Our safety cultures need a fix

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.