Patient safety

‘Landmark report’ to seek more compassionate response to patient concerns

The government has ordered a review into how UK authorities respond to concerns about medical treatments.

Speaking in the House of Commons yesterday, health and social care secretary Jeremy Hunt said that the government will release a “landmark report” amidst “serious concerns” over three particular interventions, including the recent vaginal mesh scandal.

Vaginal mesh has been used to address complications such as urinary incontinence after childbirth, and the health secretary said it has been linked to “crippling life-changing side effects.”

Hunt also highlighted the hormone-based pregnancy test Primados, which is reported to have led to miscarriages and birth defects in the 1960s, and was prescribed to 1.5 million women until it was withdrawn in the 1970s.

Prime minister Theresa May said that the government recognises that there are “many individuals whose lives have been affected by this.”

“There is an issue with our regulatory of healthcare system and we are determined to address it, and I've been clear that we need to do better,” the prime minister said. “We need to see a faster more understanding response to patients when they raise concerns.”

The third scandal Hunt cited was the use of sodium valproate, a medication used to treat epilepsy, bipolar disorder and migraines, in pregnancy, which has been “definitively linked” to autism and is thought to have affected up to 20,000 babies.

“Many have endured and continued endure severe complications and a tremendous amount of pain and ill health,” Hunt said, paying tribute to those who have responded with not just “understandable anger,” but also the “resolute determination to campaign for change on behalf of others.”

But he acknowledged that when concerns have been raised the response has “not always been good enough,” adding: “As a result, patients and their families have spent too long feeling they are not being listened to, making the agony of a complex medical situation even worse.”

The review will seek to implement a “fairer, quicker and more compassionate way of addressing issues when they arise, bringing different voices to the table from the start, and giving individuals and their families a clear path to answers and resolution.”

Findings of an EU review into sodium valproate are expected in March, and in preparation for this Hunt has tasked system leaders with a forming a rapid coordinated response. There will be a push for a new warning signal on packaging, an update to NICE guidance, and a push for the drug to be contraindicated in women of childbearing age without effective contraception.

Lord O’Shaughnessy has been charged with the task of driving forwards the recommendations of an expert working group to improve the systems of monitoring the safety of medicines in pregnancy, which will include offering the children affected by Primados a full genetic clinical evaluation, better training for obstetricians and guidance on dosing, and the accessibility of electronic yellow card reporting for patients and clinicians at the point of care.

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