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Found 194 results
  1. News Article
    In July last year, the Independent Medicines and Medical Devices Safety Review – chaired by Baroness Cumberlege— published its landmark report, First Do No Harm. It followed a two-year review of harrowing patient testimony and a large volume of other evidence concerning three medical interventions: Primodos, sodium valproate and pelvic mesh. Yesterday, in a written statement to Parliament, the Minister for Patient Safety, Suicide Prevention and Mental Health, Nadine Dorries, gave an update on the government’s response to the recommendations of the Cumberlege Review. In an article in The Times today, Baroness Cumberlege welcomes that the government has now accepted the need for a patient safety commissioner for England and the amendment to the Medicines and Medical Devices Bill, which is being considered in the House of Lords today, which she hopes "will swiftly become law". However, she also states that "... a full response to the review's is still outstanding 6 months after publication. Action is urgently needed to ensure we help those who have already suffered and reduce the risk of harm to patients in future". Read full story (paywalled) Source: The Times, 12 January 2021
  2. News Article
    The Becker's Clinical Leadership & Infection Control editorial team chose the top 10 patient safety issues for healthcare leaders to prioritise in 2021, presented below in no particular order, based on news, study findings and trends reported in the past year. COVID-19 Healthcare staffing shortages Missed and delayed diagnoses Drug and medicine supply shortages Low vaccination coverage and disease resurgance Clinical burnout Health equity Healthcare-associated infections Surgical mistakes Standardising safety efforts. Read full story Source: Becker's Healthcare, 30 December 2020
  3. Content Article
    The MHRA safety review examined safety data for risks of major birth defects or abnormalities and concerns with the child’s development including learning and thinking abilities for other key antiepileptic drugs. It found that a number of these epilepsy medicines may be associated with some increased risks in pregnancy. Valproate (Epilim) is already known to be seriously harmful if taken in pregnancy and should only be prescribed to a woman if a pregnancy prevention plan is in place. Importantly, two antiepileptic medicines in particular, lamotrigine (Lamictal) and levetiracetam (Keppra), have both been found to be safer than other antiepileptic drugs in pregnancy. The MHRA advises patients never to stop taking their current epilepsy medicines without first discussing it with a healthcare professional. Dr Sarah Branch, Director of MHRA’s Vigilance and Risk Management of Medicines Division said: "Patient safety is our highest priority, and we are committed to making sure women are aware of the risks of taking certain epilepsy medicines during pregnancy, particularly valproate." "We have shared this important review with doctor and nurses so they can use it to inform discussions with their patients." "If a woman is planning to become pregnant, and is taking a medicine for epilepsy, even if this is some time in the future, it is very important that she should discuss with a healthcare professional the right treatment for her, taking into account the results of this review." "It is vitally important that women don’t ever stop taking any epilepsy medicine without discussing it first with a healthcare professional."
  4. 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
  5. Content Article
    Background From 2008 to 2014 my company ran education sessions on managing medicines in a mental health trust. In common with some other mental health trusts, the provider also looked after paediatric community services. This is not a mental health service. It covers children with complex health needs including enteral feeding tubes, ventilation, epilepsy and rapidly changing medicines. Children under the care of this service may be taking in excess of 15 different medicines per day, have complex titration regimes, emergency drugs with associated care plans, plus numerous ‘as required’ (prn) medicines. It is not unusual for children with complex conditions to be under the care of up to five different providers, and to move between three different providers in one day. For example, from a home care service to the special school, to respite care, maybe also being seen in an outpatient clinic on the same day too. As a result, parents frequently have to repeat the information on their child’s medicines every time they move to another service, or a new person is involved. Understanding the safety issues The idea for change came about because of concerns that the staff in children’s respite care were not learning what they needed about children’s medicines, as the learning was geared to the majority of staff who worked in mental health. So a new learning package for children’s staff was commissioned. Part of the work to design the learning package included a baseline assessment which was conducted with parents and staff. This soon revealed that training alone was not the answer. It showed delays in medicines information reaching GPs, workarounds for obtaining information in order to administer medicines in the houses and a general lack of confidence in the whole process. The status quo was risky and disliked by many As a result we looked at the whole system starting with the area where most concerns had been raised, which was having an up to date complete list of a child’s medicines available at all times (medicines reconciliation). The system in place for respite care involved paying a local GP (not usually from the child’s GP Practice) to write up a medicines chart for each child. The process was fraught with difficulties and delays and widely disliked by everyone directly involved. So we set about looking for a new way to manage the lists of medicines with more training and more input for the staff in the services involved. We came up with a new (and much more robust) process for medicines reconciliation in the respite care. This was fully documented in a new policy, and involved cross checking by both the staff and the parents. The “My Medicines” chart Just before this went live, we asked the parents to review and comment on it and they said ‘If you’re producing an accurate and up-to-date list of my child’s medicines, why keep it in the respite care, can’t it go with my child?’ So the "My Medicines" chart, which travels with the child, was born. The "My Medicines" process led to the design and production of a new chart which has to be signed and checked by the parents. It resulted in 40 children with complex conditions being offered a hand held paper record of their medicines (produced and validated by clinicians), which they take around with them wherever they go. Benefits and reduction of risk The new process, which continues to evolve, means that: the child’s GP is now directly involved in day-to-day medicines reconciliation (they weren’t before) the parents are always asked to check and sign the charts (they weren’t before) verbal messages about medicines are never taken incomplete (or missing) directions are rapidly rectified (never worked around). Further specific benefits of the new process include: It has reduced the risks of error, by providing full and accurate information on children’s medicine across their entire pathway. It cuts out the need for parents to keep having to repeat what medicines their child is taking to different professionals and care agencies. It frees up medical and clinical time which was previously spent chasing missing information. It has reduced the number of third part handovers and transcribing of prescription information. Looking back it’s hard to believe that the old ways of working, which caused so many difficulties (especially for frontline staff), were carried out for so long. These risky practices, or similar, are believed to still be commonplace in England. Revealing hidden incidents and near misses In evaluation phase of the project we raised 17 medicines near misses. Of these, 11 related to problems with communication of information across the child’s pathway. Resolving these has resulted in improved communication and engagement between different clinical groups and providers, and a desire from all quarters to take the project further. Previously many of these incidents were not logged or tracked across organisations. In some cases, it was only due to the vigilance of the staff and parents that they were spotted and errors avoided. Embedding change The project was well received by parents and staff and resulted in improved communication and engagement between different clinical groups and providers. This included the Consultant Paediatricians (working for the secondary care provider), who were initially sceptical. The project was less well received by the relevant medicines and prescribing committees, who were understandably concerned about who owned the “My Medicines” chart and had agreed its content. Explaining this was made more difficult because it is hard to get across the complexity of the arrangements, due to the critical nature of the children’s illnesses, in a committee setting. Working in ways that support safety I make no apologies for ensuring from the outset that it was the parents who owned the charts, which were designed by the project team (not a committee) to meet all best practice standards. It always worries me that when it comes to cross- organisational working the formal committees and systems in place can inadvertently act as a barrier to safety rather than promoting it. There is no doubt we had designed a safer process and my company was happy to take accountability for any associated risks. As a legacy of the project, a Community Paediatric Pharmacist was appointed specifically to work with this group of children. So, whatever evolves will be based on inter-disciplinary thinking and working and will have clear safety parameters. I am grateful to the enlightened thinking of the leaders who commissioned this work and supported this novel approach.
  6. News Article
    An Independent Patients' Commissioner is set to be appointed to act as champion for people who have been harmed by medicines or medical devices. Baroness Cumberlege, who recommended the new role in a landmark report earlier this year, announced that the government had budged on the issue after initial resistance. She welcomed the move saying: "Had there been a patient safety commissioner before now, much of the suffering we have witnessed could have been avoided." But she added "the risk still remains" and further urgent action is needed to protect patients from potentially harmful drugs." At an online meeting of parliamentarians, the baroness described the testimony of a victim of the medical device vaginal mesh, which has left some patients in chronic pain. The woman had told her review team: "This device took everything from me. My health, my life, my job, my dignity, my marriage, my freedom." Reflecting on this the baroness added: "The scale of suffering we witnessed means nothing short of profound change is necessary. Not necessary in a couple or three years, but necessary now." Read full story Source: Sky News, 16 December 2020
  7. Content Article
    Azithromycin is an antibiotic known for its anti-inflammatory properties which is already used to treat chronic inflammatory lung disease, or chest infections such as pneumonia. Inflammation, caused by an overly-active immune response, is a key feature of severe COVID-19. Azithromycin was considered a potential treatment for COVID-19 and investigated through an arm of the RECOVERY trial to assess whether the drug had a meaningful benefit amongst hospitalised patients with COVID-19. A preliminary analysis of the data has shown no meaningful clinical benefit of azithromycin in the hospitalised COVID-19 patients randomised to this treatment arm. The data showed no significant difference in the primary endpoint of 28-day mortality (19% azithromycin vs. 19% usual care). While researchers found no evidence of beneficial effects on the risk of progression to mechanical ventilation or length of hospital stay. The results were consistent in different subgroups of patients. However it is not possible to make conclusions about the effectiveness of azithromycin in patients in the community.
  8. Content Article
    This resource includes: What is medicines management? The right medicine for the right patient and the right time Becoming an independent prescriber Competencies and maintaining competence Specialist prescribing Delegation Unregistered staff and social care Administration Prescribing and administration Transcribing Nursing associates and medicines management Summary of available guidance
  9. Content Article
    Written Questions are a parliamentary mechanism by which Members of the Senedd can table questions specifically for a written answer by the Welsh Government or the Senedd Commission. Laura Anne Jones MS asked what progress had been made in Wales in implementing the findings of the Cumberlege Review (The Independent Medicines and Medical Devices Review). This review examined how the healthcare system in England responds to reports about the harmful side effects from medicines and medical devices and consider how it could respond to them more quickly and effectively in the future. Vaughan Gething MS, Minister for Health and Social Services, responded as follows: The Cumberlege recommendations are primarily focused on England but they have implications for Wales. I issued a written statement on 15 July about the Cumberlege review: https://gov.wales/written-statement-baroness-cumberleges-announcement-use-surgical-mesh In that statement, I said the principle of high vigilance to ensure mesh use is restricted until the same conditions Baroness Cumberlege identified in her report are met should also apply in Wales. Her recommendations were consistent with those made by the review panel, which I set up at the end of 2019. It is my expectation that sufficient levels of clinical governance, including consent, audit and research are in place in health boards in Wales to ensure all women can be confident that all possible safeguards are in place. The evidence we have already of a significant reduction in the use of vaginal mesh procedures in Wales suggests a “pause” is already largely in place, driven by a change in clinical decision making during recent years. However, it is my expectation that these additional restrictions will be the case until the requirements for increased safeguards can be met. Action has already been taken on some of the recommendations. Specialist mesh centres have been identified in Swansea and Cardiff and work is underway in establishing a UK-wide medical device information system. In addition, the Women’s Health Implementation Group will be tasked with considering many of the recommendations of the Cumberlege review as they pertain to mesh, as this is consistent with work the group is already doing in this area. My officials are examining the other recommendations which relate to Wales and are working with the other UK governments to look at those recommendations with a UK remit. The Medicines and Medical Devices Bill, currently before the House of Lords, will also impact in relevant areas. I will issue a further statement when officials have completed their assessment of the options available and their implications for the future effectiveness of Wales’ healthcare service.
  10. Content Article
    The objectives of the Medication Errors Group are aligned with and expand on WHO Medication Safety Objectives as follows: To create opportunities for those researching and investigating medication errors to network in a friendly and mutually supportive environment and disseminate their research using good quality outlets. To support healthcare professionals and/or organizations with scientific evaluation of medication errors and how to prevent them. To promote and develop teaching and education about all aspects of medication errors including their mitigation as part of pharmacovigilance, patient safety and pharmacology curricula. To support regulatory authorities with medication errors guidance evaluation and acting as a neutral bridge with the wider pharmaceutical and healthcare sectors. To organise and/or support training and tutorials to pharmacovigilance centres to further enable their role in detecting medication errors through Individual Case Safety Reports (ICSRs) by using specific methods and tools. Insights from this enhanced detection could lead to signal detection and which may inform on new and/or targeted prevention strategies to reduce medication errors. To provide a neutral and impartial forum for all stakeholders including patients to ask questions related to medication errors and obtain answers within a reasonable timeline. To communicate current activities and provide a forum for discussion and generation of new research and ideas leveraging social media and/or other communication platforms. To interact with the pharmaceutical sector and suggest evidence based solutions that can help prevent medication errors, especially in the case of look-alike and sound-alike medications. Evaluate and where appropriate recommend the need for meetings, education and/or affordable training, such as encouraging abstracts for the Annual Meeting and inputting into ISoP and chapter training meetings.
  11. Content Article
    C-Diff Dentures in the healthcare setting Discharge instructions Drug allergies End of life care Falls at home Getting the right diagnosis Handwashing Hospital ratings Influenza (the flu) Latex allergies Medical records Medication safety at home Medication safety: Hospital and doctor's office Metric-based patient weights MRI safety MRSA Neonatal abstinence syndrome (NAS) Norovirus (stomach flu) Obstructive sleep apneoa Pneumonia Pressure injuries (bed sores) Sepsis What is an MRI? Wrong-site surgery
  12. News Article
    A community trust was told to urgently review prescribing of stimulant medications for children after concern that some were posted to families but never arrived. Bridgewater Community Healthcare Foundation Trust was told that sending prescriptions through the post may be a potentially unsafe practice by the Royal College of Paediatrics and Child Health. The warning came in a report from the college after it was invited by the trust to review its community paediatrics service The trust was urged to work with primary care and clinical commissioning groups to establish shared care for children who needed these medications. Stimulant medicines are often used for children with attention deficit hyperactivity disorder. The review also found there was a “a very significant risk for patient care” with letters, reports and prescriptions being delayed or going missing due to “recurrent issues” with the post in the building used by the team covering St Helen’s. It highlighted issues with the safeguarding procedures at the trust, with each locality team having its own processes and handling a small number of cases, and called for urgent work to streamline services. Read full story (paywalled) Source: HSJ, 11 November 2020
  13. Content Article
    This report recommends investment in hubs to produce aseptic injectable medicines in England in order to create high volumes of aseptic pharmacy products which will: save time for nursing staff enable care closer to home produce significant savings.
  14. News Article
    The Medicines and Healthcare products Regulatory Agency (MHRA) has received its one millionth Yellow Card. The Yellow Card scheme is the UK’s system for reporting suspected side effects to medicines and adverse events with medical devices. This major milestone coincides with the launch of the 5th annual #MedSafetyWeek (2-8 November), which highlights the value of the Yellow Card scheme to the nation’s health, and the importance of reporting suspected side effects from medicines. The MHRA has seen an increased rate of Yellow Card reports and would like to continue to encourage more reporting this #MedSafetyWeek. MedSafetyWeek is a global campaign, with over 70 countries participating, worldwide. This year, the theme is ‘every report counts’. The MHRA will be calling upon patients and carers, as well as healthcare professionals and their organisations to report suspected side effects from medicines. Reporting helps to identify new side effects, as well as unexpected and serious safety problems. It also adds to existing information about known effects. By reporting, patients and the public can help the safe use of medicines for everyone. Read press release Source: GOV.UK, 2 November 2020