Dáil Éireann debate -
Wednesday, 4 Mar 1998

Vol. 488 No. 2

Written Answers. - Recall of Blood Products.

Pat Rabbitte

Question:

92 Mr. Rabbitte asked the Minister for Health and Children if he will make a statement on the withdrawal by the Blood Transfusion Service Board of two blood products for haemophiliacs, in view of the remote risk of CJD; when the Blood Transfusion Service Board first became aware of the problem; when his Department was first informed; the steps, if any, which have been taken to counsel those who received the products; and if he will make a statement on the matter. [5702/98]

Róisín Shortall

Question:

157 Ms Shortall asked the Minister for Health and Children if, in view of the decision by the Blood Transfusion Service Board to withdraw one of its blood products because of the theoretical risk of CJD, he will indicate when this problem was first discovered by the Blood Transfusion Service Board; the reason the blood of the particular donor who carried a specific risk was not screened and eliminated from the blood supply at an earlier stage, particularly in view of public concern about CJD; when he was first made aware of this latest problem with the Blood Transfusion Service Board's products; and the system, if any, which will be put in place to ensure there will be no recurrence of this problem. [6002/98]

Minister for Health and Children (Mr. Cowen)

I propose to take Questions Nos. 92 and 157 together.

I welcome this opportunity to make a statement in relation to two recent recalls of certain blood products by the BTSB. In relation to the first recall of products, the BTSB became aware in December 1997, on foot of a new question included in the donor questionnaire, that a donor had undergone neurosurgery in a Dublin hospital in 1983. Following further investigation as to the nature of the neurosurgery, the BTSB confirmed with the consultant concerned on 3 February 1998 that the donor had received a human dura mater graft. While the donor in question is well and while there is no proven or even probable instance of transmission of CJD by blood, blood components or blood products anywhere in the world, there is international evidence that a very small proportion of recipients of human dura mater grafts may contract classical CJD from such grafts. The BTSB informed my Department of the situation on 4 February 1998.

The BTSB immediately initiated procedures to trace previous donations given by the donor to determine whether any products derived from his donations were still available. This involved an examination of BTSB records and liaison with the pharmaceutical company to which his donations had been sent for processing. It emerged that the donations had been used in the manufacture of specific batches of Factor 8 and Factor 9, which are clotting factor concentrates used to treat people with haemophilia. The BTSB informed the Irish Haemophilia Society of the situation on 10 February 1998, as soon as details of the batches concerned were received from the pharmaceutical company, in order to co-ordinate the process of informing persons with haemophilia about the recall and the reasons for it. The BTSB also had consultations with the Director of the National Haemophilia Centre. Some of the batches in question had been distributed for self-administration by haemophiliacs in their homes. These batches were withdrawn and replacement products supplied. The Irish Haemophilia Society contacted its members by phone and post in order to address any concerns that they may have had and arranged for an expert on CJD to address a special meeting for members. I would like to take this opportunity of acknowledging the significant efforts of the society in this regard. A recall and replacement procedure was also undertaken in relation to products supplied to hospitals.

The second recall initiated by the BTSB involved two batches of albumin. Albumin is a blood product sometimes used when patients are undergoing surgery, or following significant blood loss. The BTSB became aware in January 1998 that a donor had undergone neurosurgery in 1991. Following further investigation, the BTSB confirmed on 23 February that the donor had received a human dura mater graft. My Department was notified by the BTSB of the situation on 24 February 1998. Following confirmation from the pharmaceutical company that albumin derived from previous donations given by the donor was still in circulation, the BTSB initiated an immediate withdrawal of any in-date product.

It is important to emphasise that the action taken by the BTSB in both instances was purely precautionary in the face of a theoretical rather than an actual risk. Both donors are well and there is no evidence that either donor has contracted CJD. The risk that any of their donations may have transmitted CJD is extremely remote.

Notwithstanding the negligible level of risk, the BTSB decided to withdraw any remaining stocks of product derived from the donations of these particular donors. In doing so, the BTSB went beyond the requirements of the relevant EU regulatory agency, the Committee on Proprietary Medicinal Products. The CPMP position is that no recall need be undertaken where a blood authority becomes aware that a donor who has previously donated blood is in a risk category for classical CJD. On the other hand, the Food and Drugs Administration in the United States requires that a recall of in-date stocks be undertaken, even though there is only a theoretical risk. In adopting the latter approach, the BTSB is pursuing its stated policy of an abundance of caution in respect of any theoretical risk of the transmission of classical CJD through blood transfusion. The Deputies will appreciate, therefore, that the BTSB, in applying such a policy in practice, is required to withdraw products as appropriate circumstances arise.