08 Jul IMMDS Review: First Do No Harm
Head of Research & Development
Baby Lifeline Training
Today’s First Do No Harm report of the Independent Medicines and Medical Devices Safety Review does not just alert us to failures in three interventions, but to systemic issues across medical practice.
The Review, announced in February 2018, was asked to:
- Investigate how the healthcare system in England responds to reports about harmful side effects from medicines and medical devices
- Reflect upon how responses can be more effective and rapid in the future.
The Review focused on the following medications and one medical device:
- Hormone pregnancy tests (HPTs), such as Primodos, which are no longer on the market and thought to be associated with birth defects and miscarriages.
- An anti-epileptic drug, sodium valproate, which causes harm to children when taken by their mothers during pregnancy.
- Pelvic mesh implants, which are used in the surgical repair of pelvic organ prolapse and managing stress urinary incontinence. Pelvic mesh implants have been linked to crippling, life-changing complications.
Patient-Led Systemic Change
As with many campaigns for patient safety before it, the Review was prompted by lengthy patient-led campaigns, being supported by the All-Party Parliamentary Groups and the media. As a result, the Review was asked to consider how to strengthen the patient voice in order to help build a “system that listens, hears and acts”.
The Review panel met with hundreds of affected patients across the UK, which highlighted system-wide issues and not local or individual practices or practitioners.
Something which seems all the more unjust through reading these reviews is that patients who have been harmed by a broken system need to fight to find answers and to try to improve the system for others. This has to improve for the wellbeing of every person being cared for, every professional caring for them, and the healthcare system as a whole.
Across the Review some central themes were identified as relating to all three interventions and, as the Review notes, wider systemic issues within medicine.
- The patient voice is dismissed
- Parents living with guilt
- The failure of informed consent
- Duty of Candour
- Conflicts of interest
- Guidelines and quality
- Data capture and the electronic record
- Databases and registries
- Regulation of medicines and devices and potential reforms
- Patient safety
The Review notes that there are a number of things which should be addressed in order to improve upon care, not just in the cases of these interventions but in wider medical practice.
The observed and unjust incidence of avoidable harm due to the lack of a timely, robust, and appropriate response to concerns raised is sadly not dissimilar to preceding local and national reports.
In order to reduce harm, we have to take action and learn lessons from harm before it. We cannot keep failing women and babies by recycling the same recommendations across every report and not taking responsibility for the safe care of patients.
Professor Ted Baker, Chief Inspector of Hospitals at the CQC (from the report):
“I have to say 20 years later it is very frustrating how little progress we have made. It’s clear to me that we still have not got the leadership and culture around patient safety right. As long as you have that culture of people trying to hide things – then we are not going to win this.”
The Review’s Recommendations are as follows:
- The Government should immediately apologise on behalf of the healthcare system to the families affected by Primodos, sodium valproate and pelvic mesh.
- Appoint 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
“We cannot keep failing women and babies by not acting on these thorough, impassioned reviews aimed at improving care. We welcome these recommendations with open arms: listening to concerned patients should be at the centre of what we do in our healthcare system, anything else is missing the point. In the first instance, we urge our wonderful NHS professionals to read these recommendations and form local action points in order to start to progress change.”
Judy Ledger, Baby Lifeline Training CEO & Founder