that the pharmacovigilance monitoring system may only receive limited information about suspected adverse reactions, as it is dependent on the level of information supplied by the health professional making the report and the timeliness with which the report is submitted. In some instances the reports are made quite some time after the administration of the product. The making of reports under the system does not establish a causal link between administration of the product and the reported symptoms or illness.