Case Study: CSTD use in Veterinary Medicine

Tamar Apper on August 11, 2024

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.

Trending Towards Safety: Hazardous Medicine Management in the EU

Tamar Apper on July 25, 2024

Introduction

Oncology pharmacists and nurses face significant challenges today. Increased workloads and the harmful effects of cytotoxic medications have heightened the risks and stresses faced by these healthcare workers. In response, there’s a growing focus on improving safety and working conditions, with innovative safety protocols being implemented across Europe. Some changes stem from top-down legislation, while others arise from grassroots movements. This article examines the increasing challenges faced by oncology staff and delves into safety discussions within the industry. It explores recent advancements in HMP safety measures, with a focus on the implementation of Closed System Transfer Devices (CSTDs). Lastly, it highlights significant progress in adopting safer practices and CSTD implementation across Europe.

Growing Safety Concerns in Oncology

Several recent clinical studies have raised increasing concerns about the safety of oncology healthcare workers, leading to positive changes in protective legislation. In the EU, 12.7 million pharmacists, nurses, and related personnel involved in the medicine lifecycle potentially face exposure to Hazardous Medicinal Products (HMPs).¹

In 2022, the European Trade Union Institute (ETUI) updated its list of HMPs, highlighting the dangers of cytotoxics, mutagenic, and reprotoxic substances (CMR). Drawing on the NIOSH regulations from the United States—recognized as a leader in safety—the ETUI used these guidelines to formulate its own recommendations. This has significant implications for oncology staff who handle these medications. Starting April 5^th 2024, all EU Member States must adopt the legal requirements and prevention measures of CMRD 2022 for HMPs with CMR potential. This mandates using closed systems such as closed system transfer devices for the safe manufacture and use of HMPs throughout their lifecycle.

A 2023 report by the European Commission investigates options for protecting workers from exposure to HMPs. The report emphasizes the importance of conducting a risk assessment and considering technical measures, including the use of closed system drug-transfer devices (CSTDs), to enhance safety.²

Retention and Hiring Challenges in Oncology

Retaining and hiring oncology staff has become a significant challenge across many European countries. Several factors may contribute to this issue: increased workloads, high levels of burnout and repetitive strain injuries (RSIs), and an increasing awareness of exposure risks, especially among younger healthcare workers. Oncology staff are susceptible to RSIs due to several factors: extended hours preparing and administering medications, lack of ergonomic equipment, and insufficient breaks.³

Recent studies highlighting the dangers of handling hazardous drugs have caused hesitation among potential future healthcare workers, discouraging them from entering the field of oncology due to inadequate safety measures. These contributing factors can create a vicious cycle, leading to higher turnover and increasing the workload on those who remain.^4,5

A Growing Awareness Among Nurses

Retention and Hiring Challenges in Oncology

It’s not only regulatory bodies who are taking action; healthcare workers are also advocating for better and safer working conditions. Growing awareness of exposure risks is driving grassroots demand for better safety protocols, particularly the use of CSTDs.

European Oncology Nursing Society (EONS) compiled anonymous online survey data on occupational safety, as reported by European cancer nurses. Research indicates that cancer care nurses are at high risk for exposure to hazardous drugs. The European Cancer Nursing Index (ECNI) 2022 survey revealed significant concerns about occupational safety, especially for pregnant or breastfeeding nurses. Key findings include a lack of specific guidelines (18.3%) and reports that 20% of nurses continue handling hazardous drugs during pregnancy and breastfeeding. Considering the well documented reproductive risks relating to occupational exposure to hazardous cancer drugs, this cannot be considered anything other than alarming and unacceptable.⁶

This is likely why EONS has, for the first time, formally recognized the risks oncology nurses face when handling cytotoxic medications and has recommended the use of CSTDs. A safety webinar from 2020 tentatively recommends the use of Closed System Drug Transfer Devices (CSTDs).⁷ In contrast, four years later they clearly state “the need to be better protected from serious workplace related medical risks, and occupational exposure to hazardous cancer should be minimized at all costs”. They recommend specific actions to reduce the risk of occupational exposure, such as utilizing CSTDs and systematically conducting wipe tests on work surfaces. This shift in urgency and language demonstrates a heightened awareness of the growing movement towards CSTD adoption. EONS recognizes that, although it may incur additional costs, prioritizing the safety of their staff is paramount.⁸

Leading the Way in Oncology

These advancements and increasing awareness of safety measures have sparked discussions within the industry. The United States mandates the nationwide use of CSTDs in the USP 800 guidelines, and Europe is following suit. The European landscape reveals varying levels of CSTD adoption, with countries like Belgium and Spain meeting ISOPP standard, while others lag behind with government regulation. In Germany and the Netherlands, guidelines exist from scientists or national associations but lack government support. These measures are increasingly recognized as crucial for protecting healthcare workers.

CSTDs have been proven to reduce exposure to HMPs and should be used throughout the life cycle of HMPs. CSTDs prevent leakage and spillage, with the most effective designs featuring a closed back mechanical barrier so no vapor escapes from the syringe. The EAHP published a 2022 report based on a survey of chief pharmacists across Europe focusing on protecting workers from HMP exposure. The report indicates that the majority believe combining CSTDs with BSCs and isolators is the most effective way to protect workers from exposure to HMPs.¹ Even in countries that do not have legislation mandating the use of CSTDs, the benefits are significant enough that many institutions are voluntarily adopting them.

EQUASHIELD closed back CSTD — EQUASHIELD Closed Back CSTD

Belgium Pioneers CSTDs

In 1998 a groundbreaking study by Paul Sessink came out about contamination and the exposure dangers they pose to oncology teams. This study marked the start of a dialogue regarding the risks associated with handling hazardous drugs, thanks to the efforts of Johan von Broucker in Belgium, who brought it to public awareness. As a prominent opinion leader, he passionately advocated for the implementation of CSTDs in hospitals. In 1998, Belgium became the second country, following Sweden, to adopt Closed System Transfer Devices (CSTDs). In just one year, the Belgian team astonishingly achieved a remarkable 40% market share.

Today, CSTDs are integrated into oncology units nationwide, serving both pharmacists and nurses in their vital roles. Although Belgium does not have specific regulations requiring the use of CSTD; its adoption has been driven by market demands and corporate influence. The implementation has been relatively straightforward due to lower bureaucratic hurdles. Thanks to enhanced safety measures, oncology teams are motivated, resulting in better staff retention and more successful hiring outcomes compared to other European countries. Belgium’s proactive implementation of CSTDs in healthcare settings highlights the crucial role of key opinion leaders and market demand in enhancing occupational safety.

Irish 2024 Joint Summit

Ireland began implementing CSTDs in oncology units starting in 2010. Over the last decade they have expanded from one hospital to an impressive 90% of hospitals. CSTDs are initially used during the compounding process by pharmacists, ensuring that by the time the medication reaches the nurses, it remains uncontaminated. This collaboration between pharmacy and nursing exemplifies how both fields work together to protect the entire healthcare team throughout the lifecycle of HMDs. However, significant improvements in safety measures are still needed; for instance, not all HMDs are administered using CSTDs.

A summit on preventing occupational exposure to hazardous medicinal products was held in Dublin in January 2024. Attendees spanned the entire spectrum of the Irish healthcare and social care community, including professionals, frontline staff, government agencies, regulators, trade unions, policymakers, academics, and occupational health. They all attended with the goal of updating regulations to protect healthcare workers from occupational exposure. Presentations by experts and active discussions highlighted the importance of safety measures for professionals in the Irish healthcare sector.

Conclusion

There are numerous challenges faced by oncology healthcare teams, from increased workload and burnout to safety concerns. In recent years, there has been a growing movement towards enforcing stricter safety protocols through legislative changes. Change is not just driven from top down; both pharmacists and nurses are eager to adopt safer practices. The momentum towards safer practices in oncology is clear. Ultimately, this will lead to better health outcomes for oncology pharmacists and nurses.

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