Navigating European CMR and ETUI Guidelines in Healthcare Environments

Tamar Apper on December 12, 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 .^1,²Recent 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.⁶One 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 ingestion².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.⁹CSTDs 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

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

Case Study: CSTD use in Veterinary Medicine

Tamar Apper on August 11, 2024

Download Full Article in German

Dogs get cancer at roughly the same rate as humans, with nearly half of dogs over the age of 10 developing cancer.¹ Cancer is a common concern in small animals, and as our beloved companions, they deserve the highest standard of care. Recently, there has been a notable rise in the use of antineoplastic chemotherapy within small animal veterinary practice. This trend is primarily driven by a growing awareness among pet owners about tumor diseases, along with significant advancements in diagnostics and therapies for small animal oncology.

While such therapies were initially carried out by large oncology centers, they are increasingly being offered by specialized small animal clinics.

Safety concerns

Exposure Risks for Veterinarians and Pet Owners

The use of cytostatic drugs poses an increased risk of exposure for veterinary staff and pet owners present during chemotherapy.

Given that the substances involved possess mutagenic, teratogenic, and carcinogenic properties, and that it is difficult to define minimum quantities for these effects, it is crucial to minimize the risk of exposure for both veterinary personnel and pet owners. The risk of exposure on surfaces is further increased considering that most veterinary clinics do not employ primary engineering controls, such as safety cabinets or isolators.

Research in human medicine indicates that there is no connection between the number of chemotherapy treatments administered at a facility and the degree of exposure risk.²This means that even facilities performing a relatively small number of chemotherapy treatments must prioritize minimizing exposure risks and implementing suitable protective measures.

The European College of Internal Medicine for Companion Animals has developed guidelines for the appropriate use of antineoplastic chemotherapeutic agents.³

The compounding of intravenous infusion solutions for antitumor chemotherapy, along with the administration of chemotherapeutic agents, introduces distinct risks of contamination and exposure to cytostatic drugs. Veterinarians encounter significant exposure risks in these processes. ⁴ Key steps in the process include reconstituting the vial, accurately extracting the substance, and managing the infusion solution.

Syringe unit with a closed syringe plunger prevents toxic aerosols from escaping.

Risks of Bacterial Contamination

Small animals need much less medication than humans, but the medications often come in standard-sized vials, resulting in significant waste. Traditional systems carry a high risk of microbial contamination, making multiple withdrawals unsafe, especially for immunosuppressed patients who are more vulnerable to sepsis. Additionally, many cytostatic drugs are costly, and disposing of unused substances is both expensive and harmful to the environment.

Use of CSTDs for the Application of Cytostatic Drugs to Small Animals

Utilizing a closed system transfer device (CSTD) mitigates both environmental and microbial contamination risks, protecting medical personnel and pet owners.

Currently, only a limited selection of CSTDs are available on the market in small animal oncology.⁵ EQUASHIELD has undergone extensive testing in human oncology, clinically backed to be safe and easy to use. The use of CSTDs does not exempt the oncologist of the obligation to adhere to current legal regulations governing chemotherapy. Nonetheless, it is strongly advised for veterinarians to prioritize their own safety.⁶

Case Study: Oncology at the Kleintierzentrum Kinzigtal Small Animal Center

This summary highlights the experiences of Kleintierzentrum Kinzigtal Small Animal Center, written by Dr. Jörg Schäffner, as they transitioned to EQUASHIELD CSTDs. For the complete article, please download here.

At the Kinzigtal Small Animal Center in Baden-Württemberg, Germany, we regularly provide chemotherapy for various tumors, including lymphomas, mastocytomas, and epithelial tumors like prostate and anal sac carcinoma. Treatments often involve intravenous administration of cytostatic drugs such as vincristine, doxorubicin, and carboplatin, with a successful slow infusion method.

Before the introduction of EQUASHIELD CSTDs, the conventional system left staff vulnerable to exposure. Before application, the calculated volume of a cytostatic drug was drawn from the sealed glass vial. Since multiple doses were often extracted from a single vial, this process introduced a risk of contamination for both the user and the surrounding environment. Another potential source of exposure and contamination arose when air was introduced to equalize the pressure between the vial and the syringe. Finally, there was the risk of needlestick injuries.

Veterinarian administering cytotoxic drug chemotherapy to small animals

Introducing EQUASHIELD

Over the past year, we have effectively mitigated these risks by utilizing the closed EQUASHIELD system. Administering treatment to restless, unsedated animals requires a safe and user-friendly approach to effectively prevent contamination of medical staff, pet owners, and the surrounding environment. It is crucial for us to have a system that can accommodate the unpredictable movements of the patient, ensuring the safe and hazard-free administration of cytostatic medications. The self-locking vial adapter, which remains firmly connected to a vial once it has been opened, and the syringe unit connected to the double-membrane closure system thus safely reduces both hazards. The sterilized air is introduced into the drug vial from the sealed chamber in the syringe unit to equalize pressure.

As the syringe unit is locked to the Luer Lock Adaptor of the infusion system, there is no risk of disconnection and subsequent contamination even if the patient moves. The slow application is carried out in a stress-free and controlled manner. Even when the syringe unit plunger is pulled back, the pressure equalization system reduces the risk of environmental contamination from aerosols. After administering the cytostatic drug and flushing the infusion tubing, the entire system is safely removed and disposed of in designated waste containers. Using CSTDs minimizes the risk of bacterial contamination, allowing us to make multiple withdrawals from the vial while effectively addressing the issue of waste.

Concluding Thoughts

In our experience, the introduction of EQUASHIELD is a significant contribution to safe chemotherapy. Our consistent positive experiences with EQUASHIELD, characterized by intuitive and safe handling, along with significant time savings compared to other systems, validate the findings of a study from North America.⁷ EQUASHIELD reduces the risk of microbial contamination of opened cytostatic vials.⁷ For medical staff and pet owners, exposure risks have been effectively reduced. Implementing EQUASHIELD has significantly improved occupational safety in our veterinary clinic.

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