The “First Do No Harm” report was published in July 2020. The review, chaired by Baroness Cumberlege, looked at patient safety issues arising from the use of Primodos (a home pregnancy testing kit used between the 1950s and late 1970s), the epilepsy drug sodium valproate, and vaginal mesh surgery. 

The report describes “…a system that does not work in a joined-up fashion, and that lacks the leadership to deliver coherent and fully integrated patient safety policy directives and standards” where…”mistakes are perpetuated through a culture of denial, a resistance to no-blame learning, and an absence of overall effective accountability.”

Cumberlege and her team found the system to be “…disjointed, siloed, unresponsive and defensive” concluding that it failed to listen to patients’ concerns and moved at a “glacial” pace to address problems when they were eventually acknowledged. 

The principal recommendation of the report is to create a new role of independent Patient Safety Commissioner (PSC), “… a person of standing who sits outside the healthcare system, accountable to Parliament…” who would “…be the patients’ port of call, listener and advocate, who holds the system to account, monitors trends, encourages and requires the system to act.” 

The government response to the report got off to a slow start with Cumberlege describing the lack of progress as “woeful” in November last year. However, in December the government announced that the legislative basis for a new Patient Safety Commissioner would be incorporated in an amendment to the Medicines and Medical Devices Bill. These amendments have recently been published and were passed through the Commons on 27th January.  

The government’s accompanying factsheet describes the PSC as “…a champion for patients…to promote the safety of patients and the importance of the views of patients in relation to medicines and medical devices.”

A positive change 

Confirmation that change will follow the Cumberlege report is welcome news. It would have been unforgivable if women and families harmed by the issues identified in the review were neglected again by a failure to implement the report’s central recommendation. However, it would be a mistake to view the issues identified in the report as being unique to the specific areas of healthcare covered in the review.

The Francis report (2013) into the serious failures at Mid-Staffordshire trust told a story of appalling suffering of many patients and described the local trust as not listening sufficiently to its patients. Francis also described a “…plethora of agencies, scrutiny groups, commissioners, regulators and professional bodies, all of whom might have been expected… to detect and do something effective to remedy non-compliance with acceptable standards of care…,” which they failed to do. 

Following the Francis report, the patient safety landscape has changed significantly as efforts have been made to ensure patient experience and the voice of harmed patients is never again overlooked. These changes include the establishment of the regional Health Watch network and national Health Watch – the “independent national champion for people who use health and social care services…” who “…have the power to make sure that those in charge of health and social care services hear people’s voices,” as well as the introduction of a statutory duty of candour on all healthcare providers registered with the Care Quality Commission (CQC).

Despite this, evidence suggests that we still have a long way to go. The interim Ockenden report (Dec 2020) into serious failures in maternity care at Shrewsbury and Telford Trust, includes “listening to women and families…” as an immediate and essential action. Ockenden recommends that every trust in the country appoints an independent advocate who would be “…available to families attending follow up meetings with clinicians where concerns about maternity or neonatal care are discussed, particularly where there has been an adverse outcome.”

Joining the dots

The Cumberlege report make welcome and well evidenced recommendations for change, but the danger of engineering solutions to specific problems explored in focused inquiries is that we create an even more fragmented and complex system for patients to navigate, creating multiple pathways depending on arbitrary circumstances, when what patients really want is a system that is clear, accessible, easy to navigate and effective for everyone. 

The central issue Cumberlege intends to address with the Patient Safety Commissioner role—the current reticence of the healthcare system to listen and hear the voices of harmed patients and families—is much wider that the circumstances explored in her review. 

Instead of creating an even more fragmented and disjointed system for harmed patients and families to navigate, why not strengthen the advocacy available for all patients and ensure that the new Patient Safety Commissioner has a system wide remit to truly become a champion of all patient voices. 

Doing so would ensure that we not only learn from the terrible failure to listen to women and families harmed through Primodos, sodium valproate and vaginal mesh, but that we also reduce the risk of further major inquiry reports concluding that other serious risks to patient safety could have been recognised and acted on sooner, if only the voice of harmed patients and families had been properly heard.   

James Titcombe, Patient Safety Campaigner and co-founder of Harmed Patients Alliance.

Joanne Hughes, Co-founder Harmed Patients Alliance, Author www.mothersinstinct.co.uk, Patient Safety Campaigner and Advocate for Restorative Healing Approaches after Healthcare Harm. Twitter: @Mothers_Inst_UK

Competing interests: None declared.