Navigating European CMR and ETUI Guidelines in Healthcare Environments

Navigating European CMR and ETUI Guidelines in Healthcare Environments

December, 2024

With the growing demand for cancer treatments, the number of healthcare workers exposed to hazardous medicinal products (HMPs) is increasing, exposing up to 12.7 million EU healthcare professionals and 40% of nurses annually .1,2  Recent advancements in cancer research present new treatment options that lead to improved outcomes. These breakthroughs also introduce challenges associated with new toxicity profiles and concerns for occupational safety. 

In Europe, ensuring workplace safety in environments with hazardous substances requires an understanding and implementation of regulatory guidelines. This blog examines the CMR (Carcinogens, Mutagens, and Reproductive Toxicants) guidelines, alongside the ETUI list (European Trade Union Institute), to highlight their role in protecting workers in oncology and pharmacy. 3,4 

Hazards While handling CMRs in the EU 

Nurses exposed to cytotoxic drugs face serious risks, including being twice as likely to experience miscarriage. 5 The European Oncology Nursing Society (EONS) gathered data on occupational safety in an anonymous online survey.6 One in five nurses reported handling hazardous cancer drugs during pregnancy and breastfeeding. Over a third of respondents noted risks of negative repercussions if pregnant or breastfeeding nurses requested alternative duties. Some nurses reported a lack of introductory education for handling HMPs. A key finding from the study is EONS’ official acknowledgment of the risks oncology nurses face when handling HMPs. To address these dangers, they recommend implementing specific safety measures, including the use of a Closed System Transfer Device (CSTD). 

Overview of ETUI list and CMR Guidelines   

The ETUI report outlines HMPs covered under the EU’s CMR Directive 2022/431 to control and limit exposure to substances that can cause cancer, genetic mutations, or reproductive toxicity. It helps employers comply with new regulations and enhance worker safety. Based on the U.S. National Institute for Occupational Safety and Health (NIOSH) classifications and adapted to European standards, it categorizes HMDs into three toxicity levels with corresponding safety measures. It focuses on identifying, assessing, and managing the risks associated with HMD exposure in the workplace.  

Harmful Effects of HMP Exposure in the Workplace  

HMPs, primarily used in cancer treatment, present health risks to healthcare workers due to potential exposure during handling. Even small, ongoing doses can be dangerous, leading to acute and chronic health effects. 7 Exposure results in effects that may take years to manifest, causing thousands of cancer deaths annually, as well as numerous miscarriages, fertility issues, and congenital disabilities.8  

Healthcare environments are complex, and risks arise during preparation, administration, and disposal processes. Paths of exposure include dermal absorption, inhalation, and ingestion 2. This mainly affects oncology nurses and pharmacy staff, but can also affect patients, visitors, and family members through contact with contaminated surfaces.  

Lifecycle of hazardous drugs in the hospital

Recommendations for Safe Handling of HMPs from Most to Least Effective 

The ETUI report offers a hierarchy of controls to prioritize the most effective safety measures for preventing exposure.  

/ Elimination: Removing the HMP 

/ Substitution: Replacing the HMP 

/ Engineering controls: Isolating healthcare workers from HMP 

/ Administrative controls: Establishing procedures to minimize the duration, frequency, or intensity of exposure to HMP 

/ Personal protective equipment (PPE): Wearing gloves, goggles, and other protective gear to reduce exposure to HMP 

Strategies for Safe Handling in Chemotherapy  

In healthcare units handling HMPs like chemotherapy, elimination and substitution isn’t feasible. The most effective measure is to implement engineering controls, which means ensuring a closed system. A fully closed system combines the use of a safety cabinet or isolator with a Closed System Transfer Device (CSTD) to provide the highest level of containment.  

Without a CSTD, compounding within a safety cabinet often results in drug residues lingering on gloves, vials, and surfaces, which spreads throughout the rest of the lifecycle.9 CSTDs are essential for minimizing vapor escape and leakage, preventing exposure during both compounding and administration. 

EQUASHIELD CSTD Advantages   

EQUASHIELD CSTDs offer proprietary technological advantages that make them safe, simple, and closed. The portfolio of products is backed by independent and peer-reviewed studies to prevent vapor escape, leakage, and microbial ingress, covering more routes of exposure than alternative solutions.

EQUASHIELD CSTD technological advantages

The Syringe unit is fully encapsulated, preventing not just external exposure but also plunger and barrel contamination. It features a patented closed back and utilizes sterile air drawn directly from its sealed back chamber, eliminating the need for extra steps to equalize pressure.10 This sets EQUASHIELD apart from other brands, making it the easiest and most user-friendly system available.11,12 

Equashield syringe unit technology

Case Study of Improved Safety Practices   

Hospitals in Southwest Germany transitioned to EQUASHIELD’s CSTD to enhance safety in handling hazardous drugs. The head of pharmacy made this change due to exposure risks. Since integrating the system seven years ago, they have reported improved staff satisfaction, measured reduced contamination, and streamlined workflows. The improved safety standards have reduced turnover while enhancing safety and morale. 

Act now 

As new research emerges and technology advances, healthcare institutions must regularly update their safety protocols. Through training, updated technology, and a strong safety culture, healthcare professionals minimize risks. By following regulatory guidelines and recommendations, healthcare institutions create a safer work environment for oncology nurses and pharmacy staff.  

Download this all-encompassing guide with everything you need to know : Transform Your Hazardous Drugs Management Approach with this Step-by-Step Guide 

 

Related Blogs

CMR list and ETUI regulation
December, 2024
#Europe
#Germany
#hazardous drugs
#Head of Pharmacy
#regulations
#UK

Navigating European CMR and ETUI Guidelines in Healthcare Environments

Implementing CSTDs in Ostlab hospitals in Germany
September, 2024
#air-tight
#CSTD Administration
#CSTD Preparation
#Head of Pharmacy
#leak-proof

Case Study: Implementing EQUASHIELD CSTDs in German Ostalb Hospitals

August, 2024
#air-tight
#CSTD Administration
#Europe
#Germany
#leak-proof
#Veterinarians

Case Study: CSTD use in Veterinary Medicine  

References

  1. Inclusion of Hazardous Medicinal Products within the scope of the Carcinogens and Mutagens Directive, European trade union institute, ETUI, 2020 https://www.stopcanceratwork.eu/wp-content/uploads/2020/10/ETUI-Briefing-Note-HMP-CMD4.pdf 
  2. European Commission, (2021), Study on hazardous medicinal products (HMPs), Brussels 
  3. EU CLP Classification System of Carcinogenic, Mutagenic, and Reprotoxic (CMR) Substances Guidance for the safe management of hazardous medicinal products at work. Published by the European Commission Directorate-General for Employment, Social Affairs and Inclusion, Directorate EMPL.C — Working Conditions and Social Dialogue Unit C.2— Health and Safety at Work.  Retrieved from https://osha.europa.eu/sites/default/files/KE0322175ENN_0.pdf. 
  4. Lindsley, I., & Musu, T. (2022). The ETUI’s list of hazardous medicinal products (HMPs). European Trade Union Institute, Brussels. Retrieved from https://www.europeanbiosafetynetwork.eu/wp-content/uploads/2022/10/The-ETUIs-list-of-hazardous-medicinal-products-HMPs_2022.pdfhttps://www.stopcanceratwork.eu/wp-content/uploads/2020/10/ETUI-Briefing-Note-HMP-CMD4.pdf 
  5. Lawson CC, et al. Occupational exposures among nurses and risk of spontaneous abortion. Am J Obstet Gynecol 2012;206(4):327.el-8 
  6. Sharp, L., Fransson, P., Fowler, M., & Ullgren, H., 2024, Aspects of occupational safety: a survey among European cancer nurses. Retrieved from https://pubmed.ncbi.nlm.nih.gov/38669954 
  7. Nyman et al., 2007; Ratner et al., 2010; US Department of Health and Services, 2019 
  8. Directive 2004/37/EC on the Protection of Workers from Risks Related to Exposure to Carcinogens or Mutagens at Work (CMRD – Directive (EU) 2022/431). Detailed legal text outlining the protection measures for workers exposed to carcinogens or mutagens, aiming to enhance safety standards across the European Union. Full document accessible at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02004L0037-20220405. 
  9. Kicenuik, K., Northrup, N., Dawson, A., Locke, J., Villamil, J. A., Chretin, J., Sfiligoi, G., Clifford, C., Rosenberg, M., Hamilton, T., Regan, R., ParsonsDoherty, M., Mallett, C., Philibert, J., Impellizeri, J., & Hofmeister, E. (2015), University of Georgia, USA. Retrieved from Treatment Time, Ease of Use and Cost Associated With use of Equashield™, PhaSeal®, or no Closed System Transfer Device for Administration of Cancer Chemotherapy to a Dog Model 
  10. Smith, S. T., & Szlaczky, M. C. (2015). Syringe plunger contamination by hazardous drugs: A comparative study. Journal of Oncology Pharmacy Practice. Karmanos Cancer Center, Detroit, USA. Retrieved from: https://www.equashield.com/clinical-studies/syringe-plunger-contamination-by-hazardous-drugs-a-comparative-study/ 
  11. Berdi, F. (2015). Comparing The Efficiency of Closed System Transfer Devices for Compounding Pharmacy Practice & Products. Retrieved from https://www.equashield.com/clinical-studies/comparing-the-efficiency-of-closed-system-transfer-devices-for-compounding/ 
  12. Kicenuik, K., Northrup, N., Dawson, A., Locke, J., Villamil, J. A., Chretin, J., Sfiligoi, G., Clifford, C., Rosenberg, M., Hamilton, T., Regan, R., ParsonsDoherty, M., Mallett, C., Philibert, J., Impellizeri, J., & Hofmeister, E. (2015). Treatment Time, Ease of Use, and Cost Associated With the Use of Equashield™, PhaSeal®, or No Closed System Transfer Device for Administration of Cancer Chemotherapy to a Dog Model. University of Georgia, USA. Retrieved from https://www.equashield.com/clinical-studies/equashield-phaseal-no-cstd-for-administration-of-cancer-chemotherapy-to-dog-model/ 

Â