How digital records can improve safety



Marlene Winfield

Non-executive director
Date: 29 July 2020

Earlier this month, Baroness Cumberlege’s review, “First Do No Harm” presented a damning indictment of three different treatments that thousands of women had complained about for years with little effect. Women told the Independent Medicines and Medical Devices Safety Review that they were not given adequate warnings about three treatments: pelvic mesh repair, anti-epilepsy drug sodium valproate and the oral pregnancy test Primodos.

The safety of these three treatments had been called into question for years, decades even, yet the healthcare system continually ignored the complaints of women and their children, whose lives had been damaged and destroyed. When finally their concerns were taken seriously, actions to address them were too slow and disjointed.

For the women who battled to get their voices heard, the news from the report came as no surprise. And sadly, as someone who for decades has worked closely to support patients harmed by medications and devices, it came as no surprise to me either.

In the 1980s, I ran a support group for women injured by a faulty contraceptive device called the Dalkon Shield. Many of these women had also had their pain and problems dismissed as ‘women’s problems’ and not recorded in a way that could be widely monitored. I am also on the board of the Thalidomide Trust, another drug that was released into the market without ongoing monitoring of its effects. Although the limb and other abnormalities the drug caused were obvious to doctors, lack of shared information meant it took longer than it should have to put the pieces of the puzzle together.

First Do No Harm catalogues the shocking lack of information about treatments and outcomes. Some 100,000 women were given plastic mesh implants to treat incontinence, with thousands later reporting a wide range of symptoms, some of which have been life-changing. It is estimated that 20,000 babies have been affected by birth deformities caused by sodium valproate, with women saying they weren’t warned of the risks of taking the drug in pregnancy. Meanwhile more than a million women took the oral pregnancy test Primodos, which was later linked with children being born with malformations and birth defects. Yet none was warned of risks associated with the drugs and devices they were using, nor the early signs of problems.

“The healthcare system collects a huge amount of information. But it cannot answer these fundamental questions. How then can it spot trends and complications and act swiftly and coherently to protect patients and prevent harm? How then can it design and provide the services that those affected need to lead as full a life as possible? How then can the healthcare system be considered a system for all?” Baroness Cumberlege states in the report.

Sixty years after Thalidomide and 40 years after Dalkon Shield, seeing the same patterns occurring over and over again is a great disappointment to me. It is absolutely essential that any person taking a new drug or using a new device knows what to look out for and is carefully monitored. We now have great capability to record information in health records in a standardised way to enable that monitoring across the country. If using that capability means that problems can be picked up more quickly, potentially preventing thousands of people from suffering, how can we not be using it?

The report states that the “siloed and disjointed” medical system has contributed to these failings. I wholly agree. Lack of a collaborative approach, where the patient’s input is listened to and valued, is detrimental to safety in many areas of care. Connecting different parts of the system by making information understandable and shareable will go a long way to bringing about safer and more efficient services.

For example, in the case of vaginal mesh surgery, if there had been ongoing monitoring of standardised information recorded in patients’ records, the warning symptoms women were experiencing, such as pain and bleeding, could have been recognised as common themes much earlier. And it is likely that many women could have been spared life-changing injuries.

The NHS can’t keep making the same mistakes. If we are to offer the best possible care and support, it’s imperative we ensure that people have the information to make informed choices about treatments and that clinicians have the information to help people make those choices and to react quickly to early signs of problems. That will only happen if we are able to collect and share information to monitor safety more proactively. And that will only happen if our systems to record and share patient information follow common standards across the country. Without that, it is unlikely we will ever achieve really effective regulation of medicines and devices.

At the moment, we are seeing the crucial role monitoring plays in a pandemic. The Cumberlege Report shows that we need to take more seriously its crucial role in other aspects of care. We need to work together to deliver a more joined-up, safer system for monitoring of medicines and medical devices.

The capability is there, it is only the impetus that is lacking.

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