7 June 2022: Rawlins - B

Apart from the witness’, all other eyes are on the impending release of the Sir Robert Francis QC report on the Compensation Framework Study at some point today (probably at 2pm). Sir Michael has been joined on the couch by a walking stick.

Sir Michael did not remember there being an adverse reaction entry in a Current Problems publication related to factor concentrates for the treatment of patients with bleeding disorders. Counsel gave (unrelated) examples of how other treatments had been highlighted through these processes. The witness could not say why such attention was not given to blood concentrates. Examples from other medicines safety processes also demonstrated a UK propensity to paternalism and not worrying patients by telling them certain information. Actual yellow cards were made available to doctors, but all too often when the was an adverse reaction to report, they could not find one. Eventually, it was agreed to include them with the BNF (British National Formulary - a reference book on all medicines listing uses, side-effects and other information).

The yellow card process involved the cards being sent to a central unit to be recorded and collated. For no apparent reason, it was normal when a particular drug received three yellow card warnings, then that prompted an investigation. For context, there were 165,373 yellow card reports in the first 24 years of its operation, and in the year 1986 there were 15,527 yellow card reports (more than had ever previously been received in a year). However, it was generally understood that there was massive under-reporting. This might have been down to “reporting fatigue”; doctors just got tired of submitting reports through yellow cards. On a more focused vein related to adverse reactions, if a patient developed jaundice, for example as a result of a blood product or any other intervention, that should have been reported. Generally, the expectation was for serious adverse reactions to always be reported, but with newer treatments then both serious and non-serious adverse reactions were to be reported. Basically, the yellow card scheme relied heavily on doctors first of all picking up on an adverse reaction and then actually reporting these. Between 1972 and 1980, only 16% of doctors (mostly GPs) actually did submit reports. This was seen as a serious loss of vital data (not to mention putting patients at risk). Sir Michael’s team did a small exercise of allowing pharmacists to report. Rather than doctors being against this (as was expected), they overwhelmingly welcomed it. Also, the reports by pharmacists were actually more detailed and useful than those from doctors. The major issue, which seems to have been allowed to go unchecked, was the very infrequent use of yellow cards within hospital settings.

There were some regional centres, but not one in Scotland. The location of regional centres was related to the (incidental) location of people who happened to have a particular interest in the subject of the safety of medicines. The process involved a senior medical professional investigating cases when the number of yellow cards reached a certain level, including considering the seriousness of the reaction. The investigator did not rely alone on the reports associated with the cards, but also on relevant published research. Then this would be used to carry out a risk/benefit analysis, leading to a judgement and recommendation on the continued use or suspension of a licence for the highlighted drug. All hepatitis incidents should have been seen as serious adverse reaction, and so reported, said the witness. A yellow card is more technically known as an adverse drug reaction (ADR). A table was displayed showing the number of ADR reports for blood products. It was from the pre-AIDS era. The main point was the very low levels of reporting by clinicians treating bleeding disorder patients.

(There was an unexpected 10 minute break called. It was noted that Sir Brian went over to speak with Jenni who was leading the questioning of the witness. Normally, the Chair simply leaves the room through the door behind him.)