Proposed amendments to the reformed Pharmaceutical Legislation: patient safety and medication shortages

21 November 2023

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).  



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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