The Unseen Dangers: Understanding the Occupational Risks of Chemotherapy Drugs and the Protective Role of EQUASHIELD’s CSTD

Introduction

Chemotherapy drugs, vital in cancer treatment, are not without risks for healthcare professionals, particularly nurses. Their handling poses occupational hazards due to the drugs’ potent and toxic nature. Understanding these risks and the protective measures provided by Closed System Drug-Transfer Devices (CSTDs), especially EQUASHIELD’s CSTD, is crucial for healthcare workers’ safety.

The Occupational Risks of Handling Chemotherapy Drugs

According to the CDC, healthcare workers, particularly nurses and pharmacists, face significant risks when handling chemotherapy drugs. The NIOSH (National Institute for Occupational Safety & Health) article, “Hazardous Drug Exposure in Healthcare,” states that these risks can lead to “acute and chronic health effects such as skin rashes and reproductive issues.” 

This includes “infertility, spontaneous abortions, and congenital malformations” as well as an increased risk of “leukemia and other cancers​​.” Exposure over time is associated with birth defects and miscarriages.

Doctor checking pregnant woman

Key Exposure Points For Health Professionals

Exposures occur through the compounding process and frequent handling of these drugs during administration. Healthcare workers, including nurses and pharmacists, who are in direct contact with these potent and toxic substances, are seen as the more vulnerable groups. 

According to OSHA, exposure to hazardous drugs during preparation and administration poses significant health risks, including cancer, organ toxicity, and reproductive issues. Occupational hazards are increased in the preparation phase while complying with the very low level of pharmacological compounding compared to the administration phase. The levels of risk are pretty high, and they result from processes that expose workers to substances that have the potential to cause harm. 

Therefore having proper knowledge of the harmful agents associated with this process and the safeguarding measures, such as the EQUASHIELD’s Closed System Drug Transfer Devices (CSTD), would go a long way in enhancing the work-related health and safety of the healthcare workers.

Routes of Exposure

Health worke­rs can inhale chemotherapy drug particle­s or vapors when preparing or giving treatme­nt. OncoLink, a cancer resource in Pe­nnsylvania, warns about these exposure­ risks. They state inhaling vapors is dangerous and can le­ad to other exposure through skin contact or ne­edlestick accidents. Strict safe­ty measures must be use­d to prevent these­ exposure risks.

Monitoring surface contamination of hazardous drugs is crucial, as evidenced by findings from a study conducted by the Canadian Journal of Hospital Pharmacy.

The study highlights that these hazardous drugs can settle on work surfaces and pose a risk of indirect transfer through contact, emphasizing the importance of regular environmental monitoring and rigorous cleaning protocols to safeguard healthcare workers from occupational exposure.

Threats on Healthcare Workers

A case study from the University of Michigan on the threats that affect cancer care workers found that nurses “handling hazardous drugs had twice the risk of reproductive problems.” 

The lead study author, Christopher R. Friese elaborates, “This is an invisible threat.” He further examines, “Early on we could understand that a needle stick conveyed serious health risks… This is a subtle threat, but it’s a daily threat.”

The Role of EQUASHIELD’s CSTD in Protecting Healthcare Workers

EQUASHIELD’s CSTD provides a crucial layer of protection against these occupational risks. By design, it mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system, thus minimizing the risk of exposure during the compounding and administration of hazardous drugs​​.

The use of EQUASHIELD’s CSTD can “effectively eliminate spills and leakage during the compounding of gemcitabine” and antineoplastic drugs. According to the article “Maximizing Efficiency and Safety in Healthcare: Real Life Case Studies on Cost Savings with Closed System Drug Transfer Devices (CTSDs),” it can significantly reduce the risk of surface contamination and exposure. Therefore providing a safe working environment for anyone in the space. 

Pharmacist using EQUASHIELD CSTD

Highlighting EQUASHIELD’s CSTD studies, the National Library of Medicine inscribes the effectiveness of “Reducing Leakage during Antineoplastic Drugs Compounding,” EQUASHIELD discovered that gemcitabine (GEM) was not detected in samples when using the EQUASHIELD® II system, indicating its effectiveness in preventing contamination. 

Moreover, a significant reduction in detectable levels of antineoplastic drugs “in surface sampling wipes after the implementation of the EQUASHIELD’s CSTD.” Notably, the design of EQUASHIELD with a metal rod as a syringe plunger prevents contamination of the plunger itself, a common contamination site in other CSTDs​​.

Comparative Analysis with Other CSTDs

EQUASHIELD has been compared with other CSTDs in terms of containment of liquids and vapors – demonstrating its effectiveness in reducing operator exposure to hazardous drugs reinforces the critical role of CSTDs like EQUASHIELD in protecting healthcare workers​​.

When addressing the issue of hazardous drug exposure and the transfer of environmental contaminants, NIOSH employs a CSTD successfully. It create­s “an airtight seal betwee­n drug vials, syringes, and IV bags.” This mechanical approach “preve­nts the release­ of harmful aerosols and vapors.” It greatly reduce­s risks from direct contact, skin exposure, and inhalation.

Conclusion

The­ occupational hazards of handling chemotherapy drugs are significant and can se­riously impact healthcare workers’ he­alth. Using CSTDs, especially EQUASHIELD’s CSTD, effe­ctively reduces the­se risks by preventing drug le­aks and surface contamination. Healthcare facilitie­s must adopt such protective measure­s to ensure staff safety and we­ll-being.

Discover the Financial and Safety Benefits of CSTDs

Closed System Transfer Devices (CSTDs) play a critical role in protecting the health of pharmacy staff during hazardous drug compounding. Each year, over 8 million healthcare professionals in the US and 12 million in Europe face the risk of exposure to hazardous drugs, a concern that has been extensively studied. (1)(2) CSTDs, with their advanced design, serve as powerful barriers, preventing exposure to dangerous drugs and reducing contamination. They also minimize waste and enhance the well-being of the staff working in hospitals and pharmacies.    

In the following sections, we will explore the significant impact of CSTDs on the compounding process.

The Key Benefits of Using CSTDs in Pharmaceutical Compounding 

A closed-system drug transfer device effectively minimizes contamination risks in healthcare settings.

Prioritizing Safety with Closed-System Transfer Devices

Closed System Transfer Devices (CSTDs) have become essential tools in drug compounding for both pharmacists and nurses, in order to address the issue of hazardous drug exposure. According to NIOSH, a CSTD mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapour concentrations outside the system.(3) By creating an airtight connection between drug vials, syringes, and IV bags, they successfully prevent the release of harmful aerosols and vapours, significantly reducing the risks associated with direct contact, skin exposure, and inhalation. (4)

More Occupational Safety with CSTDs

CSTDs employ various technologies, each offering different levels of safety. Physical barriers establish a closed system, containing hazardous drugs, while air-cleaning technology filters out particles from the air. (5) This rigorous containment strategy provides a protective environment for healthcare staff, minimizing the potential long-term health risks associated with hazardous drugs.

Reducing Contamination Risks and Occupational Exposure to Chemotherapy Drugs 

One standout benefit of a closed-system drug transfer device is the significant reduction in contamination hazards for healthcare workers. Research shows a substantial decrease in hazardous drug exposure when CSTDs are the preferred medical devices in use, with a contamination rate of 12.24% compared to 26.39% with standard isolators. (6) By adopting CSTDs, pharmacists, nurses, clinicians, and other staff can enhance safety measures, creating a safer and more secure healthcare setting. 

Contamination Control in Chemotherapy Drug Compounding: CSTDs vs. open systems

In this section, we will compare CSTDs with their market alternatives. We will shed light on their distinctive features and provide guidance on the most suitable choice for various drug-compounding scenarios.

CSTD products 

These devices maintain a sealed environment throughout the drug preparation process. Equipped with vial adapters and other components, CSTDs ensure that hazardous drugs are contained, protecting pharmacy staff. Particularly for dangerous drugs, CSTD performance is invaluable, effectively preventing the release of aerosols or vapours.

Open Systems

Open systems possess a degree of permeability due to their inherent lack of a complete seal. They are simpler and often more affordable, making them suitable for drugs with a lower contamination risk. However, their protective capabilities do not match those of CSTDs. 

In conclusion, CSTDs offer enhanced protection, especially for hazardous drugs. The choice between CSTDs or alternative solutions should be based on the nature of the drug (hazardous vs non-dangerous), potential staff risks, and regulatory standards, always with a focus on safe and secure compounding. When compounding hazardous drugs one should always use CSTDs as the devices are the only ones able to ensure safety during the process.

The Mastery of Contamination Prevention 

In addition to their numerous benefits, CSTDs excel at preventing contamination. Their design provides a dual defence mechanism: they prevent environmental contaminants from entering the system and ensure that hazardous drug particles and vapours are securely sealed within. This robust shield significantly reduces the danger of accidental contamination, setting CSTDs apart in terms of efficiency and protection for healthcare professionals and patients alike.

How do CSTDs prevent drug spills and leakage?

Furthermore, CSTDs offer impeccable protection against drug spills and leakage. They accomplish this through a foolproof mechanism that restricts the entry of environmental contaminants and securely contains hazardous drugs or vapours. Once activated and sealed, the CSTD system prevents any inadvertent entry or exit, including bacteria or particulate matter. This level of precision safeguards the compounding process from unintended breaches, highlighting the unparalleled capability of CSTDs in ensuring the integrity of drug handling. 

The Financial Benefits of Transfer Devices with Closed Systems

In the world of healthcare, financial considerations are just as important as security. That’s why we’re taking a closer look at the economic advantages of CSTDs. This section explores how CSTDs save money and reduce waste, highlighting the long-term financial benefits of investing in these devices in the healthcare sector. 

Using a Drug Transfer Device Enables Cost Savings through Waste Reduction

Using CSTDs offers significant cost savings by minimizing drug waste. By providing protection against microbial growth, the use of the vial can be extended, allowing for longer periods of use beyond the original expiration date. Studies show that implementing CSTDs reduces drug waste by an average of 72.5%. (7)  This not only conserves valuable medications but also has a positive environmental impact by reducing the disposal of hazardous drugs. 

Optimizing Drug Compounding with CSTDs

Efficiency studies have demonstrated that the closed systems extend the sterility of single-use vials, enabling the practice of vial sharing which significantly cuts down the volume of drugs thrown away after just one use. Remarkably, studies highlighted that CSTDs can preserve vial sterility for as much as seven days, with contamination rates remaining negligible up to 30 days, leading to considerable financial savings due to reduced drug wastage (8). 

These devices not only ensure precision in medication measurement and dispensing, leaving minimal residue, but their design also prevents any medication leaks and drips, maximizing every drop. The controlled air pressure and accurate dosing provided by CSTDs also play a crucial role in averting the risks associated with overfilling or underfilling vials, which further trims down waste. Such efficiency has been shown to provide substantial economic benefits. Cost savings from integrating CSTDs into healthcare practices range from 7-15% on overall drug and device expenses. This can translate into annual savings of around £480,000 by recovering an average of 57% of unused drugs from vials, with Hungarian hospitals reporting noteworthy savings, particularly with costly parenteral biological agents (9). Collectively, CSTDs make a compelling case not only for their role in reducing drug waste but also for optimizing healthcare resources through their economic use. 

Enhancing Results by Integrating CSTDs with DVO

Combining CSTDs with Drug Vial Optimization (DVO) techniques provides a comprehensive approach to protection and efficiency. While CSTDs ensure a secure drug-handling environment, DVO maximizes medication extraction from vials with minimal residue. This combination not only protects healthcare professionals but also offers long-term financial benefits, establishing a sustainable and cost-effective solution for patient care and financial health. 

Factors that influence the vial savings when compounding hazardous drugs with CSTDs and DVOs 

Calculating vial savings during the preparation of cytostatic drugs with CSTDs and Drug Vial Optimization (DVO) depends on multiple variables, such as the drug specifics, equipment, and compounding procedures. Key considerations include: 

Drug concentration: Higher concentrations may yield more doses per vial, enhancing DVO savings. 

Vial size: Bigger vials could result in more savings by optimizing usage. 

Vial cost: Selecting vials should be cost-effective, balancing the price per millilitre with potential waste. 

Shelf life: Consider the drug’s stability post-mixing to prevent waste from expiring drugs.  

Compounding efficiency: Properly trained staff using CSTDs and DVO can minimize errors and waste. 

Regulatory adherence: Comply with all regulations to ensure safe compounding practices. 

Demand analysis: High demand for a drug could mean significant savings through vial optimization. 

DVO efficiency: The efficacy of the DVO technology used affects the amount of extractable doses. 

Drug properties: Consider the compounding impact of drug characteristics like viscosity and solubility. 

Staff education: Skilled staff using CSTDs and DVO technology can maximize their well-being at the workplace while increasing cost savings. 

Long-Term Cost Savings: CSTDs vs. Alternative Solutions 

In addition to the economic and sterility benefits presented earlier, CSTDs address also the financial consequences of contamination in healthcare settings. Exposure to hazardous drugs poses risks to healthcare professionals and patients, resulting in significant financial strains. These strains include costs associated with potential medical expenses due to staff harm, and the management of contamination fallout. Using CSTDs in drug compounding provides a key solution for such issues and ensures financial profitability in the long term. 

The Ripple Effect: The Costs and Consequences of Staff Exposure to Hazardous Drugs 

Human errors in healthcare settings can have detrimental effects on staff, leading to a series of costly repercussions. Immediate expenses include medical treatment, testing for exposure to hazardous drugs, and time off work. Furthermore, staff illnesses can result in workforce shortages, requiring the need for temporary hires and additional expenses. These issues disrupt operations and drive up costs. Additionally, if patients are adversely affected, legal and compensation expenses may arise. Given these financial strains, it is crucial to implement preventive strategies to address the broad impact of staff exposure incidents. (10)

Mitigating Contamination Costs with CSTDs: A Proactive Approach

By using Closed-System Drug-Transfer Devices (CSTDs) to ensure a sealed environment during drug preparation and administration, the risk of staff contamination can be significantly reduced. This helps minimize immediate medical expenses related to exposure treatments, prevents operational disruptions, and eliminates the likelihood of legal and compensation claims. Implementing CSTDs demonstrates a proactive commitment to healthcare safety, protecting the well-being of healthcare professionals while also ensuring cost-effectiveness in operations. 

Maximising Your CSTD Return on Investment by Investing in Staff Education

Investing in staff education for the proper use of Closed System Transfer Devices (CSTDs) is paramount in the healthcare sector, both for ensuring safety and enhancing financial outcomes. Effective training equips staff with the necessary skills to operate, maintain, and create efficient protocols for CSTDs, leading to fewer errors, reduced contamination risks, and improved chemotherapy administration. This not only advances patient care and satisfaction but also significantly increases return on investment (ROI) by minimizing costly mistakes such as drug spillage and avoiding needlestick injuries, which can cost between £10,000 to £620,000 alone, according to a report in Scotland. (11) Hence, comprehensive training is a strategic investment that yields long-term financial benefits by optimizing medication use and reducing healthcare risks. Equashield provides free training for all healthcare professionals interested in improving occupational safety and well-being in hospitals and pharmacy environments.

Choosing the Right CSTD: Factors to Consider 

Selecting the appropriate CSTD is not as simple as choosing any other item. Comparing CSTDs in a real-world setting requires thorough education for all staff involved in testing. Here are the key aspects to consider when selecting a CSTD

Safety: When it comes to handling hazardous drugs, the safety of healthcare personnel is the top priority. Utilizing a completely closed CSTD is crucial to provide the utmost level of protection against the risks linked to exposure and contamination.

Compatibility: Ensure the CSTD is compatible with all tubing and pump equipment used in your facility. 

Effectiveness: Evaluate the device’s ability to prevent work environment contamination and exposure to high vapour concentrations when disconnecting IV tubing after infusion. 

Ease of use: Choose a device that is user-friendly and does not require extensive training. 

Cost: Consider the device’s total cost of ownership and its fit within your facility’s budget. 

Reliability: Select a device with a proven track record of success and reliability. Those designed with the closed-back syringe tend to be the safest and show the highest CSTD performance.

Ensuring Compatibility with Existing Regulations and Protocols

Before integrating a Closed System Transfer Device (CSTD) into your healthcare facility, it is crucial to ensure it aligns seamlessly with your country’s existing protocols and regulations. Different regions may have specific guidelines for medication safe handling and increased risk exposure. Verify that the chosen CSTD meets the regulatory requirements and healthcare protocols in your area. This step is vital for maintaining compliance, enhancing patient safety, and streamlining your drug transfer processes.

 

CAR-T Cell Therapy and Gene Therapy: A Revolution in Cancer Treatment 

The ongoing battle against cancer has seen a paradigm shift with the advent of CAR-T cell therapy, a revolutionary approach that utilizes the patient’s own immune system to fight cancer. This innovative treatment, coupled with gene therapy, is transforming the landscape of cancer care. 

Unveiling CAR-T Cell Therapy

Chimeric Antigen Receptor T-cell (CAR-T) technique was designed to augment the body’s natural defenses by equipping T cells, the soldiers of the immune system, with engineered receptors known as CARs. These receptors enable the T cells to recognize and attack specific cancer cells, thereby providing a targeted approach to cancer treatment. 

CAR-T cell therapy has proven to be a game-changer in treating certain types of blood cancers, such as B-cell acute lymphoblastic leukemia and diffuse large B-cell lymphoma, that had previously shown resistance to conventional treatments1

Manufacturing Process of CAR-T Cell Therapy 

The production of CAR-T cells involves several intricate steps, each requiring meticulous precision to ensure the utmost safety and efficacy of the final product. The process commences with the collection of T cells from the patient’s blood through a procedure called leukapheresis, where a specialized machine separates the desired cells.  

These collected cells, which play a crucial role in the immune system, are then transported to a laboratory, where they undergo a series of genetic modifications to express Chimeric Antigen Receptors (CARs) on their surface. This genetic engineering process involves precisely inserting the CAR gene into the T cells, allowing them to recognize and target specific cancer cells. Subsequently, the modified cells are cultured and expanded in the lab, undergoing rigorous quality control checks to ensure their purity, potency, and safety.  

Once these quality standards are met, the final product, consisting of the genetically modified CAR-T cells, is prepared for infusion back into the patient, where they can potentially combat the cancer cells with enhanced specificity and effectiveness. 

Contamination Risks in Cell Therapy Manufacturing: Safeguarding Patients and Preserving Quality 

Contamination can occur at various stages of cell therapy manufacturing, such as during genetic modification, cell expansion, or product formulation. Even a small presence of external contaminants, such as microorganisms or particles, can undermine the therapeutic value of the treatment and pose significant risks to patients. 

Complications arising from contamination may evade standard quality control measures, leading to the release of a contaminated batch. If administered to patients, this could result in adverse effects, reduced treatment effectiveness, or even serious harm. Moreover, such incidents could have far-reaching consequences for the manufacturer, including financial burdens, legal challenges, damage to reputation, and ethical concerns. 

Role of Closed System Devices 

CSTDs play an important role in the manufacturing and quality control processes of CAR-T cell therapy, improving sterility, decreasing batch failure rates and improving overall process efficiency. These devices prevent the introduction of contaminants into the system and restrict the escape of hazardous drugs or vapors, ensuring a safe and controlled working environment2

Throughout the therapy manufacturing process, from transportation to quality control, air removal, and sampling, Closed System Transfer Devices (CSTDs) play a role in reducing contamination risks. Let’s take a closer look at how these devices effectively safeguard the integrity of the therapy. CSTDs offer a controlled environment for testing and analysis. By maintaining a closed system, these devices minimize the chances of external contaminants infiltrating the samples, thereby ensuring accurate and reliable results. This is particularly crucial as even the slightest contamination can skew test outcomes and lead to erroneous conclusions. 

By incorporating Closed System Transfer Devices (CSTDs), CAR-T companies can significantly reduce the potential for contamination throughout the manufacturing process of CAR-T cell therapy. These devices serve as a reliable defense mechanism, contributing to the safety, effectiveness, and integrity of the end product.