Date of prep: December 2020
Prescribing information and
adverse events reporting
For healthcare professionals only
After two years of work the Independent Medicines and Medical Devices Safety Review, chaired by Baroness Julia Cumberlege has published a far-reaching report largely comprising very difficult testimony from victims of medical harm.
The report looked specifically at issues involving sodium valproate, Primodos and pelvic mesh. The report includes painful testimony from people who have been negatively impacted by these three areas and goes beyond these three areas in its recommendations.
As part of the process of investigating the three areas above the report has unearthed deeper more systemic problems within the healthcare system in this country.
In particular, the report authors highlight the need for the patient to be heard and involved much more in their care. The issue around conflict of interest between practitioners and companies in the market was talked about at length. The report describes the fact that the healthcare system is not good at spotting trends and that this is because the patient is not involved enough.
Reference is made to the fact that we are in an ‘exciting’ time of technological developments but that there are also risks existing and future that will emerge as technology in healthcare develops. The process for reporting of adverse event and the use of patient-reported outcome measures were raised.
The report makes reference to the fact that patient safety issues still exist and that the culture of learning from mistakes could be much better.
The report makes nine recommendations which are as follows:
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.
Recommendation 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.
Recommendation 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.
Recommendation 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.
Recommendation 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.
Recommendation 6: The 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.
Recommendation 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.
Recommendation 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 pharmaceutical and medical device industries of payments made to teaching hospitals, research institutions and individual clinicians.
Recommendation 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.
Chair of the Independent Medicines and Medical Devices Safety Review Baroness Julia Cumberlege commented:
“I publish this report at a time when the NHS has been facing enormous challenges arising from the Covid-19 pandemic. NHS staff have risen to those challenges, proving day after day their ability to provide excellent care often in the most testing of circumstances. All of us have, quite literally, applauded them for their tireless commitment. This Review, however, has been about people who have suffered avoidable harm.
“Having spent two years listening to heart-wrenching stories of acute suffering, families fractured, children harmed and much else, I and my team thought the title of this report an appropriate one. It is a phrase that should serve as a guiding principle, and the starting point, not only for doctors but for all the other component parts of our healthcare system.
“The three areas we were asked to explore, Primodos, sodium valproate and pelvic mesh, were new to us so we travelled the country, not only England but Scotland, Wales and Northern Ireland. We met and listened to over 700 people, mostly women, often accompanied by their partners, other family members and sometimes their children. We are indebted to all of them. Their dignity and courage in telling us the intimate and harrowing details of their damaged lives has made a great and lasting impression on us.
“The patient groups, some of whom have campaigned for decades, have been invaluable to us; well informed, knowledgeable, and research-based. They never failed to ensure we learnt from them and were up to date with emerging developments. They are outstanding communicators and expert in the subject matter.
“We have found that the healthcare system is disjointed, siloed, unresponsive and defensive. It does not adequately recognise that patients are its raison d’etre. It has failed to listen to their concerns and when, belatedly, it has decided to act it has too often moved glacially. Indeed, over these two years, we have found ourselves in the position of recommending, encouraging and urging the system to take action that should have been taken long ago.
“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.
“We are entering a new world, in which innovation and technology will bring exciting change. There is potential to do so much good, but we must ensure the risks of increasingly complex healthcare are understood and where the system is not sure of the risks it must say so. Had it done so in the case of our three interventions, I have no doubt that much anguish, suffering and many ruined lives could have been avoided.
“My team and I are clear that our recommendations will improve the lives of people who have been harmed and make the system safer in the future. Implementation needs to be approached with a new urgency and determination, founded on the guiding principle that our healthcare system must first do no harm.”
Responding to the publication of the report, Duncan Rudkin, Chief Executive of the General Pharmaceutical Council, said:
“This important report shines a spotlight on how medicines and medical devices can harm as well as help. We will carefully review the report and its strategic recommendations and look at what actions we can take in response.
“We would like to express our sympathies for everyone who has experienced harm from medicines and medical devices. We also want to pay tribute to the patients and family members who have worked tirelessly to raise awareness of these patient safety issues; it is vital that we learn from and act on what they have told us.
“As an organisation we are committed to doing more to enable patients and the public to raise concerns and safety issues with us, to listen to their concerns, share this information with others across the system and to act quickly and effectively in response. Greater involvement of patients and the public in our work will strengthen action we take to ensure safe and effective pharmacy care.
“We expect the pharmacy professionals and pharmacies we regulate to provide person-centred care to all patients and to respond openly and honestly to any safety concerns that patients raise.”
Pharmacy in Practice is a UK pharmacy publication with its roots in Scotland.