Vol. 503 No. 5
1 Mr. R. Bruton asked the Minister for Health and Children the reason for the delay in informing 6,000 women who were tested under the hepatitis C national screening programme that the anti-D they received was partially infected; and the arrangements being made for them to be re-tested. [10659/99]
I established an expert group in September 1997 to make recommendations to me on the clinical and non-clinical management of women who received anti-D which was infected or potentially infected with hepatitis C, but who tested negative for the virus.
As a result of the deliberations of the expert group the following priority groups were identified as requiring further review: those women who tested ELISA negative but who reported a history of jaundice within six months of the administration of anti-D; and those women who tested ELISA positive but negative on a confirmatory RIBA test. The women in these categories have been referred to their general practitioner, offered further testing and referred to one of the designated hepatology units for any necessary follow up.
A further group involves women who received infected or potentially infected anti-D in 1977-78 or between 1999 and 1994 but who have not come forward for testing. Women who have not been tested and may have been exposed to infected or potentially product remain a priority group. A further national campaign was initiated by the Blood Transfusion Service Board in October 1998. The optional screening programme for those who have not come forward remains in place and I have ensured that sufficient resources are available for this purpose.
The remaining group of women are those who tested ELISA negative and received either infected or potentially infected product. The level of infection was on average 25 per cent in product manufactured in 1977 and 1978. Product manufactured between 1991 and 1994 was less than 1 per cent infectious. The BTSB has carried out an extensive cross-matching exercise between those women who were identified from available anti-D cards and from checks of hospital patient records as having received infected or potentially infected anti-D and those women who tested ELISA negative under the national screening programme. As a result of this exercise over 5,500 women have been identified. The current position is that any woman who wishes to be advised of available information on the serological status of the anti-D they received may do so by contacting the BTSB.
Following careful consideration of the complex medical, legal and ethical issues involved, the group decided that these women should be directly informed by way of consultation with their general practitioner. The purpose of the consultation is to inform the person that they received an infected or potentially infected anti-D, to re-confirm that the patient is serologically negative for hepatitis C using the ELISA test and to reassure the patient that she is not currently infected. Repeat testing will be available as a precaution, if the person so wishes, although expert medical opinion is that there will be no change in their serological status.
As the Deputy will appreciate, given the numbers of women involved there is considerable preparatory work necessary in advance of the commencement of this programme. This work involves the completion of the text of the scientific and medical documentation for the information of general practitioners, ensuring accurate linkage of recipient names to their individual general practitioner and having in place the necessary support services, including counselling if required. As soon as these arrangements are finalised, the programme will be launched. I am sure the Deputy will agree it is important that the programme is organised and managed in an efficient and effective manner in the best interests of the women concerned and avoids any unnecessary anxiety.
In the case of the 5,500 women to whom the Minister referred, was it not known at the time they were tested that they had been given a batch which was potentially infected? Consequently, why would they not have been informed of this fact at the earliest possible opportunity, which was then?
What was known at the time was that far more potentially infectious product or vials of product had been given out than was reflected in terms of those who came back in for testing. In other words, before one could inform people on an individual basis the cross-matching, which I addressed in my reply, had to be carried out. The board had to be able to get the list of those who tested ELISA negative, then find out from the anti-D cards which batches they received and then cross-match those with the persons concerned who tested ELISA negative. That is a long, tortuous process because of the lack of good data in many circumstances.
The priority group remains those who received product but who have not come forward for testing. There were two other smaller groups, as I mentioned earlier. Those women who tested ELISA negative but who reported a history of jaundice within six months of the administration of anti-D have to be contacted. It is a much smaller group – I think there are 32 cases. The number of women who tested Elisa positive but negative on a confirmatory RIBA test was 68. The first category is far larger. The number of vials concerned would indicate that it is an ongoing process.
People have a right to be informed on the basis that an analysis of the legal authorities examined in the report of the expert group looking at this matter suggests that, when an individual receives either medical treatment or a medical product from either a doctor, a hospital or a manufacturer, and where that initial treatment poses a subsequent danger which was previously unknown but now is known or merely identified, the individual is owed a duty of care to be informed of that risk, even where that risk is theoretical, minimal, distinct or remote.
We want to make sure we launch a campaign with all the necessary components in place to avoid any unnecessary anxiety. To be called back and given this particular information will obviously cause some anxiety to people but, as I said, the medical evidence suggests that the serological status of the people concerned is not likely to change. As I understand it, there will be no change.
I accept that. Is it not the case that many of these women were tested as far back as 1994? Why has it taken five years to realise that the duty of care was to provide these women with information which should have been made available at the earliest possible opportunity? I do not see how this position could have been adopted by those advising the BTSB or, indeed, the Minister.
Did the cross-matching exercise unearth information other than that women, who already had been tested negative, had received potentially infected product? If so, what action has been taken on that? What steps is the Minister putting in place to trace the 13,000 women who have received potentially infected product but who have not yet reported for testing?
On the last point, continuing efforts are being made by the BTSB through the targeted look-back programme and the optional screening programme to try to identify those people and to have them come forward for testing. Those efforts are continuous. It is a priority group.
As to the notification being given now rather than then, apart from the work which had to be done on the cross-matching of individual cases it is important to point out that the result of the initial testing in 1994 was Elisa negative. On foot of these results, the woman's GP was notified of a hepatitis C anti-body negative result, which is in line with international practice. As this cohort of women were negative for hepatitis C they were not a priority group for the BTSB which was concentrating on identifying and tracing persons who had not come forward for testing. When the BTSB had addressed the priority groups it was in a position to intensify the extensive cross-matching exercise which was necessary to identify those who had definitely received an infected or poten tially infected product and who had tested ELISA negative.
I set up the expert group in September 1997 with the specific brief of deciding whether this cohort required further follow-up. In the course of its deliberations the expert group examined and made recommendations in relation to other groups which it considered to have higher priority, to which I referred. It was necessary for the group to examine the legal and ethical issues involved in informing the cohort they had received an infected or potentially infected product. Having decided the women should be informed the group must consider how best to do this and what the protocol should be in relation to the clinical management of this cohort. Those are the reasons this issue has arisen now.
I am puzzled that 6,000 women have tested negative and 13,000 have not yet been tested. It seems the tracing programme has not been a great success. Does that concern the Minister?
It is not possible to say how many women will eventually be found to have received infected product and are ELISA negative. However, it is known that 4,062 infectious or potentially infectious vials of anti-D were manufactured and issued in 1977-8 and a further 17,545 such vials were manufactured and issued in 1991-4, giving a total of 21,607 infectious or potentially infectious vials of anti-D which were manufactured and issued. Of the 1991-4 vials, 1,208 were returned to the BTSB leaving 20,399 vials with varying levels of infection.
There will be a significant number of cases where, due to lack of hospital records and the non-return of anti-D cards to the BTSB, it will not be possible to confirm whether an individual did or did not receive infectious or potentially infectious anti-D. Accordingly, the documentation issued to the GPs as part of this programme will contain advice on how to treat any women who, although not identified in this programme, are worried about their position and require information. Once this programme has been completed it is intended to notify all GPs of the protocol in dealing with any women who are concerned.
The Minister did not answer my question.
