The Independent Medicines and Medical Devices Safety Review (IMMDS Review), chaired by Baroness Cumberlege, has recently published its report.
The title of the report, ‘First Do No Harm – the report of the IMMDS Review’ is a direct reference to one of the oldest principles in medicine, and there are some old recurring themes identified in the report.
The general remit was focused on individuals who have suffered avoidable harm, and the specific remit was to look at three particular areas: Primodos (a hormone pregnancy test associated with birth defects and miscarriage, withdrawn in the late 70s), sodium valproate (a widely used and effective anti-epileptic associated with malformations, autism and developmental delay in children whose mothers were prescribed this in pregnancy) and pelvic mesh implants (used in the surgical repair of pelvic organ prolapse/to manage stress incontinence and associated with life changing and severe complications).
The report makes for sobering reading, in particular the personal accounts of people affected by these interventions (many of whom are obliged to live with daily pain and suffering beyond imagination for those who have not gone through a similar experience).
The main overarching themes identified are familiar:
- Theme 1: “no one is listening” – the patient’s voice dismissed.
- Theme 2: “I’ll never forgive myself” – parents living with guilt.
- Theme 3: “I was never told” – the failure of informed consent.
- Theme 4: redress – “we want justice.”
- Theme 5: “we do not know who to complain to.” – complaints
- Theme 6: duty of candour – preventing future error
- Theme 7: conflicts of interest. “We deserve to know”
- Theme 8: “holding to account” – guidelines and quality.
- Theme 9: “collect once, use often” – data capture and the electronic record.
- Theme 10: “collecting what matters” – databases and registries.
- Theme 11: “time to change focus” – regulation of medicines and devices and potential reforms
- Theme 12: patient safety – doing it better.
The fact that duty of candour is a recurring theme indicates an ongoing lack of commitment to the principle, and combined with the other themes of failure to warn and to listen to patients indicates that the patient/clinician relationship is often still one of leader and subordinate, leaving patients feeling disempowered and vulnerable when things go wrong.
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