Ian Lindsley, Secretary of the European Biosafety Network, gave a presentation to the conference of the International Society of Oncology Pharmacy Practitioners, ISOPP 2023, in Seville on 3 March entitled ‘Is your pharmacy ready for EU legislation?’
He spoke about the March 2021 report produced by the European Commission identified almost 1.8 million workers exposed to relevant HMPs in the EU and recommended to add 3 groups of hazardous medicinal products – antineoplastics, immunosuppressants and antivirals to Annex I of the Carcinogens and Mutagens Directive.
In March 2022, new legislative changes in the revised Carcinogens, Mutagens and Reprotoxic Substances Directive (CMRD) included HMPs and reprotoxins in the scope of the Directive, a broader definition of HMPs than just cytotoxics and a requirement for training those in healthcare handling HMPs and CMRs. The new law has been transposed into national law in all EU member states by 5 April 2024.
The European Parliament and the Council share the common understanding that “hazardous medicinal products which contain substances which meet the criteria for classification as carcinogenic (categories 1A or 1B), mutagenic (categories 1A or 1B) or reprotoxin (categories 1A or 1B) in accordance with Regulation (EC) No 1272/2008 fall under the scope of Directive 2004/37/EC. All requirements of Directive 2004/37/EC apply to hazardous medicinal products accordingly.”
Under the hierarchy of control of the EU legislation carcinogen, mutagen or reprotoxic substances must be manufactured and used in a closed system as in healthcare, it is often not technically possible to replace or substitute HMPs. Closed systems in healthcare and veterinary includes the use of biological safety cabinets, containment isolators and closed system transfer devices (CSTDs).
The EU legislation also requires new EU guidance on handling HMPs to be published and disseminated and this is due to be published very soon. The new EU guidance includes the same broader definition of HMPs and states that HMPs belong to a wider range of therapeutic groups. The guidance is also extended to all types of organisation and at all stages throughout the life cycle of HMPs, from manufacture to disposal, not just in specific areas like pharmacy or preparation
Ian also spoke about the ETUI list of HMPs which he co-authored which is the first and only list of HMPs publicly available identifying hazardous drugs used in the EU that strictly fall within the scope of the CMRD. The application of the European guidance on HMPs to the drugs identified in the ETUI list will help prevent future occupational exposure in millions of workers across the EU.