16 November 2022: Haemovigilance & Pharmacovigilance Panel - A

The venerable panel on haemovigilance (HV) and pharmacovigilance (PV) included: Professor James Neuberger who is the Chair of The Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO); Professor Mark Bellamy the Chair of the Serious Hazards of Transfusion (SHOT) Steering Committee; and Doctor Alison Cave the Chief Safety Officer for the Medicines and Healthcare products Regulatory Agency (MHRA). With such titles in operation, the session ran the risk of being rather technical.

A brief overview of each panel members’ background was given. It did not include the establishment connections of Prof Neuberger, including him being the son of Prof. Albert Neuberger, the brother of Prof. Michael Neuberger, Prof. Anthony Neuberger, and David Neuberger who is Baron Neuberger of Abbotsbury (President of the Supreme Court of the United Kingdom), and the brother-in-law of Julia Neuberger (cross-bencher who worked on the David Cameron “big society” agenda). Dr Cave has had a very high-flying career in the UK and internationally. Prof Bellamy sounded uncannily like Clement Freud (a cultural reference for older readers). He too has a very comprehensive CV, is still practicing in intensive care and anaesthesia, as well as being on various committees. Prof Neuberger also had a charmed progression, becoming involved in liver and hepatitis issues which tracks the key periods of Inquiry investigation, and he has had various leadership roles in medical and advisory bodies. The point was made about the value of practicing doctors giving up their time to participate in committees and boards.

Prof Neuberger gave an overview of SaBTO. It is an independent body hosted by the Department of Heath and Social Care (DH). Blood is a SaBTO matter while blood products is a MHRA issue. SaBTO advises Ministers and officials and has a track record of operating to high standards with very qualified experts involved. There are two lay members. The witness asserted the independence of the group, despite the closeness to the DH. The witness said he sets a culture which allows people to speak out without fear or reluctance. There needs to be robust discussions at times. In relation to transparency, they seek to publish their minutes in a timely fashion. They also write to professional bodies and journals for them to disseminate information. He mentioned the large amount of information doctors are sent all the time, so it is an issue to continue to make every effort to get their information out there. Members of SaBTO are publicly named, so could be approached by colleagues. He sees this as part of them knowing the range of views from their own specialism.

Prof Bellamy was next to review his group, SHOT. But first, on behalf of SHOT he mentioned how he and SHOT were deeply sorry for what happened to infected and affected people through transfusion practice. The work of SHOT is to protect against infection from transfusions and to improve all aspects of transfusion safety. Before 1996 there was not a HV scheme in the UK; which gap SHOT filled. It too is an independent body. It is overseen by a Steering Group whose members are representatives of the stakeholder bodies including the Medical Colleges. The funding comes from the four national blood transfusion agencies. The Steering Group is independent of the transfusion bodies. There are lay members on the Steering Group, and their inputs have been invaluable. SHOT has specialist people working for them. That may involve them looking at reports and research and then feeding the relevant information to the respective Working Expert Group. These groups also draw members in an open process. Many are doctors, others are associated healthcare professionals, or biomedical scientists. In most cases these people will have full-time jobs separate from the time they give to SHOT. The witness mentioned that there is a great deal of information on their website. There are about 4,000 reports that are considered annually and judged to see if they are worth further attention relevant to SHOT. Their reports are disseminated online, and through their annual Congress which includes UK and international participation. There are web-based meetings and reports are distributed in electronic formats and are downloadable. They don’t always know the degree to which their recommendation and reports gain traction. Surveys are also carried out and SHOT published these too. The question about equalities was seen as a balance against preserving anonymity. So far, anonymity has trumped over equalities. The relationship between SHOT and MHRA was initially cautious, but the current relationships are positive. They sit on each other’s governance bodies. They are not rival bodies. There are key differences in the roles, remits, and ways of working that help to support collaboration which are mutually beneficial.

Dr Cave was not required to go over the work of the MHRA since that had been done by Dame June Raine during her evidence.

It was noted that there are different ways people can contribute to, for example, SaBTO since they sometimes have short-life working groups for people to be co-opted on to. SaBTO was also positive about its relationships wit the other two bodies represented. The relationship is one of “admiration, however grudging” (said with a smile).

Counsel wanted to explore the situation of there being not just one body to cover all aspects of vigilance. Dr Cave requested that she be able to revisit the area of HV since it was very complex and multi-faceted. There was a distinction between blood (whole), blood components (therapeutic constituents), and blood products (treatments derived from human blood). Each of these are covered by different legislation. Blood products have a stronger international aspect whereas the others are mainly the concern of UK origination. MHRA is the competent body for HV regulation, including the power to inspect facilities, review collection processes, and to monitor serious adverse events. PV is the domain of the Yellow Card Scheme, not HV.

Focussing on blood components which are domestically sourced, it starts out being a MHRA competence, then transfers to SHOT. The Serious Adverse Blood Reactions and Events (SABRE) reporting platform is a key tool. There is a duty on the blood establishments to report using the SABRE platform. This covers collection, testing, processing, storage, and distribution of blood or components in situations that might lead to the death or other life-threatening issues related to a patient. These include the questions being asked to screen donors, as well as processing factors such as testing and storage issues. It is not just about actual problems causing harm to a patient, but also “near misses” such as someone noticing a wrong label on a vial and correcting it. The near misses are less likely to be reported, but that may be an indication of the success of the system. It relies on the reporter of problems doing what they are supposed to do. There are broad definitions of a “serious adverse event” (SAE) and a “serious adverse response” (SAR). Depending on the issue reported, it may go to one or both bodies.

Guidelines on the mandatory reporting of adverse events included a guidance flow-chart to assist people in knowing what and how to report. For example, if a person receives a unit of blood which coincidentally is compatible and so produces no harm, it is still a SAE since the patient should not have received that unit and it could have caused harm. There are also aspects to the reporting process about who should do the reporting. It would be relatively unusual for a doctor to do the reporting. A transfusion specialist or lab manager are much more likely to be expected to be the reporter. A reporting person has guidance via SABRE on how to report, including there being an initial notifying report and then a confirmatory report.

It was noted that as a consequence of the cuts to the NHS, the designated person role to report SAE types of issues are too often not being filled in hospitals. It was also noted that the overall processes related to incident reporting are changing with a new version of how to do things being notionally launched in August 2022 for roll out in 2023. When a report is made on the SABRE system, the bodies monitoring these have a number of powers to initiate corrective action, and if required it is transferred between the agencies for their respective processes to be followed.

The Chair wanted to understand where the responsibility lies for the period when a blood component is in transit between venues. It connects to what is referred to as “cold-chain compliance”. If blood item is not used for the original purpose, it may still be useable if it was kept sufficiently cold, but if cold-chain compliance cannot be ensured, then that blood component is no longer considered useable. And if there is a cold-chain problem, that then requires to be responded to by the relevant bodies. It resulted in the panel acknowledging a matter for interpretation in the documentation which was highlighted by the Chair.