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Found 58 results
  1. Content Article
    This is an Early Day Motion tabled in the House of Commons on the 21st October 2021, which notes disappointment with the UK Government’s response to the Independent Medicines and Medical Devices Safety Review. The motion calls on the Government to reconsider its response and to implement all nine recommendations in their entirety, and to ensure patient safety remains paramount in any changes to regulatory approval frameworks.
  2. Content Article
    This week the Department of Health and Social Care released the UK Government’s response to the recommendations of the Independent Medicines and Medical Devices Safety Review, sometimes referred to as the Cumberlege Review. In this blog Patient Safety Learning sets out its reflections on this.  
  3. Content Article
    This report is from the Patient Reference Group established to provide advice, challenge and scrutiny to work to develop the government response to the Independent Medicines and Medical Devices Safety (IMMDS) Review, sometimes referred to as the Cumberlege Review.
  4. Content Article
    This report from the Department of Health and Social Care sets out the Government's response to the recommendations of the Independent Medicines and Medical Devices Safety (IMMDS) Review, sometimes referred to as the Cumberlege Review.
  5. Content Article
    In the UK over 1000 people with epilepsy die every year and it's estimated that more than half of these deaths could be avoided. This is a free evidence-based tool, supporting clinicians in discussing risk with people with epilepsy. It includes risk factors linked to epilepsy mortality, including (but not restricted to) Sudden Unexpected Death in Epilepsy (SUDEP). To watch the introductory video and register for access to checklist, follow the link below to the SUDEP Action website.
  6. Content Article
    The Valporate Safety Implementation Group (VSIG) is a clinically-led group set up to help facilitate the reduction of the use of sodium valporate in women and girls where there is a safer alternative.
  7. Content Article
    Sodium Valproate is a treatment for epilepsy and bipolar disorder. It can cause an increased risk of developmental, physical and neurological harms to the human embryo or fetus. This NHS letter is a reminder of information that every woman and girl of childbearing age should receive from their doctors when the drug is first prescribed. It contains important reminders of safety considerations, including around contraception, pregnancy and regular prescribing reviews. Further recommended reading: Sodium Valproate: The Fetal Valproate Syndrome Tragedy Analysing the Cumberlege Review: Who should join the dots for patient safety? (Patient Safety Learning) Findings of the Cumberlege Review: informed consent (Patient Safety Learning) First Do No Harm. The report of the Independent Medicines and Medical Devices Safety Review Regulatory flaws: Women were catastrophically failed in the mesh, Primodos and Sodium Valproate tragedies (Kath Sansom)  
  8. Content Article
    This booklet, from Healthcare Improvement Scotland, is for parents, carers and families of children and young people up to the age of 18 who:have been diagnosed with epilepsy, ormay be going through assessment.
  9. Content Article
    To support patients to understand the risks of taking sodium valproate during pregnancy, NHS England has launched two new shared decision-making tools. This is part of an NHS-wide effort to reduce the use of valproate in people who can get pregnant, and to help those that do continue with valproate to prevent pregnancies.
  10. News Article
    Campaigners have called for a change in how epilepsy services are delivered after "alarming" new research revealed that nearly 80% cent of deaths in young adults could have been avoided. It comes as researchers behind the first ever national review into deaths linked to the condition warned that "little has improved in epilepsy care" despite previous findings of premature mortality. They describe the situation as a "major public health problem in Scotland", adding that deaths "are not reducing, people are dying young, and many deaths are potentially avoidable”. In particular, the Edinburgh University team found that adults aged 16 to 24 were five times more likely to die compared to the general population, a problem they said may be linked to the "vulnerable period of transition from paediatric to adult care". Overall, for adults with epilepsy aged 16 to 54, the mortality rate was more than double that for the age group as a whole, with as many as 76% of these deaths potentially preventable and the majority occurring among patients from the most deprived areas. Read full story Source: The Herald, 11 November 2021
  11. News Article
    In a Letter to the Editor published in The Times yesterday, the All Party Parliamentary Group on First Do No Harm Co-Chair Baroness Julia Cumberlege argues in favour of the work of the Independent Medicines and Medical Devices Safety (IMMDS) Review and its report 'First Do No Harm'. "Inquiries are only as good as the change for the better that results from their work." Read full letter (paywalled) Source: The Times, 5 January 2021
  12. News Article
    Staff at a specialist care unit did not attempt to resuscitate a woman with epilepsy, learning difficulties and sleep apnoea when she was found unconscious, an inquest heard. Joanna Bailey, 36, died at Cawston Park in Norfolk on 28 April 2018. Jurors heard she was found by a worker whose CPR training had expired, and the private hospital near Aylsham - which care for adults with complex needs - had been short-staffed that night. Support worker Dan Turco told the coroner's court he went to check on Ms Bailey just after 03:00 BST and found she was not breathing and had blood around her mouth. The inquest heard he went to get help from colleagues, including the nurse in charge, but no-one administered CPR until paramedics arrived. It was heard Mr Turco's CPR training had lapsed in the weeks before Ms Bailey died, unbeknown to him. Mr Turco said he had since received training and has had his first aid qualifications updated. Cawston Park, run by the Jeesal Group, a provider of complex care services within the UK, is currently rated as "requires improvement" by the Care Quality Commission. Read full story Source: BBC News, 23 November 2020
  13. News Article
    Despite being one of the world's oldest known medical conditions, public fear and misunderstanding about epilepsy persists, making many people reluctant to talk about it. That reluctance leads to lives lived in the shadows, lack of understanding about individual risk, discrimination in workplaces and communities, and a lack of funding for new therapies research. People with epilepsy die prematurely at a higher rate compared to the general population. The most common cause of death from epilepsy is sudden unexpected death in epilepsy, known as SUDEP. For many people living with epilepsy, the misconceptions and discrimination can be more difficult to overcome than the seizures themselves. International Epilepsy Day seeks to raise awareness and educate the general public on the true facts about epilepsy and the urgent need for improved treatment, better care, and greater investment in research. hub resources Safety advice for people with epilepsy RCPCH: Epilepsy passport Antiepileptic drugs: review of safety of use during pregnancy (MHRA)
  14. Content Article
    This is an Early Day Motion tabled in the House of Commons on 18 May 2022, which calls on the Government to implement the recommendations of the Independent Medicines and Medical Devices Safety Review in full, including paying compensation to people disabled by sodium valproate.
  15. Content Article
    In this article for The Guardian, journalist Sirin Kale speaks to Janet Williams about the impact the epilepsy drug sodium valproate has had on her family. Janet took the medication to treat her epilepsy throughout her two pregnancies in 1989 and 1991, but had never been warned about the potential risks to her babies. Foetal valproate syndrome can cause spina bifida, congenital heart defects and developmental delays and is believed to have affected around 20,000 children in the UK. Both of Janet's sons were affected by the medication and require full time care as a result. Janet describes how being told about the risks would have enabled her to make an informed decision about whether to have children, and how her experience led her to help set up In-FACT (the Independent Fetal Anti Convulsant Trust) in 2012.
  16. Content Article
    This is an Early Day Motion tabled in the House of Commons on 5 September 2022, which calls on the Government to implement the recommendations of the Independent Medicines and Medical Devices Safety Review in full, in particular recommendation 4 of the report calling for the establishment of separate schemes to meet the costs of additional care and support to those who have suffered avoidable harm.
  17. Content Article
    COVID-19 is associated with increased risks of neurological and psychiatric sequelae in the weeks and months thereafter. How long these risks remain, whether they affect children and adults similarly, and whether SARS-CoV-2 variants differ in their risk profiles remains unclear. This study from Taquet et al. looked at the risks of 14 different disorders in 1.25 million patients two years on from Covid, mostly in the US. It then compared them with a closely-matched group of 1.25 million people who had a different respiratory infection. In the group who had Covid, after two years, there were more new cases of dementia, stroke and brain fog in adults aged over 65; brain fog in adults aged 18-64; and epilepsy and psychotic disorders in children, although the overall risks were small. Some disorders became less common two years after Covid, including anxiety and depression in children and adults and psychotic disorders in adults. The increased risk of depression and anxiety in adults lasts less than two months before returning to normal levels, the research found.
  18. Content Article
    This survey by In-FACT (Independent Fetal Anti Convulsant Trust) is intended to provide patients, no matter what anti-epileptic drug (AED) they are prescribed or what condition the AED is prescribed for, the opportunity to report problems and worries about taking their medication during pregnancy. The results will be used to inform In-FACT's ongoing work to improve medication safety and their engagement with the Medicines and Healthcare products Regulatory Agency (MHRA).
  19. Content Article
    In this blog by the British Society of Criminology, Sharon Hartles critically examines the journey so far towards the implementation of the remaining eight recommendations set out in the landmark publication of the Medicines and Medical Devices Safety Review First Do No Harm report in July 2020.
  20. Content Article
    At the First Do No Harm All Party Parliamentary Group (APPG) meeting on 26 January 2021 with the Minister for Patient Safety, Nadine Dorries MP, attendees asked a large number of questions, not all of which could be answered by the Minister due to time constraints. The unanswered questions were submitted to the Minister’s office at the Department for Health and Social Care for a written response. The Department has now provided answers.
  21. Content Article
    This webpage from Epilepsy Action, provides information about the possible risks in and outside the home if you have epilepsy. It describes how to do a safety check. It covers how you approach risk and how to help yourself feel more confident about going out. Finally it offers some practical tips on staying safe wherever you are.
  22. Content Article
    In this written statement to Parliament, the Minister for Patient Safety, Suicide Prevention and Mental Health, Nadine Dorries, gives an update on the government’s response to the recommendations of the Independent Medicines and Medical Devices Safety (IMMDS) Review, sometimes referred to as the Cumberlege Review. Nadine Dorries concludes: "The report of the IMMDS Review powerfully demonstrates the importance of hearing the patient voice in patient safety matters. The actions outlined here demonstrate the government’s commitment to learning from this report, and will support vital work already underway to hear the voice of the patient as part of the NHS Patient Safety Strategy. We currently plan to respond further to the report of the IMMDS Review during 2021."
  23. Content Article
    Women receiving treatment for epilepsy are being urged to discuss with a healthcare professional the right treatment for them if they anticipate becoming pregnant even sometime in the future, following a Medicines and Healthcare products Regulatory Agency (MHRA) safety review. Lamotrigine (Lamictal) and levetiracetam (Keppra) have been found to be safer than other antiepileptic drugs in pregnancy. The MHRA advises patients not to stop taking their current medicines without first discussing it with a healthcare professional.
  24. Content Article
    In this editorial for the British Medical Journal, Helen Haskell summarises the findings and recommendations of the Cumberlege Review, First Do No Harm. Helen argues that while the report has the potential to be a powerful tool for change in and beyond the UK, patients and families now need to see evidence of action.
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