Paris, June 10th, 2021

CytoPrevent* Advisory Board proposals to update the CMD

While the European Commission has just started the Trilog process to amend the Carcinogen and Mutagen Directive (CMD), CytoPrevent Advisory Board wishes to express some key concerns and formulate its expectations regarding the outcomes.

The health risks faced by healthcare professionals handling Hazardous Drugs are clearly documented and will increase next decades if no enforceable measures are taken. Protective measures and dedicated closed safety devices to reduce these risks to a level As Low As Reasonably Achievable (ALARA), are available being apart of the solution.

In order to achieve safe working conditions, it is critical to reach a robust legal framework of protection. This means not only recommendations or guidelines (they are too soft, and history has shown, they will not be implemented at Member State level if they are not enforceable) but a truly enforceable legislation. This means that the Hazardous Drugs have to be placed in Annex 1 of the CMD with a list of HMPs established and updated regularly.

The scope of the amended CMD should include comprehensive measures focused on three pillars:
1. Training
a. Up-to date detailed information on Hazardous Drugs and related risks
b. Special instruction program with regular updates
2. Prevention and Protection
a. Risk assessment and organizational measures
b. Use of Personal Protective Equipment and closed systems with a special attention for the use Closed Safety System for Administration (CSSA) where the highest risk exists mainly at nursing (0.7 million nurses are daily exposed to Hazardous Drugs)
3. Control
a. Quality and safety indicators for practices including monitoring
b. Health surveillance of exposed workers
c. Regular review of incidents and accidents

To ensure the effective implementation and a strict compliance of these measures every medical organization dealing with Hazardous Drugs ought to put into place a dedicated task force headed by a supervisor.

What we recommend should not be seen as complex and excessive but as basic and normal working conditions to protect healthcare workers working in a risky environment. Healthcare workers and patients deserve to be protected by legislation through robust measures that are legally binding for all the actors and not by guidelines and other soft measures that can easily be put aside. The past has shown that this did not work and has resulted in the adverse health risks we face today and will increase in the future if no ENFORCEABLE measures are taken.

*CytoPrevent is a group of scientific experts from several countries, dedicated to increase protection for healthcare workers handling, preparing, or administering cytotoxic drugs. This multidisciplinary initiative was launched on April 24, 2020, to raise awareness among European policymakers and recommend new measures to prevent contamination risks or make them “as low as reasonably achievable”. The CytoPrevent group involves scientists, pharmacists, doctors, nurses, who express their common views through open and independent discussions.

Read the original paper here.

[1] Direct CMD: Carcinogens and Mutagens Directive (CMD) Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (sixth individual Directive within the meaning of Article 16 (1) of Council Directive 89/391/EEC).