#Pharmacy Compounding Automation Archives

Maximizing Efficiency and Safety in Healthcare: Real Life Case Studies on Cost Savings with Closed System Drug Transfer Devices (CSTDs)

Ilya Viten on February 5, 2024

CSTDs have been instrumental in transforming medication safety in healthcare facilities. As the industry increasingly focuses on the well-being of healthcare professionals, these devices are recognized for their role in optimizing resource management, reducing product waste, and addressing occupational health risks. According to NIOSH (National Institute for Occupational Safety and Health)¹, CSTDs ensure safe, contained drug transfers, minimizing exposure to hazardous drugs and offering significant financial benefits.

CSTDs: Boosting Occupational Safety and Cutting Costs in Pharmacy Compounding

In healthcare environments, especially during the compounding process, Closed System Drug Transfer Devices (CSTDs) play a crucial role in minimizing the risks of hazardous contamination. They establish a secure, airtight connection between drug vials, syringes, and IV bags, effectively preventing exposure to harmful aerosols and vapors. By incorporating physical barriers, CSTDs ensure the containment of hazardous drugs, thereby significantly reducing the risk of exposure to hazardous particles.

Research shows a reduction in contamination risk from 26.4% with standard isolators to 12.2% with CSTDs², enhancing safety measures for pharmacists, nurses, and other healthcare professionals.

To further illustrate the impact of CSTDs, this paper explores real-world case studies where pharmacies and compounding centers have successfully implemented these systems, leading to substantial financial savings alongside enhanced safety measures.

Relevant Cost Reductions Proven by Extended Beyond Use Date (BUD): Case Studies at Mount Sinai and Bronson Battle Creek

The implementation of Closed System Transfer Devices (CSTDs) in healthcare settings, particularly in outpatient cancer centers, has shown significant potential for cost savings by reducing medication wastage. Notable examples come from Mount Sinai Hospital – New York, USA and Bronson Battle Creek (BBC) Cancer Care Center – Michigan, USA.

At Mount Sinai Hospital, by extending the BUD (Beyond Use Date) of single-dose vials from 6 hours to 7 days, the hospital could significantly reduce the amount of discarded medication. This led to substantial savings for six agents, enough to offset the cost of using Equashield solution to comply with USP 800 standards.³ The figures were impressive, showing an annual cost reduction of $530,000, underscoring the economic advantages gained from incorporating the CSTDs.⁴

Similarly, Bronson Battle Creek Cancer Care Center (BBC) also implemented a CSTD, aiming to decrease waste and offset the cost of CSTDs implementation in a comprehensive cancer care center. The results demonstrated financial efficiency in reducing drug wastage, applicable in both large university hospitals and smaller community healthcare settings³.

Relevant Cost Reductions Proven by Extended Beyond Use Date (BUD): Case Studies

More Real-Life Examples: Demonstrating Financial Gains with CSTDs and Automated Drug Compounding

Recent research, including one conducted by the Pharmacy Department of the Centre Regional de Lutte Contre le Cancer Léon Bérard⁵, has shown that Equashield CSTDs (closed system transfer devices) minimize contamination risks compared to traditional methods, leading to safer work environments, reduced direct contact with hazardous drugs, and significant financial benefits⁶.

The study, “An economic evaluation of vial sharing of expensive drugs in automated compounding,”⁷ highlights the economic advantages of an innovative approach to drug compounding. By implementing an automated compounding process with a vial-sharing strategy, significant cost savings were achieved. This method, contrasting with traditional manual compounding, led to avoiding drug wastage during the automated process. The study revealed that over six months, the cost of drug wastage for 1001 preparations of rituximab, pemetrexed, bevacizumab, and trastuzumab combined, amounted to €34.133, €46.688, and €88.255 for different manual compounding scenarios. In contrast, the automated compounding with vial sharing resulted in substantial savings, with an estimated total cost reduction exceeding €280.000 between 2017 and 2021. This approach not only presents an economic advantage but also contributes to environmental sustainability by minimizing drug wastage. Additionally, automated compounding saves valuable staff time, enhancing overall efficiency alongside its other benefits.

Reducing Liability and Undesired Healthcare Costs in Drug Compounding

CSTDs (closed system transfer devices) have emerged as key players in mitigating potential liability and contributing to cost-effective practices. They provide a closed and secure environment, reducing exposure to hazardous drugs and minimizing potential financial burdens. A case study in Genoa⁸ found that using Equashield during drug compounding resulted in no detectable levels of gemcitabine, a cytostatic drug used in chemotherapy, highlighting both safety benefits and potential cost savings.

Before the implementation of Equashield II, the study found detectable levels of GEM contamination in various samples, including on operators’ gloves, suggesting that the preparation systems used at the time were not fully sealed. This was evident in the results, where GEM was detected in several samples, indicating a risk of occupational exposure to the drug.

Reducing Liability and Undesired Healthcare Costs in Drug Compounding

After the introduction of Equashield II, the study observed a significant change. The subsequent monitoring from 2020 to 2021 showed that gemcitabine was not present at detectable levels in any of the evaluated samples when using the Equashield II system. This contrasted with the results obtained using the TexiumTM/SmartSiteTM system, where GEM dispersion was still observed after compounding, with positive samples ranging from 9-23%.

The absence of detectable levels of GEM in samples when using Equashield II indicates that this CSTD was effectively able to eliminate spills and leakage during the compounding of gemcitabine, thereby significantly reducing the risk of contamination and exposure. This result underscores the effectiveness of Equashield II in creating a safer environment for healthcare workers by minimizing the potential for hazardous drug exposure during the compounding process.

By preventing exposure-related health problems, CSTDs such as Equashield help to reduce sick leave costs and potential legal consequences. As such, these devices play a vital role in protecting healthcare facilities against both safety and financial risks.

To conclude our exploration of real-life examples and case studies, let’s summarize the key advantages of CSTDs that have been consistently observed across various healthcare settings.

Summarizing the Success: Key Advantages of CSTDs in Pharmaceutical Compounding

The integration of CSTDs has significantly improved staff confidence in medication administration. Healthcare workers felt safer and more confident in handling hazardous drugs, knowing that the risk of exposure was minimized.

Streamlined operations

The use of CSTDs can lead to faster medication preparation and administration. These devices are designed to minimize connections and disconnections during compounding, ultimately saving valuable time and reducing costs.

Minimize the risk of exposure to hazardous drugs

CSTDs offer the potential to reduce direct exposure of healthcare workers to hazardous drugs by creating a closed environment. The impact is significant: one study found that contamination was reduced from 26.4% with traditional methods to 12.2% with CSTDs, resulting in reduced sickness absence and a safer workplace.⁹

Improved productivity

A study at Nebraska Methodist Hospital found that CSTDs significantly improved the time efficiency of compounding. The task was completed in 36.4 seconds with EQUASHIELD, one of the CSTDs evaluated, compared to 87.7 seconds with other CSTD brands and 63 seconds with traditional needle and syringe methods.¹⁰

Innovations Lead to Cost Savings in Drug Compounding: The Financial Impact of CSTDs and Automation

Reflecting on the case studies and real-life examples, it’s clear that the compounding of hazardous drugs is evolving with a focus on innovative solutions like Closed System Transfer Devices (CSTDs) and automated compounding systems. These technologies not only mitigate the risks associated with hazardous drugs but also lead to significant cost savings. For instance, the study “The Future of Hazardous IV Drug Preparation is Here” ¹¹ highlights that the use of automated systems can substantially reduce operational expenses. It’s estimated that savings from the reduced waste of partial vials can amount to $70.000 annually while avoiding medication errors can save approximately $18.720 per year. Additionally, the elimination of costs associated with CSTDs, estimated at $117.000 annually for both prescription and nursing doses, underscores the financial efficiency of these technologies. This trend towards automation and CSTDs is pivotal in enhancing healthcare safety and ensuring the financial viability of pharmacies.

Conclusive Insights: Embracing CSTDs and Automation for Safer, More Cost-Effective Drug Compounding

The series of case studies and real-life examples we’ve explored provide valuable insights into the evolving landscape of drug compounding, particularly with hazardous drugs. The key takeaway is the significant role of Closed System Transfer Devices (CSTDs) and automated compounding systems in driving cost savings and enhancing safety in healthcare settings.

Cost Savings through Extended BUD and Reduced Wastage

The cases of Mount Sinai Hospital and Bronson Battle Creek (BBC) demonstrate how extending the Beyond Use Dating (BUD) of single-dose vials, as enabled by CSTDs like Equashield, can lead to substantial cost savings. By minimizing medication wastage, these healthcare facilities have shown annual cost reductions, highlighting the economic benefits of CSTD implementation.

Enhanced Safety and Efficiency

The integration of CSTDs has been shown to not only improve safety by reducing contamination risks but also to enhance operational efficiency. This dual benefit is crucial in a healthcare environment where both safety and cost-effectiveness are paramount.

Innovative Approaches in Compounding

Studies like “An economic evaluation of vial sharing of expensive drugs in automated compounding” underline the financial and environmental advantages of innovative compounding methods. Automated compounding with vial sharing, in contrast to traditional manual methods, has resulted in significant time and cost savings while reducing drug wastage.

Mitigating Liability and Health Risks

CSTDs have also been instrumental in mitigating potential liability and health risks associated with the compounding and administration of hazardous drugs. By providing a safer working environment, they help reduce healthcare costs and potential legal consequences.

In conclusion, the adoption of CSTDs and automated compounding systems represents a strategic move towards more efficient, safe, and cost-effective drug compounding practices. These innovations not only enhance the safety of healthcare professionals but also offer substantial financial benefits, making them a valuable addition to any healthcare facility’s medication management strategy.

EQUASHIELD Pioneers AI in Production Lines

Tamar Apper on November 2, 2023

AI has been heralded as the future of production lines, providing a level of automation and control that is unparalleled- surpassing limited human visual perception by employing advanced image processing techniques. At EQUASHIELD, we take pride in our early adoption of AI technology. We have seamlessly integrated it into our automated warehouse, production lines, and packaging. This results in enhanced efficiency, improved product quality, and reduced waste.

The use of AI in the production lines at EQUASHIELD is an integral part of our success. The AI system ensures constant quality control and provides real-time status updates for each product throughout the automated assembly process, thanks to the integration of over 300 cameras across 500 stations. Cameras and sensors play a crucial role in facilitating the automated machine operations by providing valuable data including orientation, barcode reading, OCR (Object Character Recognition), and defect detection. This ensures a high level of consistency and accuracy in the production process, reducing costly errors, and minimizing the need for manual labor.

Revolutionizing Product Tracking and Packaging

Another one of the key benefits is the ability to extract vital information for product tracking and automatic packaging. The system reads UDIs (Unique Device Identification), prints checks, and conducts end-of-the-line blister checks to ensure that every product is flawless and ready for use. The cameras have superior zoom capabilities compared to the human eye, leading to enhanced flaw detection. This level of automation and quality control is crucial when it comes to medical products, where any flaw could have serious consequences for patient health.

Utilizing Predictive Maintenance to Reduce Waste and Save Time

At EQUASHIELD, the utilization of AI models is an ever-evolving process. We employ a wide range of models to enhance the image processing capabilities of our production lines. Predictive maintenance is another crucial application of AI. By collecting real-time data and employing data science algorithms, we can anticipate potential mechanical failures resulting from incorrect calibration of parameters such as temperature and torque resulting in reduction of production down time. Smart defect detection possesses a deep understanding of potential issues, promptly indicating and aiding technicians in resolving them effectively. As a result, the production lines considerably reduce product waste while identifying flaws in production. This has resulted in significant time and cost savings, as well as improved product reliability, customer satisfaction and retention.

By implementing automated quality control and real-time status updates, we ensure a consistent and accurate production process. Furthermore, the ability to extract crucial information for product tracking and enable automatic packaging adds an extra layer of quality assurance. With a range of AI models utilized in our production lines, we are at the forefront of the industry, continuously enhancing image processing capabilities and improving product quality. At EQUASHIELD we are proud to set a higher standard in the world of medical device manufacturing.

The use of AI in our production lines has a direct impact on the quality and reliability of our products. By ensuring constant quality control and reducing waste, we can confidently stand behind our products and guarantee their effectiveness for healthcare professionals. This level of precision and efficiency would not be achievable without the integration of AI technology, making EQUASHIELD a leader in revolutionizing medical device manufacturing. By continuously evolving and improving our production processes, we strive to provide the best possible products for the healthcare industry. So, our customers can have peace of mind knowing that they are using safe, reliable, and high-quality medical devices from EQUASHIELD.

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

Tamar Apper on September 18, 2023

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.

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