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HomeStudy supporting the assessment of different options concerning the protection of workers from exposure to hazardous medicinal products, including cytotoxic medicinal products
Final report
Study supporting the assessment of different options concerning the protection of workers from exposure to hazardous medicinal products, including cytotoxic medicinal products
Final report
Publication metadata
The aim of this study is to investigate options for protecting workers from exposure to hazardous medicinal products (HMPs), including cytotoxic medicinal products, that fall within the scope of the CMD (the Carcinogens and Mutagens Directive (2004/37 EC)). The study provides a comprehensive baseline analysis which leads to the assessment that in the EU today there are 1.8 million workers exposed to HMPs, of which not all are carcinogens or mutagens. The study concludes that the HMPs concerned (e.g. those which are carcinogens or mutagens) are within the scope of the CMD but observes deficiencies in the consequent implementation. The study identifies three drivers of this situation: 1) lack of legal clarity and unclear definitions of HMPs, 2) deficiencies in the flow and/or transfer of information and 3) lack of awareness and support tools. The study defines nine possible options for addressing these drivers. Based on a screening, three options were selected for further analysis: 1) add relevant pharmacotherapeutic groups of HMPs to Annex I of the CMD, 2) introduce central EU guidelines and standards of practice, and 3) prepare a definition of HMPs and prepare a list of HMPs and active agents that meet a certain definition. Illustrative estimations of costs and benefits are developed, but these are subject to much uncertainty due to knowledge and data gaps.
- Published:
- Corporate author(s): COWI , Directorate-General for Employment, Social Affairs and Inclusion (European Commission) , IOM
- Personal author(s): Sand Jespersen, Malene ; Lassen, Carsten ; Madsen, Peter G ; Werbrouck, Stine ; Wähler, Lorenz Carl ; Christensen, Frans ; Sessink, Paul ; Cowie, Hilary ; Cherrie, John ; Mueller, Will ; Basinas, Ioannis
- Themes: Workers' health and safety
- Subject: carcinogenic substance , data collection , directive (EU) , health care profession , health risk , medicinal product , occupational health , occupational medicine , safety standard , toxic substance
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| ISSN | ISBN 978-92-76-29361-3 | DOI 10.2767/17127 | Catalogue number KE-04-21-039-EN-N |
- Released on EU Publications:
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