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PATI ENT SAFE T Y


substantial role to play in patient safety, identified that the current system is confused and complex with no clear understanding of how it is organised and who is responsible for what. It seems that little has changed, and the same confusion which appeared then, is still in place. Patients constantly fall through the cracks and, furthermore, are rarely heard. First Do No Harm reports that we and the system are not good at spotting trends in practice and outcomes, which give rise to safety concerns. It is almost a given that healthcare is becoming more complex and, as technology increasingly drives change, we must ensure that our systems listen to the concerns of patients and that we have the mechanisms to monitor trends. The Review was tasked to look at three areas and to explore Primodos, pelvic mesh and sodium valproate. A brief review of each of these three findings will be made and some conclusions drawn.


Sodium Valproate Sodium Valproate is a medication used for epilepsy and bipolar management. It is also used for migraine prophylaxis and pain management. The drug was first licensed for use in the UK, in 1972, and had a known teratogenic effect (harmful to the developing foetus). It was advised, in the data sheet to be only used in severe and resistant cases of epilepsy.


Data on the risks of use of valproate in pregnancy emerged in the early 1980s, which suggested in the literature that there was a link to exposure of the foetus in utero and physical malformations. However, at that time, doctors were advised that the risk did not justify discouraging a woman who needs anticonvulsant treatment, from having a child or changing a satisfactory drug regimen. During the early 2000s further evidence emerged of neurodevelopmental effects and further reports of autistic spectrum links as late as 2010. Advice to doctors developed over time but it was frequently not passed on to patients and any concerns expressed by patients were dismissed before their pregnancies, preventing the women from making informed choices. It also reports that, even today, many women have not been informed and are unaware of the risks they are taking. Despite considerable evidence now being available, it is said that there is information overload in primary care and that time pressures preclude reading of the particular warnings by GPs. When a newborn child is affected by


Foetal Valproate Spectrum Disorder the women’s ability to access support or make decisions about subsequent pregnancies are ignored or dismissed. The report identifies that there are still hundreds of babies being born currently whose mother has exposed


SEPTEMBER 2020


I have conducted many reviews and inquiries over the years, but I have never encountered anything like this; the intensity of the suffering experienced by so many families, and the fact that they have endured it for decades. Much of this suffering was entirely avoidable, caused and compounded by failings in the health system itself. Baroness Cumberlege


them to Valproate despite the teratogenic risk being well recognised and undisputed. The review identified that specific to the


use of Valproate that all girls and women of child-bearing potential should be informed and: l Have received counselling about the risks of Valproate treatment and the need for effective contraception, and have signed a Risk Acknowledgement Form.


l They are on highly effective contraception. l They are reviewed by their specialist at least annually.


Affected children have a higher chance of having birth defects such as cleft lip and palate, spina bifida, heart problems and limb defects. They also have reported difficulties with language, intellectual disability, memory problems, learning and behavioural issues. In addition, they may also meet criteria for the autistic spectrum or attention deficit hyperactivity disorder.


There has been a growing awareness over many years of the impact of the medication, but still the risks are not appropriately explained to patients enabling them to make choices about planned pregnancies. In addition, there has been no effort to collect data on the number of affected children born. Despite academic papers showing trends, no action was taken to be proactive to prevent further disastrous outcomes. The health system was very slow to respond to the emerging data, either with warnings, regulatory action or by commissioning further research. The severity of the outcome was often minimised and ability to manage the consequences overestimated and on balance, doctors prioritised the medical treatment of epilepsy. Further, there is uncertainty between GPs and neurologists as to which of them is best placed to advise on pregnancy risks and knowledge of alternative contraception advice. Doctors often gave advice based on assumptions, without involving patients in the decision-making process.


The Cumberlege Report suggests that an apology is well overdue, and that support is required for those who have suffered avoidable harm. It recommends that specialist centres are established for all families affected by teratogenic medication, to provide integrated medical and social care expertise to enable those affected to access the services they need, in one place.


Pelvic Mesh Pelvic mesh has been used to assist pelvic organ prolapse and to treat stress urinary incontinence. The report cites patient experiences of severe and chronic pain, infections, reduced mobility, sexual difficulties, autoimmune issues and psychological strain. Furthermore, mesh complications have also led to relationship and family breakdown, loss of employment, loss of a home and financial hardship. The outcome data that currently exists does not capture all reported symptoms, hence complication rates are not fully understood. Surgery to implant mesh, widely known as TVT, became very fashionable and the “gold standard” in the early 2000s. There was clearly an unmet need. Although colposuspension had been the previous surgery, it declined rapidly and many hundreds of TVT procedures were undertaken. There was very little post-surgery monitoring undertaken and when immediate complications were identified by the patients, they were ignored by the surgeons who told them they were hysterical women.


Lack of data


There is once again a lack of data of the number of women who have suffered and many complications do not arise until long after the surgery. There is a considerable effort being made to set up specialist centres where surgeons are removing some or all implanted mesh. However, this is a complex operation and there are few specialist surgeons, the outcomes are far from certain. There is a lack of academic literature and even the experts disagree on the likely


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