In this blogpost Dr Victoria Moore explores the role of the Patient Safety Commissioner, arguing that it may not be sufficient to ensure patient safety
I am nearly a couple of months late for New Year predictions, but nevertheless, here is mine for 2022. I predict that the new Patient Safety Commissioner (PSC) role – established only recently via the Medicines and Medical Devices Act 2021 – is going to fall short on a number of fronts. Although, for reasons I touch on below, we are in sore need of a PSC, the role’s remit, as set out in the recent advert for the job, reveals a far-too-limited understanding of what patient safety entails. This will, unfortunately and inevitably, present issues for patients down the line.
The main problem, which this blog post explores, can be summarised thus: a narrow understanding of patient safety causes further safety issues and unfairly disadvantages some patients. Before delving into this, some brief background.
Who is the Patient Safety Commissioner?
The PSC role was created in response to a recommendation by the Independent Medicines and Medical Devices Safety Review (IMMDS Review) led by Baroness Cumberlege. The Review examined how the English healthcare system responded to concerns about harmful side effects from specific medicines and medical devices, and considered how future responses to such concerns could be quicker and more effective. The Review argued:
‘we do not need another regulatory body in an already crowded field. But we do need a new voice, with statutory powers, to talk and act from the perspective of the patient, to encourage the system to do what needs to be done and hold it to account’.
In January 2022, recruitment for the new PSC commenced, with the successful applicant expected to be announced later this year. The PSC will be an independent statutory office holder sponsored by the Department of Health and Social Care (DHSC) and accountable to the Parliament. The core role of the PSC is to ‘promote the safety of patients in the context of the use of medicines and medical devices and to promote the importance of the views of patients and other members of the public in relation to the safety of medicines and medical devices.’ Herein lies the first problem.
A Narrow Understanding of Patient Safety
Safety in healthcare extends far beyond ensuring the safety of medicines and medical devices. For example, recent research into avoidable harm within primary care in England found that diagnostic error accounted for most harms. This was followed be medication errors and delayed referrals. A lack of coordination and continuity of care across healthcare services exasperated the issues. For patients, ‘feeling safe’ incorporates having ‘confidence that they would be listened to seriously, treated with respect and dignity, not unduly hurried, disbelieved, judged negatively, patronized, or have their concerns dismissed as trivial.’ A feeling of safety in healthcare may be far too vague an aim for the PSC to be concerned with, but its absence can indicate broader, significant failings in healthcare.
That is a lesson that should have been learnt long ago, particularly when the failings of Mid Staffs were brought to light. The safety issues in that instance did not relate to patients’ concerns about medicines or medical devices being unheard, but of patients’ very basic care needs being ignored and their relatives’ concerns entirely dismissed. This dismissive attitude towards patients has since continued throughout the NHS, as evidenced in the IMMDS Review and Ockenden interim report. The latter involved reviewing the cases of 1862 families where mothers and/or babies had died or experienced significant harm whilst receiving maternity care at the Shrewsbury and Telford Hospital NHS Trust. The findings are already highlighting a failure to listen to women and provide them with compassionate care.
Thus, to focus simply upon the safety of medicines and medical devices is missing the bigger picture. The underlying issue is the all-too-frequent failure of healthcare professionals to respect the lived experiences of their patients and to work in partnership with them whilst providing healthcare.
A Matter of Fairness to All Patients
The second problem with the remit of the PSC stems from the narrow understanding of patient safety. As things now stand, a person who is harmed by a medical device could report this to the PSC. The PSC will not investigate the individual case as this is the responsibility of other bodies, but the PSC will have the power to make these other bodies respond.
However, a patient who is not harmed by a medicine or medical device will not have this option of approaching the PSC to champion their voice. By way of example, this means that a patient harmed because of a poor hospital discharge experience would not be able to raise this with the PSC. This presents a significant risk of further fragmentation within the healthcare system regarding how patient’s safety incidents are addressed. The complaints procedure is already complex and confusing. Those harmed due a reason unrelated to medicines or devices are therefore likely to be increasingly disadvantaged, being neither listened to nor supported in the aftermath of a patient safety incident.
If only one aspect of patient safety is subject to enhanced scrutiny, there is a perverse incentive for the healthcare system to focus improvement efforts upon these areas only and to disregard the other elements. This is unfair to patients, and potentially increases the risk of harm from system factors.
Conclusion
The PSC is a welcome addition to the healthcare system and certainly has the potential to improve safety matters in the narrow context of medicines and medical devices. However, the same level of advocacy is needed for patients experiencing harm relating to any aspect of their healthcare. A failure to do so introduces inequality in how patients are treated following a safety incident and risks perpetuating safety failures.
The decision to create the PSC as part of the Medicines and Medical Devices Act 2021 was too hasty, particularly given the introduction of the Health and Care Bill shortly after. The latter, with its aim to support safety across the NHS, is an obvious better fit for granting the necessary broader remit to the PSC. Unfortunately, we are now in a position where the PSC is bound, because of the remit of the role, to fail to influence patient safety to the extent that is so urgently needed.
Written by: Victoria Moore