NHS building

First Do No Harm: The Independent Medicines and Medical Devices Safety Review

By John Tingle

A new hard-hitting report on medicines and medical device safety published in the U.K. presents controversial proposals that have the potential to improve National Health Service (NHS) patient safety.

The report, The Independent Medicines and Medical Devices Safety Review, was published on July 8th, 2020 after a two year investigation chaired by Baroness Julia Cumberlege. The review investigated two medications — Primodos and sodium valproate — and one medical device — pelvic mesh.

The reviews remit was to examine how the healthcare system in England responded to reports about harmful side effects from medicines and medical devices and how best to respond in the future.

“The Review was prompted by patient-led campaigns that have run for years and, in the cases of valproate and Primodos, over decades, drawing active support from their respective All-Party Parliamentary Groups and the media,” the introduction states.

The report is hard hitting. The review heard harrowing and distressing patient testimony and a large volume of other evidence about the three medical interventions. The report states:

“The patients’ stories were harrowing. Our two-year journey took its toll on all of us but that paled into insignificance in the face of so much adversity borne with such resilience and bravery by those we met and heard from. They told their stories with dignity and eloquence, but also with sadness and anger, to highlight common and compelling themes.”

A wide-ranging report

The review report begins with a stark and controversial statement to set the tone:

“We have found that the healthcare system – in which I include the NHS, private providers, the regulators and professional bodies, pharmaceutical and device manufacturers, and policymakers – is disjointed, siloed, unresponsive and defensive. It does not adequately recognise that patients are its raison d’etre. It has failed to listen to their concerns and when, belatedly, it has decided to act it has too often moved glacially.”

This opening reflects the wide-ranging nature of the report. Beyond the specific medications and device discussed, comments and recommendations are also made about broader issues such as patient rights, informed consent, candor, redress, litigation, complaints, health carer defensiveness, and other matters.

Review themes

The report picks up on a number of themes that point to systemic patient safety problems in the NHS and difficulties in establishing an ingrained patient safety culture.

Several themes were identified in the review report, including:

Theme 1: ‘No-one is listening’ – the patient voice dismissed

Theme 3: ‘I was never told’ – the failure of informed consent

Theme 5: ‘We do not know who to complain to’ – complaints

Recommendations

Recommendation 2: The appointment of a Patient Safety Commissioner who would be an independent public leader with a statutory responsibility. The Commissioner would champion the value of listening to patients and promoting users’ perspectives in seeking improvements to patient safety around the use of medicines and medical devices.

Recommendation 3: A new independent Redress Agency for those harmed by medicines and medical devices should be created based on models operating effectively in other countries.

Conclusion

This a very challenging, well-researched, and clearly structured report that lays down a gauntlet of important challenges for patient safety and health care regulation in the U.K.

The review report puts forward some sensible recommendations which have the potential to improve patient safety in the NHS. Some would involve major structural changes to how health care disputes are resolved and regulated, and would have to sit alongside other well established NHS regulatory bodies and stakeholders, such as NHS Resolution, Healthcare Safety Investigation Branch (HSIB) ,Care Quality Commission (CQC), NHS England and NHS Improvement, and Parliamentary and Health Service Ombudsman (PHSO)

The NHS is currently in the process of developing and implementing a NHS patient strategy, and could add these new proposals to it — a possibility, to be certain, but one that depends on Government appetite and interest.

John Tingle

John Tingle

John Tingle is a regular contributor to the Bill of Health blog. I am a Lecturer in Law, Birmingham Law School, University of Birmingham, UK; and a Visiting Professor of Law, Loyola University Chicago, School of Law. I was a Visiting Scholar at Harvard Law School in November 2018 and formerly Associate Professor at Nottingham Law School, Nottingham Trent University in the UK. I have a fortnightly magazine column in the British Journal of Nursing where I focus on patient safety and the legal aspects of nursing and medicine. I have published over 500 articles and a number of leading texts in patient safety and nursing law. My current research interests are in global patient safety, policy and practice, particularly in African health care systems. My most recent publication is: "Global Patient-Safety Law Policy and Practice," edited by John Tingle, Clayton O'Neill, and Morgan Shimwell, Routledge 2018.

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