According to current USP <795> standards, facilities must ensure that personnel are appropriately trained and can perform nonsterile compounding tasks.1 However, for many pharmacies, training, education, and resources have been focused primarily on sterile compounding. Staff may have variable experience, and many hospital pharmacies do not have the dedicated staff for a nonsterile compounding service, so this work is often shared amongst shifts and locations.2 However, with expanding training requirements for licensure and to align with patient care requirements, the need for a dedicated, standardized nonsterile compounding training program is growing in importance. At St. Jude Children’s Research Hospital (SJCRH), we recognized this need (see the SIDEBAR). In order to ensure that the program is as comprehensive as possible, a team of pharmacists and pharmacy technicians created a workgroup focused on developing a standardized training checklist that could be used for all pharmacy staff that compound nonsterile medications.
At SJCRH, the Pharmaceutical Services division prepares both hazardous and nonhazardous “simple” nonsterile compounded preparations for patients. SJCRH partners with a local compounding pharmacy for more complex nonsterile compounded preparations. Many of our patients are unable to take tablets and capsules for a variety of reasons, so pharmacy compounded oral suspensions are a common alternative. Our compounding program encompasses inpatient and outpatient settings. In July 2020, a workgroup was created to review our current nonsterile compounding training process and develop content and procedures for a standardized training checklist. The workgroup included the following roles: compounding manager, staff pharmacist with extensive nonsterile compounding experience, pharmacy technician supervisors for both the inpatient and outpatient areas, and a pharmacy technician that frequently engages in nonsterile compounding.
The current and proposed versions of USP <795> were the primary source for topics to address in the training checklist. A review of the guidelines identified the following key topics:
The workgroup discussed additional issues that require training. One common concern was clarifying expectations for how and when to clean the equipment (eg, mortar and pestle, spatulas, etc) used in compounding. Likewise, it was important to ensure that staff understood the requirements for the online compounding documentation and verification system. Once the topics were established, the workgroup reviewed each one to define the expectations for completing the tasks, reviewed any existing training documents and standard operating procedures, and looked for any additional sources of education (see the TABLE). In addition, the workgroup reviewed existing literature that aligns with the identified training topics for future didactic training modules.3,4
Addressing Gaps in Compliance
Per USP <795>, training must be didactic and observational. Additionally, USP <795> defines compounders as both the technicians doing the physical compounding as well as the pharmacists overseeing the work and verifying the product. Furthermore, many state licensures required multiple hours of training to be completed as part of the license renewal process. As the workgroup reviewed the standards, the following gaps were identified in our original training procedures:
With these gaps in mind, we focused first on the didactic training elements since they were the easiest to standardize. The work around the didactic training elements also covered the need for inclusion of pharmacists in the training and the need to develop additional standard operating procedures.
All pharmacy quality control tasks and compounding competencies are documented through an online QC system. The system gives us the flexibility to create our own learning modules in addition to using the ones provided. We have expanded the tasks and competencies to cover both sterile and nonsterile compounding.
The first didactic training module was a slide deck that addressed the topics in the TABLE. When needed, this module referred to practice that is specific to SJCRH. The compounding manager developed the first draft of the slide deck with feedback from the subject matter experts. Pictures and specific examples were purposely incorporated to meet different learning styles (see FIGURE 1). The draft was then further refined with critiques from the workgroup.
Next, evaluation questions were created for the information presented in the slide deck to assess comprehension of the topics covered. Our online QC system allows for the easy upload of the didactic training and the evaluation questions. This didactic training went out to all pharmacists and pharmacy technicians involved with nonsterile compounding in February 2021. Ongoing didactic training is completed during the month of February. Staff will be divided up throughout the year for the ongoing observational assessments. The online QC system will notify staff and evaluators of assessments due within the next month.
Sterile vs. Nonsterile Compounding Training
Sterile compounding personnel are familiar with the tripod of elements that buttress all sterile compounding training programs (initial/annual):
SJCRH plans to use this same model for the nonsterile compounding training program:
In addition to the didactic modules, paper checklists have been converted to online competency checklists within our competency management system (see FIGURE 2). These checklists will serve as the backbone of the observational evaluations. Using the online QC system simplifies management of the module/observation assignments and analysis of the results. Having a single competency management system for both sterile and nonsterile compounding makes it easier to provide documentation for inspections and audits.
SJCRH is fortunate to have staff dedicated to compounding, with a manager of compounding position as well as a pharmacy technician position that focuses on sterile compounding quality assurance activities (eg, environmental monitoring, staff evaluations, training, etc). As we expand to replicate the training and evaluation processes from sterile to nonsterile, identifying staff to help manage the program will be a crucial step. Because the training procedures must meet the needs of inpatient and outpatient pharmacy areas, staff managing these processes will need to have experience in both sites of care. Several pharmacy technicians who are at a high level on the career ladder will take on the role of managing the observational evaluations. Currently, our inpatient and outpatient locations share nonsterile compounding facilities; however, in the next few years, the outpatient location will be moving to a new building. It is essential that we develop trainers/evaluators for both inpatient and outpatient staff now so training and assessment will be standardized in both areas.
Routine review of training and evaluation programs through comparison to guidelines, regulations and inspections by state boards of pharmacy, and current literature allows our training programs to evolve over time. Not only was content updated, but the scope of the training and evaluation program was expanded to meet regulatory requirements and safety elements.
When developing a standardized training program, our experience highlights the importance of establishing a workgroup with a variety of expertise to ensure all elements are addressed. This team can also serve as subject matter experts and primary observational evaluators. As SJCRH went through the evaluation of our training process, we identified some gaps which were addressed via updated policies and training. Online QC systems and workflows are critical to documentation and implementation, especially if pharmacy services occur across multiple areas and teams. As rules, regulations, and guidelines evolve over time, so will our program to ensure that safe and efficient nonsterile compounding remains a priority for our team.
Cindy Brasher, PharmD, MS, BCPS, BCSCP, is the manager of compounding at St. Jude Children’s Research Hospital. She received her PharmD from the University of Tennessee College of Pharmacy, completed the health system’s pharmacy administration PGY1/PGY2 residency program at Mission Hospital in Asheville, North Carolina, and a master’s in pharmacy administration through the University of North Carolina Chapel Hill. Currently, Cindy is serving on the ASHP Section Advisory Group on Compounding, ACCP Clinical Administration PRN, and the UT Alumni Association Board of Governors. She focuses on regulatory compliance and process improvement for sterile, nonsterile, and hazardous drugs.
About St. Jude Children’s Research Hospital
St. Jude Children’s Research Hospital (SJCRH) is a premier basic science research center and one of the largest centers in the world for research and treatment of pediatric cancers and other catastrophic diseases of children. The hospital’s mission is to advance cures and means of prevention for catastrophic pediatric diseases through research and treatment. The Department of Pharmacy and Pharmaceutical Sciences, a clinical and academic department within the institution, contributes to this commitment by providing advanced practice pharmaceutical services that individualize care for each child at St. Jude while supporting a collective research endeavor.