Preventing exposure to carcinogenic hazardous drugs Europe’s Beating Cancer Plan for Europe has to consider the potential benefits for workers, the healthcare system, patients and their families, by what has already identified as a preventive instrument in the roadmap, namely further legislative measures to reduce exposure to carcinogenic substances in the workplace.
Every year more than 12.7 million healthcare workers in Europe, including 7.3 million nurses, are potentially exposed to hazardous cytotoxic drugs, which are mainly used to treat cancer and are carcinogenic, mutagenic and reprotoxic. Studies show that hospital workers who handle cytotoxic drugs are three times more likely to develop malignancy and that nurses exposed to cytotoxic drugs are twice as likely to miscarry. Given that the roadmap says that 40% of cancers are preventable, now is the time to intervene to apply the control measures in the existing Carcinogens and Mutagens Directive 2004/37/EC (CMD) to the preparation, administration and disposal of hazardous drugs to prevent exposure.
In terms of the European legislative framework, the CMD is the only effective and existing legislation which is regularly reviewed to protect workers, patients and carers from exposure to hazardous drugs. There are risks for the families of patients who stay with them in hospital but also because cancer treatment is increasingly being delivered in the home and, with an ageing population, in increasing numbers. Most patients and their families will be completely unaware of the potential danger of exposure to carcinogenic drugs and how to handle them properly and that includes the most vulnerable: the young, the elderly and pregnant women.
The only way to change behaviour and practice and introduce effective preventative and risk management measures is to ensure that a list of hazardous drugs is included in the CMD. These drugs must be manufactured, used and disposed of in a ‘closed technological system’ as defined by the CMD. Across the EU there is very little protection from exposure in practice and there is institutional resistance to behavioural change to prevent exposure.
On 5 June 2019, the third revision of the CMD (CMD3) included amendments recognising and prioritising for the first time the specific importance of protecting workers and patients who are exposed to such drugs through work involving: the preparation, administration or disposal of hazardous drugs, including cytotoxic drugs; services related to cleaning, transport, laundry or waste disposal of hazardous drugs or of materials contaminated by such drugs; or personal care for patients treated with hazardous drugs. The European Commission is required by CMD3 to complete a study and consultation at the latest by Q2 2020 on assessing the option of further amending the Carcinogens and Mutagens Directive to include hazardous drugs, including cytotoxic drugs, and then to produce a report including a potential legislative proposal. The main legislative option included in the assessment to amend the Directive is to include hazardous drugs as either a category in Appendix I or a list of specific drugs in Appendix III. However, it is not clear that the European Commission will either complete the study and assessment by 30 June 2020, as required by the CMD3 legislation, or include hazardous drugs, including cytotoxic drugs, in the subsequent fourth revision of the CMD (CMD4) later in 2020.
The European Commission must include in its CMD4 report or accept Parliamentary amendments for the revision of the CMD in 2020 that include hazardous drugs, including cytotoxic drugs, as a category in Appendix I. Healthcare workers, patients and their families deserve to be protected by legislation now with the best possible systems of work, technology and education and training to avoid the risk of toxic and genetic damage and deadly diseases that may result from exposure to hazardous drugs.