EU Guidance for safe management of hazardous medicinal products at work.

5 October 2023

P Sessink (Exposure Control Sweden)

April 28, 2023, the European Commission has published a guidance for the safe management of hazardous medicinal products at work. It is a non-binding document for workers, employers, public authorities, and safety experts to underpin their approaches to workers’ protection from hazardous medicinal products.
The guidance, issued with the involvement of many stakeholders in the healthcare sector, provides an overview of existing good practice and practical advice aiming at reducing workers’ exposure to hazardous medicinal products.
Stakeholders in the healthcare sector have often stressed the need to better protect staff exposed to hazardous medicinal products. These products are used to treat a wide range of diseases, including cancer, but can cause unintended effects in people other than patients themselves, such as the workers exposed to them.

To address stakeholders’ concerns, the Commission has put forward a concrete action in the EU strategic framework on health and safety at work 2021-2027 - the preparation of a guidance for safe management of hazardous medicinal products.
The Commission involved many stakeholders in the drafting process. Numerous workshops, personal meetings and on-site visits in different Member States took place to obtain stakeholders’ views and feedback. This way the Commission’s services could benefit from their expertise and in-depth knowledge.

The guidance was developed to provide practical examples for reducing the workers’ exposure to hazardous medicinal products 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 hazardous medicinal products, 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 guidance is available at: and will be translated in all member state languages.

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