As the Government takes further steps to ease the COVID-19 lockdown there is now more non-COVID-19 patient safety activity going on. A key matter to bear in mind when the new reports are published and the media stories read is the ‘new normal’ in the NHS. This is the new NHS climate of care that now exists after the worst of the COVID-19 pandemic has passed. We should now factor into our considerations whether the Government and the NHS now has an appetite, after all that has happened with COVID-19, to embark on major patient safety and health regulatory changes to meet recommendations made in newly published reports. The Government and the NHS have all taken risks to cope with the crisis, such as using retired staff, doctors working in other specialities, students as NHS staff and so on. This all could translate into an NHS and a Government taking a less risk-adverse approach to matters than they were doing before the pandemic. McLellan et al (2020) discussed these issues and the NHS and Government attitudes to patient safety in the Health Service Journal's ‘Health Check’ podcast episode covering the Cumberlege (2020) report.
Update on Shrewsbury and Telford Maternity Scandal
Whatever the Government and NHS appetite for reform and change, the emerging care quality crisis at the Shrewsbury and Telford NHS Hospital Trust is guaranteed to keep patient safety a live public issue.
Lintern (2020) revealed that in a leaked letter seen by The Independent, Professor Ted Baker, Chief Inspector of Hospitals at the CQC, expressed acute concerns over care at the Shrewsbury and Telford Hospital NHS Trust:
‘Prof Baker has warned national health chiefs that issues are still present today across wards at the trust—with inspectors uncovering poor care in recent visits that led to “continued and unnecessary harm” for patients.’
And in that same letter Professor Baker:
‘… raised the prospect that the Care Quality Commission (CQC) could recommend the trust be placed into special administration for safety reasons, which has only been done once in the history of the NHS—at the former Mid Staffordshire NHS Trust…”
The unfolding events in Shrewsbury and Telford are tragic for all concerned. It is very concerning, particularly for the local citizens in the area that the trust serves, that poor-quality care is still a continuing issue. This crisis continues to raise fundamental questions about the NHS patient safety culture and the systemic problems facing the NHS in this area, such as the age-old criticism that the NHS is generally poor at learning lessons from past adverse events. Given the history of patient safety NHS over the years the Shrewsbury and Telford crisis is unlikely to be the last.
The Cumberlege Report
The report of the Independent Medicines and Medical Devices Safety Review, chaired by Baroness Julia Cumberlege, was published on 8 July 2020 after 2-year investigation. The review investigated two medications—Primodos (a hormone pregnancy test) and sodium valproate (an antiepilepsy drug)—and one medical device, pelvic mesh:
‘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 review's 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.
Harrowing stories
The report is a hard-hitting one and the stories of women and their families who were adversely affected by the three medical interventions are harrowing. The report considers several issues including those faced by women and their families in getting their voices heard about the problems they were facing. Issues such as clinician attitudes, informed consent, the operation of the health regulatory system and patient complaints are all discussed. The report makes several key recommendations with the potential to significantly improve our patient safety system and to stop these types of events from ever happening again.
A broken NHS patient safety system?
The report covers a wide field and while discussing the matters relating to the three medical interventions, it also investigates the context of the healthcare regulatory and patient safety system more generally and finds it severely wanting:
‘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.
The words, ‘disjointed, siloed, unresponsive and defensive’ I would argue are a fair summation of the systemic patient safety problems that the NHS has faced over the past 20 years or more and continues to face today. The same sentiments have been expressed in countless other reports on patient safety and health care regulation.
I would also argue that successive governments and NHS leaders have acknowledged and continue to acknowledge, that these words do accurately describe the patient safety problems that currently beset the NHS. There is much agreement and resolve about what needs to be done about these common failings. The problem is, as events show in Shrewsbury and Telford, culture change in the NHS does not happen quickly and the NHS is perplexingly bad at learning and implementing the lessons from past adverse health events.
Report review themes
Theme 1: ‘No-one is listening’—the patient voice dismissed
‘In our travels around the country and in the volume of emails and correspondence we received, the personal written testimonies and video-recorded stories, patients—almost universally women—spoke in disbelief, sadness and anger about the manner in which they were treated by the clinicians they had reached out to for help.’
The type and style of the clinician's communication is characterised as ‘defensive’, ‘dismissive’ and ‘arrogant’:
‘The words ‘defensive’, ‘dismissive’ and ‘arrogant’, cropped up with alarming frequency. They spoke of being ‘gaslighted’ and of not being believed, particularly in relation to pelvic mesh and the suffering of pain.’
This ‘talking-down’ attitude chronicled in the report was the central message that came through in the media coverage. In putting this stark message out to the public, NHS and Government, the report has succeeded in a central aim, even if some of its recommendations are not adopted by the Government. McLellan et al (2020) explored in their podcast the value that the report has in conveying the message about poor clinician communication and nobody really listening.
‘Some clinicians’ reactions ranged from ‘it's all in your head’ to ‘these are women's issues’ or ‘it's that time of life’ wherein anything and everything women suffer is perceived as a natural precursor to, part of, or a post-symptomatic phase of, the menopause.’
Theme 3: ‘I was never told’—the failure of informed consent
From a legal as well as a human rights personal patient perspective, the report's findings on informed consent are very worrying particularly in the light of the Supreme Court case, Montgomery v Lanarkshire Health Board [2015] UKSC 11.
The efforts of health professional bodies to highlight and subscribe to this focus on informed consent is noteworthy and adds to the disappointment with the report's findings on this issue:
‘We have been appalled by the numbers of women who have come forward to say they never knew they had had mesh inserted, or where they gave consent for ‘tape’ insertion they did not know they were being implanted with polypropylene mesh or were misinformed as to the extent of longer term adverse side effects. They did not know because no-one told them, let alone sought their properly documented informed consent.’
A telling statement is made in the report, which sums up well the problem of informed consent in practice:
‘In their evidence to the Review, the professional associations admit clinicians have not always ‘done justice’ to the process of acquiring informed consent.’
We may well have the law and proactive professional codes stating the proper practice that clinicians should follow in obtaining consent. Unfortunately, it seems that the message on proper practice is still permeating down through the NHS and has yet to reach some quarters.
Theme 5: ‘We do not know who to complain to’—complaints and Theme 12: Patient safety—doing it better
These raise some very important issues which include the apparent complexity of the complaints process. Many of those contacted for the report expressed frustration at the lack of a clear pathway for them to make a complaint or raise care concerns. Patients struggle, the review says, to navigate the complaints system. In terms of patient safety, the review argues that the system is fragmented as each regulatory body works within its own remit. The system is not sufficiently joined up despite recent initiatives and a new approach is needed. A recommendation is for the creation of a new Patient Safety Commissioner to improve matters. Among several other recommendations there is also a call for new independent Redress Agency for those harmed by medicines and medical devices.
Conclusion
The publication of patient safety reports on non-COVID 19 related matters are now becoming more frequent. We also continue to read about long-running patient safety crises. The Cumberlege report has taken a deep dive into patient safety issues surrounding three medical interventions. Out of the report have also come some very valuable and wide-ranging recommendations to safeguard patient rights, and to improve our patient safety and our health regulatory system.
However, any proposal to add more patient safety or regulatory organisations to our current system needs to be treated cautiously. The notion that less is more should apply when we discuss the current NHS patient safety and regulatory environment. We have an absolute abundance of agencies and organisations already and they all still need direction and time to improve. The Cumberlege report (2020) raises some fundamental issues and shines a bright light on some major NHS care failings that need to be urgently addressed.