SUMMARY OF STUDY

To reinforce protection of workers from exposure to hazardous medicinal products, including cytotoxic medicinal products: an Independent Group to European Commission made a study with different proposals

The study was implemented during the period November 2019 to December 2020.
COWI A/S [1] led the implementation of the work which was conducted in close collaboration with IOM (Institute of Occupational Medicine), and under the supervision of the framework contract holder, Fondazione Giacomo Brodolini (FGB).

The study has included extensive consultation with relevant stakeholders:

• Representatives of the social partners in healthcare (the European Federation of Public Service Unions (EPSU) and the European Hospitals and Healthcare Employers’ Association (HOSPEEM).
• Relevant Member State authorities.
• Key pan-European organizations; European Oncology Nursing Society (EONS), and European Federation of Pharmaceutical Industries and Associations (EFPIA).
• Experts from; European Chemicals Agency (ECHA), European Association of Hospital Pharmacists (EAHP), European Society of Oncology Pharmacy (ESOP), European Biosafety Network (EBN), EPSU, Belgian Federal Public Service Employment, Labour and Social Dialogue.

 Beyond these consultations, five Member State-specific workshops have been organized (Spain, Portugal, Poland, Netherlands, and Romania), and a stakeholder conference was conducted in September 2020.

The aim of this study was to investigate options for protecting workers from exposure to hazardous medicinal products (HMPs), including cytotoxic medicinal products.

The study estimates that almost 1.8 million workers are today exposed to the relevant hazardous medicinal products (HMP), and it is estimated that 88% of them are employed in hospitals, clinics, and pharmacies. The nursing professionals is the largest single occupational group that is exposed (40%).

Epidemiological studies of highly exposed workers suggest increased risks to be 83%, 64% and 46% for breast cancer, hematopoietic cancers, and miscarriages, respectively.

The identification and assessment of the specific products from which the workers should be protected is difficult because:

– there is no common EU definition of HMPs

– classification information according to the regulation on classification, labelling and packaging (CLP) criteria is lacking or uncertain.

NIOSH has developed definitions and classifications which concluded that the main pharmacotherapeutic groups of concern are antineoplastic agents, antivirals, and immunosuppressants.

The study has identified three main drivers regarding workers exposed to HMPs, to reducing this exposure:

• Lack of legal clarity and of a common EU definition of such HMPs,
• Deficiencies in the flow and/or transfer of information,
• Lack of awareness and support tools to provide effective and efficient protection of workers.

But in addition to the three identified drivers, stakeholders have often also frequently pointed out insufficient enforcement as an important factor.

The study identifies three main types of options to address these drivers:

1. a) amending the CMD to further address HMPs,
2. b) amending other relevant legislation outside the occupational safety and health (OSH) domain to include provisions related to workers’ protection from exposure to HMPs,
3. c) developing (or updating) non-legislative instruments at EU level to improve the occupational safety and health of workers exposed to HMPs.

Some sub-options have been also identified:

1. Add relevant pharmacotherapeutic groups of HMPs to Annex I of the CMD. But defining the pharmaceutical groups to add to the CMD can be complex. But this option is strongly supported by many stakeholders. This option will not as such introduce a change, but rather provide a strengthened explicitness, which could in turn also lead to improved compliance/enforcement.

1. Introduce central EU guidelines and standards of practice. This option is a supported option by many stakeholders, who express a strong relevance of, and need for, ‘EU-endorsed’ guidelines which would help to increase awareness and identify good approaches to risk management, yet without introducing legally binding requirements.

Guidelines that are accepted, widely used, and relevant can contribute to improved compliance/enforcement.

1. Prepare a definition of HMP and prepare a list of HMPs and active agents that meet a certain definition. EU-level definitions and associated lists can provide clarity and transparency that help employers and employees to better understand responsibilities and rights as regards the CMD.

All options are about strengthening compliance with the CMD as it stands.in delivering improved compliance through enhancing the knowledge of authorities, employers, and employees about their rights and responsibilities, and/or about the measures that can be taken.

The increased focus on proper handling of HMPs will contribute to reducing anxiety and fears among health care workers.

[1] COWI A/S is an international consulting group, specializing in engineering, environmental science and economics, with headquarters in Lyngby, Denmark.

To read the full study, click here.

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