Written Answers. - Immunisation Programmes.
Micheál Martin
Question:
25
Mr. Martin
asked the
Minister for Health
the steps, if any, he will take to ensure that a mandatory reporting scheme is introduced for doctors and other health professionals in relation to the reporting of adverse reactions to immunisation programmes; and if he will make a statement on the matter.
[17155/96]
Micheál Martin
Question:
26
Mr. Martin
asked the
Minister for Health
if he will ensure that a comprehensive data base relating to the operation of immunisation programmes is compiled; the current position in this regard; and if he will make a statement on the matter.
[17156/96]
Micheál Martin
Question:
27
Mr. Martin
asked the
Minister for Health
if he has satisfied himself with the ongoing surveillance of the Hib vaccine in Ireland; if he will outline in detail the monitoring procedures of newly authorised vaccines; and if he will make a statement on the matter.
[17157/96]
I propose to take Questions Nos. 25, 26 and 27 together.
The Irish Medicines Board operates a reporting scheme for doctors and other health professionals. This involves a free post "yellow card" system and is similar to the systems in many other EU member states. The board requests doctors to report all adverse drug reactions. It is a condition of product licensing that drug companies must report all suspected adverse drug reactions to the Irish Medicines Board. The board produces an annual report of side effects which gives anonymised data on all suspected adverse drug reactions reported to the board and doctors are regularly reminded of the methods of reporting. In addition, within the last year, the board has initiated a system of drug safety newsletters which are sent to doctors on a regular basis highlighting recent relevant safety issues.
I would also like to point out that the contract between health boards and general practitioners for the delivery of the primary childhood immunisation programme requires general practitioners to report suspected adverse reactions to the Irish Medicines Board and to the health board.
The Irish Medicines Board has a system of "monitored release" or intensive surveillance of newly authorised products which can be imposed as a condition of the product authorisation. However, in the case of Hib vaccine currently in use in Ireland, the board received, as part of the authorisation application, extensive data both on safety and efficacy of its use over many years. The data came from both Europe and the USA. It was on the basis of these data, submitted by the applicant, that the safety profile contained in the product authorisation documents was drawn up and completed.
I am satisfied with the procedures already in place for the monitoring and reporting of adverse reactions and I do not have any proposals at this stage to introduce a mandatory reporting scheme.
As regards the data base on the operation of immunisation programmes, I am pleased to inform the Deputy that health boards are currently developing systems which will ensure that comprehensive information will be available regarding uptake levels, etc.
