Dáil Éireann debate -
Wednesday, 18 Oct 2000

Vol. 524 No. 3

Written Answers. - Medical Records.

Denis Naughten

Question:

134 Mr. Naughten asked the Minister for Health and Children if, further to Parliamentary Question No. 162 of 15 December 1999 in relation to trivax vaccine records, he is now in a position to respond; his views on whether it is acceptable that a Member of the Oireachtas has to wait ten months for a reply to a parliamentary question; when the reply will be forthcoming; and if he will make a statement on the matter. [22523/00]

Minister for Health and Children (Mr. Martin)

In December 1999 my Department contacted the Irish Medicines Board in relation to the issues raised by the Deputy. A report has now been received from the Irish Medicines Board.

The board has indicated that an extensive examination of the available records has been undertaken. It adds that the preparation of a response required some time to accomplish as original case reports were archived and it was necessary to obtain these in order to compile a response. All original case reports had to be retrieved from the board's archives and manually checked.

In each case where details of the vaccine batch were available, information on the quality of the batch concerned was sought by the board from the relevant pharmaceutical company. However, I am informed that extensive difficulty was encountered in tracking much of the batch quality data as the companies concerned have undergone mergers since the product was first authorised.

In the period 1972 to 1996 the National Drugs Advisory Board – the Irish Medicines Board since 1995 – received 91 adverse drug reaction reports associated with the administration of trivax vaccine. Many involved minor symptoms which resolved spontaneously within a few days. The reporting of suspected adverse reactions does not establish a causal link between the administration of a medicinal product and the reported symptoms or illness in individual cases. Where vaccination is concerned, cases may involve coincidental illness at the time children were vaccinated.

The following tabular statement sets out the information requested, in so far as it is available. The Irish Medicines Board has indicated that the information provided reflects the verbatim data provided in the case reports and it is acknowledged that some of the batch numbers may be incomplete or incorrect. However, given the passage of time since many of the reports were made, it has not been possible to reconcile some apparently incomplete/incorrect batch records.

I regret the delay in providing this information to the Deputy. Given the nature of the information requested and the consequent need to examine records now archived and covering a period of some 25 years, it has taken time to compile this information and provide a response.

Suspected Adverse Reactions associated with the use of

Trivax

Year	Batch No.
1972	Unknown
1972	Unknown
1973	Unknown
1973	Unknown
1975	Unknown
1976	Unknown
1978	Unknown
1978	Unknown
1978	Unknown
1978	Unknown
1980	A99195
1981	Unknown
1982	Unknown
1982	Unknown
1982	52654
1983	Unknown
1983	Unknown
1984	B54898
1984	Unknown
1984	854898
1984	854898
1984	854898
1984	A58049
1985	Unknown
1986	Not stated
1986	A58493
1986	A58946
1987	A0269A
1987	Unknown
1988	Unknown
1988	A0846A
1988	A0846A
1991	Unknown
1991	Unknown
1991	Unknown
1992	Unknown
1992	Unknown
1992	Unknown
1992	Unknown
1992	Unknown
1992	Unknown
1992	Unknown
1992	E444779V
1993	NA2861A
1993	Unknown
1993	AA2861A
1993	DB228A
1993	AA2861A
1993	AA2861A1
1993	Unknown
1994	A4477
1994	E34479A
1994	E34478L
1994	Unknown
1994	E34477H
1994	E34475
1994	E34479B
1994	E34477H
1994	AA2861A
1994	E34477H
1994	E4479U
1994	E34478L
Year	Batch No.
1994	E344774
1994	E34479
1994	F4475
1994	E4479N
1994	E44479V
1994	Unknown
1994	E34437M
1994	A4477
1994	Unknown
1994	A4477
1995	E4479L
1995	E4008N
1995	E4008N
1995	E4008N
1995	E4008N
1995	K0188
1995	E44479
1995	E3447H
1995	E44479V
1995	E4479N
1995	E4479N
1995	E4008N
1995	E44471V
1995	E4408N
1995	Unknown
1995	E34477H
1995	E44479N
1995	308012
1996	E400BN