Healthcare system 'not safe enough' for women taking medication during pregnancy concludes review

The NHS and wider healthcare system is "not safe enough" for women taking medication during pregnancy, a damning review has concluded.

"Harrowing" accounts of patient pain and suffering have been detailed in the review into the hormone pregnancy test Primodos, the anti-epilepsy drug sodium valproate and pelvic mesh.

The Independent Medicines and Medical Devices Safety Review investigated whether the response of the healthcare system to concerns raised about the clinical interventions was sufficiently robust, speedy and appropriate.

It concluded that the response was not adequate and resulted in "avoidable harm" and said that the healthcare system is “not safe enough” for those taking medications in pregnancy or being treated using new devices and techniques.

"Patients are being exposed to a risk of harm when they do not need to be. And, while we have looked in detail at only three interventions, we have heard nothing that would lead us to believe that things are different for other surgical procedures and devices or other medications,” the review said.

It added that patients had been "abandoned by a system that fails to recognise and then correct its mistakes at the earliest opportunity".

It estimated that thousands of women could have been spared from suffering complications due to pelvic mesh had guidance been followed, while the use of hormone pregnancy tests "should have been stopped" more than a decade before they were eventually withdrawn from the UK.

The reviewers said an estimated 20,000 Britons have been affected after being exposed to the sodium valproate as developing babies and that "hundreds" of babies are still being born each year to mothers taking the drug who are "unaware" of the risks.

The inquiry found that the healthcare system "does not know" how many women have been affected by these scandals and it has a "glacial" and "defensive" response to concerns over treatments.

More than 700 families from across the UK affected by the issues gave "harrowing details of their damaged lives", which Baroness Cumberlege, chair of the review, described as "heart-wrenching stories of acute suffering, families fractured, children harmed and much else".

"We met with hundreds of affected patients and their families... it became all too clear that those who have been affected have been dismissed, overlooked, and ignored for far too long. The issue here is not one of a single or a few rogue medical practitioners, or differences in regional practice. It is system-wide," the review states.

In a letter to Health Secretary Matt Hancock, Baroness Cumberlege said: "We have found that the healthcare system - in which I include the NHS, private providers, the regulators and professional bodies, pharmaceutical and device manufacturers, and policymakers - is disjointed, siloed, unresponsive and defensive.

"It does not adequately recognise that patients are its raison d'etre. It has failed to listen to their concerns and when, belatedly, it has decided to act it has too often moved glacially.

"The system is not good enough at spotting trends in practice and outcomes that give rise to safety concerns."

She added: "We must ensure the risks of increasingly complex healthcare are understood and where the system is not sure of the risks it must say so. Had it done so in the case of our three interventions, I have no doubt that much anguish, suffering and many ruined lives could have been avoided."

The review, launched in 2018 by the then health secretary Jeremy Hunt, made a series of recommendations including: the appointment of an independent Patient Safety Commissioner who sits outside the healthcare system; a call for the Government to issue an immediate "fulsome apology" on behalf of the healthcare system to the families affected; reform at the medicine and medical devices regulatory body; a register for all "financial and non-pecuniary interests for all doctors".

Health Minister Nadine Dorries paid tribute to the patients and families whose lives, she said, “have been turned upside down” by mesh, sodium valproate and Primodos.

She said: "While the NHS is a beacon of brilliant care and safety in the majority of cases, as this report demonstrates, we must do better. Our health system must learn from those it has failed, ensure those who have felt unheard have a voice and, ultimately, that patients are better protected in future.

“We will now give this independent review the full and careful consideration it deserves before setting out our full response."