Key messages

• Nurses and other workers in hospitals may become exposed to various hazardous medicines unless proper precautions are taken.
• New measured data on exposure to hazardous medicines are collected together with detailed information on practises applied at hospitals to promote safe handling practises.
• The study supports the implementation of EU legislation on carcinogenic, mutagenic and reproductive toxic chemicals at work and its recent updates concerning the hazardous medicines. 

Overview

This cross-sectoral study focuses on hazardous medicinal products, such as cytotoxic drugs ↗, inhalation anaesthetics, and disinfectants. Cytotoxic drugs, which are medications commonly used in chemotherapy to treat cancer, work by destroying or preventing the growth of cancer cells. However, these drugs can also pose risks to human health because they often have harmful properties, including the ability to cause cancer (carcinogenic), create genetic mutations (mutagenic), or negatively affect reproduction (reproductive toxicity). Similarly, common inhalation anaesthetics have been suggested or are known to exert reproductive toxic properties. The aim of the study is to introduce human biomonitoring for assessing both exposure and early health effects in healthcare settings. It will take place in 20-24 hospitals across 10-12 EU member states, with the following objectives:

• Identify key exposures and relevant exposure scenarios in hospitals
• Explore how human biomonitoring can improve chemical risk assessments for priority chemicals in healthcare environments
• Examine the contributions of various exposure sources—such as drug spillages, patient excreta, and drug packaging—to assess aggregated exposure to these medicines in hospital settings
• Develop human biomonitoring-based approaches to better assess and manage chemical exposures in hospital settings

The project aligns with recent guidelines for hazardous drugs, including cytotoxic drugs, ensuring compliance with occupational health and safety protections outlined by the EU Occupational Safety and Health Directive ↗ and the Carcinogens, Mutagens and Reprotoxic substances Directive ↗. These were recently amended to include also hazardous medicinal products and reproductive toxic compounds. In this way, the study addresses key regulatory developments and contributes to the improvement of occupational health and safety standards in the healthcare sector.

Achievements & Results

A consortium of institutes from 11 countries has been established, with partners confirming their participation to recruit hospitals and study participants. Together, the consortium identified priority chemicals for the study and selected specific biomarkers to measure exposure and effects. A generic study design has been developed, alongside detailed protocols for hospital recruitment, participant involvement, information sharing, questionnaires, and the collection, storage, and shipment of biological samples.

The digitalisation of the workers' questionnaire has been completed, and candidate laboratories for biomarker analysis have been identified. Quality assurance and control measures for biomarker and occupational hygiene sample analyses have been developed, with sampling already underway in some countries.

The study’s focus on hazardous medicinal products was narrowed to cytotoxic drugs, as there was insufficient support to include antibiotics or other medicinal products.

Work is ongoing to prepare information materials for hospitals and workers. Informal discussions with the European Commission's Directorate-General for Employment (DgEMPL ↗) and the European Agency for Safety and Health at Work (EU OSHA ↗) have helped shape the project design. A protocol paper detailing the study methodology is currently being drafted.  

Policy relevance

• The project supports the implementation of the recent updates to EU CMRD, which now includes hazardous medicinal products.