The Independent Medicines and Medical Devices Safety Review, titled ‘First Do No Harm’, has published its recommendations after interviewing hundreds of women and their families affected by medical interventions that caused avoidable harm to thousands.
The review, chaired by Baroness Julia Cumberlege, covers three interventions:
- sodium valproate, an epilepsy medication that causes harm to unborn children when their mother, unaware of the risks, takes it during pregnancy
- pelvic mesh, used to treat pelvic organ prolapse and urinary incontinence, which has caused extreme complications in many women
- Primodos, a hormone pregnancy test taken by women between the 1950s and the late 1970s, associated with damage to children, who still need care as adults.
Over the last two and a half years over 700 women and their families were interviewed about their experiences with sodium valproate, pelvic mesh and Primados. They described the suffering caused by these interventions and the wide-ranging impacts they have left on their lives.
The report is critical of the healthcare system as ‘disjointed, siloed, unresponsive and defensive’ and highlights the need for innovation in medical care to include conduct more pre-market testing, post-marketing surveillance and long-term monitoring.
The report makes nine major recommendations:
- that the government issues a full apology on behalf of the healthcare system to the families affected
- the appointment of a Patient Safety Commissioner for patients to report their concerns to, who holds the system to account, monitors trends and demands action
- that schemes should be set up to meet the cost of providing additional care and support to those affected who are eligible to claim
- the establishment of a Redress Agency to provide both non-monetary and financial support
- the establishment of specialist centres: one for pelvic mesh and the other for those affected by medications taken during pregnancy
- that the Medicines and Healthcare products Regulatory Agency (MHRA) is overhauled to improve the way that concerns about medicines and devices are detected and acted upon, engaging with patients to track over time how well they improve health and quality of life
- a central database to collect these details
- that the General Medical Council (GMC) includes a list of financial and non-financial interests for all doctors
- that a task force is set up to implement these recommendations.
The full report can be read here.