This Review was announced in the House of Commons on 21 February 2018 by Jeremy Hunt, the then Secretary of State for Health and Social Care. Its purpose is 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 Review was asked to investigate what had happened in respect of two medications and one medical device:
- hormone pregnancy tests (HPTs) – tests, such as Primodos, which were withdrawn from the market in the late 1970s and which are thought to be associated with birth defects and miscarriages;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; and to make recommendations for the future.
The Review was prompted by patient-led campaigns that have run for years and, in the cases of valproate and Primodos over decades, drawing active support from their respective All-Party Parliamentary Groups and the media.
- 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.
- 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.
- 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 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.
- 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.
Response from Patient Safety Learning
Patient Safety Learning welcomes the publication of the First Do No Harm report today from the Independent Medicines and Medical Devices Safety Review.
The Chair of the review, Baroness Julia Cumberlege, highlighted in this that they found the healthcare system to be "disjointed, siloed, unresponsive and defensive" to the patients effected by these issues. She also noted that:
‘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’
The report highlighted some key themes consistent with other major patient safety failures:
- Patients not being engaged in their care: Lacking the information required to make informed choices, awareness of how to report problems and their experiences not being recognised.
- Ineffective reporting: Data not being utilised to identify and address patient safety issues. Existing reporting systems not being effective enough to capture this information and share learning widely.
- Blame culture: Persistent failure to acknowledge when things go wrong for fear of blame, reducing the ability to address threats to patient safety.
Patient Safety Learning considers that patient safety is currently treated as one of many priorities to be weighed against each other. We think it is wrong that safety is negotiable. Patient safety must be core to the purpose of healthcare, reflected in everything that it does.