The Cumberlege Review – our safety cultures need a fix

First published in Independent Practitioner Today in October 2020

Two recommendations could lead to far more information being published about individual practitioners’ areas of clinical accreditation and financial interests. Michael Rourke reports.

Independent medicines and medical devices’ safety were examined in a report First Do No Harm in July by Baroness Cumberlege.

In a letter to the Health Secretary accompanying the review document, her overall conclusions are summarised bluntly: ‘The healthcare system – in which I include the NHS, private providers, the regulators and professional bodies, pharmaceutical and devices manufacturers and policy-makers . . . is disjointed, siloed, unresponsive and defensive.’

This report, coming so soon after the publication of the Paterson Inquiry earlier this year, has highlighted a number of failings in healthcare. 

While it will be for the Govern­ment to determine what, if any, steps to take, these two public­ations together with the repercussions from the Covid-19 pandemic, may place healthcare reform – both NHS and private – higher on the agenda than usual.

The review was asked to investigate what had happened in England in respect of two medications and a medical device: hormone pregnancy tests, sodium valproate and pelvic mesh implants. 

As the report acknowledges, these are three disparate interventions governed under two separate product regulatory frameworks. 

The review expressly did not cover other medications or devices where concerns had been raised – although it states that the list is long. Notwithstanding this, the conclusions of the report clearly apply more broadly than these three treatments and potentially to the other UK jurisdictions.

A difficult read

The review is long and detailed, amounting to 267 pages, including 12 appendices and a further 12 annexes. It is not an easy read for anyone involved in healthcare. 

It includes 12 ‘themes’ and accom­panying actions for imp­rovement alongside nine recommendations for the Government. The report is aimed at the Govern­ment and introducing systemic changes to improve patient safety. If implemented, the changes could well be widespread.   

In the longer term, the recommendations such as to overhaul the Yellow Card and improve data-gathering systems can only be welcomed. 

The Review considered that the system cannot be relied upon to identify and respond promptly to safety concerns. Whilst acknowledging that innovation in medical care “has done wonderful things”, the review has concluded that “innovation without comprehensive pre-market testing and post-marketing surveillance and monitoring of outcomes is, quite simply dangerous”. The review highlighted that for the interventions it was reviewing, the system simply could not answer how many women who had been treated or affected have had negative outcomes.

Two recommendations could lead to far more information being published about individual practitioners’ areas of clinical accreditation and financial interests.

Recommendation 7 concerns the creation of a central database of implanted devices.  Within the detail of this recommendation the Review notes that identifying individual clinician competencies is not presently an easy task. The recommendation is that the GMC expands the details of registrations to include all doctors’ clinical interests and accreditations.

Recommendation 8 is that the GMC register should also include a list of all financial and non-pecuniary interests for all doctors, and mandatory reporting of all payments made by pharmaceutical and medical device industries to clinicians and others. This recommendation was linked to Theme 7 of the review “Conflicts of interest – ‘we deserve to know’”. This sets out the potential conflicts of interests of clinicians in practice, in the governance of panels reviewing safety issues (where participants may have interests) from manufacturers and in research.

Individual practitioners may, in future, be required to provide more details of treatments undertaken (to a form of central database) and have expanded details of practice accreditation and both financial and non-financial interests. However, whilst these recommendations may, or may not be implemented by the government, practitioners will already be aware of their existing duties under the GMC’s Good Medical Practice (GMP) requirements which chime these recommendations.

GMP requires you to Recognise and work within the limits of your competence“ and to “take prompt action if you think that patient safety, dignity or comfort is or may be seriously compromised”. This includes reporting colleagues who may be unfit to practise. Whilst a more easily accessible register may increase knowledge about accreditations, it is fundamental practitioners should not endanger patients by practising in areas outside of their competence. This is also linked to Theme 8 of the Review (”Holding to account – Guidelines and Quality”). The recommendations from that Theme apply to both NHS and private hospitals, emphasising that both should encourage clinical audit and have systems for monitoring quality at board level.

GMP requires practitioners to have honesty in financial dealings. This requirement forbids practitioners from allowing financial considerations to affect the way you treat, refer or commission services for patients. Practitioners must be open about financial interests and declare these. Any inducement, gift or hospitality that may affect or be seen to affect the way you prescribe for, treat or refer patients or commission services for patients is also prohibited.

There are elements of the 12 Themes which practitioners can consider now to improve their own practise. The most directly applicable to individual practitioners are found in Themes 1, 2, 3, 5 and 6.

Theme 1 – “No-one is listening”

The Review sets out that large numbers of the women interviewed about their experiences did not believe they had been listened to when describing their experiences to treating doctors. In Hempsons’ experience such experiences by patients can lead to complaints, even where there is no clinical wrong or legal complaint. Ensuring that patients are listened to, and any clinical conclusions or recommendations clearly explained (see below concerning consent) can reduce the risks of complaints or litigation.

Theme 2 – “’I’ll Never forgive myself’ – Parents living with guilt”

The Review was, of course, looking at poor outcomes for children, and this Theme highlighted the guilt felt by parents for the harm caused unwittingly by them. However, this Theme, whilst rightly noting that the parents and women were not themselves at fault, again links to Theme 3 and consent.

Theme 3 – “I was never told”

One of the most important themes from a medico-legal perspective is Theme 3 concerning informed consent. The law of informed consent is now set by the case of Montgomery v Lanarkshire Health Board. We have previously written about this decision in “Keep it legal – informed consent – Montgomery Five Years on” and the importance of informed consent. In summary, patients need:

  • To be given all the information they require to make a decision;
  • In a manner that they can understand;
  • The information should be tailored to the specific concerns of the individual patient;
  • Should include the options and risks of adverse outcomes;
  • If adverse outcomes are unknown, this should be explained to the patient.

Reviewing how you obtain consent to procedures, the information that you provide (and ensuring that this includes information about alternative options and risks) and how you document what has been consented to, is a key requirement in modern medicine. The last issue of recording work clearly, accurately and legibly is a requirement of GMP. The Review, however, calls the sheer variety of consent forms now in use as “bewildering and a major source of confusion”. The Review indicates that where appropriate and with the agreement of the patient and doctor, conversations about consent should be audio or video recorded.

In the longer term, the Review has recommended that a single patient-decision aid should be produced for each surgical procedure or medical intervention and that NICE should take the lead on facilitating this. Pending this, a point to consider is whether, if you are using these forms, they are clear and appropriate. The forms introduced in the wake of Montgomery could be refreshed and improved. Whether video or audio recording of consultations will become commonplace will need to be seen. If this is to be undertaken, aside from the issue of consent, thought will need to be given to issues over the safe and secure storage of these to comply with data protection requirements.

Theme 5 – “‘We do not know who to complain to’ – Complaints”

This Theme raises the issue that patients find navigating complaints systems for healthcare confusing and difficult. In both the private and NHS sector there should be clear details of how to complain. In the private sector there are less avenues for complaint, but as noted under Theme 1, ensuring that patients are listened to, and complaints dealt with appropriately, can reduce the risk of complaints escalating. For CQC registered providers, having an effective complaints system is a regulatory requirement.

Theme 6 -: “Duty of Candour – ‘preventing future errors’”.

The Review notes that patients considered that there was a lack of open conversation when things had gone wrong. The Theme highlights that there is a professional duty of candour on practitioners, including a statutory duty for CQC registered providers. The review highlights that identifying breaches of this, and enforcement, has not been “entirely effective”. Linked to Theme 5 and Theme 1 above, listening to patients, and dealing with patients concerns openly is likely to be a greater concern of regulators and employers in the future.

Themes 4 and 7 -12 contain detailed and important comments and recommendations on the resolution of issues for the interventions considered and the systemic failures concerning patient safety. Recommendations include wider data gathering (including registries and databases), a Patient Safety Commissioner, improved assurance processes and amending the regulatory approaches governing the MHRA. It will need to be seen how these recommendations are taken forward, but on the back of two reports highlighting safety concerns in the private and NHS sectors, at least some of the recommendations are likely to be adopted.