The latest update from the European Agency for Safety and Health at Work (EU OSHA) highlights a significant shift in workplace safety, particularly for healthcare workers who handle Hazardous Medicinal Products (HMPs).1
This update stems from the most recent changes to Directive 2004/37/EC, which now incorporates reprotoxic substances and features an indicative list of HMPs.2 These developments aim to increase worker safety, particularly for healthcare professionals prone to exposure from preparation and administration of HMPs.
A Brief Background
Understanding Directive 2004/37/EC
Directive 2004/37/EC, commonly referred to as the Carcinogens, Mutagens, and Reprotoxic substances Directive (CMRD), is a key piece of legislation aimed at protecting workers from exposure to hazardous substances.
Initially, it addressed carcinogens and mutagens, ensuring worker safety from risks such as cancer and genetic anomalies. Through amendments, most notably Directive 2022/431/EU, the scope has widened to cover reprotoxic substances—agents harmful to human reproduction.
The significance of this expansion can’t be understated, as it includes many hazardous medicinal products, making this legislation more responsive to the risks encountered by healthcare and related sectors.
The Importance of the Recent Update
The EU Commission’s latest OSHA update establishes an indicative list of HMPs to assist employers in identifying potential hazards. This list couples with enhanced guidelines that stress replacing harmful substances wherever possible or relying on tools, such as closed systems and CSTDs, to minimize exposure.
Key Changes in the Update
The most noteworthy alterations include the following:
/ Addition of Reprotoxic Substances
Reprotoxic substances are now fully recognized under the CMR framework. This step amplifies protection for workers handling substances linked to fertility issues, birth defects, or developmental disorders.
/ Indicative List of Hazardous Medicinal Products
For the first time, there’s an EU-endorsed indicative list of HMPs. This includes antineoplastics, immunosuppressants, and antiviral medicines, among others. These drugs, while vital for treating patients, present risks to healthcare workers due to their classification as Category 1A or 1B carcinogens, mutagens, or reprotoxic agents.
This list offers clarity for employers performing risk assessments and deciding on safety measures.
/ Expanded Employer Obligations
Employers are now mandated to introduce robust safety protocols. This includes offering regular worker training, conducting detailed risk assessments, substituting hazardous substances where feasible, and using closed systems to prevent exposure.
Employer Responsibilities
Under these updated guidelines, employers are required to adopt a proactive approach to minimize workplace hazards. Here’s a breakdown of what’s expected:
1. Comprehensive Risk Assessment
Employers must evaluate all possible exposure routes—dermal, respiratory, and oral—when handling HMPs. Data must be renewed regularly and made available to authorities upon request.
2. Implementation of Closed Systems
Where substitution isn’t possible, a closed technological system must be employed. Closed System Transfer Devices (CSTDs), like those offered by EQUASHIELD®, play a important role here, preventing exposure and minimizing contamination.
3. Worker Training and Information
Employers must ensure all workers handling HMPs receive regular training. This includes understanding potential risks, proper handling protocols, and how to react in case of exposure incidents.
4. Hygiene and Safeguards
Worker safety goes beyond prevention—employers are required to provide protective clothing, hygiene facilities, and regular health surveillance to detect early signs of exposure-related conditions.
Impact on Healthcare Workers
A Healthier Workplace for Medical Professionals
These updates are set to transform how healthcare workers like pharmacists, oncology nurses, and pharmacy technicians handle cytotoxic medications. With exposure linked to serious health risks—including cancer, miscarriages, and respiratory issues—the provision of safer environments is long overdue.
For example, studies reveal nurses handling cytotoxic drugs are three times more likely to develop malignancies compared to those not exposed.3 The new OSHA recommendations emphasize protective measures to reduce these distressing statistics.
Safety with CSTDs
In the life cycle of HMPs from manufacture to disposal, as set out in the European Commission Guidance for the Safe Management of HMPs at work 2023, a closed system in healthcare means the use of biological safety cabinets (BSCs), containment isolators and closed system transfer devices (CSTDs). Isolators and BSCs are effective in preventing contamination and occupational exposure in the preparation of HMPs in the pharmacy, whilst CSTDs are effective across the whole life cycle of HMPs and in particular in the administration of HMPs on the wards.
EQUASHIELD® CSTDs offer industry-leading solutions. With features like a closed-back syringe plunger and leak-proof design, these devices minimize contamination better than other alternatives.4
Complementary Solutions and Prevention
When discussing protective measures, CSTDs are just the beginning. Employers and healthcare facilities can also reduce exposure risks by leveraging pharmacy automation systems.
The Role of Automation in HMP Handling
Advanced technologies like EQUASHIELD® Mundus Mini HD automate processes, reducing manual manipulation and potential exposure points. Robots and automated systems ensure precision, decrease errors, and boost staff safety.
Cross-sector Applications
Beyond healthcare, these updates emphasize protective measures in waste disposal, veterinary care, and even hospital cleaning staff working with contaminated linens or equipment.
By using a combination of CSTDs, automation, and routine safety training, all industries involved in HMP handling can meet OSHA’s directives while fostering safe working conditions.
Taking Action for Safer Workplaces
Employers, healthcare professionals, and safety managers must align their practices with these updated OSHA regulations.
If you’re unsure where to start, EQUASHIELD®’s EQ Academy offers incredible resources—including tutorials and webinars—on safe HMP handling practices. Their closed system transfer devices and pharmacy automation solutions are trusted by industry leaders to meet the highest safety standards.
Consider the following actionable steps to ensure compliance and protect workers handling HMPs:
/ Perform an updated risk assessment for all hazardous materials.
/ Transition to closed systems like EQUASHIELD® CSTDs.
/ Train all relevant staff using OSHA-aligned education programs.
The EU OSHA update represents a fundamental step forward in protecting workers from the risks posed by Hazardous Medicinal Products. By emphasizing preventative systems like CSTDs and prioritizing worker well-being, employers can create safer, more efficient work environments.
Businesses have a responsibility to not only meet these updated standards but also to safeguard their teams and reduce the long-term impacts of exposure. With comprehensive strategies and advanced solutions like those from EQUASHIELD®, compliance is not just achievable—it’s a path to a healthier workforce.
Need help upgrading your safety measures?Contact EQUASHIELD® or visit EQ Academy today to explore how you can enhance your workplace safety while adhering to the latest OSHA directives.
MABs (Monoclonal Antibodies) are proteins engineered to recognize and bind to specific targets, such as antigens on the surface of cells. They are highly selective in their action, allowing them to precisely target and address disease-related molecules.1
MABs are pivotal in modern medicine, providing effective treatments for various conditions such as cancer, autoimmune diseases, inflammatory disorders, and infectious diseases. Their versatility and effectiveness have made them a cornerstone of numerous therapeutic approaches.2 However, their classification as hazardous drugs by the national institute for occupational safety and health (NIOSH) underscores the potential occupational risks they pose to healthcare workers involved in their preparation and administration.3
Occupational Risks of Handling MABs
The risks associated with MABs stem from four primary exposure mechanisms:
Dermal Contact: Accidental spills during preparation or administration can lead to skin absorption.
Mucosal Absorption: Handling MABs without adequate safety protocols can lead to mucosal exposure, such as through splashes to the eyes or mouth.
Inhalation of Vapors: Aerosolized particles or vapors from hazardous drugs can be inadvertently inhaled by healthcare workers.
Oral Ingestion: Contamination of surfaces or improper hand hygiene can result in accidental ingestion of hazardous substances.4
Certain monoclonal antibodies, particularly those conjugated with cytotoxic agents or radioisotopes, present heightened risks.5,6 Examples include brentuximab vedotin, gemtuzumab ozogamicin, inotuzumab ozogamicin, trastuzumab deruxtecan, and trastuzumab emtansine—all of which are listed as hazardous drugs by NIOSH3 and as products medicinal hazardous (HMPs) by ETUI (the European trade union institution).7 Chronic exposure, even at low levels, could potentially result in health complications. Over the years associations have been made between the therapeutic use of MABs and the increased risk of developing malignancies such as lymphoma. In addition, some literature categorizes MABs as “substances with developmental toxicity.”8
Despite their widespread use, the long-term effects of low-dose exposure to these hazardous agents on healthcare professionals remain uncertain.2 Adopting the precautionary principle can prioritize measures to minimize occupational exposure to these agents whenever possible.9
The Role of CSTDs in Ensuring Safety
Closed System Drug-Transfer Devices (CSTDs) provide an essential layer of protection when preparing and administering hazardous medicinal products. These devices are specifically designed to prevent contamination and reduce risks of exposure. CSTDs create a closed system that ensures vapors and fluids remain contained during drug preparation and administration. This containment minimizes the risk of accidental exposure for healthcare workers by reducing the chance of leaks or spills. CSTDs act as a shield not only for healthcare workers but also for the environment and patients, ensuring that hazardous substances are handled responsibly and safely.10
When to Use CSTDs for Handling MABs
Guidelines from institutions like the National Institute for Occupational Safety and Health (NIOSH) recommend CSTDs when handling MABs classified as hazardous.3 While some MABs may have lower toxicity profiles, healthcare organizations should carefully assess the risks based on available medical literature and regulatory guidance to determine when CSTDs are necessary. For instance, a hospital or clinic handling trastuzumab emtansine would benefit significantly from CSTD implementation due to its cytotoxic properties.
Choose EQUASHIELD’s CSTD
EQUASHIELD’s CSTDs set the standard in safety and usability, providing healthcare institutions with advanced solutions for hazardous drug handling.
Innovative Design Features
/ Closed Back Syringe: EQUASHIELD’s syringe unit is fully closed, preventing vapor release and accidental plunger disconnection, which could result in spills or exposure.
/ Leak-Proof Membranes: These protect against accidental needle sticks while maintaining sterile conditions, reducing the risk of infections or injuries.
/ Full Volume Use: FDA-cleared syringes enable safe usage up to their maximal volume, reducing the number of syringes needed and minimizing waste. This feature improves workflow efficiency, particularly in high-demand environments
/ User-Friendly Design: The ergonomic design of EQUASHIELD’s CSTDs reduces the learning curve, promoting quick adoption by healthcare staff and enhancing operational efficiency. This user-focused approach ensures that safety measures are seamlessly integrated into daily practices.11
The Advantages of Using EQUASHIELD’S CSTD when handling MABs
/ Healthcare Worker Safety: By minimizing exposure to hazardous substances, EQUASHIELD CSTDs protect personnel from potential health risks associated with handling MABs. The closed design prevents vapors from escaping and reduces the likelihood of leaks or spills, ensuring a safer working environment.
/ Environmental Safety: The use of CSTDs reduces contamination in preparation and administration areas, creating safer workspaces for healthcare teams.11
/ Compliance: EQUASHIELD CSTDs support adherence to regulatory recommendations, such as the National Institute for Occupational Safety and Health (NIOSH) recommendation to use CSTDs when handling MABs classified as hazardous.3 Compliance with these guidelines not only enhances worker safety but also reduces liability for healthcare institutions.
/ Patient Safety: By preventing microbial contamination and maintaining sanitary conditions, CSTDs enhance the safety and efficacy of administered treatments. This is particularly crucial in oncology settings, where even minor contamination could have significant implications for immunocompromised patients. 11
EQUASHIELD Implementation
EQUASHIELD’s Customer Experience provides full support for healthcare facilities adopting their Closed System Transfer Devices (CSTDs). Their expert clinical team offers in-person consultations, hands-on training, setup assistance, and ongoing resources to ensure a smooth transition and optimal device use.
Conclusion
The safe handling of monoclonal antibodies is essential to protecting healthcare workers, patients, and the environment. EQUASHIELD’s CSTDs offers a robust approach to minimizing risks associated with hazardous medicinal products while enhancing compliance and safety standards. For any handling procedures, healthcare professionals are strongly advised to follow the manufacturer’s instructions and institutional guidelines. By investing in advanced protective measures, healthcare institutions can ensure a safer and more efficient working environment, ultimately improving outcomes for all stakeholders.
Oncology nurses are at the heart of cancer care. They provide more than just medical expertise—they offer empathy, compassion, and support during some of the most challenging moments in a patient’s life. But what does empathy look like in action, and how can oncology nurses channel it for better patient care while protecting their own well-being?
This post explores the role of empathy in cancer care, its impact on nurses and patients, and actionable strategies to transform empathy into meaningful, measurable improvements in care environments.
What Is Empathy in Cancer Care?
Empathy in cancer care goes beyond understanding a patient’s condition. It involves recognizing their emotional, physical, and psychological struggles while providing care that addresses those needs holistically.
For oncology nurses, this means listening attentively to patients, validating their fears and hopes, and translating those insights into compassionate, personalized treatment. Empathy bridges the emotional gap in patient care, transforming clinical relationships into human experiences.
The Dual Impact of Empathy in Oncology Nursing
While empathy is essential, oncology nurses often walk a fine line between caring for others and safeguarding their own well-being. Positive nurse and patient experiences are crucial as they are linked to a range of beneficial outcomes.
The Benefits of Empathy
/ Better Patient Outcomes: Cancer patients often face fear and uncertainty. An empathetic approach helps establish trust and reduces emotional barriers between patients, their families, and caregivers. This trust leads to open communication, creating a collaborative care environment. 1 Empathic care leads to higher patient satisfaction scores, reduced stress levels, and improved adherence to treatment plans. Research shows that empathy in healthcare leads to better treatment adherence and improved patient satisfaction. When patients feel understood, they are more likely to follow care plans and share vital health concerns, leading to better outcomes. 2
/ Positive Feedback Loops: For many cancer patients, the relationship with their oncology nurse becomes a source of comfort and stability. Empathy fosters a deeper connection, turning routine care into a reassuring and supportive experience. Patients who feel valued often express gratitude, boosting job satisfaction and reinforcing the importance of empathic care.
/ Enhanced Team Morale: When nursing teams adopt empathy as a shared value, it fosters a collaborative atmosphere, reducing burnout and improving team dynamics.
/ Stronger financial performance: Workplaces that prioritize empathy foster more positive environments, resulting in higher employee retention, reduced burnout, and fewer cases of illness.
The Challenges of Empathy
/ Nursing Burnout: Constant emotional engagement with patients can lead to caregiver fatigue and burnout. Many patients endure severe pain or recieve palliative care, and over time, the emotional burden on nurses takes a significant toll.
/ Pressure to Balance: Nurses must juggle technical responsibilities with compassionate care, which can feel overwhelming.
A New Perspective on Empathy in Action
Empathy often requires time and focus, both of which are precious commodities in an oncology nurse’s day. Empathy isn’t a one-way street. To provide exceptional care to their patients, oncology staff need the support they rightfully deserve. One innovative way to ensure this is by incorporating CSTDs into their workflow.
What Are CSTDs?
According to NIOSH, a Closed System Drug-Transfer Device (CSTD) is a device designed to mechanically prevent environmental contaminants from entering the system while also ensuring that hazardous drugs or vapors cannot escape. CSTDs allow safe preparation and administration of hazardous drugs, reducing the risk of exposure for oncology nurses. EQUASHIELD® offers CSTDs that are easy to use, efficient, and proven to minimize contamination risks.
/ Prioritize Personal Safety First: Driven by their innate empathy, nurses consistently prioritize the safety and comfort of their patients, often at their own expense. By using CSTDslike EQUASHIELD®, nurses are protected from exposure to hazardous drugs. This enables nurses to focus on caregiving without constant concern for personal safety.
/ Secure Connections: Experience peace of mind with secure connections, guided by intuitive red-to-red markings and clicking mechanism. Designed with simplicity in mind, it reduces the stress of managing technical administrative tasks, allowing nurses to focus more on building meaningful connections with patients.
/ Streamline Workflow to Focus on Patient Connection: By spending less time on technical tasks, you can dedicate more time to building meaningful connections with your patients. Devices like EQUASHIELD®’s CSTD reduce time spent on manual tasks, freeing nurses to concentrate on providing attentive, compassionate care. EQUASHIELD streamlines the compounding process with fewer steps than any competitor and achieves the fastest average administration time in the industry.4,5
/ Ergonomic Design Means Fewer Repetitive Strain Injuries: Repetitive movements can heighten the risk of joint pain and carpal tunnel syndrome, leading to fatigue, absenteeism, and even long-term disability. These issues often contributes to job burnout, diminishing both motivation and the ability to empathize with others. EQUASHIELD CSTDs are ergonomically designed, ensuring easy handling with minimal force to handle.
Caring for Nurses to Care for Patients
For empathy to thrive in cancer care, it must be viewed as a standard—not an optional—practice. Here’s how healthcare institutions and nurses can make that shift permanent:
/ Leading By Example: Empathy must start at the top. When leadership prioritizes the health and wellbeing of the oncology staff, it sets the tone for the entire team.
/ Ongoing Guidance and Training: Implementing structured guidance and training in areas like patient communication and stress management helps nurses feel supported in their roles.
/ Building a Supportive Culture: Healthcare organizations must proactively address compassion fatigue by fostering environments where nurses can debrief, seek mental health support, and recharge.
/ Patient-Centered Policies: Advocate for systems that prioritize time for patient interactions.
/ Technology Integration: Use tools like EQUASHIELD CSTDs to streamline repetitive processes, freeing up nurses to focus on the patients.
When oncology nurses are empowered to protect their well-being, they’re better equipped to care for their patients and continue making a profound difference.
Empathy as a Transformational Tool
Empathy can transform cancer care. For oncology nurses, it drives patient-centered actions and boosts morale.
By strategically channeling empathy, oncology nurses can enhance care environments while protecting their own emotional and physical health. EQUASHIELD® recognizes the vital role nurses and pharmacists play in cancer care and is committed to developing solutions that support oncology healthcare workers.
Curious to learn how EQUASHIELD®’s Closed System Transfer Devices can elevate your practice and keep you safe? Contact us to explore your options. Let’s work together to create safer environments—for your patients and for you.
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.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.
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.
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.
This account is based on interviews and written documentation provided by the hospitals, and has been approved for publication.
In an era where oncology healthcare workers face growing challenges, the implementation of Closed System Transfer Devices (CSTDs) is significantly enhancing their safety. This life saving technology has been adopted by many countries as a standard, however Germany has not yet mandated their use. Three German hospitals have pioneered the use of closed-system transfer devices (CSTDs) out of concern for their oncology team’s exposure to dangerous medications. They adopted EQUASHIELDs CSTDs to enhance their hazardous drug handling procedures, ensuring a safer and more efficient work environment. The hospitals documented the entire process and conducted in-depth interviews with the pharmacy manager to assess the efficacy of the system. This blog post explores the impact of EQUASHIELD’s Closed System Transfer Device (CSTD) on Ostalb hospitals over a 12-month period from January to December 2017, with an updated evaluation conducted in 2024.
Understanding the Risks in Oncology
Oncology healthcare professionals face the risk of exposure to hazardous antineoplastic drugs on a daily basis. The very nature of these cytotoxic drugs which makes them so effective in combating cancer cells also makes them dangerous to healthy cells.
Infusion therapy typically necessitates individual preparation for each patient before administration. The preparation process can lead to errors, spillages, needlestick injuries, aerosolization, and workplace contamination. Potential exposure poses significant health risks to workers throughout the entire lifecycle, from preparation through waste disposal. While patients receive concentrated doses of a limited number of Hazardous Medicinal Products (HMPs) for a defined period, workers may be exposed to small doses of a wide range of hazardous medicinal products over decades, with some experiencing daily exposure year after year.1
Exposure can occur via skin contact, ingestion, or inhalation of airborne particles. Short term health effects from minimal exposure to hazardous drugs over a long period include hair loss, taste disturbances, headaches, reproductive disorders, miscarriages, infections, and respiratory diseases. Often, the effects of exposure are long-term, not becoming evident for years or even generations of continuous exposure. Given that cancer can take decades to manifest, a diagnosis of breast cancer or leukemia in a nurse or pharmacist today might stem from workplace exposure to hazardous drugs starting in the 1980s. 2
These risks necessitate that health facilities treating cancer patients implement stringent safety precautions. Essential precautions include using personal protective equipment (PPE), following local regulations, and employing suitable solutions like CSTDs for handling chemotherapy drugs.
What are CSTDs?
According to the National Institute for Occupational Safety and Health (NIOSH), a CSTD (Closed System Transfer Device) is a drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drugs or vapors outside of the system. CSTDs play a crucial role in ensuring safe drug compounding and administration by protecting healthcare practitioners from exposure via leaks, spills, and vapor release.
Improving Oncology Safety at Ostalb Hospitals
Ostalb Klinikum Mutlangen, along with two affiliated hospitals in Southwest Germany, were preparing and administering around 6,500 chemotherapy cycles and 20,000 cytostatic preparations annually. While many countries have established stricter protocols for managing hazardous drugs, Germany has not yet followed suit. Recognizing the paramount importance of staff safety, Ostalb hospitals chose to lead the way in Germany by pioneering the use of CSTDs. Before switching to EQUASHIELD, the pharmacy was not using a closed system for handling hazardous drugs.
The pharmacy manager was eager to transition to a safer system primarily due to exposure risks. In a dedicated effort to improve safety for their oncology healthcare workers, the hospitals decided to adopt CSTDs. They identified their criteria for choosing a CSTD brand as follows:
A system consisting of defined connectors, Vial Adaptors, Syringe Adaptors, and Luer Lock components for administration
A leak-proof device that can manage multiple membrane access
A system that will reduce occurrences of accidental disconnections and spike falloffs
A system that is practical to use and will not impede workflow of busy hospital staff
A system that is clinically validated to effectively protect healthcare workers
The Decision Process
The primary reason for selecting a closed system transfer device was to protect the oncology staff from hazardous drug contamination. The hospitals also aimed to preserve medication integrity and streamline the compounding process. The Pharmacy Manager at the time recognized the critical importance of safeguarding Pharmacy Technicians in the hazardous drugs compounding department. The high volume of daily production and the gradual decline of focus throughout the day had led to needlestick injuries. Recognizing these hazardous incidents, she was committed to transition to a safer system for her team. She also felt a responsibility to protect the oncology nurses from exposure by residual chemicals on the outside of the prepared medications they were handling.
The concept of a closed system remained a critical topic of discussion within the team. However, until they discovered EQUASHIELD there had been no practical closed system available on the market that could effectively meet their stringent requirements for both safety and functionality. The decision process to switch to a closed system took approximately six months and involved convincing the hospital management of its benefits, which outweigh the costs, keeping the staff safe. The Ostalb hospitals assessed various CSTD brands and chose EQUASHIELD based on their clinically proven safety and efficacy, product reliability, and user-friendly design.
Implementing EQUASHIELD CSTDs
Staff Reactions
It took one week for the pharmacy technicians to adapt to the EQUASHIELD system. The adoption process was seamless and intuitive, allowing them to effortlessly learn how to use the products. After the training and clinical onboarding the staff quickly adapted and learned how easy and intuitive is to use EQUASHIELD CSTDs in their workflow. After this period, they expressed high satisfaction and a preference for this system over others.
The hospitals reported several significant improvements immediately after implementation:
Improved safety for healthcare professionals
Reduced risk when handling cytotoxic drugs, resulting in improved workflows and stress-free handling of patient doses
Completely dry connections with no spills or drips
No foaming during drug withdrawal
Easier preparation when reconstituting lyophilized powders
User friendly and fail proof application due to the red marked notches that indicate specifically how to apply it
Compatibility
The hospitals noted smooth integration. Components they use include syringe units, spike adaptors, luer lock adaptors, female connectors, and vial adaptors. They utilized a standard tubing system.
The hospitals have adopted EQUASHIELD for all cytotoxic preparations, including antibodies, finding it advantageous over the previous method of using specific equipment for each medication based on compatibility.
One-Year Evaluation
Overall Improvements
One year after adopting EQUASHIELD’s CSTDs, all three Ostalb hospitals witnessed significant improvements in multiple areas. EQUASHIELD’s CSTD system substantially reduced contamination in the pharmacy and hospital. Reduced preparation times resulted in significant time savings in daily production. The system’s user-friendly design, with intuitive handling and clear application markings, ensures reliable and fail proof administration. Administration times have been reduced, and repetitive motion injuries have been prevented. The customer service team is responsive and ensures quick delivery, usually within 3-4 days.
Evaluating Surface Contamination Reduction
Wipe sampling was performed at multiple locations within the hospital system at various time points following the EQUASHIELD implementation. Of the three types of drugs used for sampling—Cisplatin, Fluorouracil, and Cyclophosphamide—all trackers pointed to lower traces of drug residue, with the vast majority being under 0.2 ng per sample detection limits.
This reduction in contamination not only enhances the safety of pharmacists and nurses but also contributes to a clean and safe environment for support staff throughout the lifecycle of the medication.
Time Savings
In addition to improving safety, EQUASHIELD’s CSTD have also proven to be time savers in drug preparation. When calculating the time saved while preparing top chemotherapy agents used daily, it was identified that drug preparation times could be reduced significantly by using EQUASHIELD CSTD. In some cases, the time savings were as much as 3.5 minutes per dose. Cetuximab alone saved 455 minutes annually. Similarly, other medications such as Fluorouracil, Avastin, and Herceptin achieved significant time reductions. The annual time savings in drug preparation for each staff member across 29 evaluated drugs totaled over 3,856 minutes.
Evaluating EQUASHIELD 7 Years Later
Seven years after integrating EQUASHIELD’s CSTD system into their daily operations, the hospitals continue to see improvements in staff satisfaction, time savings, and contamination reduction. The Ostalb hospital’s experience has been positive since its implementation. They are satisfied with the premium safety standards and would never consider using an alternative system. Annual wipe tests confirm that the enhanced safety levels, achieved since adoption, are consistently maintained. The system’s ease of use and safety features have significantly improved the workflow in the pharmacy department. An unexpected benefit is that the exceptional safety standards make it significantly easier to retain and recruit new staff to the oncology department. As a result, staff turnover has decreased significantly for the past seven years.
Adopting EQUASHIELD’s closed system technology has brought significant benefits to Ostalb hospitals, enhancing safety, streamlining workflows, and boosting staff morale.
Navigating the New EU Directives on HMPs
The implementation of EQUASHIELD CSTDs has ensured hospital compliance with the latest EU directives on hazardous medicinal products (HMPs). The new regulations outline which medicines are considered carcinogenic, mutagenic, or reprotoxic potential. Under the new regulations, hospitals are required to use closed systems for the updated list of HMPs by April 2024. The EQUASHIELD system meets and exceeds these safety requirements, providing a safe and efficient solution for pharmacists and nurses.
If you’re interested in learning more about how EQUASHIELD can benefit your healthcare facility, please reach out to one of our experts here.
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.2 This 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.
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.
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.
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 5th 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
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.
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.
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.
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.
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.
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.
The Critical Role of Advanced Technologies in Minimizing Risks from Hazardous Drug Handling
The preparation and administration of hazardous drugs, particularly chemotherapy agents, present significant contamination risks. These processes put both healthcare staff and patients in contact with dangerous chemicals, potentially leading to serious health issues such as dermatological problems (e.g., rashes and hypersensitivity reactions), reproductive disorders, and chronic conditions. The threat of liver damage from prolonged exposure highlights once more the necessity for comprehensive health monitoring and the implementation of protective strategies.
The National Institute for Occupational Safety and Health NIOSH emphasises managing these risks to ensure high levels of occupational safety in pharmacies, compounding centres, and other healthcare facilities. Studies published in Springer and the Oncology Nursing Society’s journal have shown the adverse effects of hazardous drugs not only on individuals but also on the workplace environment, advocating for strict contamination control measures. This includes using closed-system transfer devices and automation solutions to mitigate occupational exposure to these environmental contaminants.
Several case studies illustrate the effectiveness of such modern technologies in improving safety levels in pharmacies and hospitals. These real-life examples highlight the practical advantages and challenges of implementing CSTDs, offering a deeper understanding of their critical role in safeguarding healthcare communities and environments.
Mitigating Hazardous Drug Surface Contamination: Evaluating the Efficacy of Standardized Cleaning and Closed System Transfer Devices
A study assessed the reduction of hazardous drug surface contamination in pharmacy compounding and administration areas through standardised cleaning workflows and closed system transfer devices. It aimed to mitigate the risks hazardous drugs pose to healthcare workers and patients by comparing the effectiveness of these interventions. The research focused on evaluating contamination levels post-implementation of enhanced cleaning protocols alongside CSTD utilisation.
Methodology
Conducted across six different areas within pharmacy and nursing departments, the procedure involved the collection and analysis of 90 individual samples for five commonly compounded hazardous drugs over initial phase, 3-month, and 6-month intervals. The assessment utilised a rigorous testing protocol to measure the presence of hazardous drug residues on surfaces.
Results
The findings demonstrate that through standardised cleaning protocols and the integration of CSTDs, healthcare facilities can significantly reduce the risk of exposure to hazardous drugs. This comprehensive evaluation across multiple time points and locations revealed no detectable residue in all 90 samples analysed, highlighting the critical role of meticulous cleaning processes and the employment of secondary engineering controls like CSTDs in maintaining a safer work environment.
Conclusions
The study supports the adoption of standardised cleaning protocols and closed system transfer devices as effective strategies for maintaining low levels of surface contamination. By demonstrating the effectiveness of these strategies, the study offers valuable insights for healthcare facilities aiming to enhance occupational safety and patient care standards.
Assessing the Performance of Closed System Drug-Transfer Devices in Vapor Containment
An independent study evaluated the vapour containment performance of six commercially available closed-system drug transfer devices against the draft vapour protocol released by NIOSH. This research aimed to quantitatively assess the effectiveness of these CSTDs in containing gas/vapour within a controlled test environment. Utilizing 70% isopropyl alcohol (IPA) as a challenge agent, the study simulated drug compounding and administration processes, measuring IPA vapour concentrations that escaped the devices.
Methodology
The methodology closely adhered to the NIOSH draft protocol, incorporating two specific tasks outlined by NIOSH, with additional steps included to thoroughly evaluate the devices. Each device underwent these tasks ten times to ensure a comprehensive assessment.
Results
The results revealed a significant variance in performance among the tested closed system transfer devices: only three devices managed to maintain IPA vapour release below the 1.0 ppm threshold defined by NIOSH for successful containment across all tasks. Notably, the Equashield device demonstrated superior performance, consistently maintaining vapour release levels well below the 1.0 ppm threshold, affirming its efficacy as a truly closed system under the robust vapour challenge posed by the study.
Conclusions
This study contributes to the safety and efficacy discourse of CSTDs in healthcare settings, suggesting that future testing and protocol adjustments consider these devices’ operational realities. By demonstrating that only half of the evaluated closed-system drug transfer devices met NIOSH’s quantifiable performance threshold, the research highlights the need for healthcare facilities to critically assess CSTD technology choices. The standout performance of the Equashield device underscores its effectiveness in protecting healthcare workers from hazardous drug exposure, making it a noteworthy option for facilities prioritising safety and efficiency in drug handling processes.
Evaluating Vapor Containment Efficacy of CSTDs
Another study evaluated the vapour containment capabilities of CSTDs utilizing various containment technologies. Conducted in partnership with the Health and Safety Laboratory (HSL) in Buxton, UK, the research aimed at reviewing the draft protocol proposed by NIOSH for CSTD evaluation. The study compared the effectiveness of devices employing physical barriers against those using air-cleaning technology in containing hazardous drug vapours.
Methodology
The methodology replicated the NIOSH test protocol within a specially constructed environmental test chamber, incorporating both the original protocol instructions and the device manufacturers’ instructions for use (IFU). The evaluation involved simulated pharmacy manipulations, including drug reconstitution and IV bag preparation, using a surrogate mixture to challenge the systems. Vapour release was measured using advanced detection technologies, providing a comprehensive analysis of each system’s containment performance.
Results
The study highlighted differences in vapour containment among the tested devices, indicating that adherence to manufacturer-specific IFUs is crucial for maintaining the integrity of CSTD operation and ensuring an accurate assessment of vapour containment efficacy.
Conclusions
This study contributes valuable insights into the safety protocols necessary for handling hazardous drugs in healthcare settings, aiming to enhance worker protection against potential drug vapour exposure.
Assessing Syringe Plunger Contamination in Hazardous Drug Handling: A Comparative Analysis of Closed System Transfer Devices
In a comparative analysis, researchers examined cyclophosphamide contamination on syringe plungers using different CSTDs in oncological compounding. The study compared the performance of Becton Dickinson’s syringe plungers with Phaseal™ CSTDs against those from Equashield™, assessing their ability to minimize hazardous drug exposure during chemotherapy preparation and administration.
Methodology
Utilizing the ChemoGlo™ sampling kit for precise analysis, the study tested cyclophosphamide contamination levels on syringe plungers after conducting multiple drug transfer cycles within a Forma Class II, 2A Biological Safety Cabinet. The syringes were categorised into three groups, each subjected to a set number of drug transfer cycles to simulate varying degrees of usage intensity.
Results
The findings revealed significant contamination levels exceeding 2000 ng when used with Phaseal™ CSTDs, highlighting a potential risk of hazardous drug exposure. Conversely, Equashield™ syringes demonstrated no detectable contamination, underscoring their superior capability in preventing drug leakage and ensuring a safer oncology compounding environment.
Conclusions
This comparative study underscores the critical importance of employing effective CSTDs to safeguard healthcare workers from exposure to hazardous drugs during chemotherapy preparation and administration. The superior performance of Equashield™ syringes in maintaining a contamination-free compounding process emphasises the need for adopting advanced CSTDs in oncology practices.
Assessing the Impact of Closed System Drug Transfer Devices on Antineoplastic Drug Safety in Healthcare Settings
A comprehensive study critically examined the effectiveness of CSTDs, specifically TexiumTM/SmartSiteTM and Equashield® II, in minimizing leakage and contamination during the compounding of antineoplastic drugs in a centralized cytotoxic drug preparation unit. The primary aim of this research was to assess the capability of these leading CSTDs to reduce occupational exposure to hazardous drugs, with a particular focus on gemcitabine (GEM), by preventing leaks and spills during the drug preparation and administration process.
Methodology
The research involved a detailed analysis of wipe and pad samples collected from inside and outside the drug preparation area over five years. The focus was on detecting GEM contamination to evaluate the sealing efficiency of the CSTDs used.
Results
Findings indicated a significant reduction in GEM contamination with the adoption of Equashield® II, demonstrating its superior ability to prevent drug leakage and ensure a safer working environment.
Conclusions
This investigation highlights the critical role of CSTDs in safeguarding healthcare workers from exposure to hazardous antineoplastic drugs. The Equashield® II system, in particular, was shown to be highly effective in eliminating risks of spills and leaks.
Evaluating Efficiency, Ease of Use, and Cost of Closed System Transfer Devices for Chemotherapy Administration in Veterinary Oncology
This study assessed the treatment time, ease of use, and associated costs of administering chemotherapy using CSTDs versus traditional methods in a veterinary setting. The primary goal was to evaluate the operational efficiency, user experience, and financial considerations of two prominent CSTDs, Equashield™ and PhaSeal®, compared to conventional chemotherapy administration methods.
Methodology
The study employed a prospective experimental simulation approach, engaging veterinary technicians from oncology speciality practices.
Results
The investigation revealed that Equashield™ facilitated the fastest administration times and was also found to be easier to use than PhaSeal® and the no-CSTD approach.
Conclusions
This research underscores the importance of integrating CSTDs into veterinary oncology to safeguard healthcare workers without detracting from treatment efficacy.
Improving Safety in Hazardous Drug Handling: Recommendations for Healthcare Facilities and Compounding Centres
Adopting closed system transfer devices (CSTDs) is recommended to reduce contamination risks. CSTDs have proven effective in maintaining a safer working environment by significantly lowering the risk of exposure to hazardous drugs.
Facilities are encouraged to evaluate and select CSTDs based on their proven performance in vapour containment and their ability to prevent drug leakage and syringe plunger contamination.
Furthermore, the implementation of standardised cleaning protocols alongside the use of CSTDs is crucial. Rigorous, consistent cleaning methods have been shown to effectively eliminate hazardous drug residues on surfaces, further safeguarding healthcare personnel and patients.
Healthcare facilities should adopt a comprehensive approach that includes both technological solutions like CSTDs and enhanced cleaning workflows to ensure the highest levels of safety.
Training and education on the correct use of CSTDs and adherence to cleaning protocols are essential for healthcare workers. Regular competency assessments and ongoing education on handling hazardous drugs should be instituted.
Evaluating the efficacy of CSTDs and cleaning protocols should be an ongoing process. Healthcare facilities are advised to conduct periodic reviews and assessments of their hazardous drug handling practices.
Finally, the financial aspect of adopting CSTDs should be considered, with an emphasis on cost-effectiveness without compromising safety. The studies suggest that while initial investments may be required, the long-term benefits justify the expenditure. Healthcare facilities should explore various CSTD options, considering both upfront costs and long-term savings in terms of improved occupational safety and health outcomes.
By adhering to these recommendations, healthcare facilities and compounding centres can significantly enhance the safety of their environments, protecting both their workers and patients from the risks associated with handling hazardous drugs.
The meticulous compounding of hazardous medicines is a critical aspect of healthcare, demanding the highest quality standards to ensure patient safety and treatment efficacy. This article aims to present how these standards are upheld within the British healthcare system.
The Regulatory Framework for Compounding Hazardous Medicines in the UK
In the UK, a carefully structured regulatory framework governs the compounding and administration of hazardous medicines. Here’s a detailed breakdown of the key organizations involved and how they interact with each other.
Medicines and Healthcare Products Regulatory Agency (MHRA)
Primary Role: The MHRA stands at the forefront, overseeing all aspects of medicine and medical device regulations across the UK.
Interactions: It sets the overarching standards and guidelines, directly influencing the operations and practices of other regulatory bodies like the GPhC, PASG, and BOPA.
The main responsibilities of the MHRA for compounding hazardous medicines include:
Setting Standards and Guidelines: Developing and enforcing guidelines for the safe compounding of hazardous drugs, ensuring adherence to Good Manufacturing Practice (GMP) standards.
Quality Assurance: Overseeing the quality management systems in pharmacies and hospital settings to ensure that compounded medicines meet the required safety and quality standards.
Monitoring and Inspection: Conducting regular inspections of compounding facilities to ensure compliance with regulatory requirements and GMP.
Pharmacovigilance: Implementing robust pharmacovigilance systems to monitor adverse drug reactions and ensure timely reporting and action on any safety concerns associated with compounded medicines.
Enforcement and Compliance: Taking appropriate enforcement actions against non-compliance and ensuring that pharmacies and hospitals adhere to the established compounding standards and regulations.
General Pharmaceutical Council (GPhC)
Primary Role: This council regulates pharmacy professionals and pharmacies, ensuring compounding processes meet the highest safety and quality standards.
Interactions: Working in line with MHRA’s regulations, the GPhC is responsible for implementing these standards at the pharmacy level, collaborating closely with the PASG to ensure compliance and enforcement.
The main responsibilities of the GPhC in regulating the compounding of hazardous medicines include:
Setting and Enforcing Standards: Establishing clear, rigorous standards for the compounding of hazardous drugs in pharmacies and hospitals.
Inspection and Monitoring: Regularly inspecting pharmacy facilities to ensure compliance with compounding standards and safe practices.
Guidance and Training: Providing guidance and resources for pharmacy professionals regarding the safe compounding of hazardous drugs, including training requirements.
Quality Assurance: Ensuring that pharmacies have robust quality assurance processes in place for the compounding of hazardous drugs.
Pharmacy Registration and Compliance: Overseeing the registration of pharmacies and ensuring they comply with the legal and professional requirements for compounding hazardous drugs.
Risk Management: Implementing and enforcing risk management strategies to minimise the risks associated with the compounding of hazardous drugs.
British Pharmacopoeia Commission (BPC)
Primary Role: The BPC sets the quality standards for medicinal substances, fundamental for compounding processes.
Interactions: It provides the scientific basis for MHRA’s regulations, guiding the Expert Advisory Groups in advising on best practices for medicinal products.
Standard Setting for Medicinal Substances: Developing and maintaining the British Pharmacopoeia, which provides the official standards for the quality of medicinal substances, including those used in compounding hazardous drugs.
Guidance on Formulations: Offering detailed guidance on the formulation of medicines, ensuring that compounded drugs meet the necessary quality and safety standards.
Ensuring Consistency and Quality: Ensuring the consistency and quality of medicinal substances and preparations, which is critical in the compounding process, especially for hazardous drugs.
Updating Standards: Regularly updating and revising the standards in the British Pharmacopoeia to reflect advancements in pharmaceutical science and technology.
International Collaboration: Collaborating with international bodies to align the UK’s pharmaceutical standards with global best practices
BPC works in conjunction with the MHRA to align the standards with broader public health protections and medicine regulations.
For the latest information on the standards and guidelines set by the BPC, healthcare professionals and institutions like yours can refer to the British Pharmacopoeia, which is now legally effective. Check the 2024 edition here.
The Commission on Human Medicines
Primary Role: The Commission on Human Medicines is pivotal as an advisory body, providing critical guidance and recommendations to ensure the safe and effective use of medicinal products in the UK.
Interactions: It plays a significant role in advising the Licensing Authority, impacting the regulation of medicines by the MHRA. The Commission’s evaluations and recommendations directly inform the regulatory landscape for compounding hazardous drugs, influencing policy and practice at all levels.
Advisory Role: Providing expert advice to the Licensing Authority on the safety, quality, and efficacy of medicinal products, including those used in compounding hazardous drugs.
Evaluation of Safety and Efficacy: Assessing the safety and efficacy of medicinal products, particularly those classified as hazardous, to ensure they meet the required standards for patient use.
Risk-Benefit Analysis: Conducting risk-benefit analyses of medicinal products to guide decision-making processes regarding their use and compounding.
Guidance on Medicinal Standards: Offering guidance on standards and best practices for the compounding and use of hazardous drugs, based on the latest scientific and clinical evidence.
Monitoring Adverse Drug Reactions: Monitoring adverse drug reactions and other safety concerns related to compounded hazardous drugs and advising on appropriate actions to mitigate risks.
Policy Recommendations: Making policy recommendations to regulatory bodies to enhance the regulatory framework governing the compounding of hazardous drugs.
Expert Advisory Groups (EAG)
Primary Role: These groups offer specialized advice on various aspects of medicinal products.
Interactions: They play an advisory role to both the MHRA and BPC, impacting the development and refinement of guidelines for hazardous drug compounding.
Appointed by the Commission on Human Medicines and the British Pharmacopoeia Commission the Expert Advisory Groups play a crucial consultative role in the regulation of compounding hazardous drugs in hospitals and pharmacies in the UK. They consist of experts in various fields of medicine and pharmaceuticals.
The main responsibilities of these Expert Advisory Groups include:
Providing Specialized Advice: Offering expert guidance on specific issues related to the compounding of hazardous drugs, including safety, quality, and efficacy.
Recommendations on Standards and Practices: Recommending standards and best practices for the compounding of hazardous drugs, ensuring they align with current scientific understanding and clinical evidence.
Reviewing and Updating Guidelines: Assisting in the review and updating of guidelines and standards, particularly those published in the British Pharmacopoeia and other regulatory documents.
Risk Assessment and Management: Contributing to the assessment and management of risks associated with the handling and compounding of hazardous drugs.
Innovation and Research Support: Providing insights into the latest research and technological advancements that can impact the compounding of hazardous drugs and suggesting ways to incorporate these into current practices.
Liaison and Coordination: Facilitating communication and coordination between the Commission on Human Medicines, the British Pharmacopoeia Commission, and other regulatory bodies to ensure cohesive and comprehensive regulation
The Licensing Authority
Primary Role: The Licensing Authority, comprising the Secretary of State and the Minister for Health, Social Services, and Public Safety, is entrusted with the critical task of ensuring that the compounding of hazardous drugs in the UK adheres to stringent safety and quality standards.
Interactions: It is the body responsible for the issuance and regulation of licenses for the manufacturing, assembling, or importing of medicinal products. By ensuring compliance, enforcing regulations, and updating policies, the Licensing Authority shapes the environment within which pharmacies and manufacturers operate, thus safeguarding public health.
Granting and Regulating Licenses: Issuing licenses for the manufacturing, assembling, or importing of medicinal products, including hazardous drugs.
Quality and Compliance Oversight: Ensuring that licensed entities adhere to the required quality standards for compounding hazardous drugs.
Regulation Enforcement: Enforcing regulations related to the compounding of hazardous drugs, including imposing penalties for non-compliance.
Policy Formulation: Developing and updating policies and guidelines to ensure the safe handling and compounding of hazardous drugs.
Monitoring and Auditing: Conducting inspections and audits of facilities to ensure compliance with established standards and regulations.
Risk Management: Implementing risk management strategies to minimise potential hazards associated with the handling and compounding of hazardous drugs.
Pharmaceutical Aseptic Services Group (PASG)
Primary Role: The PASG focuses on aseptic preparation, upholding stringent standards for the compounding of hazardous drugs.
Interactions: It aligns its practices with the guidelines set by MHRA and GPhC, conducting audits and overseeing quality control in pharmacy environments.
This group operates under the framework of the Royal Pharmaceutical Society, focusing on establishing and maintaining high standards for aseptic preparation and ensuring the safety and efficacy of compounded drugs.
Standard Setting: Developing and maintaining standards for aseptic compounding of hazardous drugs, ensuring practices meet national and international guidelines.
Quality Assurance and Control: Implementing quality assurance and control measures to guarantee the sterility and safety of compounded drugs.
Risk Management: Establishing robust risk management protocols to minimise the risks associated with handling and compounding hazardous drugs.
Training and Education: Providing specialized training and educational resources to healthcare professionals involved in aseptic compounding.
Policy Development: Formulating policies and guidelines for the safe compounding of hazardous drugs, including the use of Personal Protective Equipment (PPE) and containment strategies.
Monitoring and Compliance: Conducting regular audits and inspections to ensure compliance with established standards and procedures in aseptic compounding.
Royal Pharmaceutical Society (RPS)
Primary Role: The RPS establishes national standards for aseptic preparation services in the UK, ensuring the quality and safety of compounded hazardous medicines.
Interactions: Collaborates with the NHS Pharmaceutical Quality Assurance Committee to audit and assure the quality of pharmacy aseptic units, aligning with MHRA guidelines and supporting the framework established by the GPhC and PASG.
The RPS is instrumental in developing and maintaining national standards for the aseptic preparation of medicines, with a particular focus on ensuring the quality and safety of hazardous drug preparations. In close partnership with the NHS Pharmaceutical Quality Assurance Committee, the RPS has instituted quality standards and auditing processes to uphold the integrity of pharmacy aseptic units. While these standards are tailored to the NHS, they also provide a benchmark for educational purposes and international healthcare entities.
The main responsibilities of the RPS in regulating the compounding of hazardous drugs include:
Developing national standardsthat guide aseptic preparation services.
Overseeing the preparation of critical medicines, particularly in settings that involve unlicensed hospital aseptic preparation units.
Collaborating to establish audit programs that maintain the high quality of aseptic units within the NHS.
Primary Role: BOPA specifically addresses oncology pharmacy practices, emphasizing the safe compounding and administration of hazardous drugs in this field.
Interactions: Operating under MHRA’s regulatory framework, BOPA collaborates with both the NHS and UKONS to develop specialized training and policies for oncology-related scenarios.
BOPA plays a significant role in guiding and influencing the practice of compounding hazardous drugs, particularly in the field of oncology, within hospitals and pharmacies in the UK. BOPA’s focus is on enhancing patient care and safety in cancer treatments, where handling and compounding hazardous drugs, like chemotherapy agents, require stringent protocols.
The main responsibilities of BOPA in this context include:
Setting Clinical Standards: Developing and advocating for clinical practice standards in oncology pharmacy, particularly regarding the safe compounding and administration of hazardous drugs.
Providing Education and Training: Offering educational resources and training programs to oncology pharmacy professionals for safe and effective compounding practices.
Promoting Research and Best Practices: Encouraging research in oncology pharmacy and disseminating best practice guidelines for compounding hazardous drugs.
Quality Assurance and Safety: Focusing on quality assurance measures to ensure the safety and efficacy of compounded oncology medications.
Policy and Guidance Development: Contributing to the development of policies and guidance related to oncology pharmacy, including the handling and compounding of hazardous drugs.
Collaboration with Regulatory Bodies: Working alongside healthcare regulatory bodies to influence policy decisions and regulations governing the compounding of hazardous drugs in oncology.
National Health Service (NHS)
Primary Role: The NHS oversees broader healthcare practices in the UK, including the safe compounding of hazardous drugs within NHS facilities.
Interactions: It implements safety protocols and training by MHRA guidelines and coordinates with entities like UHB to enforce local policies and procedures.
NHS in the UK plays a critical role in regulating the compounding of hazardous drugs in hospitals and pharmacies. This involves overseeing practices to ensure the safety and efficacy of drug preparation, particularly when dealing with cytotoxic and other chemotherapeutic agents that pose significant risks to both healthcare providers and patients.
The main responsibilities of the NHS in this context include:
Establishing Safety Protocols: Implementing comprehensive safety protocols for the handling, compounding, and administration of hazardous drugs.
Staff Training and Education: Providing extensive training and education to healthcare staff, emphasizing the safe handling of hazardous drugs and the use of Personal Protective Equipment (PPE).
Quality Assurance: Ensuring quality assurance in the compounding process, including adherence to aseptic techniques and proper storage conditions.
Risk Assessment and Management: Conducting risk assessments to identify potential hazards and implementing strategies to mitigate these risks.
Regulatory Compliance: Enforcing compliance with relevant laws and regulations, including COSHH (Control of Substances Hazardous to Health) regulations, and ensuring adherence to NHS policies and guidelines.
Monitoring and Auditing: Regularly monitoring and auditing pharmacy aseptic services and compounding units to ensure compliance with safety standards.
United Kingdom Oncology Nursing Society (UKONS)
Primary Role: UKONS concentrates on standardizing practices among oncology nurses, particularly in administering Systemic Anti-Cancer Therapy (SACT).
Interactions: It ensures that nursing practices align with the standards set by BOPA and the training requirements of the NHS, enhancing the safe administration of oncology treatments.
UKONS plays a pivotal role in regulating the process of compounding hazardous drugs, particularly Systemic Anti-Cancer Therapy (SACT), in hospitals and pharmacies across the UK. The SACT Competency Passport, developed by UKONS, serves as a key tool in this regulation.
The main responsibilities of UKONS in the context of compounding hazardous drugs include:
Standardizing Competencies: Developing and updating the SACT Competency Passport to ensure a standardized level of knowledge and skill among healthcare professionals handling and administering SACT.
Promoting Safe Handling of SACT: Emphasizing the safe handling and administration of SACT to minimize occupational exposure risks to healthcare professionals.
Education and Training: Providing theoretical and practical guidance for the education and training of nurses and other healthcare professionals in the safe administration of SACT.
Clinical Practice Assessment: Implementing a structured approach for clinical practice assessment to ensure practical proficiency in SACT administration.
Annual Reaccreditation: Instituting a process of annual reaccreditation to maintain and update competencies in SACT administration.
Patient-Centred Care Focus: Highlighting the importance of patient-centred care during SACT administration, including patient education and support.
Adaptability to Various Settings: Ensuring that the competencies and guidelines are adaptable to different healthcare settings and roles involved in SACT administration.
Feedback and Continuous Improvement: Encouraging feedback and ongoing improvement of the SACT Competency Passport to align with evolving practices and patient needs in oncology care.
University Hospitals, Pharmacies and Compounding Centres
Primary Role: They represent the practical application of these standards in a healthcare facility setting, focusing on safety procedures and staff training.
Interactions: It adopts and implements policies and procedures in line with NHS and MHRA guidelines, ensuring local compliance and effective risk management.
University Hospitals, pharmacies and compounding centres focus predominantly on establishing rigorous protocols and procedures to manage the risks associated with handling and administering cytotoxic and chemotherapeutic agents.
Their main responsibilities in this context include:
Developing Safe Handling Procedures: Establishing detailed procedures for the safe prescribing, handling, and administration of cytotoxic and other chemotherapeutic agents.
Staff Training and Competency: Ensuring that medical, nursing, and pharmacy staff are adequately trained and deemed competent in handling hazardous drugs, including specific training for chemotherapeutic agents.
Patient Safety and Consent: Implementing procedures to ensure patient safety, including informed consent processes for patients undergoing treatment with hazardous drugs.
Risk Assessment and Management: Performing thorough risk assessments and management strategies for the use of hazardous drugs in various clinical settings.
Quality Control and Assurance: Overseeing the quality control processes for compounding hazardous drugs, ensuring compliance with aseptic techniques, and correct storage and handling.
Policy Development and Compliance: Developing and maintaining policies in line with national guidelines and regulatory requirements for the safe handling of cytotoxic drugs.
Monitoring and Reporting: Regularly monitoring the handling and administration of hazardous drugs and ensuring the reporting and management of any related incidents or near misses.
This integrated network, led by the MHRA, and supported by organizations like the GPhC, PASG, BOPA, NHS, and all the others mentioned above ensures that the compounding and administration of hazardous drugs in the UK are not only safe and effective but also centred around the needs of patients.
How to Apply Good Manufacturing Practice (GMP) Standards When Compounding Hazardous Medicines
Understanding Good Manufacturing Practice in Compounding Hazardous Medicines
In the intricate world of pharmaceutical compounding, Good Manufacturing Practice (GMP) stands as a beacon of quality and safety. Particularly in the compounding of hazardous medicines, GMP is not just a set of guidelines but a vital framework ensuring that every medication is produced with the highest standards of safety and efficacy. This introduction sets the stage for understanding how GMP standards are meticulously applied in the compounding of hazardous drugs.
The Role of GMP in Ensuring Consistency, Quality, and Safety for Healthcare Workers Compounding Hazardous Drugs
By following the GMP standards, pharmacies and healthcare facilities can:
Minimize contamination risks.
Ensure accurate dosing and ingredient mixing.
Maintain an environment that protects both the product and the healthcare professionals involved in compounding.
Uphold stringent quality control throughout the compounding process.
Specific GMP Requirements for UK Compounding Pharmacies and Outsourced Facilities
Compounding pharmacies in the UK, along with outsourced facilities dealing with hazardous drugs, must adhere to specific GMP requirements. Key steps include:
Comprehensive Risk Assessment: Identify potential hazards in compounding processes and implement appropriate safety measures.
Qualified Personnel: Ensure that staff are adequately trained in handling hazardous materials and understand GMP principles.
Facility Design and Maintenance: Design facilities to prevent cross-contamination. Regular maintenance and cleanliness are paramount.
Equipment Validation: Validate all equipment used in compounding to ensure accuracy and safety.
Detailed Documentation: Maintain thorough records of compounding processes, ingredient sourcing, and staff training.
Regular Auditing and Inspection: Periodic audits and inspections are essential to ensure ongoing compliance with GMP standards.
Quality Control Measures: Implement rigorous testing procedures for both raw materials and finished products.
Reporting and Addressing Non-Compliance: Establish protocols for reporting GMP violations and taking corrective actions.
For a more comprehensive understanding of GMP and its application in compounding hazardous medicines, further resources and training are recommended.
Best Practices in Quality Control and Assurance for Compounding Hazardous Drugs
Next, we shift our focus to the twin pillars of quality control (QC) and quality assurance (QA) in the compounding of hazardous drugs. This part of the article emphasizes the critical role these practices play in ensuring that compounded medications not only meet safety standards and comply with GMP but also retain their intended efficacy, especially in high-risk scenarios like aseptic preparations.
The Crucial Role of Quality Control and Assurance
Quality control and assurance in compounding hazardous medicines are paramount due to the high risks involved. As per NHS England’s guidelines, stringent QC and QA practices ensure that compounded medications meet the necessary safety, quality, and efficacy standards (NHS England). This is especially vital in aseptic preparations where the risk of contamination can have dire consequences.
Quality Control Procedures: A Closer Look
Testing
Regular and thorough testing is a cornerstone in compounding hazardous drugs. This includes sterility tests, endotoxin tests, and potency checks, as emphasized by the Specialist Pharmacy Service (SPS).
Documentation and Record-Keeping
Meticulous documentation is key. This encompasses compounding procedures, outcomes, and any deviations or incidents.
The NHS England guidance underlines the importance of digital platforms like iQAAPS for effective documentation and compliance management.
Equipment and Processes Validation
Equipment and processes require regular validation to ensure consistent quality. This includes clean rooms, sterilization processes, and compounding techniques.
Validation ensures that every aspect of the compounding process adheres to predefined standards and is capable of consistently delivering quality products.
Operator Training and Validation
Compounding personnel must be adequately trained and periodically revalidated to maintain proficiency in handling hazardous drugs.
As per NHS England’s guidance, this includes assessing and ensuring staff competence in aseptic techniques and handling hazardous substances (NHS England).
Adherence to Standards and Guidelines
Following established standards, such as those outlined in the “Quality Assurance of Aseptic Preparation Services” by the Royal Pharmaceutical Society and the NHS Pharmaceutical Quality Assurance Committee, is crucial (RPS).
These standards provide a comprehensive framework covering all aspects of aseptic preparation, including risk management, equipment validation, and staff training.
Risk Management and Compliance in Compounding Hazardous Medicines
Understanding the Risks in Pharmaceutical Compounding
The compounding of hazardous drugs in pharmaceutical manufacturing presents a unique set of challenges, demanding meticulous risk management and unwavering compliance with regulatory standards. These processes are critical for ensuring the safety and effectiveness of medications, while also safeguarding the health of those involved in their preparation.
The Critical Role of Risk Assessment
Risk assessment is the cornerstone of managing potential hazards in pharmaceutical manufacturing, particularly in the compounding of hazardous drugs. It involves a systematic evaluation of processes to identify potential risks to both product quality and personnel safety.
Identifying Hazards
This initial step involves recognizing all possible risks associated with the compounding of hazardous drugs, ranging from chemical toxicity to environmental contamination.
The identification of hazards in pharmaceutical compounding requires a multi-faceted approach:
Comprehensive Inventory: Begin by creating a comprehensive inventory of all substances used in the compounding process. This includes active pharmaceutical ingredients, excipients, and any cleaning agents. Reference the Control of Substances Hazardous to Health (COSHH) Inventory Document for guidance on documenting substances.
Material Safety Data Sheets (MSDS): Obtain and review the MSDS for each substance, which provides crucial information on chemical properties, toxicity, handling, storage, and disposal requirements.
Workplace Exposure Limits (WELs): Consult the latest WELs, which are legal limits on the amounts of hazardous substances in the air, as provided by the HSE guidelines, to assess airborne risks.
Process Analysis: Analyse the compounding process step by step to identify where and how workers might be exposed to hazardous substances. This includes examining handling procedures, the potential for aerosol generation, and points of environmental release.
Consultation with Experts: Engage with health and safety committees, pharmacists, and industrial hygienists to review procedures and identify potential hazards that may not be immediately obvious.
Equipment Review: Ensure that all equipment used in the compounding process is examined for containment efficacy. Closed-system drug-transfer devices (CSTDs) should be considered to minimize exposure.
Legislative Framework: Familiarize yourself with the legislative framework relevant to hazardous drug compounding, such as the COSHH regulations and any specific guidance for pharmaceuticals, to understand the legal requirements for hazard identification.
Cytotoxic Specificity: For cytotoxic drugs, refer to specialized guidance like the HSE’s “Safe handling of cytotoxic drugs in the workplace” to understand specific risks associated with these potent compounds.
Evaluating Risks
Once potential hazards are identified, the next critical phase is risk evaluation. This process quantifies the likelihood and severity of the identified risks and their potential impact on both product quality and personnel safety. Here’s how to approach this:
Use of Risk Matrices: Employ risk matrices to gauge the severity of the hazard and the likelihood of its occurrence. This method combines qualitative and quantitative assessments to prioritize risks.
Consult WELs and Occupational Exposure Limits: Refer to Workplace Exposure Limits and Occupational Exposure Limits for hazardous substances as outlined by HSE guidelines, to determine acceptable levels of exposure and assess the extent to which current practices exceed these benchmarks.
Quantitative Exposure Assessments: Perform quantitative exposure assessments for tasks that involve handling hazardous drugs. This includes air monitoring for volatile substances and surface contamination assessments for non-volatile compounds.
Health Surveillance Data: Review health surveillance data, if available, to understand the historical impact of substance exposure on employees’ health. This data can highlight trends and help assess the potential chronic health risks.
Severity of Consequences: Assess the severity of potential adverse events on both health and the environment. For instance, consider the implications of exposure to reproductive toxins or the impact of a chemical spill.
Exposure Duration and Frequency: Evaluate the duration and frequency of exposure to hazardous substances. This includes considering both routine operations and the potential for accidental exposures.
Mitigation Efficacy: Examine the current control measures in place for their effectiveness. Review incident reports and near-misses to evaluate if current mitigation strategies are sufficient.
Consultation with Regulatory Bodies: For complex risk evaluations, consider consulting with regulatory bodies or external experts. They can provide insights into risk assessment methodologies that are compliant with current regulations.
Task-Specific Risks: Use task-based risk assessments for activities involving hazardous drugs, as recommended by the Royal Pharmaceutical Society. This approach looks at the risks associated with the compounding process itself.
Documentation and Review: Document all findings thoroughly. This documentation should be readily accessible for review and use in future risk assessments and audits.
By taking these practical steps, organizations can systematically evaluate the risks associated with the compounding of hazardous medicines. This evaluation not only informs the implementation of appropriate safety measures but also ensures that risk mitigation strategies align with the latest health and safety standards, thereby safeguarding both product integrity and occupational health.
Implementing Mitigation Strategies
Based on the risk evaluation, appropriate mitigation strategies are developed. These may include engineering controls, like closed-system drug-transfer devices, administrative controls, and the use of personal protective equipment (PPE).
Continuous Monitoring and Review
Risk assessment is an ongoing process. Regular monitoring and review are crucial for ensuring the effectiveness of the mitigation strategies and for adapting to any changes in processes or regulations.
The Imperative of Regulatory Compliance
Compliance with regulatory guidelines is not just a legal obligation but a moral imperative in pharmaceutical manufacturing. The guidelines provided by agencies like the Health and Safety Executive (HSE) and the Royal Pharmaceutical Society are designed to prevent adverse events, ensuring the highest standards of safety and efficacy in drug compounding.
Sterile vs. Non-Sterile Compounding Practices
Sterile vs. Non-Sterile Compounds: Understanding the Basics
Sterile Compounds are medications prepared under strict aseptic conditions to ensure they are free from all forms of microbial life. These compounds are typically used in injections, eye preparations, and other routes of administration where sterility is paramount for patient safety.
Non-sterile compounds, in contrast, are prepared in a less stringent environment. They include oral medications, ointments, and creams where absolute sterility isn’t a necessity, though quality and safety remain crucial.
Regulations and Best Practices for Sterile Compounding
Aseptic Techniques and Cleanroom Standards
When it comes to sterile compounding, aseptic techniques are the cornerstone. As outlined in the “Guidance for ‘specials’ manufacturers” by the UK Government, these techniques involve meticulous practices to avoid contamination, including proper hand hygiene and the use of sterilized equipment (GOV.UK).
The environment where sterile compounding occurs is equally vital. Cleanrooms or controlled environments, adhering to standards such as ISO Class 5, are essential. These spaces are designed to maintain low levels of environmental pollutants and are equipped with High-Efficiency Particulate Air (HEPA) filters to ensure air purity, as emphasized in the “Transforming NHS Pharmacy Aseptic Services in England” report (NHS England).
Closed System Transfer Devices (CSTDs)
The use of CSTDs is a critical aspect of handling sterile products, particularly in oncology pharmacy. These devices prevent contamination during the transfer of medication from one container to another, ensuring the sterility of the product and safeguarding healthcare workers from exposure to hazardous drugs.
Sterility Testing
A fundamental component of quality control in sterile compounding is sterility testing. This process involves checking compounded sterile preparations for microbial contamination, ensuring the safety and efficacy of the medication for patient use. The rigorous standards for sterility testing are part of the broader regulatory framework outlined in “The Human Medicines Regulations 2012” (Legislation.gov.uk).
The distinction between sterile and non-sterile compounding is more than just a procedural difference; it’s about ensuring patient safety and medication efficacy. Adhering to stringent regulations and best practices, from aseptic techniques to cleanroom standards and sterility testing, is paramount in the pharmaceutical industry. By following these guidelines, pharmacists and technicians contribute significantly to delivering safe and effective personalized medication therapies.
Labelling and Packaging Requirements for Compounded Hazardous Medicines
Moving beyond the compounding process, we must consider the critical aspects of labelling and packaging of compounded hazardous medicines. This section will highlight the stringent regulations governing labelling and the importance of accurate and informative packaging in maintaining product integrity and ensuring patient safety.
Labelling Regulations for Compounded Pharmaceuticals
Compounded pharmaceuticals, particularly cytotoxic drugs used in cancer treatment and other diseases, require stringent labelling regulations. According to the “Human Medicines Regulations 2012“, all medicinal products, including compounded ones, must be clearly labelled. This labelling should include essential information such as the name of the medicine, strength, route of administration, posology, and warnings. The regulations ensure that healthcare professionals and patients can easily identify the medicine and understand its proper use, minimizing the risk of medication errors.
Importance of Accurate Labelling for Patient Safety
Accurate labelling of compounded hazardous drugs is vital for patient safety. As these drugs can have teratogenic, genotoxic, and carcinogenic properties, improper handling or administration due to mislabelling can lead to severe consequences. The guidelines from “Hospital Pharmacy Europe” highlight the need for well-labelled packaging to prevent occupational exposure and ensure safe administration to patients. Labels must be informative and clear, allowing healthcare workers to recognize and handle these drugs safely.
Packaging Considerations for Product Integrity and Stability
The packaging of compounded hazardous medicines is as crucial as labelling. The “Human Medicines Regulations 2012” stipulate that packaging must not only be secure but also maintain the integrity and stability of the product. Specialized packaging is recommended to prevent material breakage and contain spillage, especially during transport from manufacturers to hospitals. For instance, some manufacturers use moulded plastic containers for cytotoxic agents to confine any contamination in case of spillage. This approach minimizes the risk of exposure to pharmacy storekeepers and other healthcare workers.
Pharmacovigilance and Reporting Adverse Events for Compounding Hazardous Medicines
Introduction to Pharmacovigilance in Compounded Product Safety
As we near the conclusion, the focus shifts to pharmacovigilance – the watchful eye ensuring the safety of compounded medicines. This segment will discuss the importance of adverse event reporting and how it contributes to improving patient safety and refining compounding practices, thereby playing a pivotal role in the realm of hazardous drug compounding.
Pharmacovigilance involves the science and activities related to detecting, assessing, understanding, and preventing adverse effects or any other medicine-related problem. This vigilance is particularly vital in the area of compounding hazardous drugs, where the risks are inherently higher due to the nature of the substances involved. The goal of pharmacovigilance in this context is to minimize risks, maximize benefits, and promote the safe and effective use of compounded hazardous medicines.
Adverse Event Reporting Requirements and Timelines for Compounded Hazardous Drugs
The reporting of adverse events in the context of compounded hazardous drugs is a critical component of pharmacovigilance. It is mandatory to report adverse events electronically, except in exceptional circumstances. For all veterinary medicines, including compounded hazardous drugs, serious adverse events, human adverse reactions, and unintended transmission of infectious agents must be reported on an expedited basis. The Marketing Authorisation Holder (MAH) is responsible for validating all reported adverse events to ensure that the minimum information required is included in the report. These reports should be followed up to obtain additional information relevant to the case as necessary.
In the UK, for example, serious adverse events in animals and all human reactions occurring must be reported promptly, and no later than 15 calendar days from receipt to the appropriate regulatory body. This expedited reporting is essential for timely intervention and mitigation of risks associated with the use of compounded hazardous drugs.
Contribution of Reporting to Improvement and Patient Safety in Compounding Hazardous Drugs
The systematic reporting of adverse events in the compounding of hazardous drugs is not just a regulatory requirement but a cornerstone for improving patient safety and drug efficacy. Each reported event provides valuable data that can be analysed to understand better the risks associated with compounded hazardous drugs. This information is crucial for identifying trends, potential safety concerns, and areas for improvement in compounding practices.
Through diligent reporting and analysis, pharmacovigilance activities contribute significantly to enhancing the safety profile of compounded hazardous drugs. They help in refining compounding processes, improving drug formulations, and developing better guidelines for safe handling and administration. Ultimately, this leads to a higher standard of care and protection for both patients and healthcare professionals who handle these medications.
Emerging Trends in Pharmaceutical Compounding
In the final stretch of our journey, we explore the emerging trends and challenges in pharmaceutical compounding. This section will delve into the evolving legislative landscape, technological advancements, and the challenges of adapting to these changes. It will underscore the importance of staying updated with regulatory changes and embracing new technologies to enhance the safety and efficacy of compounding hazardous medicines.
Legislative Trends
The landscape of hazardous drug handling in healthcare settings is undergoing significant transformation, driven by evolving regulatory frameworks worldwide. A notable example is the recent updates to the Clinical Oncology Society of Australia’s position on the safe handling of monoclonal antibodies, reflecting a global shift towards more stringent safety protocols. These changes mirror the principles outlined in the USP General Chapter <800>, which was revised in December 2017 to enhance patient and healthcare worker safety. This chapter provides a comprehensive set of standards for the entire lifecycle of hazardous drugs, from their receipt to disposal, ensuring a holistic approach to safety.
Technological Trends
The compounding of hazardous drugs is undergoing a significant transformation, thanks to technological advancements. A key development in this area is the use of Closed-System Drug-Transfer Devices (CSTDs), which are instrumental in preventing the release of hazardous drug particles into the environment during their preparation and administration. This innovation enhances safety measures significantly. Complementing this, there’s a growing trend towards automated compounding processes. These automated systems drastically reduce the need for direct contact with hazardous drugs, thereby minimizing exposure risks for healthcare professionals in hospital environments.
Challenges in Adapting to Regulations and Technology
Keeping Pace with Regulatory Changes
Adapting to the dynamic regulatory environment remains a formidable challenge for healthcare facilities globally. The complexity and frequency of updates, as exemplified by regulations like USP <800> and the evolving guidelines in Australia, demand constant vigilance and adaptability. Ensuring compliance necessitates ongoing education and training for healthcare professionals involved in the compounding and handling of hazardous drugs. It’s imperative for healthcare institutions to invest in continuous learning and stay informed about global best practices to effectively navigate these regulatory waters.
Technological Adaptation
The integration of new technologies like CSTDs and automated compounding systems into healthcare practices presents certain challenges. One of the primary concerns is the financial aspect, as these advanced technologies typically incur higher costs. Moreover, adopting these new systems and equipment involves a learning curve. It requires healthcare workers to undergo comprehensive training and develop new skills to effectively use these technologies. This adaptation is crucial for ensuring both the safety of the healthcare environment and the efficacy of drug-compounding processes.
Environmental and Safety Concerns
The manufacturing and compounding processes for hazardous drugs raise environmental and safety concerns. The challenge lies in implementing sustainable practices that align with regulatory standards while ensuring the safety of healthcare workers and patients. This includes managing waste effectively and minimizing the environmental footprint of compounding practices.
The Importance of Staying Updated
In the face of these trends and challenges, it is imperative for healthcare facilities and professionals to stay informed about regulatory changes and industry best practices. Regular training, attending seminars, and engaging with professional bodies are essential steps in this direction. Staying updated not only ensures compliance with regulations but also enhances the overall safety and efficacy of compounding hazardous medicines.
In conclusion, the compounding of hazardous medicines is entering a new era marked by stringent regulations and innovative technologies. Navigating this landscape requires a proactive approach in adapting to regulatory changes and embracing technological advancements. By doing so, we can ensure the highest standards of safety and care in the pharmaceutical industry, ultimately benefiting both healthcare professionals and patients alike. As we move forward, it is crucial for all stakeholders to collaborate and share knowledge, ensuring that the compounding of hazardous medicines continues to evolve in a safe, efficient, and compliant manner.
