The Scottish Government is holding a consultation to gather views about the role of Patient Safety Commissioner, which is being created in Scotland. The consultation is open to anyone who wants to contribute and it closes on 28th May 2021.
The Patient Safety Commissioner role could be a great asset to the ME community, providing an independent position of power to report harms caused by the health system and other authorities and organisations. However, it’s being suggested that the focus of the role should be specifically on the safety of medicines and medical devices which would mean that treatments outside of this, such as Cognitive Behavioural Therapy (CBT) and Graded Exercise Therapy (GET), wouldn’t be included.
The role is being created following a recommendation in the report from the Independent Medicines and Medical Devices Safety Review, called “First Do No Harm”, which is also known as the Cumberlege review or report. The report focuses on how the health system responds when patients and their families raise concerns about the safety of treatments. It reviewed patients’ experiences of pelvic mesh implants, sodium valproate and hormone pregnancy tests, but its findings and recommendations could apply to a wide range of patients, including people with ME.
For many years people with ME and ME organisations, including #MEAction Scotland and #MEAction UK, have campaigned against the use of CBT and GET for patients with ME but have had nowhere to formally report the harm it has caused. Systems for reporting adverse drug reactions do exist, such as the Yellow Card Scheme, but they do not allow for patients to report adverse reactions to treatments and therapies.
The Patient Safety Commissioner role could provide a way to fill this gap in reporting and ensure therapies like GET can be formally reported. Even as guidance around GET begins to change, we know it will take time to filter down through NHS systems and so we need to be able to take action where it’s found that these harmful therapies are still being offered.
#MEAction Scotland is submitting a response to the consultation suggesting this but you can also submit a response as an individual or a support group. The more responses the Government receives asking to widen the scope of the role, the more they will see it as an important issue.
We have provided some suggested answers to the consultation questions below which you can copy and paste to save you time and energy if helpful, but you are welcome to write your own response. There are 16 questions in total and the responses are submitted online through the Government website. You can save your response and come back to it later to break up the activity.
Consultation questions and suggested responses:
1. Do you agree that the Patient Safety Commissioner role should first focus on medicines and medical devices, as set out in the Cumberlege Review?
Suggested answer: No
Suggested comments:
I believe that the Patient Safety Commissioner role should also focus on treatments and therapies. Patients with Myalgic Encephalomyelitis (ME) have been harmed by being treated with Graded Exercise Therapy (GET) and Cognitive Behavioural Therapy (CBT). Despite patient surveys showing the majority of patients saw a deterioration of their health* there was nowhere to report this. The Patient Safety Commissioner should listen to all patients that have been harmed by the health system.
2. If the role were to expand in the future, which specific aspects of patient safety do you feel the Patient Safety Commissioner should focus on?
Suggested response:
The most important expansion of the role is to ensure that it also includes assessment of the safety and regulation of treatments and therapies as well as medicines and medical devices. Beyond this I believe the Patient Safety Commissioner role should be led by patients’ voices and should connect with patient organisations to hear from them. Myalgic Encephalomyelitis (ME) affects over 20,000 people in Scotland and the patient community has a great deal of knowledge and understanding that is being ignored or misunderstood by healthcare professionals.
3. Do you believe that the Patient Safety Commissioner should be independent of the Scottish Government?
Suggested answer: Yes
Suggested comments:
The Patient Safety Commissioner should be responsible to the Scottish Parliament, not to the Scottish Government, as they will need to be free to challenge the government when required.
4. Do you believe that the Patient Safety Commissioner should be independent of the NHS?
Suggested answer: Yes
Suggested comments:
The Patient Safety Commissioner should be independent of NHS Scotland otherwise it would be too easy for NHS Scotland to regard the Commissioner as one of its own advisors and neglect their recommendations where they conflict with other priorities. NHS Scotland could effectively minimise the impact of the Commissioner’s role by restricting the budget and staff available to them or reduce the visibility of the Commissioner’s findings by failing to publish them.
5. Who should the Patient Safety Commissioner be accountable to?
Suggested response:
The Patient Safety Commissioner should be accountable to the Scottish Parliament, who may need to challenge the government to implement the Commissioner’s findings.
6. How much do you know about existing policies and organisations already* in place to support patients' voices to be heard within the healthcare system?
*(listed in table 1 on page 11)
Note: You will need to choose from the dropdown based on your own knowledge. The table mentioned includes the Patient Rights (Scotland) Act 2011, the Charter of Patient Rights and Responsibilities, the NHS complaints process, the Scottish Public Services Ombudsman (SPSO), Patient Advice and Support Service (PASS), Care Opinion, regulatory bodies, the organisational Duty of Candour procedure and the Yellow Card Scheme.
Suggested comments:
Many of these existing policies involve complaining to the organisation that the patient has been harmed by, which can be traumatic and can also mean complaints are more easily dismissed. To access some of these services, such as the SPSO, you already need to have put a great deal of energy and time into the process.
7. In your view, despite the existing ways patients can make their voices heard*, why do you think people still feel that this is not happening?
*(listed in table 1 on page 11)
Suggested response:
The current processes are often confusing and complex and, with so many different places to report, trends are not always easy to recognise. As shown in the Cumberlege report, patients are often dismissed or not believed when they try to make a complaint. Patients with Myalgic Encephalomyelitis (ME) have limited energy and may experience cognitive issues that make lengthy, complex processes extremely difficult, often impossible, to complete. Many patients with ME report agencies not being joined up, meaning they have to make their complaints many times over and still find they are ignored.
8. In your view, what should the main functions of the Patient Safety Commissioner be?
Suggested response:
The main functions of the Patient Safety Commissioner should be to listen to patients and patient organisations and take the time to understand their experiences, and then to speak truth to power and intervene where harm is happening. They will need to be very well informed about health issues and led by science, as opposed to popular opinion or party politics.
9. What skills and expertise do you think the Patient Safety Commissioner needs to carry out their role?
Suggested response:
The Patient Safety Commissioner will need to have compassion, empathy and a willingness to listen. They will need analytical skills to identify trends, prioritise issues and comprehend problems. They will need to be decisive and confident to work entirely independently without influence.
10. What support do you think the Patient Safety Commissioner would need?
Suggested response:
It is likely that the Patient Safety Commissioner would need a team to achieve this role. The analysis, comprehension and interpretation of data may be done by supporting staff, as well as regular communication about activity and progress. They may also need access to independent legal advice.
11. Do you think that the Patient Safety Commissioner role should be established in law?
Suggested answer: Yes
Suggested comments:
The ME advocacy organisation #MEAction Scotland previously saw how difficult it was for the Public Petitions Committee to obtain responses from Health Boards regarding the use of GET on ME patients. A statutory position will be needed to increase cooperation and enforce compliance to implement change where required.
12. What are your views on how creating a Patient Safety Commissioner might affect the protected characteristics of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, and sex?
Suggested response:
ME predominantly affects women; it is believed the ratio of women to men affected could be as high as 4:1*. As seen in the Cumberlege Report, the UK health system is prone to gender bias, both conscious and unconscious, with many female patients being dismissed as having “women’s issues” or being told “it’s all in their head”. The Commissioner role could provide a platform to empower and amplify women’s voices in the Scottish healthcare system.
The role could also support the Scottish Government’s commitment to address racial inequality in Scotland. The Race Equality Framework acknowledges the current poorer health outcomes for minority ethnic groups in Scotland, and also that “minority ethnic groups are less likely to report having long-term limiting health conditions and disabilities”. Having a Commissioner who is willing to listen and advocate for patients from minority ethnic groups may help to rebuild trust in the healthcare system.
13. The Fairer Scotland Duty places a legal responsibility on certain public bodies in Scotland to actively consider how they can reduce inequalities caused mainly by people's financial situation. What are your views on how having a Patient Safety Commissioner might affect this inequality?
Suggested response:
Due to the fact that there are no safe treatments for ME currently offered on the NHS, many patients have to pursue treatment privately – and this route is not accessible to people who can’t afford it. Many people with ME are unable to work and often family members have to reduce or leave work to take on caregiving responsibilities, so the illness can have a direct impact on reducing income.
A Commissioner listening to and championing the patient voice, and working alongside other agencies such as the Department for Work and Pensions could be invaluable to supporting patients struggling financially.
14. If you live in an Island Community, what are your views on how having a Patient Safety Commissioner might affect access to safe, high‑quality public services where you live?
Suggested response:
A Patient Safety Commissioner could champion safe, high-quality public services for all patients, and highlight to the Scottish Government and NHS where patients are at a disadvantage because of their location.
15. What are your views on how having a Patient Safety Commissioner might affect respecting, protecting and fulfilling the rights of children and young people as set out in the UN Convention on the Rights of the Child?
Suggested response:
Myalgic Encephalomyelitis (ME) has been reported in children as young as five*. The Patient Safety Commissioner’s role should mean that they are more informed about specific health challenges facing children and young people and can advise others such as the Children and Young People’s Commissioner and the Minister for Children and Young People. This role will be particularly relevant to upholding Article 24 of the UNCRC – “Every child has the right to the best possible health.”
*https://meassociation.org.uk/about-what-is-mecfs/children-and-adolescents/
16. Do you have any further comments on the Patient Safety Commissioner role that you haven't covered in your responses to the previous questions?
Suggested response:
The use of Graded Exercise Therapy (GET) to treat ME has caused permanent and serious harm to a large number of people in Scotland. It is anticipated that the new NICE guideline on ME/CFS, to be published in August 2021, will recommend the abandonment of GET and CBT and the adoption of more suitable strategies (i.e. pacing). But this change won’t happen immediately. Without a concerted effort to re-educate medical professionals and students, patients will continue to be mistreated, with devastating consequences, for a long time to come. I hope the Patient Safety Commissioner will support the ME community in this important task.
