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Potency Analysis Provides Insight to Student Aseptic Compounding Technique Errors

Objectives: Direct observation of students’ aseptic technique is a common evaluation method used in schools of pharmacy. This study was to determine if direct observation scores were predictive of a compounded sterile preparation’s (CSP”s) potency and to discover what misunderstandings students might have about individual technique steps.

Methods: P1 students performed three aseptic technique skill based encounters separated by two weeks. Their performance was evaluated using an observation based rubric. The encounters consisted of transferring drug solution from a vial (Vial), an ampule (Ampule), and a reconstituted powder (Reconstitution) to an IV bag. Students also determined their CSPs’ potency.

Results: The mean potency of the Vial and Ampule encounters met the ±10% goal of expected potency, and both were statistically different than the Reconstitution encounter which fell outside of the goal. The percent of students meeting the goal of ±10% was 59.3% (Vial), 80.3% (Ampule), and 50.4% (Reconstitution). The observation scores were significantly different between all three encounters. There were no correlation between the observational scores and the measured potency for any encounter whether or not the student met the goal potency.

Implications: Up to 50% of students did not meet the goal potency although their observation scores were acceptable. The potency data provided the critical insight that students were not adequately trained to account for pressurization when manipulating vials during the aseptic compounding process. The results suggest that both observation scores and potency analysis be part of an overall assessment of students compounding sterile preparations.

Lee R.K., Shrewsbury R.P.: Potency Analysis Provides Insight to Student Aseptic Compounding Technique Errors. American Journal of Pharmaceutical Education, 83(9): Article 7338 (2019).

The Impact of the Pharmacist’s Intervention on Patient Education and Dosing of Suspensions

Objective: A compounding exercise modeled on a published stability study was originally intended to demonstrate how BUDs could be determined for compounded suspensions. In the initial study, the student results did not mirror the published reference. Hypotheses for this failure were tested in subsequent yearly studies. A final hypothesis study with a new objective proved that the students’ failure was due their inability to properly shake a suspension and reinforced the importance of pharmacists counseling patients on these proper administration techniques.

Method: Students compounded a zonisamide suspension and sampled their preparations weekly. Zonisamide was suspended in Simple Syrup or 0.5% methylcellulose and stored at room or refrigerated temperate. All zonisamide samples were analyzed by HPLC using the same analytical method and instrumentation. The final hypothesis study imposed an intervention during weeks 5-7 which provided explicit verbal and visual confirmation of the proper shaking technique, and supervision of students’ sampling technique.

Results: The initial study determined that students’ weekly average potencies ranged from 71-122%, with relative standard deviations (RSD) of 17-53%. In the final hypothesis study before the intervention, potency results ranged from 64-111%, with RSD of 17-76%. During the intervention, potencies minimized to 91-118%, and RSD declined to 5-29%, which were more consistent with the literature reference results.

Implications: The final hypothesis study intervention indicated that explicit auditory and visual patient instructions about the proper shaking technique of suspensions resulted in more uniform dosing of zonisamide. By implication, such instructions to patients from pharmacists will reduce dosing inconsistencies at home.

Darst E.C., Shrewsbury R.P.: The Impact of the Pharmacist’s Intervention on Patient Education and Dosing of Suspension. American Journal of Pharmaceutical Education, 83(5): Article 6781 (2019).

Effect of Course Structure on the Accuracy of Nonsterile Compounded Preparations

Objective: In the school’s legacy curriculum, nonsterile compounding was intermittently taught throughout a five semester Pharmaceutical Care Laboratory sequence. After a curriculum transformation, nonsterile compounding was continuously taught within a 6-week block. This study investigated if students in the new course structure attained the same level of compounding competency as students in the legacy course structure.

Method: Four nonsterile preparations compounded by students common to both the legacy curriculum (PCL) and the transformed curriculum (TC) were compared using relative potency or weight variation as a measure of compounding competency. These preparations 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 TC hydrocortisone medication stick mean being outside of the acceptable range of the laboratory’s criteria. The 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.

Implications: The relative potency results suggested that equivalent competency in the two students 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.

Yoo, KY., Shrewsbury R.P.: Effect of Course Structure on the Accuracy of Nonsterile Compounded Preparations. American Journal of Pharmaceutical Education, 82(9): Article 6463 (2018).

Does Student Self-Analysis of Their Nonsterile Preparations Improve Compounding Confidence?

Objective: In a published study by Park and Shrewsbury, compounding confidence was reported to be 70% when students had access to a compounding textbook, online video library and question test bank, Formulation Records, graded Compounding Records from previous compounds, and in-laboratory teaching assistants. The study raised the question, “Is 70% the maximum limit of a student’s compounding confidence, or would an additional resource or experience result in a higher confidence level?” This current study was designed to determine if self-analysis of their nonsterile preparation’s potency was that resource or experience that would increase student confidence.

Method: Self-efficacy surveys were given to P1 and P3 students at the beginning and the end of a semester in which they completed their regularly scheduled compounding course. The survey assessed their confidence in general compounding skills and their perception that an added 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 impact their compounding ability (9.38 (1.12) to 8.98 (1.18)) while P3 students had a significant increase (8.09 (2.18) to 8.68 (1.82)) in the same item. This study also hypothesized that students who made nonsterile compounded preparations with less than 10% error would have greater confidence improvement. However, no statistical differences were found.

Implications: The data showed that self-analysis of nonsterile preparations did increase student confidence to approximately 85% in this group of students. This indicates that a self-analysis component included in a compounding laboratory experience would be is beneficial in increasing student confidence in compounding skill and nonsterile preparation quality assessment.

Jih J.S., Shrewsbury R.P.: Does Student Self-Analysis of Their Nonsterile Preparations Improve Comopunding Confidence? American Journal of Pharmaceutical Education, 82(10): Article 6473 (2018).

Student Evaluation of Online Pharmaceutical Compounding Videos

Objective: The objective was to describe pharmacy students views of the effectiveness of an expansion of the compounding laboratory website at the UNC Eshelman School of Pharmacy. Originally, there were 39 videos and 3 animations available. In 2011, an additional 59 videos and 2 animations were added. Concurrently, all of the interactive questions were updated to fully integrate with the expanded video library.

Method: Professional students were surveyed about the expanded video library regarding accessibility, functionality, and usefulness, and how using the library impacted their learning of compounding. Surveys from 391 students were analyzed by 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 ANOVA, z-test, and a homogenicity of variance (Levene’s) test.

Results: The response rate to the survey was 85%. The compounding videos were used by 386/391 students to prepare for their laboratory sessions. Thirty-four percent (34%) of students used the videos an average of 30 minutes or less per week preparing for lab; 56% used the videos 1-2 hours per week. The videos were preferred to the required textbook, the Formulation Records, and asking for information from their small group teaching assistants. Approximately 80% of students were satisfied with the functionality and accessibility of the videos. There were some statistically significant differences between professional years and/or campuses with some of the rating scale questions. The analytical results of the API concentrations for compounded preparations were not statistically different. All students, regardless of professional year or campus affiliation, put their confidence/competent at about 70% of the rating scale.

Implications: No standardized compounding curriculum was found in U.S. Schools of Pharmacy according to a COS report from AACP. Limited resources was cited as a possible reason for the lack of standardization. This study suggests that pharmlabs, an open access website for pharmaceutical compounding, could be an accessible, functional, and useful resource for Schools of Pharmacy.

Park H., Shrewsbury R.: Student Evaluation of Online Pharmaceutical Compounding Videos. American Journal of Pharmaceutical Education 80(2): Article 30 (2016).

Long-Term Results of an Analytical Assessment of Student Compounded Preparations

Objective: To investigate the long-term (i.e., 6 year) 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 were compared for differences in the analyzed content of the active principal 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.

Roark A., Anksorus H., Shrewsbury R.: The Long-Term Results of An Analysis Requirement Assessment of Student Compounded Preparations. American Journal of Pharmaceutical Education 78(9): Article 164 (2014).

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.

Alford E., Shrewsbury R.: Impact of Required Versus Optional Remake of a Preparation on Pharmacy Students’ Compounding Accuracy. American Journal of Pharmaceutical Education 77(4): Article 73 (2013).

Assessment and Recommendations of Compounding Education in AACP Member Institutions

In August 2009, the American Association of Colleges of Pharmacy (AACP) Council of Sections established a Task Force to assess the current status of compounding education at its member institutions and to provide recommendations for future direction. The Task Force conducted a survey in late June 2010 of faculty members enrolled in the AACP Pharmaceutics and Pharmacy Practice sections to gain qualitative information of the current state of compounding education. The survey results were then organized around eight curricular topics for which the Task Force members provided interpretations and recommendations. A final report was sent to the AACP Council of Sections on February 15, 2011. This publication provides the information contained in that final report to the professional community.

Shrewsbury R., Augustine S., Birnie C., Nagel K., Ray D., Ruble J., Scolaro K., Athay Adams J.: Assessment and Recommendations of Compounding Education in AACP Member Institutions. American Journal of Pharmaceutical Education 76(7): Article S9 (2012).

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.

Robertson J.L., Shrewsbury R.P.: Video Teleconferencing in the Compounding Laboratory Component of a Dual-Campus Doctor of Pharmacy Program. American Journal of Pharmaceutical Education 75(9): Article 181 (2011).

A Hybrid CD-Internet Delivery System for Pharmaceutical Care Laboratory Instruction

Objectives: The Laboratory contains twenty compounding experiences. Students can have up to a week delay between the scheduled pre-lab lecture and actual experience. A hybrid CD-Internet CD-ROM was developed to give students on-demand access to multimedia information about the laboratory outside of the School. The CD-ROM allows students to review pre-lab material in preparation for their laboratory.

Methods: The CD-ROM was used in the 1999-2000 academic year. A comparison of these students and the previous year’s students (who did not have the CD-ROM) included individual laboratory grades, results of product analysis, and time to complete the laboratory. A survey was also completed by the 1999-2000 students.

Results: Analysis of the Fall semester data showed no statistical difference in time, grades, or analytical accuracy between the two classes. A trend existed between improved total laboratory grade and the usage of the CD-ROM. Students preferred to either print the material, or view and print the material compared to viewing the material alone. An analysis of the Spring semester will also be presented.

Implications: This is a new teaching method for UNC students. Their reliance on printed materials indicates they are not acclimated to using newer online delivery methods. The trand toward improved grades with CD grades was suggestive of the technology’s benefit. The full benefit of the CD-ROM delivery system will not be seen immediately but will take time to impact student learning.

Shrewsbury R.P.: A Hybrid CD-Internet Delivery System for Pharmaceutical Care Laboratory Instruction. North American Web 2000 International Meeting, Fredericktown, New Brunwick.

Accuracy in Prescriptions Compounded by Pharmacy Students

Most compounded prescriptions are not analyzed to determine the accuracy of the employed instruments and procedures. The assumption is that the compounded prescription will be ±5% the labeled claim. Two classes of School of Pharmacy students who received repeated instruction and supervision on proper compounding techniques and procedures were assessed to determine their accuracy of compounding a diphenhydramine hydrochloride prescription. After two attempts, only 62% to 68% of the students could compound the prescription within ±5% the labeled claim; but 84% to 96% could attain an accuracy of ±10%. The results suggest that an accuracy of ±10% labeled claim is the least variation a pharmacist can expect when extemporaneously compounding prescriptions.

Shrewsbury R.P., Deloatch K.H.: Accuracy in Prescriptions Compounded by Pharmacy Students. International Journal of Pharmaceutical Compounding 2:139-142 (1998).