Learning from the report of the independent medicines and medical devices safety review: “first do no harm”

Abstract

This is a review of the learning points from the Independent Medicines and Medical Devices Safety Review, ¹ chaired by Baroness Julia Cumberlege CBE DL. This system-wide review was initiated by the then Secretary of State for Health and Social Care, following patient-led campaigns. It looked at how the “healthcare system reacted as a whole, and how that response can be made more robust, speedy and appropriate”.

We aim to highlight the learning points for doctors in Obstetrics and Gynaecology as these are relevant to our current practice and future changes in our healthcare system. These are:

Aims of the review: why it was initiated and how it was conducted

Overarching themes and missed opportunities to prevent avoidable harm

Three clinical scenarios: their histories, issues and adverse events associated with their use and the current response in Scotland

The hormone pregnancy test - Primodos

The anti-epileptic drug - sodium valproate

Surgical mesh for prolapse & incontinence

The recommendations made by the review and implementation guidance

Responses to the review, such as apologies issued by BSUG ² /BAUS ³ /RCOG, ⁴ and compensations schemes such as the Scottish scheme as recommended by the review