First Do No Harm
Reprint from PIPELINE Issue 62; October 2020 © Copyright Pharmaceutical Information and Pharmacovigilance Association. All rights reserved.
In February 2018 Jeremy Hunt, the then Secretary of State for Health and Social Care, announced a review (chaired by Baroness Julia Cumberlege) to examine how the healthcare system in England responds to reports about harmful side effects from medicines and medical devices and to consider how to respond to them more quickly and effectively in the future.
The Independent Medicines and Medical Devices Safety (IMMDS) Review [1] was prompted by patient-led campaigns, in particular:
• hormone pregnancy tests (HPTs) – tests, such as Primodos, which were withdrawn from the market in the late 1970s and which are thought to be associated with birth defects and miscarriages;
• sodium valproate – an effective anti-epileptic drug which causes physical malformations, autism and developmental delay in many children when it is taken by their mothers during pregnancy; and
• pelvic mesh implants – used in the surgical repair of pelvic organ prolapse and to manage stress urinary incontinence. Its use has been linked to crippling, life-changing, complications.
Over the course of two years, the review heard from hundreds of patients and healthcare system stakeholders. The final report was published on 8 July 2020. It runs to 277 pages, including appendices, but is well worth a read.
The key themes of the report are:
- patients were involved in their care appropriately and then not believed or supported when complaining of subsequent problems;
- a defensive blame culture running throughout the healthcare system, leading to a resistance to change and transparency;
- a chronic underreporting of adverse events, with the Yellow Card Scheme poorly known or understood;
- available safety data not being used to best effect;
- a healthcare system that is disjoined and not properly integrated.
Discussions of the themes themselves provide a great deal of food for thought on where things went / are going wrong and are also a great insight into how other sides of the healthcare system, that we in pharma are not directly involved with, work. However, the report boils down to nine formal recommendations:
Recommendation
1. The Government should immediately issue a fulsome apology on behalf of the healthcare system to the families affected by Primodos, sodium valproate and pelvic mesh.
2. The appointment of a Patient Safety Commissioner who would be an independent public leader with a statutory responsibility. The Commissioner would champion the value of listening to patients and promoting users’ perspectives in seeking improvements to patient safety around the use of medicines and medical devices.
3. A new independent Redress Agency for those harmed by medicines and medical devices should be created based on models operating effectively in other countries. The Redress Agency will administer decisions using a non-adversarial process with determinations based on avoidable harm looking at systemic failings, rather than blaming individuals.
4. Separate schemes should be set up for each intervention – HPTs, valproate and pelvic mesh – to meet the cost of providing additional care and support to those who have experienced avoidable harm and are eligible to claim.
5. Networks of specialist centres should be set up to provide comprehensive treatment, care and advice for those affected by implanted mesh; and separately for those adversely affected by medications taken during pregnancy.
6. The Medicines and Healthcare products Regulatory Agency (MHRA) needs substantial revision particularly in relation to adverse event reporting and medical device regulation. It needs to ensure that it engages more with patients and their outcomes. It needs to raise awareness of its public protection roles and to ensure that patients have an integral role in its work.
7. A central patient-identifiable database should be created by collecting key details of the implantation of all devices at the time of the operation. This can then be linked to specifically created registers to research and audit the outcomes both in terms of the device safety and patient reported outcomes measures.
8. Transparency of payments made to clinicians needs to improve. The register of the General Medical Council (GMC) should be expanded to include a list of financial and non-pecuniary interests for all doctors, as well as doctors’ particular clinical interests and their recognised and accredited specialisms. In addition, there should be mandatory reporting for the pharmaceutical and medical device industries of payments made to teaching hospitals, research institutions and individual clinicians.
9. The Government should immediately set up a task force to implement this Review’s recommendations. Its first task should be to set out a timeline for their implementation.
Recommendations 2, 6 and 7 are probably the most relevant for PIPA members, professionally.
The PIPA QPPV Workstream is looking at the role of the QPPV in the context of patient centricity, so will look to see how this could tie in with any Patient Safety Commissioner. The newly created role will be an important advocate for patients but shouldn’t end up being another stakeholder acting in isolation from all others. The QPPV would be an obvious advocate for a commissioner within companies, especially as they retain an ability to influence safety systems. As I came to finish writing this article, Scotland was the first of the UK nations to announce it would appoint a Commissioner. It may not be clear what will actually be entailed, but it’s a positive step; “What the patient safety commissioner’s role looks like, where it will sit, and how it will function will need to take cognisance of the Scottish context, so will require further work, including consultation with patients” [2].
Recommendation 6 is of particular interest in light of confirmation that the Medical Devices Regulation (MDR) will not be applicable in the UK, as it is coming into force post-Brexit so will not be automatically retained in the UK. Firstly, it will be interesting to see how the MHRA grasp the opportunity to diverge from Europe on medical devices themselves. The following is from the MHRA post-Brexit guidance on medical devices [3]:
“The Independent Medicines and Medical Devices Safety Review … has highlighted the importance of strengthened regulations that do more to protect patients. We are committed to improving the standards and scrutiny of medical devices that reach UK patients. This will be enabled through the powers currently being created through the Medicines and Medical Devices Bill.
We have the opportunity to develop a robust, world-leading regulatory regime for medical devices that prioritises patient safety. We will take into consideration international standards and global harmonisation in the development of our future system.”
Secondly, it may well be instructive as to the MHRA’s appetite for future divergence on medicines regulation. The current post-Brexit PV and QPPV expectations need further clarification as it currently stands (writing this at the start of September), but it certainly looks like continuity will be the short-term plan. Medical device legislation may be the first sign we get as to the direction of the long-term future of PV in the UK.
It’s also a recommendation that should be seen as a green light to the industry to support the MHRA and shout about the PV side of their operations. Another development, as this article was being written, was the pause in AstraZeneca’s Covid-19 vaccine trial due to a serious adverse event (SAE) being experienced by one of the subjects. This should be used as an opportunity to increase awareness of what clinical safety and PV involves because, in the absence of explanation, it will definitely be used by anti-vaxxers if all people are aware of from the trial is a high profile SAE without context!
Recommendation 7 may also lead to greater harmonisation of device and medicine regulation, with the use of registries. How this would work in practice is tied into 6 and the MHRA’s review of device regulation.
It is worth remembering that none of the recommendations in the report are binding, so may not immediately translate into real change. However, it’s an important document for anyone working in healthcare as a daily reminder that we are not working in a coherent and integrated system. The report lays bare the real-world outcomes of that system and should focus all stakeholders’ minds to improve things. In the short-term we can all play our part by making sure we do our jobs with the dependencies of other stakeholders in mind, and also start to shed any blame culture which will be needed to breakdown the barriers of the current system.
References
1. https://www.immdsreview.org.uk/index.html
3. https://www.gov.uk/guidance/regulating-medical-devices-from-1-january-2021
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