Last week, the Independent Medicines and Medical Devices Safety (IMMDS) Review published its report First Do No Harm, examining how the healthcare system in England responds to reports about the harmful side effects from medicines and medical devices. The review focused on looking at what happened in relation to three medical interventions:
- Hormone pregnancy tests (HPTs) - tests, such as Primodos, which were withdrawn from the market in the late 1970s and which are thought to be associated with birth defects and miscarriages.
- Sodium valproate - an effective anti-epileptic drug which causes physical malformations, autism, and developmental delay in many children when it is taken by their mothers during pregnancy.
- Pelvic mesh implants - used in the surgical repair of pelvic organ prolapse and to manage stress urinary incontinence. Its use has been linked to crippling, life- changing, complications.
The scale and severity of avoidable harm that resulted from these three interventions over a period of several decades is shocking. Commenting on the report’s publication, its Chair Baroness Julia Cumberlege emphasised the impact on those involved, reflecting on harrowing stories of “relationships destroyed, careers broken, and as a result financial ruin, with no income, many lost their homes, and faced their children being taken into care”.[1]
The report also states strongly that patients or their families should not be left to “join up the dots of patient safety” for patient safety.[2]
In this blog, we will consider the report’s findings, highlighting the key patient safety themes that are consistent with those found in many other patient safety scandals in the last twenty years. We will then look at what needs to change to prevent these issues recurring so that this does not become another “seminal report to gather dust on a shelf”.[3] We will respond to the challenge that if it is not for the patient to ‘join the dots’ for patient safety, then who should and what action is needed to reduce harm.
Review findings
Numerous reports have been published in the past twenty years on patient safety scandals, yet systematic causes of unsafe care continue to persist.[4] The reports reflect common themes around a failure to learn from mistakes, not sufficiently engaging patients in their safety during care, and a culture of blame that undermines our ambitions to design and deliver safer care.[5]
Patient Safety Learning sees a similar set of themes and issues reflected in the findings of the Cumberlege Review.
Failing to involve patients in their care
One theme running throughout the Cumberlege Review has been a failure to engage patients in their care, most noticeably around the issue of informed consent.[6] Examples of this include:
- Cases where women underwent pelvic mesh procedures without being aware that mesh would be used.
- Patients taking sodium valproate during pregnancy without knowledge of the risks it posed to their unborn child.
- Patients not being informed of risks involved, with doctors giving “advice based on their own assumptions, without involving patients in the decision-making process”.[7]
Persistence of a culture of blame
We know that a blame culture continues to persist in the NHS, discouraging staff from speaking up.[8] This Review reflects these concerns, stating patients felt that the clinicians involved had been reluctant to acknowledge where things had gone wrong or have open conversations about the adverse effects of interventions. The Review noted that they “heard about the failure of the system to acknowledge when things go wrong for fear of blame and litigation”.[9]
Incident reporting
Another theme the Review highlighted is the need to improve incident reporting in healthcare, specifically regarding medicines and devices. It noted that the system “cannot be relied upon to identify promptly significant adverse outcomes arising from a medication or device because it lacks the means to do so”.[10] In particular, the Review referred to concerns about existing systems, such as the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card scheme, stating that it is hampered by a lack of awareness among both the public and healthcare professionals.[11]
Lack of support for patients after unsafe care
The Review also points to the barriers patients face when raising concerns about the care they have received, mentioning issues such as:
- Difficulties in navigating the complex complaints system in healthcare.
- Concerns that complaints had been disregarded, with this seen as contributing towards “the system’s culture of denial and resistance to acknowledging mistakes will continue unchallenged”.[12]
- Quoted in the report, one mesh-affected patient said, “I have had a constant battle to get the help and treatment I needed with my mesh complications. ‘Gaslighting’ and a ‘fobbing off’ culture appears to be rife…”[13]
Health inequalities
The interventions focused on in the Review were all taken or used by women, and its findings highlight consistent themes around sexist attitudes to patients’ concerns. It cites examples of the dismissal of symptoms and concerns as attributable to “women’s problems” and an approach from some clinicians “wherein anything and everything women suffer is perceived as a natural precursor to, part of, or a post-symptomatic phase of, the menopause”.[14]
System leadership and regulatory gap
The notion that there is a gap in leadership at a system level for patient safety is not a new one. In its 2018 report Opening the door to change, the Care Quality Commission (CQC) noted that, while different organisations had different roles to play in patient safety, the current system was “confused and complex, with no clear understanding of how it is organised and who is responsible for what”.[15] Earlier this year, the Independent Inquiry into the Issues raised by Paterson also commented on the regulatory structure, stating that “the regulators appeared to be waiting for someone else to act. It is our view that in this case, the regulation of the healthcare system failed”.[16]
The Cumberlege Review reaches a similar conclusion, noting that the system is uncoordinated and “has failed to demonstrate it can both recognise system-wide shortcomings and remedy them”.[17] The Review states:
“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”.[18]
A patient safe future: making change happen
The Cumberlege Review is stark in its criticism of the NHS’s current approach to patient safety and the failure to listen to and respond to patient concerns. Patient Safety Learning believes that, in response to this Review, there are 3 options for action.
Leaders in the NHS could:
- Option 1 - Ensure that the current system works, holding organisations to account for delivering their responsibilities for patient safety – ‘as now, but better’.
- Option 2 - Supplement the current system with new roles and responsibilities to highlight the patient voice, ensuring that patients receive information, services and redress. This would require the creation of a Patient Safety Commissioner and Redress Agency – ‘as now – with extra focus on patient voice and redress’.
- Option 3 - Design patient safety into the heart of the health and social care system. This includes overarching leadership for patient safety across the health and social care system, standards for patient safety across the system with published organisational and system goals for safer care – ‘patient safety as a core purpose’.[19]
In its final recommendation, the Cumberlege Review calls for the Government to “immediately set up a task force to implement this Review’s recommendations”.[20] These recommendations touch on a number of different issues, some of which address and support specific issues to these cases and others involving wider system changes, such as the new Patient Safety Commissioner role and an independent Redress Agency.
While such proposals have their individual merits, will they serve to address the persistent patient safety themes of this Review and so many others? Will NHS leaders stick with the current ways of working, make a few improvements, or take this opportunity for transformational change?
Patient safety as a core purpose
At Patient Safety learning, we know that the main causes of unsafe care are systemic. Avoidable harm in healthcare has a complex set of causes and to make real progress we need to address underlying system issues.
We believe that key to this is patient safety being treated as a core purpose of health and social care, not one of several competing strategic priorities to be traded off against each other. In our report, A Blueprint for Action, we set out an evidence-based analysis of why harm is so persistent and what is needed to deliver a patient-safe future, identifying six foundations of safe care: [21]
We believe it is important to consider the Cumberlege Review recommendations in this wider context. We see the need for a transformation in our approach to patient safety, one that responds to and actions the recommendations from report and inquiries from the last 20 years.
Shifting the culture
We share the Review’s view of the importance of moving towards an approach where patient safety incidents are considered through “a non-adversarial process with determinations based on avoidable harm looking at systemic failings, rather than blaming individuals”.[22] It recommends the creation of an independent Redress Agency as a means to tackle this.
While redress and litigation are one part of this, we believe that, in practice, it is a much broader issue. What is needed is a move towards a culture in healthcare where staff can feel safe and secure in reporting patient safety concerns, knowing these will be actively welcomed, listened to and acted on. It will require direct action to change the culture in healthcare at both leadership level and within individual organisations across the whole health and social care system.
Set out in more detail in A Blueprint for Action, we have called for all organisations to regularly and independently assess their organisational culture and have programmes of action to ensure a just and learning culture is in place.
Listening to patients
The Review recognises that “the patient voice and influence within the NHS and the overall delivery of health and care needs to be strengthened”, with its solution being a new Patient Safety Commissioner.[23] Envisaged as a champion of the patient’s voice, this role is intended to “bring a unique and focused perspective to efforts to improve patient safety that complements the work of current organisations and agencies”.[24]
We need a system where patients are listened to, responded to with candour, invited to contribute to patient safety as part of the clinical team, can voice their concerns if things go wrong, and know that their insights will inform improvement and the prevention of future harm. We also think there is a need to develop ‘harmed patient care pathways’ that outline the provision of advice, guidance, and practical and psychological support to patients and families when they are harmed by unsafe care.
We see value in this proposal but consider that even a well-resourced Patient Safety Commissioner on their own would not be able to bring about the fundamental change that is required to tackle unsafe care and empower patients. What is required is a step change in how we support and engage patients in patient safety.
While a Patient Safety Commissioner may play an important role, these changes need to happen throughout the health and social care system, from the bottom up.
A delivering safer care task force
The Cumberlege Review recommends the establishment of a task force to implement its findings. If we are to make the wider-ranging changes needed for safe care, we believe that any such task force needs to look at patient safety more widely than just this report. Such a task force should include recommendations made by other recent major patient safety reports including those that do not as yet have a Government response, such as the CQC’s Opening the door to change and the Paterson Inquiry.[25]
Patient Safety Learning welcomes the opportunity to contribute to a system-wide task force to ensure that patient safety is designed as a core purpose into health and social care, and to ensure that patients are listened to and are safe from harm.
Patients should not be asked to join the dots for patient safety; this is the responsibility of healthcare leaders who must seize this opportunity to drive the changes needed for safer care.
[1] Baroness Julia Cumberlege, The IMMDS Review: Press Conference Speech, 8 July 2020. https://www.immdsreview.org.uk/downloads/IMMDSReview_Baroness_Cumberlege_speech.pdf
[2] The IMMDS Review, First Do No Harm, 8 July 2020. https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf
[3] The Independent, Cumberlege inquiry: We must not allow this seminal report to gather dust on a shelf, Jeremy Hunt says, 8 July 2020. https://www.independent.co.uk/news/health/cumberlege-inquiry-jeremy-hunt-nhs-patient-safety-a9606186.html
[4] Liam Donaldson, An Organisation with a Memory: Report of an Expert Group on Learning from Adverse Events in the NHS, 2000. https://qi.elft.nhs.uk/wp-content/uploads/2014/08/r_02-an-organisation-with-a-memory-l-donaldson.pdf; Ian Kennedy, Learning from Bristol: The Report of the Public Inquiry into Children’s Heart Surgery at the Bristol Royal Infirmary 1984- 1995, 2002. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/273320/5363.pdf; Robert Francis QC, Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry, February 2013. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/279124/0947.pdf; Dr Bill Kirkup, The Report of the Morecambe Bay Investigation, 2015. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/408480/47487_MBI_Accessible_v0.1.pdf; The Right Reverend Graham Jones, Report of the Independent Inquiry into the Issues raised by Paterson, 2020. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/863211/issues -raised-by-paterson-independent-inquiry-report-web-accessible.pdf
[5] Patient Safety Learning, The Patient-Safe Future: A Blueprint For Action, 2019. https://s3-eu-west-1.amazonaws.com/ddme-psl/content/A-Blueprint-for-Action-240619.pdf?mtime=20190701143409.
[6] The report defines informed consent as “the patient’s right to be told whatever information they need and in a manner that they understand – not what the reasonable clinician chooses to say – to make a decision on whether or not to proceed with a particular procedure or medication”. The IMMDS Review, First Do No Harm, 8 July 2020. https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf
[7] Ibid.
[8] Results of the most recent NHS Staff Survey suggests 40.3% of those asked do no agree that their organisation treats staff fairly who are involved in an error, near miss or incident and 28.3% suggested answered that they would not feel secure raising concerns about unsafe clinical practice. NHS Survey Coordinator Centre, NHS Staff Survey 2019: National results briefing, February 2020. https://www.nhsstaffsurveys.com/Caches/Files/ST19_National%20briefing_FINAL%20V2.pdf; Patient Safety Learning, Results of the NHS Staff Survey, 18 February 2020. https://www.patientsafetylearning.org/blog/results-of-the-nhs-staff-survey-2019
[9] The IMMDS Review, First Do No Harm, 8 July 2020. https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf
[10] Ibid.
[11] MHRA, Yellow Card, Last Accessed 9 July 2020. https://yellowcard.mhra.gov.uk/
[12] The IMMDS Review, First Do No Harm, 8 July 2020. https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf
[13] Ibid.
[14] Ibid.
[15] CQC, Opening the door to change: NHS safety culture and the need for transformation, 2018. https://www.cqc.org.uk/sites/default/files/20181218_openingthedoor_summary.pdf
[16] The Right Reverend Graham Jones, Report of the Independent Inquiry into the Issues raised by Paterson, 2020. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/863211/issues -raised-by-paterson-independent-inquiry-report-web-accessible.pdf
[17] The IMMDS Review, First Do No Harm, 8 July 2020. https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf
[18] Ibid.
[19] Patient Safety Learning, The Patient-Safe Future: A Blueprint For Action, 2019. https://s3-eu-west-1.amazonaws.com/ddme-psl/content/A-Blueprint-for-Action-240619.pdf?mtime=20190701143409.
[20] The IMMDS Review, First Do No Harm, 8 July 2020. https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf
[21] Patient Safety Learning, The Patient-Safe Future: A Blueprint For Action, 2019. https://s3-eu-west-1.amazonaws.com/ddme-psl/content/A-Blueprint-for-Action-240619.pdf?mtime=20190701143409.
[22] The IMMDS Review, First Do No Harm, 8 July 2020. https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf
[23] Ibid.
[24] Ibid.
[25] CQC, Opening the door to change: NHS safety culture and the need for transformation, December 2018. https://www.cqc.org.uk/sites/default/files/20181218_openingthedoor_summary.pdf; The Right Reverend Graham Jones, Report of the Independent Inquiry into the Issues raised by Paterson, 2020. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/863211/issues -raised-by-paterson-independent-inquiry-report-web-accessible.pdf
