Imagine a world where we get the information about medicines and medical devices that we need to make the right choicesDr Henrietta Hughes, Patient Safety Commissioner, England about our healthcare. And those who deliver care to us get the right information to share with us so that we give truly informed consent. A world where we can ask questions and raise concerns in a psychologically safe environment, knowing that the feedback is welcomed, and the right actions taken. And where the system responds swiftly in a coordinated and compassionate way.

That’s my ambition. My role as Patient Safety Commissioner was set up following the Independent Medicines and Medical Devices Safety Review (known as First Do No Harm) that spotlighted where harm had been caused, specifically by pelvic mesh, by sodium valproate, and by pregnancy hormone drugs that led to birth defects. The report identified key themes - patients were not given the right information, their concerns were dismissed, and the health system did not listen or learn.  

Patient voices

For true patient participation we need patient voices to be embedded in the design and delivery of healthcare.

And when we seek information and views from patients, we need to spread the net wide. We know from research that if groups of patients are excluded from sharing their views and experiences, their health outcomes suffer. It’s no coincidence that the patient groups in the report whose voices were not heard were predominantly women. But people from minority ethnic groups may also be disproportionately affected by inherent bias in the system. For example, using pulse oximeters in patients from minority ethnic backgrounds risks missing low oxygen levels.

Services need to be commissioned with a wide range of patients’ views and experiences included, using language that is patient-centred and does not appear to blame people for their problems or responses to treatment. I’m pleased that the NHS England Patient Safety Strategy calls for Patient Safety Partners to be appointed so that the views and experiences of patients are included in the way services are set up and run.

Shared decisions

But what about at an individual level - how can patients participate fully in their care? The health system has been evolving along with other sectors to engage people in making shared decisions and taking shared responsibility. Some people may be fearful of this, as they may feel under prepared or lacking the experience to make the right decision.

The reason why patient participation is so important is because it addresses the fundamental question - what matters to you?  This is a question which helps to describe the context of the decision for this person or family, at this moment in their life. It can also help to identify more suitable alternatives.

Sodium valproate

First Do No Harm described women taking sodium valproate, an effective anti-epileptic medication, who were not warned of the risks to the unborn child. Ten percent of babies born to women on sodium valproate have a risk of physical malformations and 40% risk being affected with autism or learning difficulties. It’s shocking that hundreds of pregnant women were prescribed sodium valproate in the four years to March 2022 and not offered safer alternatives. I have heard from doctors that patients do not want to change their epilepsy medication because it will impact on driving or being able to work. But from patients I have heard that they are fearful about becoming pregnant on sodium valproate and would rather change to a safer medication and have the chance of starting a family.

Similarly with patients affected by pelvic mesh surgery information about possible side effects, such as pain on intercourse, was not shared. More worryingly this was not deemed to be a side effect and the manufacturers were under no obligation to share this with surgeons.


My perception is that both these cases are fundamentally about consent. The landmark case of Montgomery vs Lanarkshire Health Board showed that it’s not about the information that healthcare professionals choose to give but about the information that the patient needs to receive to make their choice and consent to treatment. This helps keep people safe and rebalances the power to give people more control in shaping their own health and care.

In this legal case about medical negligence, which was decided by the Supreme Court, it was decided that when a doctor seeks a patient’s consent to treatment, the question of whether the information given to a patient is adequate is judged from the perspective of a reasonable person in the patient's position.

It is easier to ask questions and develop trust when there is continuity of care and the chance to have an unhurried conversation in a confidential space.  There are many good examples where this is happening but it’s patchy and people’s experience of care differs.

Patient participation shouldn’t stop at the point of treatment as any problems need to be quickly identified and rectified. The Yellow Card system is the system for flagging side effects from medicines and medical devices in the UK; both patients and health professionals can report side effects. Yet after pelvic mesh surgery, patients’ feedback about problems was not routinely collected so the richness of information that could have acted as a warning sign to the system was lost and harm continued.

If you are taking a medicine or using a medical device, know, check, and ask about your treatment, and please flag any concerns.

The key to patient participation is inviting people to be involved. By sharing the right information, listening to people’s views, and quickly acting on feedback, the health system can learn, in a joined up and compassionate way, and prevent future harm.

 Dr Henrietta Hughes, Patient Safety Commissioner for England