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Proposed amendments to the reformed Pharmaceutical Legislation: patient safety and medication shortages
21 November 2023
In a significant move, the European Commission proposes a comprehensive overhaul of pharmaceutical legislation in April 2023, focusing on improving medication access and addressing shortages. EHMA’s EPACT Alliance advocates key amendments, emphasising pharmacovigilance, patient safety, and hospital medicine stock visibility. The reformed Regulation and Directive aim to position the EU as a global leader in reducing medication errors, supporting the European Medicines Agency’s mandate to prevent shortages through the European Shortages Monitoring Platform. Advocates see this as a ‘once-in-a-generation’ opportunity for transformative healthcare improvements, calling for strengthened legislation.
In April 2023, the European Commission submitted its proposals for the reformed Pharmaceutical Legislation. Key objectives of the reform include increasing access to medicines by ensuring the security of supply and addressing medicinal product shortages. As amendments to the proposed revision of the EU pharmaceutical legislation (Directive 2001/83 and Regulation 726/2004) are submitted, the EPACT Alliance – initiated and run by EHMA – has produced position papers on two critical healthcare issues for healthcare managers: pharmacovigilance and patient safety, as well as the visibility and traceability of medicines stocks in hospitals.
The Proposal for a reformed Regulation and the Proposal for a reformed Directive presents a unique opportunity for the European Union to be a global leader in reducing harm from medication errors. The reformed legislation is an important milestone supporting the new mandate of the European Medicines Agency (EMA) to mitigate, manage, and prevent medication shortages via the European Shortages Monitoring Platform (ESMP).
The European Commission’s proposal contains positive steps, and more can be done to reinforce the legislation to reduce harm from medication errors and to manage and mitigate shortages of medicinal products in hospitals when they arise. As the reform presents a ‘once-in-a-generation’ opportunity to enhance the quality of care in hospitals, our suggested amendments reflect our ongoing commitment to promoting the highest standards of healthcare and ensuring the well-being of patients and healthcare professionals in our health systems.
Our position papers target pharmacovigilance and patient safety and the availability and visibility of medicines in hospital settings. Statistics indicate alarming rates of medication-related harm in hospitals, with 1 in 5 inpatients affected (OECD, 2022). In Europe, 80 million people have reported experiencing serious medication errors during a hospital stay; daily deaths from medication errors surpass deaths from breast cancer, HIV, or road traffic accidents (EHMA, 2022). Medication shortages, on the other hand, strain health budgets particularly impacting pharmaceutical expenses (ASHP, 2023). Digital solutions to manage hospital’s medication management processes exist, but their widespread adoption lags. For example, despite ample evidence supporting the value of Barcode Medication Administration (BCMA) in enhancing patient safety, only 30% of the 317 surveyed hospitals utilise BCMA (ECAMET, 2022).
We urge the EU to address the downstream determinants of harm from medicinal products and to modernise hospitals’ pharmaceutical pathways for patient safety and health system sustainability. It is crucial for the EU to ensure widespread implementation of digital medication management systems to improve medicine safety and availability in hospitals across Member States. EU hospitals need modern technological systems to reduce costs, support staff and enhance medication availability and traceability for the new European Shortages Monitoring Platform (ESMP).
OUR ASKS
To prioritise pharmacovigilance and patient safety and support hospitals and professionals to share medication stock data, we ask:
- The progressive introduction of standardised single-unit dose barcodes, such as GS1 standards, on medication blister packs, vials, pre-prepared syringes, and ampoules to reduce the harm associated with medication administration at the patient’s bedside.
- To strengthen the reporting mechanisms for adverse drug reactions by including reports of unintended medication errors in the EUDRA Vigilance database.
- To enhance communication by collecting and sharing information on hospital medication stocks with National Competent Authorities for the ESMP to proactively manage and mitigate medication shortages.
- To include and recognise hospitals as key stakeholders supporting national and European efforts to manage and mitigate the impact of shortages on patients and healthcare professionals.
These amendments are vital to enhance the quality, reliability, and safety of hospital patient care.
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I have been active in EHMA since the first years of the '90s and I have seen its evolution from a small association of members interested in sharing knowledge on health management practices to the current status of reference and advisory key player for EU, health systems and organisations, stakeholders associations, industry and universities. EHMA is now a unique knowledge hub, policy advisor, community of practice and network of best in class organisations involved in health policy and management. A place where health managers can build their competences, policy-makers and stakeholder associations envision how to implement and sustain change through health management, industry leaders understand how to engage more effectively with health organisations and systems. The right place to nurture and grow health management capabilities and capacity for every stakeholder of health systems.
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Prof. Todorka Kostadinova, Medical University of Varna, Bulgaria
I enjoy the high level of interaction and engagement in EHMA’s activities, in particular during the annual conference where the panel discussions are rich and well prepared. As a hospital manager and professor of health management, EHMA motivates and inspires me to be creative. You go back home feeling energised from seeing old friends and making new connections, as well as being convinced of serving as EHMA’s ambassador. It’s a strong feeling of interdisciplinary engagement, but it also feels like being part of family-like community.
Prof. Sandra C. Buttigieg, University of Malta, Malta
EHMA is a pre-eminent organisation for everyone working in planning, managing and delivering health services across Europe. As a long standing member of EHMA I have always been impressed by the vibrant community of managers, researchers and academics it has created and by the many opportunities for sharing knowledge and funding opportunities it has brought to its members. Its international scope is impressive and its impact is often felt in management and research across European and national health systems.
Prof. Axel Kaehne, Edge Hill University, UK
Health workforce has become more essential in operating, managing and maintaining health systems lately, particularly in crisis and emergency situations. European healthcare professions and the workforce need to be high on the agenda of managers and decision makers. The Health Services Management Training Centre, Semmelweis University in Hungary is a longstanding EHMA member, because it connects us with collaborators and experts, with whom we can have complex debates, from whom we can learn and at the end find solutions in various challenging fields of healthcare management.
Dr Eszter Kovács, Health Services Management Training Centre, Semmelweis University, Hungary
As a hospital administrator and health management professor, I see on a daily basis that the healthcare challenges require talented and skilled managers to transform it. the EHMA membership has been beneficial to bring healthcare management research and education to the demanding healthcare services world, promoting healthcare management competencies and knowledge creation.
Dr Alexandre Lourenco, APAH - Association of Portuguese Hospital Managers, Portugal
Many healthcare systems in Europe and beyond are facing similar challenges which require innovative and creative solutions. EHMA’s annual conference, webinars, Programme Directors’ group and other activities and resources provide incredible opportunities for networking, connecting and sharing experiences. A distinct feature of EHMA is the diversity of members with representation from many countries, sectors and different communities of practice – academic, policy-makers, practitioners, managers, leaders and students. The annual conference is a highlight in the calendar year, offering a friendly, fun and learningful environment for emerging and established members to engage, collaborate and meet up with old and new friends. I am proud to be a member of the EHMA Board.
Prof. Ann Mahon, University of Manchester, UK
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