EU Guidance for safe management of hazardous medicinal products at work
2 October 2024
Dr Paul Sessink, exposure control, Bjökö - SwedenDr Birgit Tans, University Hospitals Leuven - Belgium
Workshop on “implementation” of the guidance - challenges and issues.
April 28, 2023, the European Commission has published a guidance for the safe management of Hazardous Medicinal Products (HMPs) at work. It is a non-binding document for workers, employers, public authorities, and safety experts to underpin their approaches to workers’ protection from HMPs.
The guidance was developed to provide practical examples for reducing the workers’ exposure to HMPs across all lifecycle stages: manufacturing, transport and storage, preparation, administration to human patients and animal patients as well as cleaning, laundry, maintenance, and waste management. Some general information is also presented concerning identification of HMPs, creating a safe working environment, risk assessment, exposure assessment, education and training, health surveillance, and incident management.
The guidance offers a broad range of practical advice presented in a simple and reader-friendly way by using graphics, photos, and special training documents. Four types of control measures are presented for all lifecycle stages according to the STOP principle: Substitution, Technical measures, Organizational measures, and Personal protection. For each role (profession/function) is indicated what section of the guidance is relevant to read.
The aim of the workshop is to present in depth some general and specific sections of the guidance that are relevant for pharmacists involved in compounding/preparing HMPs. To avoid that the workshop will too theoretical, practical experiences from the University Hospitals in Leuven is included. Leuven has a long history concerning workers protection to HMPs and has been involved in many published studies related to occupational safety and health. Practical solutions will be presented. In addition, recommendations how to get started with the implementation of the guidance, and DO and DO NOTs will be presented, and even if all is organized well it can still go wrong. Overall, we consider that the workshop could serve as a starting point for the implementation of the EU guidance in hospitals.
The guidance is available at: https://osha.europa.eu/en/publications/guidance-safe-management-hazardous-medicinal-products-work and will be translated in all member state languages.