10 Policy
Pharmacy Practice News • February 2021
Sterile Compounding
A Standardized Solution to Better Compounding B
y recruiting a team of champions and incorporating new compounding software, AdventHealth in Florida was able to more easily standardize its compounding operations across eight locations in the Orlando area and meet all requirements of USP <797>. The journey to standardization began in 2019, after Richard Montgomery, BSPharm, MBA, the health system’s corporate pharmacy contracts and operations manager, was looking across the enterprise trying to figure out the best way to do this, he explained during a recent webinar. Although the system includes 46 hospitals across nine states, the Orlando area had eight hospitals and some freestanding emergency rooms. With a radius of 25 miles between hospitals, it wasn’t uncommon for pharmacists or pharmacy technicians to travel among campuses, making this a perfect test site for a pilot, Montgomery said. In addition, the health system’s software vendor, Pharmacy Stars, mentioned its Compounding360 module could be used to help with training and formulas.
training oversight and following up on corrective actions, were already handled by each facility. But new requirements for overseeing changes to standard operating procedures (SOPs) and developing and reviewing quality assurance programs would need to be consistent. So, Wollitz reached out to the operations manager at each campus, who in large part were the pharmacy consultants of record. They were excited to take on this new role, she said. They formed a committee to help with items that would need to be standardized across the organization; the committee was made up of the DP from each site and the director of policy and quality and Christine Hong, the quality manager for the pharmacy department, to help offer guidance. The committee met monthly to discuss SOPs or any necessary operational changes. They also reviewed any new formulas to standardize them and used the Compounding360 software to review scorecards on how each site was following policies. They used meeting time to discuss any barriers or issues seen at the campuses,
‘When you have multiple sites, being able to standardize so that staff can float back and forth makes the process much easier for individuals who might be in an unfamiliar cleanroom or unfamiliar pharmacy.’ —Michael Ganio, PharmD Some areas that Montgomery was concerned about included sterile preparation and personal protective equipment, engineering controls, training and competency, and documentation, as well as having standard formulas for IV preparations. At the time, anticipated updates for USP Chapter <797> were looming, along with a requirement to define a designated person (DP) at each site to be accountable for compounding operations and personnel, said Amanda “Mandy” Wollitz, PharmD, the program director of pharmacy policy and quality at AdventHealth Orlando. “We were really excited about that accountability piece, but we also had concerns about how it could have complications for a health system trying to function as one unit and be greater as a whole,” she said. The health system already had several policies in place detailing its compounding requirements and expectations, but there was potential for misalignment across the system. “We really had our work cut out for us.” Reviewing the chapter in depth, Wollitz noted that some operational responsibilities of the DP, such as ensuring the quality of the environment,
implementing changes across the board if necessary. Members also had access to an internal messaging channel. Standardizing operations helped in several ways, Wollitz said. One is garbing. While the 360 platform posts instructions for sterile compounding, some pharmacy locations had unique layouts that needed individual instruction. The committee reworked instructions, ensuring each pharmacy’s layout, and updated the group document. The approach also helped with formulations. Typically, one person at each campus would create these, Wollitz said; now the work is distributed among multiple experts, with some designated second checks built into the process. It also helped ensure that facilities were using recommended or contracted supplies, and improved efficiency in creating a standard list for ordering. “We also now have a unified voice and expectations. There is no longer variation at our campuses,” she said. “We have floaters who go between campuses. They might previously have found different recipes or cleaning tasks at each pharmacy. Now, through the 360 platform, everything is streamlined.”
Sterile preparation and personal protective equipment, engineering controls, and formulas for IV preparations all can benefit from standardized operations.
One of the biggest improvements that Wollitz said she has seen is in staff attending to SOP and policy reviews. The organization does an annual review and has about 20 compounding policies. It’s difficult for one person to conduct a review and catch everything that may need to be tweaked, she said, “but with the committee, we now have many sets of eyes reviewing documents for accuracy. There have been a significant number of changes that we owe to the committee review.” The committee also developed a standard compounding and investigation action plan to research the root cause of any adverse events, and created a folder for all investigations to be centralized and easily accessed through the 360 platform. The committee also created a centralized environmental monitoring team to provide feedback to the DP and panel on any trends they note, and to share corrective action plans. Additionally, the compounding platform provided the team a just-in-time scorecard to review compliance on a daily basis, enabled central control of task and formula creations, and allowed for a library to share literature and standard education. Changes can be pushed out from a central account, Wollitz said. “Our quality program increases the transparency of our practices; we meet monthly and make decisions together, which allows us to pool experience across the organization to weigh in on any significant decisions,” Wollitz said. “Engaging experts at each site and sharing compliance data across the system, I can say we have exponentially improved quality and safety across our compounding sites.” The team is planning some additional upgrades to their system. They include filming the compounding areas and putting it into a virtual reality format so new employees can explore and interact with a virtual model of their own facility’s cleanroom environment before starting work. Furthermore, they are elevating the
training component by adding additional scenarios specific to their work sites and including polls on learning styles.
A Boon for Multiple Sites Although commercial software products to help with compounding and standardization aren’t free, they can be beneficial depending on the needs of a particular health system, commented Michael Ganio, PharmD, the senior director of pharmacy practice and quality at ASHP. “When you have multiple sites, being able to standardize so that staff can float back and forth makes the process much easier for individuals who might be in an unfamiliar cleanroom or unfamiliar pharmacy,” Ganio said. “At least they know the operations are the same.” Going with an outside vendor may make sense for multiple-site health systems such as AdventHealth, he said, whereas smaller facilities may find it easier to internally manage the process through centrally stored spreadsheets, training materials or other documents to track their tasks. Factors to consider include the individual needs of the health system, how complex the compounding operations are, and how many sites and staff members are part of the process. When selecting a vendor, Ganio advised, cost is always a primary concern, especially now during the pandemic, when hospital budgets are squeezed. In addition, he said: “I always recommend getting in touch with an institution that’s already using the software, to ask questions and find out how it is used in the real world. “The important take-home [message] is that health systems standardize in some way,” Ganio added. “It’s critical to have all of this information documented and accessible to the staff.” —Karen Blum The webinar was sponsored by Pharmacy Stars. The sources reported no relevant financial disclosures.
