Prevention of Hazardous Medicinal Product Exposure in European Healthcare

Prevention of exposure to hazardous medicinal products, including cytotoxics, in the healthcare sector in Europe Dr Zinta Podniece Deputy Head of Unit Unit B3: Health & Safety DG Employment, Social Affairs and Inclusion Luxembourg European Biosafety Summit 29 October 2019, Rome

Content Current framework EU OSH legislation Risk management EU Guidance on OSH risks in healthcare sector EU-OSHA campaign 2018-19 What happens next? 3rd amendment of the Carcinogens and Mutagens Directive (CMD3): request for an assessment

EU OSH legislation European Framework Directive 89/391 EEC on Safety and Health at Work Directive 98/24/EC on the protection of workers from the risks related to Chemical Agents at work Directive 2004/37/EC on the protection of workers from the risks related to exposure to Carcinogens or Mutagens at work And other relevant individual Directives (e.g. personal protective equipment (PPE)) The national measures which transpose the EU OSH Directives place an obligation on the employer (e.g. the hospital) to identify all potential occupational hazards, including cytotoxics, to assess the associated risks and to take preventative/protective measures according to the risk assessment

Risk management Hierarchy of measures - The employer shall ensure that the risks are eliminated or reduced to a minimum by: Avoiding the use of a substance (substitution) Applying protection and prevention measures following an order of priority to: - Design of appropriate work processes and engineering controls - Use of adequate equipment and materials - Adequate ventilation - Organisational measures - Use of personal protective equipment Other important risk management issues: - Information and training of workers - Health surveillance - Arrangements for dealing with incidents and emergencies etc.

Guidance to facilitate compliance with EU legislation Guide to improve health and safety standards in health institutions in the EU Chapter on chemical risks, section 6.6 on cytotoxic drugs Work situations with the greatest exposure Effect on health and safety Specific prevention techniques and procedures Published in 2010: is an update required? Are more specific details available?

EU-OSHA campaign on dangerous substances 2018-19 The 2018-19 campaign aims to raise awareness of the risks posed by dangerous substances in the workplace and to promote a culture of risk prevention Various tools and guidance, materials, case studies, e-tool, infographics, etc. Guidance on Safe handling of cytostatics for medical and dental services, by Health Service Rioja https://healthy-workplaces.eu/

What happens next? 3rd update to the CMD (Directive(EU)2019/983, 05.06.2019) Acknowledges the importance of the protection of workers exposed to hazardous drugs, including cytotoxic drugs Request by co-legislators to the Commission: - Assess the option of amending the CMD in order to include hazardous drugs, including cytotoxic drugs, or to propose a more appropriate instrument for ensuring the protection of workers to such drugs - Assessment by 30 June 2020 - Consultation with relevant stakeholders, in particular health practitioners and health professionals - Access to the best available treatments for patients should not be jeopardized

Future study supporting the assessment Address questions such as: What are the drugs of greatest concern? What are the appropriate risk management procedures and measures? Will be based on different elements, including: Research: Scientific evidence and literature Practice: Consultation with relevant stakeholders Policy: Wide range of OSH information sources, including: - European Medicines Agency - European Public Assessment Reports - International Agency for Research on Cancer e.g. IARC Monographs - World Health Organisation Anatomical Therapeutic Chemical Classification System - National or regional guidance documents Will assess impacts of different scenarios, including: Update of CMD Development of updated guidance

Thank you for your attention!