Patient Safety Commissioner, Dr Henrietta Hughes, joined us during patient partnership week. She was in conversation with our Chief Executive Rachel Power. Because of time, she wasn't able to answer all questions asked then, so here are answers to the questions she didn't have time for. You can also watch the webinar, if you weren't able to attend the event.

Patient Safety Commissioner role

Q: What should the remit of the Patient Safety Commissioner be?

A: My remit is to champion the patient voice and the views of patients and the public in terms of safety of medicines and medical devices. Culture change and patient voice need to be central to the design and delivery of healthcare. My current focus is on sodium valproate and pelvic mesh, but other areas of medicines and medical devices safety are also being raised with me and I am seeking additional resources to escalate these.

Q: How will you make your role accessible?

A: By attending events, such as the Patients Association patient partnership week, and in person, and by patients getting in touch directly. In future the Patient Safety Commissioner website will be a way of gathering views and intelligence, that I can then amplify to health system leaders. Next year I will be arranging

Current system

Q: Does the Medicines and Healthcare products Regulatory Agency (MHRA) need a performance review?

A: There are lots of areas of improvement that MHRA is already doing including the recommendations from the First Do No Harm report and we’re having ongoing meetings and conversations.

Q: What is your view on how well the Patient Advice and Liaison Service (PALS) feedback route is working?

A: So much depends on the trusts’ leaders’ approach to patient feedback, training, and resourcing of PALS and how they work with different parts of the trust and the wider health system. It can be brilliant but also needs the support of the system leaders for changes to be adopted and embedded.

Q: How well is the national patient alert system working?

I am having conversations with the national patient safety director, who can see early signals from dispersed problems and take immediate action, for example, by alerting all providers.  

Q: What is the patient safety partners’ role in this?

A: It’s important that the voice of patients is heard by trust boards. I am looking forward to attending a meeting with patient safety partners to understand their roles, their successes, and any barriers they may face.

Individual issues

Q: What can I do when I am not being listened to in my post-stroke care?

A: I’m very sorry to hear about your experience. You may find it helpful to speak with your GP practice manager and hospital PALS team. The Stroke Association may also be able to provide advice and support. Stroke Association | Home

Q: Is there a way of finding out how many patients have died due to pelvic mesh?

A: I’ve heard individual reports of patients who have had mesh who have died. It’s difficult from the limited information I’ve seen to know whether mesh was a contributing factor in every case. Following my calls for greater data transparency I’m delighted that NHS Digital is producing a report related to the incidence of re-operations and mortality following pelvic floor procedures and aims to release the results by spring 2023, following consultation with clinicians.

Q: Where can we get more information about the Yellow Card reporting system?

A: The MHRA website has information - you can access it here

Q: When will something be done for people who have been harmed by the COVID-19 vaccines?

A: I met with Sir Christopher Chope MP, who chairs the COVID-19 vaccine damage All Party Parliamentary Group, and there is a redress scheme in operation, but concerns were raised about the time taken for patients to receive payments and about the way the scheme is designed. I am following up on Sir Christopher’s concerns about the scheme.


Q: How do we get over patients’ fear of future poor care if they complain?

A: This is about leaders welcoming feedback from patients and giving people the opportunity to share their experience without fear of victimisation. I am aiming to amplify the patient voice at Boards and to ensure that speaking up by patients and families is welcomed and leads to change.

Q: How do we improve the patient voice in primary care?

A: Patient participation groups, primary care networks and Integrated Care Boards (ICBs) are a key route, but it depends on local leadership. There are some very good examples where patients’ needs are heard and acted upon.

Q: Can you or Integrated Care Systems (ICSs) encourage sharing of information and learning between GP surgeries?

A: There is a huge amount of information sent to GPs in newsletters from the Royal College of General Practitioners, NHS England and the General Medical Council, as well as information from local medical committees but there’s not enough time to read all of these and the alerts. Clinical meetings can be a good way to share information and to reflect with colleagues but even this can be difficult when there’s so little time and very long working days. Ideally time needs to be carved out to keep on top of information.

Q: What is your view about registries to monitor patient safety?

A: They need to be designed with a diverse group of patients and multidisciplinary team to ensure we collect the information that matters. We need consent to share information with third parties, which can be very helpful in feeding back to manufacturers. Registries need to be completed with a single patient identifier and standards eg the NHS number and GS1 standards (globally unique identification keys) can also help so we are clear what is used in whom, by whom, for what indication, by which method, and when. All these factors can be significant in patient outcomes and can help to identify problems early and groups who may be more at risk.

Q: Do you envisage a time when clinicians are less frightened to offer an apology?

A: This is a whole system problem and needs a whole system solution – role modelling by senior clinicians during training, changes in regulation so that the system recognises the context in which clinicians are working, policies directed towards a just culture, press and public not looking for scapegoats, leaders feeling empowered to hear difficult feedback and to empower the workforce to respond swiftly and compassionately to patients and make the changes that need to happen.

Q: How can patients really be empowered?

A: There are great examples where patients, families, clinicians, and manufacturers have worked together, such as cochlear implants. Also, with stoma products, patients have close connections with manufacturers and pharmacies. And the expert patient programmes because patients know much more about their condition and how it affects each individual personally.

Redress for patients in First Do No Harm

Q: Is there any update on redress for those harmed by pelvic mesh, sodium valproate or Primodos?

A: I am having ongoing discussions with officials and am keen that all recommendations from First Do No Harm are addressed. I raised the voices of patients and families suffering from the impact of pelvic mesh and sodium valproate, setting out my findings in the first two months of my role. Within a week I met Minister for Women Maria Caulfield, and we discussed redress, highlighted by her in debate on harm from sodium valproate in Parliament the following day. The Minister has asked me to look deeper into this and I will be following up with patient groups to hear their voices and raise them into the heart of government.