PatientSafetyLearning Team

Today, Patient Safety Learning stands with others around the world to celebrate International Women’s Day 2021. In light of this year’s campaign theme “choose to challenge” we are raising awareness of some of the ways in which male bias can negatively impact on patient safety. Drawing on case studies and quantitative research, this blog focuses on three key areas: Design – using examples to illustrate how male-centric design of equipment and medical devices affects patient safety. Data – discussing how data which does not account for differences between the sexes impacts on patient safety. Dismissal – considering the recurring theme from personal testimonials, and healthcare scandals in recent years, that women’s voices and patient safety concerns are being ignored or dismissed. We will reflect on the key patient safety issues and inequalities in each of these areas and offer our perspective on what needs to happen moving forward to prevent future avoidable harm. Design PPE The COVID-19 pandemic has shone a spotlight on male bias in design within healthcare in relation to Personal Protective Equipment (PPE). It became clear that respiratory PPE was leaving female workers at greater risk of exposure to the virus, discomfort, and interference with their ability to work.[1] This is not a new discovery, with a 2016 survey highlighting that only 3/10 women in the UK had PPE that was designed for the female frame.[2] This seems particularly inexcusable in the NHS where three quarters of the workforce are female.[3] These design issues have serious patient safety implications for infection prevention and control. Female staff are potentially at greater risk of infection, threatening both their personal health and a further depletion of an already stretched workforce, which would inevitably impact on the delivery of safe care. Providing staff with ill-fitting masks also leaves patients vulnerable to the possibility that asymptomatic staff could pass the virus to them, risking an increase in COVID-19 hospital acquired infections. Surgical equipment Another area of concern is around the design of surgical instruments, specifically those that have been developed for larger hands and can often be less easy to hold and operate for female staff.[4] Differences in thumb size or grip strength can make the user-experience extremely variable, with smaller digits left floating in handle holes and many female staff needing to sustain greater levels of force to use the equipment. Patient Safety Learning believe it is crucial that patient safety is considered as a core part of the design and development of medical equipment and devices. These need to be safe in use and account for the people who will be using them. Although humans are remarkably good at adjusting, patients would clearly benefit from being operated on by surgeons whose tools make it easier, rather than harder, to do their work. Medical devices In recent years we have become increasing aware of the serious patient safety concerns associated with a range of medical devices predominantly used for women, such as pelvic mesh. But there is also evidence that medical devices which are otherwise seen as gender neutral, such as hip implants, can pose greater risks to female patients.[5] One hip implant (the DePuy articular surface replacement) has left women around the world with serious complications, including inflammation, painful growths, dislocations, and metal toxicity. These side effects have been associated with a lack of consideration for differences between the sexes in relation to hip movement, with such issues being far less prevalent in male patients.[6] What needs to happen? Patient Safety Learning believes: The diversity of user-experience needs to be valued and prioritised at every stage of the design process of medical equipment and devices to ensure that patient safety is not compromised. Further research is needed to understand the extent to which sex-biased design exists within healthcare and poses a risk to patient safety. Where existing evidence highlights patient safety risks of biased design, clear plans and timelines need to be set out to address unresolved issues. This is an issue that needs to be prioritised by industry and regulators such as the Medicines and Healthcare products Regulatory Agency (MRHA). Data Data gathered in medical studies is often not collated in a way whereby differences between the sexes can be analysed and understood.[7] This may be partly due to the fact that many trials include very low percentages of female cells or subjects (whether human or animal), or none at all,[8][9] making it impossible to draw any sex-specific conclusions.[10] This tendency to exclude females has even been evident in studies based on conditions that are more common in, or only relevant to, women.[11] And yet, the results are seen as valid for both sexes. Tested on males, safe for all? Research shows sex differences in our organ systems, tissues, and cells.[12] [13] There are differences in the way male and female hearts function,[14] our lung capacity,[15] metabolic reactions[16] and the way our hormones influence medication.[17] The way men and women are affected by common diseases also varies in severity, prevalence, and nature[18]; and they can react differently to drugs and treatments. Critically for the safety of such treatments, this could mean an increased or decreased likelihood of survival. Where drugs have been tested and deemed to be safe, but the data has not been disaggregated by sex and the participants have predominantly or solely been male, we are unable to truly understand how they affect the female body. Even where females have been excluded from early stages of trials (e.g. with male mice samples) but included at later stages, there is a risk that treatments which may be effective for women have already been ruled out due to their ineffectiveness on the male mice. As Caroline Criado Perez puts it in Invisible Women: Exposing Data Bias in a World Designed for Men: “The specific effect on women of a huge number of existing medications is simply unknown.”[19] Life-saving interventions missed: A case study The importance of sex disaggregated data has been highlighted by the trials of the cardiac resynchronisation therapy device (CRT-D), which is essentially a pacemaker. Based on data taken from studies, the pacemakers were previously deemed to be beneficial for anyone whose heart takes 150 milliseconds or longer to complete a full electrical wave. Guidelines reflected this, meaning anyone with a lower score would not be offered a CRT-D implant. The problem with this approach however was that the trials only included 20% of female participants, but when data from several trials was combined and analysed it became clear that women reacted differently to the device. Female participants with a lower reading of 130-49 milliseconds, who had had the pacemaker fitted, were found to have a 76% reduction in heart failure or death.[20] Had the data been analysed by sex from the start, this evidence could have been used to expand the use of CRT-D implants and improve outcomes for many women. What needs to happen? Patient Safety Learning believes that: Medical studies should be representative of females, and where they are not included, the rationale should be clearly set out, evidenced and undergo appropriate scrutiny. Where males and females are included in medical studies, the data should be disaggregated by sex so that differences in the effectiveness and risks associated with medical interventions and treatments are available for analysis. Where female sample sizes are not representative, this should be made clear when reporting the limitations of the study. Dismissal Labelled anxious, depressed or irrational Studies and testimonials indicate that women are more likely to have their physical symptoms attributed to psychological issues by clinicians,[21] [22] [23] [24] with many feeling that clinicians had dismissed them as hysterical.[25] This can manifest itself in various ways: One study showed that, of the subjects who had not reported feeling depressed, women were twice as likely as men to be prescribed antidepressants.[26] Women who go to A&E are also less likely than men to be given adequate pain relief and more likely to be given anti-anxiety drugs.[27] Women with chronic pain are more likely to be wrongly diagnosed with mental health conditions.[28] These responses can lead to delays in diagnosis and treatment for underlying physical conditions, leaving them at greater risk of poor outcomes or premature death. Criado Perez tells the story of a young woman who spent a decade seeking help for atypical bowel movements and was told that she needed to be less anxious and less stressed, that it was “all in her head”. When she was eventually referred for a colonoscopy, they found that half of her colon was diseased and that the delay in diagnosis had left her at an increased risk of developing cancer.[29] This is not an isolated incident. Studies show that women are more likely to experience longer delays in diagnosis for a brain tumour[30], and 6 out of 11 types of cancer.[31] It is widely recognised that delays in cancer diagnoses and treatment increase the risk of mortality.[32] Unheard and undervalued Last year, the Cumberlege Review[33] highlighted a number of patient safety failings[34] in relation to pelvic mesh implants, sodium valproate and hormone pregnancy tests. The scale and severity of avoidable harm that resulted from these three interventions over a period of several decades is shocking and could have been reduced if the women involved were listened to sooner and critically, if they had been appropriately informed in the first place. The review found that the women involved had been dismissed and sidelined for years as they fought hard to raise awareness of the issues and prevent others from suffering as they had. The defensive and unresponsive attitudes the women were met with highlighted a shameful disregard for the value of their voices in improving patient safety. Unfortunately, the reluctance to listen to groups representing patient safety concerns for women is not uncommon. For many years, the Campaign Against Painful Hysteroscopy (CAPH) has been raising awareness of the severe pain experienced by a significant number of women, during outpatient hysteroscopy procedures. Despite the severity and long-lasting nature of the trauma experienced by these women, the systems response has so far been inadequate,[35] and women are continuing to suffer avoidable harm.[36] What needs to happen? Patient Safety Learning believes that systems and policies need to be tackled urgently to address the sex and gender bias that results in avoidable harm. We call for the following action. 1. Women, and patient groups representing women: to be given ample opportunity to voice their concerns through feedback, reporting systems and in formal patient reported outcomes analysis to be listened to and believed to be invited to contribute to patient safety as part of the clinical team and in research. 2. Healthcare leaders to commit to using the insights from women, and patient groups representing women, to inform improvement actions that will prevent future harm. 3. Quality, evidence-based gender bias training to be made mandatory for all staff working in healthcare, whether they are clinicians, researchers, product manufacturers, policy makers etc. 4. Data regarding delays in diagnosis and treatment to be disaggregated by sex, regularly reviewed and used to inform further research and to improve outcomes. Final thoughts and intersectionality There is still a long road ahead to tackle sex and gender related bias in healthcare, and attitudes towards female patients. The ancient belief that the male body is the ‘norm’ runs dangerously deep and has contributed to a widespread acceptance that female-specific data is not necessary or even particularly relevant. This lack of data has left the medical world better equipped to diagnose, treat and care for male patients. In the absence of a comparable level of knowledge and understanding of the female body, women are being too easily labelled or dismissed as anxious without clinical investigation. A convenient labelling system that provides a smokescreen for uncertainty, whether applied consciously or not. As evidence builds that differences between the sexes play a significant role in the use of medications, devices and treatments, things are beginning to change. Although there are huge historical data gaps to fill, physicians are becoming better informed and able to tailor their approach to the female patient, using up-to-date sex-specific data. Guidelines have also been introduced in other countries to encourage improved representation of females in medical studies, although the UK’s main funders still make no requirements for gender in research design and analysis to be considered.[37] Continuing to accept the male body as an adequate representation of all humans is not just antiquated or scientifically incorrect; it costs lives. While this blog has focused on the dangers of male-focused approaches to design and data, and biased attitudes towards women, it is essential that we recognise there are complex inter-relationships that compound the issue of biological and physical diversity. There is evidence that systemic and individual biases in healthcare negatively impact on the safety and care of, but not exclusive to, the following groups: transgender patients[38] [39] [40] healthcare workers[41] [42] [43] and patients[44] [45] [46] [47] from different ethnic backgrounds. The impact here is not uniform, it is complex and manifests itself in different ways among people from Black, Asian and other ethnic backgrounds. patients living with a disability[48] [49] [50] and patients from socially deprived backgrounds[51] [52] [53]. Intersectionality is an essential consideration. It is important to consider and analyse all variables in order to effectively identify the barriers, and solutions to safer and more equitable care. Share your views We would love to hear your thoughts and feedback on the content of this blog, to leave your comments below please sign up to the hub. If you would like to share your experiences and insights on any of the issues raised you can also get in touch with the Patient Safety Learning team at [email protected] References [1] Topping A. Sexism on the Covid-19 frontline: 'PPE is made for a 6ft 3in rugby player'. The Guardian. 2020. [2] TUC. Personal protective equipment and women. 2016. [3] NHS Employers. Gender in the NHS infographic. 2019. [4] Formosa D and Bednarek N. The Dangerous Problem Of Gender Bias In Healthcare Design. Fast Company. 2017. [5] Duvernoy C, Smith D, Manohar P et al. Gender differences in adverse outcomes after contemporary percutaneous coronary intervention: An analysis from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2) percutaneous coronary intervention registry. American Heart Journal. Vol 159, Issue 4, 2010; 677-683.e1. [6] Why women are more likely to have dodgy hip implants or other medical devices. The Conversation. 2019. [7] Global Health 5050. Organisations generally fail to present sex-disaggregated programmatic data (accessed 5 March 2021.) [8] Beery AK, Zucker I. Sex bias in neuroscience and biomedical research. Neurosci Biobehav Rev. 2011;35(3):565-572. doi:10.1016/j.neubiorev.2010.07.002 [9] Jackson G. The female problem: how male bias in medical trials ruined women's health. The Guardian. 2019. [10] Curno M, Rossi S, Hodges-Mameletzis I et al. A systematic review of the inclusion (or exclusion) of women in HIV research: from clinical studies of antiretrovirals and vaccines to cure strategies. Journal of Acquired Immune Definciency Syndrome, 1:7(2) 2016. 181-8. [11] Ortona E, Delunardo F, Baggio G et al. A sex and gender perspective in medicine: A new mandatory challenge for human health: Preface. Ann 1st Super Sanita, 2016. 52:2146-8. [12] Pretz J, Pekosz A, Lane A et al. Estrongenic compounds reduce influenza A virus in primary human nasal epithelial cells derives from female, but not male, donors. American Journal of Physiology. 310:5, 415-425. [13] Marts and Keitt (2004). [14] Blair M. Sex-based differences in physiology: what should we teach in the medical curriculum? Advanced physiological education. 2007, 31, 23-5. [15]Ibid. [16] Waxman D and Holloway M. Sex Differences in the Expression of Hepatic Drug Metabolizing Enzymes. Molecular Pharmacology August 1, 2009, 76 (2) 215-228 [17] Spoletini I, Vitale C, Malorni W et al. Sex Differences in Drug Effects: Interaction with Sex Hormones in Adult Life. Sex and Gender Differences in Pharmacology. Handbook of Experimental Pharmacology, 2013; vol 214. [18] Karp N, Mason J, Beaudet A et al. Prevalence of sexual dimorphism in mammalian phenotypic traits, Nature Communications, 8:15475. 2017. [19] Criado Perez, C. Invisible Women. 2019. [20] Zusterzeel R, Selzman KA, Sanders WE, et al. Cardiac Resynchronization Therapy in Women: US Food and Drug Administration Meta-analysis of Patient-Level Data. JAMA Intern Med. 2014;174(8):1340–1348. [21] Louise Hall, 29 July 2020. Women who survived coronavirus angry after persistent symptoms dismissed as ‘anxiety’ by doctors. Independent. [22] Hoffmann DE and Tarzian AJ. The girl who cried pain: a bias against women in the treatment of pain. J Law Med Ethics. 2001 Spring;29(1):13-27. [23] Katz Institute for Women’s Health: Expert Insights. Gaslighting in women’s health: No, it’s not just in your head (accessed 5 March 2021). [24] BBC Future. How gender bias affects your healthcare: 'Everybody was telling me there was nothing wrong'. 2018. [25] Graham S. Hysterical Women website. [26] Thunander Sundbom L, Bingefors K, Hedborg K et al. Are men under-treated and women over-treated with antidepressants? Findings from a cross-sectional survey in Sweden. BJPsych Bull. 2017;41(3):145-150. doi:10.1192/pb.bp.116.054270 [27] Billock J. Pain bias: The health inequality rarely discussed. BBC Future, 2018. [28] Tunks E, Bellissimo A and Roy R (eds.). Chronic pain: Psychosocial factors in rehabilitation (2nd ed.). Robert E Krieger Publishing Co. 1990. [29] Criado Perez, C. Invisible Women. 2019. [30] Brain Tumour Charity. Finding Myself in Your Hands: The Reality of Brain Tumour Treatment and Care. 2016. [31] Din NU, Ukoumunne OC, Rubin G, Hamilton W, Carter B, Stapley S, Neal RD. Age and Gender Variations in Cancer Diagnostic Intervals in 15 Cancers: Analysis of Data from the UK Clinical Practice Research Datalink. PLoS One. 2015 May 15;10(5):e0127717. [32] Hanna T P, King W D, Thibodeau S, Jalink M, Paulin G A, Harvey-Jones E et al. Mortality due to cancer treatment delay: systematic review and meta-analysis. BMJ 2020; 371 :m4087 [33] The Independent Medicines and Medical Devices Review, First Do No Harm, 8 July 2020. [34] Patient Safety Learning. Analysing the Cumberlege Review: Who should join the dots for patient safety? 2020. [35] Patient Safety Learning. Ministers respond to concerns about painful hysteroscopies: Northern Ireland, Scotland and Wales. 2021. [36] Patient Safety Learning online forum. Painful Hysteroscopy. 2020-ongoing. [37] Howard, Ehrlich, Gamlen and Oram (2017) [38] Watkinson D and Sunderland C. How discrimination affects access to healthcare for transgender people. Nursing Times [online]; 2017, 113: 4, 36-39. [39] Cerretani J. Transgender discrimination in health care: What families should know. Boston Children’s hospital, 2020 (accessed 5 March 2021). [40] Safer JD, Coleman E, Feldman J, et al. Barriers to healthcare for transgender individuals. Curr Opin Endocrinol Diabetes Obes. 2016;23(2):168-171. [41] ITV News. Frontline ‘discriminiation’ in virus outbreak may be factor in more BAME NHS staff deaths. ITV News YouTube Channel, 2020 (accessed 5 March 2021). [42] Royal College of Nursing. BAME nursing staff experiencing greater PPE shortages despite COVID-19 risk warnings. 2020. [43] Public Health England. Beyond the data: Understanding the impact of COVID-19 on BAME groups. 2020. [44] Hoffman K. Study links disparities in pain management to racial bias. University of Virginia, 2016 (accessed 5 March 2021). [45] Lucas FL, Stukel TA, Morris AM, Siewers AE, Birkmeyer JD. Race and surgical mortality in the United States. Ann Surg. 2006;243(2):281-286.32. [46] Weiner R. African American children three times more likely to die after surgery than white peers. Independent. 2020 (accessed 5 March 2021). [47] MBRRACE-UK. Saving Lives, Improving Mothers’ Care: Lessons learned to inform maternity care from the UK and Ireland Confidential Enquiries into Maternal Deaths and Morbidity 2016-18. 2020. [48] Chartered Society of Physiotherapy. New review highlights health inequalities for people with learning disabilities. 2020 (accessed 5 March 2021). [49] Care Home Professional. People with learning disabilities up to six times more likely to die from COVID. 2020 (accessed 5 March 2021). [50] Read, S., Heslop, P., Turner, S. et al. Disabled people’s experiences of accessing reasonable adjustments in hospitals: a qualitative study. 2018. BMC Health Serv Res 18, 931. [51] The Health Foundation. Astonishing difference in the risk of avoidable death between the rich and poor. 2019 (accessed 5 March 2021). [52] Campbell D. Poorest die most often from emergency surgery, research finds. The Guardian, 2019. [53] Tinson A. Living in poverty was bad for your health long before COVID-19. The Health Foundation, 2020.

Neonatal herpes simplex virus (HSV) disease, also called 'neonatal herpes' or 'neonatal HSV', is a rare, and potentially fatal, disease which usually occurs in the first four weeks of a baby's life. It is caused by the herpes simplex virus (HSV), the same virus that causes cold sores and genital infections. HSV infections are incredibly common in older children and adults and typically cause mild symptoms, or often no symptoms at all. There are some simple things you can do to help prevent babies from catching herpes infections. These include regular hand washing, covering cold sores and not kissing babies who are not your own. Click on the link below to find out more about neonatal herpes and how to keep your baby safe.

Emerging evidence indicates that there has been an increase in the prescription of antipsychotic medications for people living with dementia in care settings during the COVID-19 pandemic. In this blog, Patient Safety Learning explores the patient safety concerns relating to the use of antipsychotic medications for people with dementia and suggests areas for further investigation and action. The pandemic has had a devastating impact on those living in care settings, particularly on people with dementia. During the initial wave of the pandemic (between March and June 2020) over a quarter of people who died from COVID-19 in England and Wales had dementia, making it the most common pre-existing condition associated with COVID deaths.[1] In addition to this, the imposition of restrictions to slow the spread of virus has had a particularly detrimental impact on the mental health, cognitive abilities, and physical wellbeing of people with dementia.[1] Recently there has been emerging evidence and reports indicating that, during the pandemic, there has been an increase in the number of prescriptions of antipsychotic medications for people with dementia.[2] This has raised the possibility that a patient safety concern that pre-dates COVID-19, namely the inappropriate prescription of antipsychotic medications to people with dementia, may have been exacerbated by the pandemic. Why are antipsychotic medications prescribed for people with dementia? Antipsychotic medications are commonly prescribed for people living with dementia in response to the behavioural and psychological symptoms of the condition.[3] Symptoms can vary and can include psychotic symptoms, such as hallucinations and delusions, as well as behavioural symptoms, such as aggression, restlessness, depression, and anxiety. If these symptoms appear to be causing the person significant distress, or if there is a risk of the person harming themselves or others, antipsychotic medications may be prescribed by their doctor to reduce the intensity of their symptoms.[4] Antipsychotic medications are accompanied by serious side effects for people with dementia, particularly if they are used for a period of several weeks. Side effects can include drowsiness, shaking and unsteadiness, and increased risks of infection, falls, blood clots and strokes.[3] Government acknowledgement of risks around the prescription of antipsychotic medications Given the significant health impacts of these side effects, the widespread use of antipsychotic medications in care settings for people with dementia is a contentious issue. Alzheimer’s Society have raised concerns about the potentially inappropriate prescription of these medications given their harmful side effects.[5] They have made the case that, in many instances, these medications may only have a moderate benefit and fail to tackling the underlying causes of patients’ behavioural and psychological symptoms.[5] The validity of these concerns has been accepted at a government level in the UK. A 2009 study by the Department of Health investigated this issue in depth and set out several recommendations aimed at reducing the use of antipsychotic medications for people with dementia.[6] The study estimated that, out of 180,000 people with dementia treated with antipsychotic medication annually, around 140,000 prescriptions were inappropriate.[6] Subsequently, through various dementia action plans and strategies, the UK Government and devolved administrations have set out plans to reduce this use of antipsychotic medications.[7] [8] [9] However, although identified as a safety risk for the past decade, it has proved difficult, in practice, to reduce the inappropriate use of antipsychotics in care settings. Despite policy commitments aimed at addressing this issue, there has been a lack of progress.[10] [11] This was the case before the COVID-19 pandemic. Now, the situation is potentially becoming worse. Increased use of antipsychotic medications during the pandemic Emerging evidence suggests that this patient safety issue may have been exacerbated by the pandemic, with new data indicating a notable increase in the prescription of antipsychotic medications for people with dementia in the UK and Canada.[2] [12] Campaigning groups and the media have drawn attention to this issue, highlighting the risks posed by a potential increase in inappropriate prescriptions of these medications.[13] [14] [15] [16] Alzheimer’s Society has called for the Government as part of its roadmap to ease lockdown to formally investigate why the use of antipsychotic medications for people with dementia has risen during this period. A range of causes are suggested as being responsible for this increase: Prescriptions being made in response to a worsening of symptoms, such as agitation and aggression. This deterioration is being linked to restricted contact with friends and family as a result of pandemic restrictions.[1] Significant pressures on staff and insufficient levels of staffing, resulting in antipsychotic medications becoming the primary option for a person experiencing distressing symptoms, rather than first trying non-drug strategies for behavioural and psychological symptoms of dementia. Reduced ability of carers and family members to be effectively involved in making decisions over the use of these medications due to significantly reduced contact during the pandemic. Key patient safety issues There is a need for further work to be undertaken to establish whether this increase in prescriptions of antipsychotic medications also represents an increase in cases where this is being done so inappropriately. However, given our awareness of the pre-existing problem with inappropriate prescriptions, we believe there are potentially three key patient safety concerns arising from this issue. 1. Health impact One concern about the increased use of antipsychotic medications in care settings is an increased risk of serious side effects. As noted earlier, there are a range of health risks associated with taking antipsychotic medications, particularly for older people with dementia, who face an increased risk of pneumonia and stroke.[17] [18] This is even more concerning for people with Lewy body dementia (dementia with Lewy bodies or Parkinson’s disease dementia) who are at risk of particularly severe reactions to antipsychotic medications and a significantly increased mortality risk.[19] 2. Informed consent and shared decision-making On informed consent, the NHS states “the person must be given all of the information about what the treatment involves, including the benefits and risks, whether there are reasonable alternative treatments, and what will happen if treatment does not go ahead”.[20] We believe it is important that people are not treated as passive participants in their care; it is vital that health and care staff respect the rights of patients and enable them to make fully informed decisions about the treatment they receive. In many cases where a person with dementia is prescribed antipsychotic medications they may lack capacity to make decisions about their care, with this responsibility falling to a person with power of attorney for decisions regarding their health and welfare. This person, who may be a family member or friend, needs to be able to make decisions on their behalf in an informed way. In normal circumstances this can be challenging. The person with power of attorney may not be aware of the right questions to ask about antipsychotic medications, their side effects, or when this treatment will be reviewed, reduced, and stopped. The concern now is that this may become even more difficult because of the pandemic, with reduced contact between a patient’s family and friends and the patient, as well as between a patient’s family and friends and those responsible for the patient’s care. They will also have significantly fewer opportunities to assess the impact of the symptoms that these antipsychotic medications are being prescribed for and to use this to inform their decision-making process. 3. Safe staffing levels Concerns about staffing levels are nothing new in social care, which was already overstretched prior to the pandemic; there are currently an estimated 112,000 vacancies in care staff in England alone.[21] Near the beginning of the pandemic, Patient Safety Learning identified this as a potential patient safety concern, noting how the increased pressure of the pandemic, coupled with a lack of care staff, may impact the quality of care.[22] Working in these high-pressure conditions, it is possible that non-drug strategies for treating behavioural and psychological symptoms of dementia are not being fully pursued. Instead, the use of antipsychotic medications may become a first choice to calm a person experiencing distressing symptoms, rather than initially employing potentially more time-consuming and resource intensive non-drug strategies. Patient safety investigation and action needed Patient Safety Learning believes that there is a need for patient safety investigation and action by the Department of Health and Social Care and the Care Quality Commission in several areas: Investigating patient safety concerns of antipsychotic medication We support calls for the Department of Health and Social Care and the Care Quality Commission to investigate the increased prescription of antipsychotic medications for people living with dementia during the pandemic. Informed consent and shared decision-making As part of its investigation, the Department should review the information provided to people with dementia and their carers on what involvement they should expect in decisions about antipsychotic medications, considering whether this is sufficient. The Department should work with charities, such as Age UK, Alzheimer’s Society, Dementia UK, and the Lewy Body Society to ensure the widest possible dissemination of patient guidance on this issue. Staff training We believe that the Department should work with organisations such as Skills for Care and the Social Care Institute for Excellence to assess what additional training may be required for staff in this area. The Department should work with these bodies to share good practice for those working in social care on the use non-drug strategies for treating the behavioural and psychological symptoms on dementia.[23] [24] Guidance and advice for care providers The Department should consider and report on the opportunities and financial incentives for non-drug strategies for treatment, providing case studies of good practice. The Department should consider and report on whether there are any financial disincentives or barriers that may be preventing the use of non-drug strategies for treatment, such as potentially increased costs of person-centred care and personalised solutions. We would like to hear your views We are keen to explore this issue further and would like to learn more from people’s experiences concerning the prescription of antipsychotic medications for people living with dementia. Are you a carer or a family member of a person living in a care setting with experience of this issue? Do you work in a care home, nursing home or in domiciliary care and have a view on this issue? If you have insights you would like to share, please email the Patient Safety Learning team or share your thoughts on the hub. References 1. Alzheimer’s Society, Worst hit: dementia during coronavirus, September 2020. 2. Robert Howard, Alistair Burns and Lon Schneider, Antipsychotic prescribing to people with dementia during COVID-19, Lancet Neurol, November 2020. 3. Alzheimer’s Society, Antipsychotic drugs, Last Accessed 13 February 2021. 4. Social Care Institute for Excellence, Antipsychotic medication and dementia, Last Accessed 13 February 2021. 5. Alzheimer’s Society, Alzheimer’s Society’s view on antipsychotic drugs, Last Accessed 13 February. 6. Department of Health, The use of antipsychotic medication for people with dementia: Time for action, 2009. 7. Medicines and Healthcare products Regulatory Agency, Antipsychotics: initiative to reduce prescribing to older people with dementia, 11 December 2014. 8. Welsh Government, Dementia Action Plan for Wales, 2018-2022, 2018. 9. Scottish Government, Scotland’s National Dementia Strategy 2017-2020, 2017. 10. Ala Szczepura et al, Antipsychotic prescribing in care homes before and after launch of a national dementia strategy: an observational study in English institutions over a 4-year period, BMJ Open Vol. 6. Issue 9, 2016. 11. Welsh Government, Measuring the prevalence of antipsychotic use in care homes in Wales: Report of the Short Life Working Group, 2019. 12. Nathan M. Stall et al, Increased Prescribing of Psychotropic Medications to Ontario Nursing Home Residents during the COVID-19 Pandemic, medRxiv, 2020. 13. Jane Buchanan and Kim Samuel, Another COVID risk – overuse of psychotropic drugs on seniors in care, Human Rights Watch, 15 January 2021. 14. ITV News, ‘It’s a chemical cosh’: How Covid increased the use of antipsychotics among people with dementia, 21 January 2021. 15. Daily Mail, Dementia patients ‘are being given “archaic and dangerous” anti-psychotic drugs to keep them sedated during lockdown putting them at risk of early death’, as grandmother, 86, dies six weeks after starting medication, 26 October 2020. 16. Vancouver Sun, COVID-19: More care home residents given ‘potentially inappropriate’ mood-calming drugs in 2020, data suggests, 13 February 2021. 17. Wilma Knol et al, Antipsychotic drug use and risk of pneumonia in elderly people, Journal of American Geriatrics Society, 2008. 18. Sanja Zivkovic et al, Antipsychotic drug use and risk of stroke and myocardial infection: a systematic review and meta-analysis, BMC Psychiatry, 2019. 19. The Lewy Body Society, Treatment, Last Accessed 17 February 2021. 20. NHS England and NHS Improvement, Consent to treatment, Last Accessed 22 February 2021. 21. Skills for Care, The state of the adult social care sector and workforce in England, October 2020. 22. Patient Safety Learning, Covid-19 and social care; we must act now to ensure patient safety, Patient Safety Learning’s the hub, 14 April 2020 23. Alzheimer’s Society, Organising treatment and care for people with behavioural and psychological symptoms of dementia: A best practice guide for health and social care professionals, 2011. 24. Social Care Institute for Excellence, Alternatives to antipsychotic medication, Last Accessed 18 February 2021.