Search the hub

Unsafe medication practices and medication-related harm are one of the leading causes of avoidable harm in health and care. This year’s #MedSafetyWeek focuses on the theme “we can all help make medicines safer”. We have collated patient interviews and blogs shared on the hub that raise awareness of medication adverse reactions, and resources on how you can report a problem. 1 MHRA: The Yellow Card Scheme The Yellow Card Scheme helps the Medicines and Healthcare products Regulatory Agency (MHRA) monitor the safety of all healthcare products in the UK to ensure they are acceptably safe for patients and those who use them. On the Yellow Card Scheme website you can report a suspected incident or problem. 2 The question that will save lives: Interview with Katinka Blackford Newman, founder of Antidepressant Risks Antidepressant medications are taken by millions of people globally. A small percentage of people who take them will experience rare but dangerous adverse reactions. In this interview, Katinka Blackford Newman tells us about her personal experience of antidepressant-induced psychosis and how this led her to campaign for increased awareness about side effects. She highlights a widespread lack of education and awareness about the risks associated with antidepressants and outlines why she is asking suicide prevention charities to ask callers one simple question about their medication. 3 Patient Safety Spotlight interview with Marie Lyon, chair of the Association for Children Damaged by Hormone Pregnancy Tests In this interview, Marie Lyon talks about her campaign for justice for families affected by hormone pregnancy tests, why she is passionate about reforming medicines regulation and the important role patient campaigners play in improving patient safety. 4 USA: FDA Adverse Event Reporting System (FAERS) public dashboard FAERS is the U.S. Food and Drug Administration (FDA) primary database for collecting and analysing adverse event reports, serious medication errors, and product quality complaints for prescription drugs and therapeutic biologics, containing reports submitted by healthcare professionals, consumers, and manufacturers. 5 Recognising adverse events and using the yellow card system Despite the role of the MHRA’s Yellow Card reporting system in pharmacovigilance in the UK, understanding and uptake of the scheme remains limited. East London NHS Foundation Trust share how they designed a survey to explore healthcare professionals’ awareness, usage and perceptions of the Yellow Card Scheme for reporting adverse drug reactions. 6 Post-SSRI Sexual Dysfunction: After 30 years, why is the health system still failing to recognise this life-limiting adverse effect? Post-SSRI Sexual Dysfunction (PSSD) is a long-term adverse effect of Selective Serotonin Reuptake Inhibitors (SSRIs), a type of antidepressant medication. In this opinion piece, Harriet Vogt, Patient Safety Partner at NHS Sussex Integrated Care Board, outlines the need for recognition and research into PSSD to allow patients to make truly informed choices when considering SSRIs. She looks at the impact PSSD has on the sexual and emotional lives of thousands of people and highlights a new research study analysing the obstacles to quantifying its incidence and prevalence. Harriet argues that while the health system is beginning to recognise the value of placing patients at the heart of efforts to improve safety, this focus on listening is rarely given to individual patients who express concern about the impact of their medication or treatment. 7 MHRA: Reporting a possible side effect to a medicine – a guide for Children and Young People The MHRA has produced a guide to download and share to help children and young people learn why it's important to report possible side effects of medication. 8 Sodium Valproate: The Fetal Valproate Syndrome Tragedy In this article, Sharon Hartles, member of the Open University’s Harm and Evidence Research Collaborative, reflects upon the use of Sodium Valporate, marketed as Epilim, to treat patients at risk of epilepsy and the subsequent harms in fetal development and birth defects that arose from its use. ‘ 9 Interview with Charlet Crichton, founder of UKCVFamily UKCVFamily was set up in November 2021 to support patients in the UK who have had an adverse reaction to a Covid-19 vaccination. The group provides help and advocacy as well as raising awareness amongst healthcare professionals, the media and the Government. In this video, founder of UKCVFamily Charlet Crichton talks to us about the side effects she experienced after having the AstraZeneca Covid vaccine. She outlines why she established the group and describes the support it offers to patients. She outlines some of the issues people face when trying to access diagnosis and treatment, and discusses the limitations of the MHRA's Yellow Card scheme in collecting data about adverse reactions. She also describes how healthcare professionals can support people with adverse reactions by taking their concerns seriously and investigating symptoms thoroughly. Share your stories Have you had an adverse reaction to medication? What do you think of the Yellow Card reporting system? Share your thoughts and experiences with us on the hub. You can comment below (you will need to be signed in first; sign up is free and easy) or email us at [email protected].

Adverse event reporting is critical for advancing patient safety within healthcare systems. A significant factor in enhancing reporting rates is establishing a 'just culture'; a framework that emphasises accountability and learning over punitive measures. While just culture significantly enhances adverse event reporting, its successful implementation requires robust commitment at all organisational levels. Reporting adverse events is essential for ensuring patient safety and fostering a culture of continuous improvement in healthcare. Adverse events, defined as unintended injuries or complications arising from healthcare management, offer crucial insights into systemic weaknesses that, if addressed, can prevent future harm. However, underreporting such events remains a significant challenge, often driven by fear of punitive actions, reputational damage or legal repercussions. To address these concerns and promote a robust reporting culture, healthcare organisations must adopt a just culture by implementing standardised frameworks for evaluating errors and establishing robust reporting systems. Transparency in handling reported incidents is critical for building trust among healthcare professionals. Understanding just culture Just culture represents a shift from a blame-oriented approach to one that balances accountability with a focus on systemic improvement. Originating in high-risk industries such as aviation, the concept emphasises that errors result from flawed processes rather than individual negligence. In a just culture, individuals are held accountable for their actions within a fair and transparent system that prioritises learning and improvement. Central to the philosophy of just culture is the idea of psychological safety. When healthcare professionals feel confident reporting errors will not lead to unjust punishment, they are more likely to disclose incidents. This openness enables organisations to identify trends, address root causes and implement preventive measures. Moreover, just culture recognises the distinction between human errors, at-risk behaviours, and reckless conduct, advocating for tailored responses that align with the nature of the behaviour. Barriers to adverse event reporting Despite its potential, the implementation of just culture faces several obstacles. A predominant challenge is the deeply ingrained blame culture within many healthcare organisations. Historical reliance on punitive measures has created an environment where professionals fear repercussions, discouraging transparency. Additionally, managerial inconsistency in addressing errors often undermines trust in the system. For instance, discrepancies in how similar incidents are handled can create perceptions of unfairness, further discouraging reporting. Another barrier is the lack of understanding and awareness of just culture principles among healthcare staff. Without proper training and education, employees may misinterpret the approach as being lenient or as failing to hold individuals accountable. Legal and regulatory pressures also pose challenges, as concerns about litigation can deter organisations from fully embracing non-punitive reporting frameworks. Strategies for implementing just culture Implementing a just culture in healthcare requires a multifaceted approach that addresses organisational, managerial and individual factors. Leadership commitment is paramount; leaders must model just cultural behaviours, demonstrate accountability and prioritise safety over blame. Developing clear policies and guidelines for error classification and response is equally important as it ensures consistency and fairness in how incidents are addressed. Education and training programmes are vital in promoting awareness and understanding of just culture principles. These programmes should emphasise the distinction between human errors, at-risk behaviours and reckless conduct, providing staff with the tools to respond appropriately. Role-playing scenarios, workshops and case studies can help reinforce these concepts and demonstrate their practical application. The integration of non-punitive reporting systems is another critical component. Such systems should be designed to facilitate easy and confidential reporting, with mechanisms to protect the anonymity of reporters when appropriate. Feedback loops are essential for ensuring that staff are informed about the outcomes of reported incidents, which can reinforce the value of reporting and build trust in the system. Measuring the impact of just culture Assessing the effectiveness of just culture initiatives requires the development of standardised metrics and evaluation tools. Key performance indicators may include reporting rates, staff perceptions of psychological safety and the frequency of systemic improvements resulting from reported incidents. Periodic surveys and interviews can provide valuable insights into staff attitudes and identify areas for improvement. Case studies from organisations that have successfully implemented just culture can also serve as benchmarks for best practices. For instance, hospitals that report significant increases in adverse event reporting rates following the adoption of just culture principles often attribute their success to strong leadership, comprehensive training, and consistent application of policies. Sustaining cultural change Sustaining a just culture requires ongoing commitment and adaptability. Organisations must regularly evaluate their policies and practices to ensure alignment with just culture principles. Staff feedback should be actively sought and incorporated into decision-making processes, fostering a sense of ownership and engagement. Continuous education and training are essential for reinforcing just culture behaviours and addressing emerging challenges. Additionally, leadership succession planning should prioritise candidates who are committed to upholding just culture principles, ensuring continuity in organisational values. Conclusion Adverse event reporting is a fundamental component of patient safety, and the principles of just culture provide a robust framework for enhancing reporting rates and fostering systemic improvements. By balancing accountability with a focus on learning and improvement, just culture creates an environment where healthcare professionals feel empowered to report incidents without fear of retribution. Leadership commitment, staff education and integrating non-punitive reporting systems are critical for overcoming barriers and sustaining cultural change. A just culture represents a paradigm shift in addressing adverse events, emphasising systemic improvement over individual blame. Its successful adoption has the potential to transform healthcare organisations, making them safer and more resilient. Future research should focus on developing standardized metrics to evaluate just culture initiatives and exploring their applicability across diverse healthcare settings.