The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published its new “Guidelines on best practices for the traceability of medicines in hospital settings”. The aim of this document is to highlight the importance of hospital traceability of medicines at the point of administration, share experiences and best practices and encourage stakeholders to implement the approaches it presents and, by extension, improve patient safety.
Safe medication processes play a fundamental role in addressing patient safety, a major concern for healthcare systems worldwide. These guidelines underscore the challenges hospitals face in their efforts to move to full traceability of medicines, when replacing manual recording – which carries the risk of incomplete or inconsistent documentation – with barcoding at primary packaging level and electronic documentation, both of which enable faster, more standardised and more secure recording and monitoring of medication-related information.
Digitalisation prompts new ways of thinking along with changes in organisational culture, processes, roles and expertise. Given the diversity of hospital resources, healthcare systems and IT infrastructures across Europe and the significant investments required, the guidelines do not propose a single model. Instead, they present best practices and a harmonised European regulatory framework for barcoding all authorised medicines at primary packaging level, with options for phased implementation.
The way forward for their practical application will be explored at the Joint EDQM–Infarmed Symposium “Healthcare and medicines: meeting patients’ needs through Council of Europe/EDQM and national programmes”, taking place on 5 and 6 May in Lisbon (Portugal), particularly during Session V, which will bring together regulatory authorities, pharmaceutical manufacturers, hospital pharmacists and patient associations.
The guidelines were adopted by the Committee of Experts on Quality and Safety Standards in Pharmaceutical Practices and Pharmaceutical Care (CD‑P‑PH/PC) and the Committee of Experts on Minimising Public Health Risks Posed by Falsification of Medical Products and Similar Crimes (CD‑P‑PH/CMED), with the intention of supporting healthcare institutions in improving patient safety by strengthening the traceability of medicines throughout the medication process. The publication is available for download from FreePub, the EDQM’s free publications platform.
See also:
- CD-P-PH/PC – Pharmaceutical Practices and Pharmaceutical Care
- CD-P-PH/CMED – Background and mission – Anti-falsification activities
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