Abstract
Objective. Accuracy checks are required by United States Pharmacopeia General Chapter <797> to ensure patient safety when dispensing compounded sterile preparations (CSP). Despite the importance of this task, reports of training pharmacy students to perform CSP accuracy checks are lacking. This study aimed to, first, report a method for teaching CSP accuracy checks to students and, second, determine whether increased time on this content and intentional focus on this skill would improve student performance in a simulated hospital environment.
Methods. A laboratory teaching team identified the six most common types of errors in CSP accuracy checks. Student performance regarding these six errors and competency grades of final accuracy checks were compared between the fall 2019 and fall 2020 semesters.
Results. Students had better overall performance on the competency assessment for accuracy checks in fall 2019 versus fall 2020, but students performed substantially better on the remediation in fall 2020 versus fall 2019. In each semester, students had different errors commonly missed during the first and second attempts.
Conclusion. Despite enhanced teaching content and the incorporation of practice testing, students performed worse in fall 2020 than fall 2019. This effect could have been explained, in part, by the virtual environment required during the COVID-19 pandemic. To improve student performance, continued improvement in teaching methods and a restructured remediation process is needed.
INTRODUCTION
United States Pharmacopeia General Chapter <797> (USP 797) provides established guidance on the preparation of compounded sterile preparations (CSPs).1 Literature on teaching pharmacy students about CSPs touches on many important aspects, including donning and doffing personal protective equipment, aseptic technique, hazardous drug compounding, hood cleaning, media fill tests, and potency analysis.2-4 One aspect of sterile compounding that has not been addressed in the pharmacy education literature, outside of one survey, is accuracy checks of CSPs.5 In that survey of 139 schools of pharmacy, Cooper and colleagues reported that of the 47 respondents, 64% covered quality assurance in the laboratory setting and 83% covered it in a lecture.5 Accuracy checks are an essential skill for all compounding personnel in the United States, and a need to prepare pharmacy graduates to accurately check a medication prior to dispensing has been identified.1,6
The requirements for accuracy checks are determined by USP 797 and include accuracy of labels, volume, and quantities of drug products or ingredients used for preparing the CSP before dispensing from the pharmacy.1 Proper sterile compounding processes, including accuracy checks, are necessary to avoid potentially fatal medication errors occurring during the compounding process.7 In 2020, the Institute for Safe Medication Practices conducted a survey of 634 pharmacy personnel to identify opportunities for safe sterile compounding practices. One of the top three safety challenges was insufficient staff training and competency.8
These insufficiencies may occur due to failure of transfer of learning among pharmacy graduates. For all levels and environments of learning, not just pharmacy, transfer of learning refers to the ability of students to apply a learned skill in various contexts. This transfer is widely assumed to be automatic.9,10 However, employers of the generalized workforce have indicated that new hires are unable to perform duties they should have learned in school despite schools indicating the knowledge and skills were included in the curriculum.10 The transfer of learning happens on a continuum, and the degree of difficulty of the transfer depends on how closely subsequent contexts resemble the original context in which the skill was learned.9,10 The more similar the original and subsequent contexts, the easier it is for students to perform the task correctly in a variety of similar contexts (ie, near transfer of learning). The opposite is true as well. The more divergent the context from the original context, the more difficult the final task will be for students. Or worse, they will not see the connection at all (ie, far transfer of learning).10 This study aimed to describe an accuracy check activity in a health-systems laboratory course and assess whether the addition of direct instruction and increased practice exercises would better stimulate transfer of learning to improve student performance on accuracy checks.
METHODS
The Medical University of South Carolina College of Pharmacy is a traditional, four-year program that admits approximately 80 students per year. The Introduction to Health Systems Pharmacy Laboratory is a required one-credit-hour course taught over 14 weeks and exposes students to hospital pharmacy practice during the second year of the curriculum. The course is divided into three subsections with no more than 27 students in each subsection. The same material is taught consecutively for three days during a three-hour laboratory class. Course content is divided into two six-week modules, one of which focuses on sterile compounding, because a course objective is to explain USP 797 requirements specific to CSPs. During the sterile compounding module, students are taught techniques in sequence, starting with basic handwashing and donning and doffing personal protective equipment and followed by aseptic technique of low and medium risk CSPs. In fall 2018, accuracy checks were introduced in week 4 of the sterile compounding module. Students were given one week of practice during week 4 and assessed during week 5.
Between fall 2018 and fall 2019, the content and teaching methods were restructured to improve student performance. To emphasize the most relevant content, the laboratory teaching team used their expertise to determine the six most common types of errors in sterile compounding (Table 1).
Type of Errors Used for Accuracy Checks in a Sterile Compounding Module of an Introduction to Health Systems Pharmacy Laboratory Course for Second Year Doctor of Pharmacy Students
During the fall 2019 semester, an instructor created a 10-minute minilecture and supplemental handout to orient students to the process of accuracy checks. During this laboratory period, students were encouraged to check a peer’s CSP as an initial practice before submitting the CSP for instructor feedback, but no effort was made to ensure peer assessments were completed. After the laboratory period, students were given optional homework to practice accuracy checks, which included one example of each of the six types of errors. It was intended as a study tool for the students and was not graded. The course coordinator provided personalized feedback to each student who completed the homework. During the next laboratory period, students completed the high-stakes competency assessment (6% of the course grade) (Table 2). Following fall 2019, the section was further modified to improve student learning by instituting a flipped classroom technique and increasing active-learning exercises.
Teaching and Assessment Methods for Accuracy Checks Used Across Semesters in a Sterile Compounding Module of an Introduction to Health Systems Pharmacy Laboratory Course
Prior to introducing the concept of accuracy checks in the fall 2020 semester, students were required to complete a no-stakes homework assignment (0% of the course grade) involving accuracy checks in the interest of encouraging students to interact with the content prior to the lecture period. During the laboratory period, a 45-minute lecture was performed remotely due to the COVID-19 pandemic and included interactive polls using an audience response system. Using the system’s map function, students clicked the error on pictures of nine CSPs. After each picture, the course coordinator and students discussed all areas of the map that were identified by students. A low-stakes homework (1% of the course grade) was required after the lecture period and was the same exercise as the preclass homework to allow students to self-reflect on their learning. Peer assessments were encouraged as in the fall 2019 semester, but they spanned two weeks of aseptic technique practice. The required homework was available during both peer assessment weeks. During the next laboratory period, students completed the high-stakes competency assessment (10% of the course grade) (Table 2).
Commonalities between 2019 and 2020 included assigned USP 797 readings, method of teaching and assessing aseptic technique, encouraged peer assessments, and a high-stakes assessment. The homework for each semester was identical, though the stakes and timing differed. In both years, the high-stakes competency assessment allotted each student 15 minutes to check five CSPs for accuracy. Students may have received any combination of the six common errors to check, but each of the CSPs contained only one error. Students were required to determine whether the medication was safe for dispensing (yes/no) and justify their determination. For grading purposes, equal weight was given to the determination of safety and the justification. Grading occurred immediately after submission. The CSPs used during the high-stakes assessment differed each year, but the concepts tested were the same. For example, in 2019, a norepinephrine ampule was utilized without a filter needle, while in 2020, an isoproterenol ampule was used (Table 2).
Students were required to remediate the competency assessment if they scored less than or equal to 70% on the first attempt. For 2019, one week separated the first and second attempts; for 2020, due to COVID-19 restrictions, only one day separated the attempts. Otherwise, the remediation process was identical. Submissions were returned to students for review, and students were allowed to ask questions about their incorrect answers on the first attempt. New CSPs were provided for the remediation process within the same six categories as the first attempt. For both years, no student checked the same medication on the first and second attempts. Grading criteria and the process were the same for each attempt.
The primary outcome of this study was the difference in student performance between 2019 and 2020 based on the earned grade on the final competency assessment. Other outcomes included a breakdown of student performance based on the type of compounding errors, remediation grades, and type of compounding errors on remediation attempts. All results are descriptive. This study was determined to be exempt by the local institutional review board.
RESULTS
The baseline characteristics of students were similar between 2019 and 2020. The number of students was 71 in 2019 and 68 in 2020. For both semesters, few students had previous experience with sterile compounding (n=8 in 2019 and n=6 in 2020). The average grade point average after the first year was 3.4 for 2019 and 3.57 for 2020. Overall, average student performance on the first attempt was worse in 2020 than in 2019; thus, the percentage of students requiring remediation was higher in 2020 (32.4%, n=22) than in 2019 (21.1%, n=15). However, the remediation performance improved between years (Table 3).
Second Year Doctor of Pharmacy Students’ Performance on Compounded Sterile Product Accuracy Checks
In 2019, students often could not identify errors related to powder vials. These errors included incorrect reconstitution of a drug and incorrect dose or concentration. Despite the remediation process in place, a small percentage of students repeated these same errors on the remediation, and three students who failed the remediation required a third attempt (Table 3).
Although students in the 2020 semester also struggled to correctly identify the incorrect dose or concentration, these students more commonly failed to identify a route of administration error. After the remediation process, students correctly identified these errors but made new mistakes on previous errors they correctly identified. One student failed the remediation requiring a third attempt (Table 3).
DISCUSSION
Since 2016, students have been consistently taught aseptic technique of CSPs across the sterile compounding module, with only minor adjustments for efficiency. To further mimic a real-world setting, accuracy checks were added to the sterile compounding module of the course in 2018. Unfortunately, student performance on this module component indicated that transfer of learning was not automatic, as students could not transfer what they learned about performing sterile compounding of a CSP to checking a CSP completed by another provider. Therefore, in 2019, the course coordinator introduced more directed teaching to improve student performance and then expanded that teaching method in 2020.
Despite additional efforts by instructors to enhance transfer of learning in 2020, student grades did not improve. This lack of improvement may be due, in part, to the setup of the laboratory time, structure, and schedule due to the COVID-19 pandemic. Due to the virtual learning environment, the course coordinator was forced to teach accuracy checks remotely, limiting the amount of hands-on learning the students could receive. Although face-to-face instruction was severely restricted during laboratory time, students were encouraged to assess their peers. However, this peer assessment was not enforced, and students preferred to leave the confined environment of the intravenous room to reduce their personal risk of COVID-19 infection.
When comparing remediation attempts between the two years, students in 2020 outperformed those in 2019, despite the same remediation procedures. Students in 2020 had one day between assessments due to COVID-19 restrictions, whereas those in 2019 had at least seven days between assessments. This timeline difference could explain the improved performance by students in 2020 and clouds the ability to directly compare the two semesters.
Another contributing factor to overall student performance may have been their interpretation of label contents. To familiarize students with required label contents, including those required by USP 797 and those commonly included in US hospitals (eg, two patient identifiers), students had to complete several tasks during the six-week sterile compounding module. These tasks included completing a prelaboratory assignment, attending an interactive lecture on labels, completing a postlaboratory assignment, and attending a practice session to identify errors on labels. Students also created their own labels from scratch using a blank address label every week during the sterile compounding module. Each week, students were given verbal and written feedback by instructors regarding these assignments and the label contents. This process was the same between both semesters. Despite these efforts, many students may have failed to identify the error in the compounding process because they misinterpreted the label. This mistake seemed more problematic in 2020 than 2019, based on the types of compounding errors students failed to identify.
Finally, a report by the Institute for Safe Medication Practices on sterile compounding was published after the introduction of accuracy checks to this course.8 Interestingly, five of the six elements of this accuracy check exercise were included in the top 10 errors in this report, validating the use of these errors in this exercise. Further, incorporating other top 10 errors identified by the report, like incorrect drug or wrong timing, into future iterations of the course will potentially enhance student learning relative to real-world experiences and potentially optimize transfer of learning.
Additional potential improvements in future iterations may include using iteration, reminding, and calling attention to differences in practice attempts; requiring peer assessment with oversight; and enhancing remediation instruction about label accuracy and CSP accuracy checks.10,11 The remediation process could be improved by including formalized student self-reflection, developing a formal learning plan, and increasing opportunities to practice before the skill is reassessed.12
Despite these limitations, this early report details methods for teaching accuracy checks to pharmacy students. The importance of these checks when dispensing CSPs cannot be underestimated. While the generalizability of these results is limited due to the single-site nature of this study, the dearth of literature on teaching accuracy checks implies this could be a potential model for other institutions to use. Continuing to identify best practices for teaching all aspects of CSP to pharmacy students will prepare them for practice and yield valuable returns for patient care and the practice of pharmacy.
CONCLUSION
Despite efforts to use foundational learning theory to teach content, student performance on accuracy checks remained below instructors’ expectations. Based on student performance, the transfer of learning from active compounding to checking compounded products was not intuitive nor automatic. Increased instruction time and practice opportunities did not improve student performance, but hands-on training was constrained and limited due to the COVID-19 pandemic. Continued efforts to improve student performance on this skill should be incorporated into future iterations of the course.
ACKNOWLEDGMENTS
I thank Crystal Herron, PhD, ELS, of Redwood Ink LLC for editorial services in preparing the manuscript for publication.
- Received January 20, 2022.
- Accepted July 28, 2022.
- © 2023 American Association of Colleges of Pharmacy
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