16 November 2022: Haemovigilance & Pharmacovigilance Panel - D

And so, to questions from core participants:

On the issue of unnecessary blood transfusions and the option of Tranexamic Acid; they said there were mythologies associated with transfusions. For example, it is not always necessary to transfuse up to the normal levels, and there was an assumption on fixing the clotting numbers even if the function was relatively normal. These are hard myths to bust. The evidence suggests don’t transfuse if they are not bleeding. Tranexamic Acid is gradually creeping into clinical practice after the Crash 1 and Crash 2 studies. Tranexamic Acid is easy and cheap. There are not a lot of reasons for not using it. A lot of cultural change is still needed, and too often the new doctors come in and you need to start again beating it out of them. It does seem strange for this to take so long to change. SHOT could have a role in promoting the use of Tranexamic Acid through its educational material.

On who would be responsible for reporting an unnecessary transfusion; they said it usually does not get reported. The idea of a named person would help, but there needs to be better records kept, perhaps with a standard proforma including the Tranexamic Acid option included. There should be more consistency to record the justification for the use of a transfusion at all.

On the incorrect use of a blood transfusion and the duty to tell the patient – and the donor – if a problem arises; they said it was hard enough to get the transfusion recorded, let alone tell people. Telling people should be done, and the information should be available for those who want to know. There are good guidelines from NICE and the blood transfusion services. (Question: If clinicians are not reading and acting on this fairly standard and now well established matter, what else are they missing?) There could be better use of technology to match clinicians to blood they use. If there is no benefit to using a blood transfusion in the benefit-risk balance, then the risk is automatically too great.

On what was around before SHOT; they said there were some localised arrangements but no systematic process. There had been two years of work to set SHOT up and running (about 25 years ago), and its establishment was motivated by incidents of people being harmed by being given the wrong transfusion.

On the improved reporting which would result if information on the infected blood scandal were prepared and used in training; they said it would certainly be useful. The Inquiry is highly topical and increasingly in the media. It is raising many important issues. It was mentioned how there are many pressures on teaching time, but the case of infected blood would certainly have an important place.

On the possible complacency within the UK due to the overall safety of its blood; they said they are always looking for improvements, including by better use of technology, engaging with patients and professionals, and more. The bodies responsible for vigilance don’t want to exaggerate the risk, but they themselves are not complacent. The complacency is there among the general medical sphere. The challenge is to reinforce the issues once the immediacy of an issue has passed. Complacency is almost natural when something is perceived as being “safe”.

On the guidance on consent as raised by SaBTO and the possibility of it having executive powers; they said it would be “nice” to have executive powers but that would require a greater resource. There is a certain comfort with being only an advisory body, but a change to having more powers would allow some alleviation to the current frustration with the time it takes for improvements to happen. It might well require a different kind of organisation. There would be benefits to having powers to impose recommendations and make them mandatory, but it would affect the organisation itself and that might be an unintended negative consequence due to the new dynamic. Currently, they get to advocate the highest standards, but that might change if things became enforceable.

On the matter of consent and the powers to ensure it happens; they said there is just not the powers given to the organisations to do much more than inform and encourage.

On the involvement of lay people in their organisations; they said it was very helpful, not least to avoid groupthink. Lay people are not there to represent patients, but they bring different knowledge and independent thinking to allow alternatives and challenge. The Chair role includes ensuring lay members are not intimidated by the array of medical experts. The lay members often ask questions the doctors had never thought of asking. It helps the doctors to realise how a non-clinician views what is being discussed.

On the time it takes to do a risk assessment; they said it does “depend” on the case, but they do have certain powers when there are more obvious or urgent dangers, for example, requiring a product to be withdrawn immediately. Smaller matters can also be fairly quickly handled, but some matters require a new group or a consultation process which automatically adds time to how long those matters take.

On the number of reports over time; they said there had been an increase but not a step-change increase. Covid may have had an impact. It may be that increases are related to better reporting and knowledge of the system.

On the possibility of looking backwards to transfusion infections before SHOT was set up in 1996; they said they can only look at reports from the reporting year.

On the possibility of SHOT making a recommendation that all patients who have received transfusions should be tested for HCV; they said it was possible in principle, but they may well have been picked up already. Basically, it would be a bigger “look-back” and would have to consider the type of testing, the parameters, the risks of people having been infected, etc. The blood services have looked at this and are putting in plans and processes to identify those patients. But there are questions to consider like if counselling is readily available, if partners are to be tested, and more. The thought was that it would be fairly simple, but this was seen to be not accurate due to all the aspects of doing it which arose. Then Covid came along. It was recognised how such an exercise might appear to be stepping on the toes of the Inquiry, but it was hoped that the initiative would be welcomed.

On why people who have “cleared” HCV still can’t donate blood or organs; they said it was an application of the precautionary principle since there were still questions. A virus can lay dormant in the body, some for years. The balance of the risk is to protect the potential recipient, while recognising that the person who might want to donate also has rights. They still have to be absolutely sure there is no risk of transmission. “Have they really cleared the virus? Would there be any element in their blood which might transmit the virus particularly to a susceptible individual?” (Ask those questions of the liver clinics after a sustained viral response is confirmed.) “The science, perhaps, is not robust but we’d rather people be safe in this case”. (Such useful quotes.)

On Monkeypox; they said it had not yet been added to their algorithms. JPAC  is dealing with it and there do not appear to be concerns about the current protections not being sufficient. There have been no reports of incidents. However, it did highlight the issue for SaBTO of only having four meetings a year. It is just not in a position to initiate action. Currently, they are monitoring the situation. For information, it was explained that JPAC is the Joint United Kingdom Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee. It has a variety of experts from relevant disciplines. They carry out “horizon scanning” using not just UK data but also international sources. “Nobody predicted SARS … nobody predicted Ebola”, but some people did predict Monkeypox.

The Chair had no further questions … “at this stage”.

The witnesses said they found it very useful to consider the questions raised by the Inquiry, to review much more critically what their organisations do. Condolences were offered to those infected and affected and there was a hope that through the very rigorous Inquiry process a similar incident could never ever occur. They hoped that maybe they would get a steer from the Inquiry where they should be going next.

The Chair thanked the panel members collectively for how it was “at times reflective, always interesting”. He noted the enthusiasm for their work, and if the Inquiry “produces something which benefits them all, then I shall be particularly delighted”.