Budgetary restrictions and staffing shortages have always been a challenge for healthcare organizations, but those issues have intensified in the wake of the COVID-19 pandemic. Increased labor costs, lack of training, supply chain disruptions, drug shortages, ongoing pandemic-related financial losses, and high turnover due to stress, burnout, and safety concerns have led to a weakened healthcare system rife with potential hazards for providers and their patients.

Adding to these challenges has been the increased use and complexity of compounded sterile preparations (CSPs), which are subject to the United States Pharmacopeia (USP) compounding standards. As patient volumes increase at health systems across the country, so too does the need for compounded sterile preparations. Compounded sterile and/or hazardous drugs, however, can also pose significant risks to patients, workers, and the environment if not prepared and handled properly.

Following several high-profile cases of contamination and infection that led to patient harm and death, the USP released revised standards to ensure patient safety, worker safety, and environmental protection wherever compounding sterile and hazardous drugs are handled. The standards affect anyone compounding, handling, or administering CSPs and require many facilities to reevaluate their cleanroom design, equipment, standard operating procedures (SOPs), and personnel competency programs:

• USP <797>: Establishes standards for drug compounding to ensure accuracy and avoid contamination of sterile products such as injections, infusions, eye drops, or inhalations. It outlines the required procedures for compounding sterile drug preparations, such as environmental monitoring, staff training, facility design, equipment, and beyond-use dating.

• USP <800>: Standardizes the requirements and processes for handling hazardous drugs as defined by the National Institute for Occupational Safety and Health (NIOSH) and aims to protect workers and environments from unintended exposure. It includes guidance for both healthcare personnel and facilities.

Revisions of the USP <797> standards were published in November 2022, with a Nov. 1, 2023 deadline for compliance for both USP <797> and <800>. Many healthcare organizations, however, are still scrambling to fully understand USP <797> and USP <800> and the changes needed to meet and exceed the minimum standards. At the same time, they are aware that failure to pass an inspection could mean closure of the compounding pharmacy and interruption to critical patient care.

Overwhelmed with other pressing issues, some entities have taken a traditional checklist approach to the revised standards, completing the minimum requirements in the hope that it will be enough to get them through. Others that want to make meaningful change for the long term have turned to the specialized expertise provided by life sciences consultants to help them navigate these confusing new standards, ensure that nothing is overlooked, and confirm that compliance standards are being met or exceeded.

Through consultation with over 50 clients, Trinity Consultants’ WorkingBuildings and SafeBridge teams have identified five key areas compounding pharmacies should consider now to save time, money, and plenty of headaches down the road:

• Rise above the minimum standard. Many healthcare facilities affected by the new standards believe that they’ve already gone above and beyond in their planning and preparation, but the standards set in USP <797> and USP <800> are just the minimum requirements for compliance. Design and engineering teams can have the best of intentions when creating or renovating these facilities; however, if they’re only adhering to the bare minimum specifications, issues are more likely to arise. Experts understand that any small mistake or oversight in the design or construction of the facility can have disastrous and costly repercussions. They can help leaders absorb the importance of designing to a higher standard from the beginning.
• Focus on design. Layout and design are crucial to the long-term health and success of compounding facilities, but these designs are also very complex—often even more complicated than designing an operating room. As such, they require careful planning and coordination with experts. By educating and collaborating with facility leaders and cleanroom design teams, consultants with professional backgrounds in commissioning, construction quality control, pharmacy operations, and designing built environments can help guide clients through the original design or rebuild of their facilities and ensure that they have the necessary components for compliance. These include strict cleanroom classification and segregation, adequate adjacencies and finishes, selection and placement of appropriate equipment, and HVAC design for the control and monitoring of temperature, humidity, and differential air pressure.
• Seek out multidisciplinary support. Many compounding pharmacies have just one pharmacist or pharmacy technician on staff and might be looking to them or a general pharmacy consultant to guide the organization toward the new USP standards. But let’s say you need important brain surgery that could save your life. Would you go to your general practitioner and trust that they could successfully complete the procedure? Or would you prefer a surgeon with decades of training, experience, and successful outcomes under their belt? Organizations need guidance from a wide bench of scientists and expert consultants who can provide the support necessary for healthcare teams to reach compliance.
• Sample for success. Some hospital and healthcare facility administrations have historically shunned hazardous drug (HD) surface sampling, believing it to be an unnecessary hassle that could open the facility to additional regulatory scrutiny. At other organizations, HD surface sampling is performed, but pharmacy staff are unsure what to do with the results. Surface sampling, however, is a crucial step in identifying potential sources of hazardous drug contamination and gaps in control systems that protect worker health. Utilizing expert consultants who can educate staff and facility leadership about the benefits of sampling, how to handle and process those surface samples, how to interpret results, and how to track their successes in keeping workers and patients safe can go a long way toward bringing this process into compliance. It’s also important to have the samples analyzed by an industrial hygiene laboratory accredited by the American Industrial Hygiene Association (AIHA) for the analysis of active pharmaceutical ingredients, such as Trinity’s SafeBridge Analytical Laboratory. SafeBridge has developed a surface method in support of USP <800> HD sampling, which can quantify 16 different HDs from a single surface sample at levels down to 0.05 ng/cm². Its USP <800> Surface Sampling Kit provides everything needed to safely sample, package, and ship samples to the laboratory for analysis.
• Go all in on the mission. Compounding pharmacy teams rarely operate in a vacuum, making it vital that all staff members understand the mission of USP <797> and USP <800> to avoid confusion over changes to hospital and drug protocols. Healthcare organizations should partner with a consultancy that can serve as a trusted advisor and clarifying voice to provide easily digestible information about new standards and answer questions as they arise. The more people on a healthcare team who understand and believe in why these protocols are important, the easier it will be to meet the new requirements.

USP <797> and USP <800> will become enforceable on Nov. 1, 2023, and facilities need to be ready. Trinity Consultants offers an AIHA-accredited analytical laboratory and comprehensive scientific expertise that can take a facility from design/renovation to analysis and interpretation of HD surface sample results. Trinity’s experts include board-certified pharmacists, industrial hygienists, toxicologists, and quality assurance specialists with decades of collective experience and extensive knowledge of OSHA, FDA, and USP. Equipped with this intelligence, they know better than anyone how to help organizations care for their workers, so they can take better care of patients. With careful planning, expert consultation, and personalized support, healthcare organizations of all sizes can move through these changes successfully—without interruptions to patient care—and come out on the other side better equipped to keep all stakeholders safe and healthy.