Compounding Education in US PharmD Curricula.

OBJECTIVE: To determine the extent of compounding education (CE) offered in United States (US) doctor of pharmacy curricula. METHODS: A 24-item survey instrument addressing various aspects of CE was developed and validated. An email containing the link to the survey instrument was shared with instructors of compounding at 122 of 141 accredited schools and colleges of pharmacy in the US. RESULTS: Of these, 112 schools and colleges responded, rendering a survey response rate of 91.8%. Survey results indicate that CE is offered to a similar extent either as a required standalone course or as integrated instruction as part of a standard course. Whereas 70.8% of programs reported mostly hands-on training in CE in their curricula, there were about 11% programs that mostly offered didactic instruction in CE. Dispersed systems and semisolid formulations are the most prepared in nonsterile compounding, while proper hand washing, garbing, and gloving are the most taught techniques in sterile compounding. Compounding education is delivered principally by pharmaceutics faculty (62.3%) compared to practice faculty (32.1%). CONCLUSION: The survey determined the extent to which CE is addressed across different schools and colleges of pharmacy in the US. Although some institutions lack minimal nonsterile or sterile compounding facilities, they may improve by modeling the established programs in the country. Leadership at pharmacy institutions may need to allocate funds for CE, and support faculty who instruct in compounding.

"Practice makes perfect" strategy for teaching aseptic techniques improved observational scores but not preparation potency.

INTRODUCTION: Student-compounded sterile preparations have been evaluated using observational scores, sterility testing, and potency determinations. Observational scores and potency determinations can be evaluated simultaneously, and three studies have been published using these assessment tools. One study found a significant number of students could not compound an acceptably potent preparation despite receiving very good observational scores. The previous study was judged to have an inferior instructional flaw, so a new teaching design, a "practice makes perfect" model, was utilized and was expected to increase the number of students compounding acceptably potent preparations. METHODS: The "practice makes perfect" method provided students with more practice and one-on-one instruction time in aseptic techniques. First-year pharmacy students received both group practice sessions and individualized instruction on six occasions interspersed between three compounding assessments. Observational scores and potency results were compared between this study and the previously published study. RESULTS: The "practice makes perfect" strategy improved students' observational scores but showed inconsistent results in the percentage of students who compounded an acceptably potent preparation and in the potency of preparations compounded by all students. There was no correlation between observational scores and potency values or between observational scores and the percentage of students compounding acceptably potent preparations at each individual observational score. CONCLUSIONS: The study demonstrated that there was either a systematic error in the analytical potency protocol or that the observations made during student compounding were not adequate to identify problems that led to poor potency.

A Student-Led Elective Provides Quality Improvement Feedback for a Required Compounding Course.

Objective. To implement an advanced elective compounding course where pharmacy students conduct investigations to improve compounding-related issues that were subsequently evaluated in a required compounding course. Methods. The elective compounding course required students to engage in self-directed learning, critical thinking, creation and evaluation of laboratory data, and self- and group reflection. Students researched and developed "solutions" to compounded preparation problems, and their solutions were tested in the next iteration of a required compounding course. For example, students in the elective course identified sources of potency variability in a ketoprofen Pluronic organogel (PLO) emulsion preparation. The students identified six variables and executed an investigative action plan. They considered all data collected and proposed a method to reduce potency variation. The recommended solution was implemented in the next offering of a required compounding course and the potency variability results were compared to the previous required course's results. Results. The mean ketoprofen PLO emulsion potency achieved in the required course prior to implementing the elective course recommendation was 129% (SD 21%), n=158. After the recommended change from elective course was implemented, the mean potency was 118% (SD 21%), n=131. Conclusion. The teaching methods and activities conducted in the elective course provided students with a deeper level of learning and understanding of compounding science, while providing practical experience in scientific research methodology. The course also provided a cyclic quality improvement feedback mechanism for the required course.

Potency Analyses Provide Insight Into Student Aseptic Compounding Technique Errors.

Objective. To determine whether direct observational scores were predictive of the potency of pharmacy students' compounded sterile preparations (CSPs) and to identify any misunderstandings students had regarding individual aseptic technique steps. Methods. P1 students performed aseptic techniques during three observational encounters separated by two weeks. Students' performances were evaluated using an observation-based rubric and were subject to potency analysis. The encounters were transferring a drug solution from a vial, an ampule, and a reconstituted powder to intravenous (IV) bags. Results. The mean potency of the diphenhydramine (vial) and lidocaine (ampule) met the ±10% goal of expected potency. These results were significantly different from those of the ampicillin (reconstitution) encounter, which was outside the goal. The percentage of students meeting the potency goal was 59.3% for the diphenhydramine, 80.3% for the lidocaine, and 50.4% for the ampicillin encounters. The observation scores were significantly different between all three encounters. There were no correlations between the observational scores and the potency for any encounter regardless of whether or not the student met the goal potency. Although their observation scores were acceptable, up to 50% of students did not meet the potency goal for each of the three encounters. Conclusion. The potency data provided the critical insight that P1 students were not adequately trained to account for pressurization when manipulating vials using aseptic compounding processes. The results suggest that both observation scores and potency analysis should be part of an overall assessment of student ability to compound sterile preparations.

The Positive Impact of an Extended Intervention on Dosing Accuracy of Student Compounded Suspensions.

Objective. To demonstrate the impact of an extended intervention on the dose accuracy and consistency of a compounded zonisamide suspension. Methods. A laboratory exercise was initially conducted by pharmacy students to determine the beyond-use date (BUD) of a compounded zonisamide suspension. The student results were inconsistent with data in a published reference study. The exercise was repeated several times testing various hypotheses to explain the inconsistency. The final hypothesis was the student techniques of shaking and sampling their suspensions resulted in inaccurate samples. Therefore, a final hypothesis study was designed to include an extended intervention (weeks 5-7) that would demonstrate the impact of explicit verbal and visual instructions on the proper shaking and sampling of suspensions on dose accuracy and consistency. Results. The initial study found that students' weekly average zonisamide potencies ranged from 71%-122% of label, with a relative standard deviation (RSD) of 17%-53%; weekly potencies in the reference study had ranged from 92%-105%. In the final hypothesis study before the extended intervention, dosing accuracy ranged from 64%-111% (RSD 17%-76%). During the 3 week long intervention, dosing accuracy became 91%-118% with a RSD of 5%-29% which were consistent with the reference study. Conclusion. Providing more explicit auditory and visual instructions to pharmacy students regarding the proper shaking and sampling techniques of their compounded suspensions resulted in more consistent and accurate dosing of a zonisamide suspension. By implication, pharmacists providing specific and personalized instructions to patients should reduce their self-dosing inconsistencies at home.

Effect of Course Structure on the Accuracy of Nonsterile Compounded Preparations.

Objective. To investigate if students in the new course structure attained the same level of compounding competency as students in the legacy course structure. Methods. Students compounded four nonsterile preparations common to both the legacy curriculum (PCL) and the transformed curriculum (TC). The preparations were compared using relative potency or weight variation as a measure of compounding competency. They represented the broad range of compounding complexities required in compounding courses at the school. Results. The mean relative potencies of three nonsterile preparations were statistically different, with only the mean of the TC hydrocortisone medication stick being outside of the acceptable range of the laboratory's criteria. However, the standard deviation (SD) was markedly different in each preparation pair suggesting that the number of students correctly compounding the preparation in the first attempt might be an important factor in the analysis. In contrast, the mean weight variation data of the phenol-menthol soft troches and enalapril tablet triturates were almost identical. Conclusion. The relative potency results suggested that equivalent competency in the two student groups was possible for preparations that involved simple solutions or filled fixed volume molds. However, the hydrocortisone medication stick data indicated that understanding the science of a preparation may require more knowledge or time.

Student Self-Analysis of Their Nonsterile Preparations and its Effect on Compounding Confidence.

Objective. To determine if students who self-analyzed their own nonsterile preparations had increased confidence in their compounding skill. Methods. Self-efficacy surveys were given to P1 and P3 students at the beginning and conclusion of a semester in which they completed their regularly scheduled compounding course. The survey assessed their confidence in general compounding skills and their perception if an additional self-analytical component to determine the potency of their nonsterile preparations would improve their confidence level score. Results. P1 and P3 students reported increased confidence in all surveyed areas at the end of the semester, with P1 students showing more dramatic increases most likely due to this being their first compounding experience in this academic institution. P1 students reported a modest but significant decrease in their perception that potency self-analysis would affect their compounding ability [9.38 (SD 1.12) to 8.98 (SD 1.18)] while P3 students had a significant increase [8.09 (SD 2.18) to 8.68 (SD 1.82)] in the same item. This study also hypothesized that students who made nonsterile compounded preparations with <10% error would have greater confidence improvement. However, no statistical differences were found. Conclusion. Self-analysis of nonsterile preparations increased student confidence to approximately 85%. A self-analysis component included in a compounding laboratory experience is beneficial in increasing student confidence in compounding skill and nonsterile preparation quality assessment.

Student Evaluation of Online Pharmaceutical Compounding Videos.

Objective. To describe pharmacy students' views on the effectiveness of an expansion of the compounding laboratory website at the UNC Eshelman School of Pharmacy. Methods. Originally, there were 39 videos and three animations available. In 2011, an additional 59 videos and two animations were added. Concurrently, all of the interactive questions were updated to fully integrate with the expanded video library. Students were surveyed about the expanded video library regarding accessibility, functionality, and usefulness, and how using the library impacted their learning of compounding. Surveys were analyzed with descriptive statistics. Means and SDs were calculated for the rating scale questions; independent t tests and Wilcoxon nonparametric tests were used to find differences between professional classes and campuses. Analytical results were evaluated with a one-way analysis of variance (ANOVA), z test, and a homogeneity of variance (Levene's) test. Results. The response rate to the survey was 85%. Compounding videos were used by 386/391 students. Thirty-four percent of students used the videos an average of 30 minutes or less per week; 56% used the videos 1-2 hours per week. Approximately 80% of students were satisfied with the functionality and accessibility of the videos. All students, regardless of professional year or campus affiliation, put their confidence/competence at about 70% of the rating scale. Conclusions. As no standardized compounding curriculum was found in US schools of pharmacy and students reported being satisfied with the website, it could be an accessible, functional, and useful resource for pharmaceutical compounding in schools of pharmacy.

Long-term Results of an Analytical Assessment of Student Compounded Preparations.

OBJECTIVE: To investigate the long-term (ie, 6-year) impact of a required remake vs an optional remake on student performance in a compounding laboratory course in which students' compounded preparations were analyzed. METHODS: The analysis data for several preparations made by students were compared for differences in the analyzed content of the active pharmaceutical ingredient (API) and the number of students who successfully compounded the preparation on the first attempt. RESULTS: There was a consistent statistical difference in the API amount or concentration in 4 of the preparations (diphenhydramine, ketoprofen, metoprolol, and progesterone) in each optional remake year compared to the required remake year. As the analysis requirement was continued, the outcome for each preparation approached and/or attained the expected API result. Two preparations required more than 1 year to demonstrate a statistical difference. CONCLUSION: The analytical assessment resulted in a consistent, long-term improvement in student performance during the 5-year period after the optional remake policy was instituted. Our assumption is that investment in such an assessment would result in a similar benefits at other colleges and schools of pharmacy.

Impact of required versus optional remake of a preparation on pharmacy students' compounding accuracy.

OBJECTIVE: This retrospective study investigated the impact of a required vs an optional remake requirement on student performance in a compounding laboratory course in which students' compounded preparations were analyzed. METHODS: The analysis data for several preparations made by students over a 3-year period were compared for differences in the analyzed content of the active principal ingredient and the number of students who successfully compounded the preparation on the first attempt. RESULTS: Students' compounding accuracy was significantly better for the ketoprofen (pluronic lecithin organogel [PLO]) emulsion (p= 0.003) and mock co-enzyme Q10 troches (p< 0.001) when remaking an inaccurate preparation was optional rather than required. There were no significant differences in the parameters for the other compounded preparations. CONCLUSION: Student performance did not decrease when students were given the option to remake an inaccurate preparation. Factors such as the difficulty of the preparation, time spent compounding, and impact on the student's final course grade also may have influenced student performance.

Video teleconferencing in the compounding laboratory component of a dual-campus doctor of pharmacy program.

OBJECTIVES: To design, implement, and assess the effectiveness of using a live video teleconferencing system to connect the main campus and a satellite campus during laboratory compounding exercises in a doctor of pharmacy (PharmD) program. DESIGN: A new laboratory facility with identical equipment and supplies to the main campus was built at the satellite campus and teleconferencing equipment was set up. Students on both campuses prepared 20 compounded formulations over a 5-course pharmaceutical care laboratory sequence. Live video teleconferencing was used for students to ask questions and for the lead faculty instructor to observe the students' technique. Faculty and staff members and teaching assistants facilitated the laboratory sessions on both campuses. ASSESSMENT: The performance of students on assayed products at the main campus was compared with that of students at the satellite campus to ensure program integrity with the compounding laboratory component. The use of video teleconferencing for teaching compounding was successful and no difference in overall student pass rates was seen. The few observed differences in student performance between the 2 campuses were believed to be a result of variations in instructor communication with distant students. CONCLUSION: Video teleconferencing can be used successfully to deliver curriculum in laboratory compounding to pharmacy students.

University of north Carolina at chapel hill school of pharmacy pharmaceutical care laboratories: compounding laboratory curriculum and renovation.

As part of a concerted effort to update its curriculum and facilities, the University of North Carolina at Chapel Hill School of Pharmacy developed a new series of laboratory courses that would provide students with better opportunities to develop skills and apply them to the modern pharmacy practice of pharmaceutical care. Curriculum revisions involved changing the compounding laboratory sequence, upgrading the video library, and tying its website to its training materials; the compounding laboratory facility was renovated to support the demands of the new curriculum. The overall goals of the renovation were to (1)increase the number of workstations in the facility, and (2)increase the ease with which students could retrieve materials necessary for laboratory projects. The renovation schedule was planned so classes were not interrupted.