The Patient Safety Commissioner (PSC), Dr Henrietta Hughes OBE FRCGP, has reported on her first 100 days in her new role. The 100 Days Report sets out Dr Hughes’ findings and priorities, based on her experience of listening to patients’ concerns since her appointment in July last year. She concludes that it is clear that the culture within healthcare is getting worse, and issues a stark warning to the government and NHS England that without radical action to listen and act to prioritise patient safety, we are heading for further ‘health scandals, severe harm and death’. Who is the Patient Safety Commissioner? The first Patient Safety Commissioner for England was appointed in response to recommendations by the Cumberlege Review which found that the healthcare system’s failure to listen and act on patients' concerns about valproate, vaginal mesh and Primodos had caused avoidable harm to thousands of women and their children. Baroness Cumberlege set out her vision for a new Patient Safety Commissioner’s role in her introduction to First Do No Harm, the report of the Independent Medicines and Medical Devices Safety (IMMDS) Review 2020: “The system is not good enough at spotting trends in practice and outcomes that give rise to safety concerns. Listening to patients is pivotal to that. This is why one of our principal recommendations is the appointment of an independent Patient Safety Commissioner, a person of standing who sits outside the healthcare system, accountable to Parliament through the Health and Social Care Select Committee. The Commissioner 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. This person would be the golden thread, tying the disjointed system together in the interests of those who matter most.” Since her appointment as Patient Safety Commissioner (PSC) in July 2022, Dr Hughes has been listening to patients and working to raise their concerns and ensure that their voices are heard within government, the NHS, and professional organisations, such as the General Pharmaceutical Council. She describes her role as promoting the safety of medicines and medical devices, promoting the voices and views of patients and the public, and helping the government and the health system to listen and act. What does the 100 Days Report by the Patient Safety Commissioner (PSC) say? During her first 100 days as PSC, Dr Hughes has heard from patients, healthcare professionals and senior leaders who want patient safety to be put at the top of the government’s and healthcare system’s agenda. Instead, the NHS’s focus is on productivity, operational performance and financial control. Medicine has become industrialised but needs to be humanised to become personal, meaningful and safer. Echoing frustrations recently expressed by Keith Conradi on his departure from HSIB, the PSC found that patient safety is too low on the DHSC’s agenda. Patients and their stories are not represented on DHSC or NHS England’s boards, and reports by the CQC and the National Guardian’s Office suggest that increasingly patients (and staff) who try to raise concerns do not feel heard. One of the many areas in which the PSC found a lack of progress since the Cumberlege (IMMDS) Review is in relation to harm caused by sodium valproate. Even now, three babies a month are being born after exposure to sodium valproate and the needs of around 20,000 children with physical and learning disabilities from valproate exposure are still not being met. There is also increasing evidence that harm can also be caused to babies whose fathers are taking valproate, and that valproate harm can affect future generations. There are strict requirements for women who are prescribed valproate to be taking effective contraception, informed of the risks and regularly reviewed by specialist prescribers, and rules relating to warnings on valproate packaging. However, Dr Hughes refers to audit data which shows that in practise nearly one in five patients taking valproate had not discussed the drug or contraception with their GP or specialist in the last year, and many were not receiving warnings, appropriately packaged tablets, or signposting by pharmacists to ensure adequate contraception. Failings in the disjointed healthcare system sometimes leaves GPs with no option but to prescribe valproate to patients at risk of life-threatening seizures. Next steps for the Patient Safety Commissioner Dr Hughes believes that if patients’ voices are to be championed and avoidable harm reduced, there must be: inclusion of the patient voice in all aspects of the design and delivery of healthcare; patient access to information and data; a psychologically safe culture; a swift, compassionate response when things go wrong. Patients’ concerns are still treated dismissively, defensively and with lack of action, particularly when the truth is inconvenient. They are not being heard or getting the information they need. Dr Hughes’ top three priorities in her role as PSC will be culture change, pelvic mesh complications and sodium valproate. She will also be holding a public consultation on the Principles of Better Patient Safety. Recognising that her three year term leaves little time to transform the attitudes, behaviours and culture of the NHS, particularly when the healthcare system is under enormous pressure, Dr Hughes warns health leaders that neglecting patient safety will inevitably result in harm. She challenges national and professional bodies, regulators, healthcare staff and patient groups to step forward and demonstrate their commitment to patient safety. Dr Hughes’ first 100 days as Patient Safety Commissioner have convinced her that there must be a ‘seismic shift in the way that patients’ and families’ voices are heard. This requires changes in legislation, regulation, policy, commissioning, education, professionalism, attitudes, behaviours, and culture. In essence, everything we do as a healthcare system because everything we do is about patients.’ Boyes Turner’s clinical negligence team are currently acting for several families whose children have been physically or cognitively disabled as a result of negligent exposure to valproate during pregnancy. We continue to raise awareness about the risks and consequences of harm from sodium valproate exposure. We welcome the Patient Safety Commissioner’s forthright and fearless 100 Days Report and her ongoing work to reduce avoidable harm by encouraging improvements in patient safety. If you have been seriously injured as a result of medical negligence, or have been contacted by HSIB/HSSIB, MNSI or NHS Resolution following your hospital care, you can speak to one of our experienced solicitors, free and confidentially, for advice on how to respond or make a claim, by contacting us here.