Volume 4, Issue 1 , Pages 19-28, January 2012
The effect of prior experience with aseptic techniques on learning outcomes in a sterile compounding laboratory course
Article Outline
- Abstract
- Introduction
- Methods
- Results
- Discussion
- Conclusions
- Acknowledgments
- Appendix 1
- Appendix 2
- References
- Copyright
Abstract
The goal of this study was to investigate the effect of prior experience in aseptic techniques on learning outcomes in the sterile compounding laboratory course among second-year professional pharmacy students. Data were collected via self-reports using pre and post course questionnaires on proficiency in 21 practical skills in aseptic compounding. In the precourse questionnaire, students were asked about prior experience with compounding of sterile preparations. A 20-question test on knowledge related to practical skills was given with the questionnaire. Student responses collected pre and post course were analyzed. Comparisons were made between two groups: students without prior experience and students with prior experience in aseptic techniques, referred to as Novices and Experienced, respectively. Differences in skills and knowledge between Novices and Experienced students identified before the course were significant and persisted after the course. Improvement in practical skills was significantly higher in Novices than Experienced students. Students with prior experience performed better on the test and in practical skills that required engagement of higher levels of the thinking process. The findings from this study address a poorly investigated but nevertheless important aspect of pharmacy education: the impact of prior experience on pharmacy students' performance in required curricular courses. Implications from this study relate to student-centered instruction and addressing the differences in knowledge and skills among students.
Keywords: Prior experience , Pharmacy , Learning outcomes , Sterile compounding
Introduction
Preparation and compounding of sterile products is a competency requirement in the pharmacy professional curricula as specified in the Accreditation Council for Pharmacy Education (ACPE) Guidelines (Appendix B) and the North America Pharmacy Licensing Examination (NAPLEX) Blueprint (Area 2.3.9).1 Student pharmacists should be proficient in identifying and describing techniques and procedures related to compounding of therapeutic agents, including sterile preparations. To achieve this outcome, colleges and schools of pharmacy offer courses on aseptic compounding. By contrast, before starting a professional pharmacy program, some students work in health care settings where they learn and use aseptic compounding techniques as a part of their job responsibilities. Recently, it was reported that 87.9% of pharmacy students had prior experience with some kind of pharmacy practice and 18.2% had work experience in a hospital/inpatient setting.2 Prior experience with pharmacy practice may give students background knowledge and skills that could accelerate learning and performance in a pharmacy program. Learning needs and outcomes of students with prior experience in aseptic techniques may be different from their classmates' who have not acquired any pharmacy skills before becoming professional pharmacy students.
Literature on the impact of prior experience on the ability of students to master course content is very limited. Mar et al.2 investigated the effect of pharmacy experience gained before matriculation into a pharmacy program on overall academic performance of student pharmacists and found no benefits. Similar results that show no effect of prior experience on overall student performance were reported from studies, including those of dental3 and medical4 students. The ultimate goal of those studies was to search for predictors of academic success that may be useful in the admission process. Although Park et al3 showed no effect of prior experience on student performance, they reported that dental students who had dental assisting experience were 2.2 times more likely to earn honors in the initial exposure to preclinical classes. Studies of medical students found that prior clinical experience resulted in increased scores on subjective evaluations of medical students' performance in surgery.4 Studies of pharmacy professional students showed that introductory pharmacy practice experience focused on practice activities, communication skills, and use of references resulted in improved clinical performance during the advanced pharmacy practice rotations.5
The objective of this study was to investigate the impact of prior experience with aseptic techniques on student performance in the sterile compounding laboratory course. It was hypothesized that students with experience in aseptic techniques gained before admission to our pharmacy professional program will perform significantly better in the sterile compounding laboratory than students with no prior experience in sterile compounding.
Methods
Course description
In our curriculum, a 1-credit required laboratory course on compounding of sterile preparations is taught in the second year of the four-year PharmD program. This course is designed to meet the needs of inexperienced students and its content is focused primarily on basic aseptic techniques and procedures required for compounding of sterile preparations. Each student participated in one 3-hour session per week for 15 weeks. Upon completion of this course, students were expected to acquire competencies in 21 skills (Appendix 1). These competencies reflected specific course objectives. During each weekly session, students were assessed for their competencies in compounding parenteral preparations and knowledge of techniques and procedures. The end-of-semester assessment was comprehensive and consisted of two parts: theoretical and practical.
Students enrolled in this course had an option to take a questionnaire before and after the course to self-evaluate their proficiency in specific skills and knowledge related to compounding of sterile preparations. The collected data allowed the faculty to discover how many students had prior experience with aseptic compounding and assess the effectiveness of laboratory instruction and student learning. It was reported that self-reported measures among health professionals can indeed provide valid and accurate results.6, 7
For the purpose of this study, students who reported no previous experience with aseptic techniques were considered as Novices and students who reported prior experience in sterile compounding were considered as Experienced students. These terms are commonly used in literature to relate to inexperienced and experienced students, respectively.8, 9
Data collection
This study was reviewed and received approval from the university's institutional review board. Data were collected from a questionnaire administered to students before and after the course. The pre and post course questionnaires consisted of two parts: (1) 21 skill queries (Appendix 1) based on specific course objectives; proficiency in each skill was scored by the students using a 0-to-4 scale (0 = none, 1 = poor, 2 = average, 3 = good, 4 = very good); and (2) 20 true/false theory questions (Appendix 2). The same items were given on the pre and post course questionnaires, except the precourse items also included queries about prior experience with sterile compounding. Completion of the questionnaires was optional and their results did not contribute to course grade. The students were instructed to answer the queries honestly and to their best of knowledge. It was emphasized to the students that pre and post course evaluation of their skills and knowledge is beneficial to the learning process.
Data analysis
The data analysis included several comparisons of precourse and postcourse scores within as well as between Novices and Experienced students. Only the responses from the students who completed both the pre and post course questionnaires were included in the data analysis.
The first analysis was done on the pre and post questionnaire data of the proficiency levels varying from 0 to 4 and by categories of experience (Novices or Experienced). The comparisons were (1) Novices before the course (pre) to Novices after the course (post); (2) Experienced students before the course (pre) to Experienced students after the course (post); (3) Novices to Experienced students before the course (pre); and (4) Novices to Experienced students after the course (post).
The data were analyzed using several nonparametric tests for independence. The Wilcoxon signed-rank test, Mann–Whitney U test, and randomization test were used in lieu of χ2 tests, because the sample sizes of the two groups being compared (Novices and Experienced) varied widely. The Mann–Whitney U test was used to compare Novices to Experienced with sample sizes of n = 62 and n = 7, respectively. The Wilcoxon test was used to compare groups with equivalent sizes and very low frequency counts (<5 for some categories), e.g., (pre) to (post) or Experienced (pre) to Experienced (post). Randomization tests for independence were used for analysis for the low frequency counts (0 in some cases).
The second analysis was performed on data representing the number of correct answers for the entire class on 20 theory questions. Like the self-reported skill proficiency data, the data from the theory questions were divided into Novices and Experienced groups. The analyses were to determine the probability of no difference between precourse scores and postcourse scores. The hypothesis test for these datasets assumed binomial distribution, and the sample size of the Novices group was large enough (n = 62) to be approximated by normal distribution. The Experienced group data sample (n = 7), however, was not large enough to use normal approximation, so the Exact Binomial test was used to compute the probability of obtaining the reported difference in the data.
Results
Characteristics of student trainees
The sterile compounding laboratory course was taught to 75 second-year student pharmacists (Class 2010). Because the responses to pre and post course questionnaires were not required, 92% of class responses were valid, ie, complete with both pre and post course responses, and qualified for data analysis. On the precourse questionnaire, students were asked to indicate whether they had prior experience in aseptic compounding and for how long. Responses to this query showed that there were two distinct groups of students who differed in the entry-level expertise. Seven students (9.2% of the class; 10.1% of the qualified responses) reported having previous experience with sterile compounding. These experiences were gained mostly in a hospital setting and their duration varied from 0.5 to 10 years (median 2 years; average 3.1 ± 3.2 years). Sixty-two students (82.7% of the class; 92% of qualified responses) reported no previous experience with preparation of sterile products. For the purpose of this study, these two groups of students were named Experienced and Novices, respectively.
Perceived proficiencies in various aseptic compounding skills reported pre and post course by Novices and Experienced students
The distribution of the responses and average scores from pre and post course self-assessment of proficiency in 21 skills related to compounding of sterile preparations is presented in Table 1. Before the course, the score values provided by Novices were below 2 (“average”) for all 21 skills (about 3- to 9-fold lower than scores selected by Experienced students). In Experienced students, precourse scores were above 2 (“average”) in 20 skills. Post course, the profiles of score distribution in Novices became more comparable with Experienced students. In Novices, a significant shift was observed from scores 0 and 1 to scores 2, 3, and 4. Figure 1 shows comprehensive and simpler representation of the data shown in Table 1. Pre course, for Novices, the average ranking scores ranged from 0.27 to 1.48 and for Experienced students from 1.86 to 3.57. After the course, the average Novices' scores ranged from 2.56 to 3.39 and from 3.29 to 4.00 in Experienced students.
Table 1. Differences in average scores and distribution of responses for each score describing the level of competency in 21 sterile compounding skills between Novices (n = 62) and Experienced students (n = 7) pre and post course
| Number | Skill | Group | Pre course | Average score | Post course | Average score | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % Responses for each score | % Responses for each score | |||||||||||||
| 0 | 1 | 2 | 3 | 4 | 0 | 1 | 2 | 3 | 4 | |||||
| 1 | Interpretation of orders | Novices | 54.8 | 21.0 | 22.6 | 1.6 | 0.0 | 0.71 | 0.0 | 0.0 | 30.6 | 54.8 | 14.5 | 2.84 |
| Experienced | 0.0 | 0.0 | 42.9 | 28.6 | 28.6 | 2.86 | 0.0 | 0.0 | 0.0 | 42.9 | 57.1 | 3.57 | ||
| 2 | Calculations | Novices | 30.6 | 21.0 | 37.1 | 11.3 | 0.0 | 1.29 | 0.0 | 0.0 | 11.3 | 51.6 | 37.1 | 3.26 |
| Experiences | 0.0 | 14.3 | 42.9 | 28.6 | 14.3 | 2.43 | 0.0 | 0.0 | 0.0 | 42.9 | 57.1 | 3.57 | ||
| 3 | Gowning and hand washing | Novices | 41.9 | 6.5 | 19.4 | 25.8 | 6.5 | 1.48 | 0.0 | 3.2 | 11.3 | 38.7 | 46.8 | 3.29 |
| Experienced | 0.0 | 0.0 | 14.3 | 42.9 | 42.9 | 3.29 | 0.0 | 0.0 | 0.0 | 0.0 | 100.0 | 4.00 | ||
| 4 | Cleaning and disinfecting | Novices | 40.3 | 9.7 | 22.6 | 19.4 | 8.1 | 1.45 | 0.0 | 0.0 | 11.3 | 38.7 | 50.0 | 3.39 |
| Experienced | 0.0 | 0.0 | 0.0 | 42.9 | 57.1 | 3.57 | 0.0 | 0.0 | 0.0 | 14.3 | 85.7 | 3.86 | ||
| 5 | Hood design and functions | Novices | 32.3 | 21.0 | 29.0 | 16.1 | 1.6 | 1.34 | 0.0 | 1.6 | 30.6 | 53.2 | 14.5 | 2.81 |
| Experts | 0.0 | 0.0 | 28.6 | 42.9 | 28.6 | 3.00 | 0.0 | 0.0 | 0.0 | 42.9 | 57.1 | 3.57 | ||
| 6 | Maintenance of hood | Novices | 48.4 | 21.0 | 22.6 | 6.5 | 1.6 | 0.92 | 1.6 | 0.0 | 35.5 | 41.9 | 21.0 | 2.81 |
| Experienced | 0.0 | 0.0 | 42.9 | 28.6 | 28.6 | 2.86 | 0.0 | 0.0 | 0.0 | 42.9 | 57.1 | 3.57 | ||
| 7 | Positioning of items inside the hood | Novices | 50.0 | 17.7 | 22.6 | 6.5 | 3.2 | 0.95 | 0.0 | 0.0 | 12.9 | 51.6 | 35.5 | 3.23 |
| Experienced | 0.0 | 0.0 | 28.6 | 28.6 | 42.9 | 3.14 | 0.0 | 0.0 | 0.0 | 28.6 | 71.4 | 3.71 | ||
| 8 | Selection of a syringe | Novices | 72.6 | 8.1 | 8.1 | 9.7 | 1.6 | 0.60 | 0.0 | 0.0 | 14.5 | 51.6 | 33.9 | 3.19 |
| Experienced | 0.0 | 14.3 | 0.0 | 42.9 | 42.9 | 3.14 | 0.0 | 0.0 | 14.3 | 14.3 | 71.4 | 3.57 | ||
| 9 | Selection of a needle | Novices | 72.6 | 11.3 | 4.8 | 9.7 | 1.6 | 0.56 | 0.0 | 0.0 | 17.7 | 56.5 | 25.8 | 3.08 |
| Experienced | 0.0 | 14.3 | 0.0 | 57.1 | 28.6 | 3.00 | 0.0 | 0.0 | 14.3 | 14.3 | 71.4 | 3.57 | ||
| 10 | Handling of needles and syringes | Novices | 62.9 | 12.9 | 16.1 | 6.5 | 1.6 | 0.71 | 0.0 | 0.0 | 17.7 | 50.0 | 32.3 | 3.15 |
| Experienced | 0.0 | 0.0 | 0.0 | 42.9 | 57.1 | 3.57 | 0.0 | 0.0 | 0.0 | 14.3 | 85.7 | 3.86 | ||
| 11 | Labeling requirements | Novices | 59.7 | 17.7 | 16.1 | 4.8 | 1.6 | 0.71 | 0.0 | 0.0 | 11.3 | 62.9 | 25.8 | 3.15 |
| Experienced | 0.0 | 14.3 | 28.6 | 42.9 | 14.3 | 2.57 | 0.0 | 0.0 | 0.0 | 42.9 | 57.1 | 3.57 | ||
| 12 | Selecting expiration date | Novices | 62.9 | 16.1 | 12.9 | 6.5 | 1.6 | 0.68 | 0.0 | 0.0 | 19.4 | 54.8 | 25.8 | 3.06 |
| Experienced | 0.0 | 14.3 | 28.6 | 42.9 | 14.3 | 2.57 | 0.0 | 0.0 | 14.3 | 42.9 | 42.9 | 3.29 | ||
| 13 | Breaking of an ampule | Novices | 72.6 | 14.5 | 9.7 | 3.2 | 0.0 | 0.44 | 0.0 | 0.0 | 14.5 | 41.9 | 43.5 | 3.29 |
| Experienced | 0.0 | 14.3 | 28.6 | 14.3 | 42.9 | 2.86 | 0.0 | 0.0 | 0.0 | 14.3 | 85.7 | 3.86 | ||
| 14 | Working with a filter needle | Novices | 69.4 | 16.1 | 11.3 | 3.2 | 0.0 | 0.48 | 0.0 | 1.6 | 30.6 | 40.3 | 27.4 | 2.94 |
| Experienced | 0.0 | 14.3 | 14.3 | 28.6 | 42.9 | 3.00 | 0.0 | 0.0 | 14.3 | 28.6 | 57.1 | 3.43 | ||
| 15 | Withdrawal of solution from a vial | Novices | 43.5 | 21.0 | 25.8 | 8.1 | 1.6 | 1.03 | 0.0 | 0.0 | 17.7 | 40.3 | 41.9 | 3.24 |
| Experienced | 0.0 | 0.0 | 28.6 | 0.0 | 71.4 | 3.43 | 0.0 | 0.0 | 0.0 | 14.3 | 85.7 | 3.86 | ||
| 16 | Reconstitution of powdered drugs in a vial | Novices | 69.4 | 12.9 | 8.1 | 9.7 | 0.0 | 0.58 | 0.0 | 0.0 | 14.5 | 48.4 | 37.1 | 3.23 |
| Experienced | 0.0 | 0.0 | 28.6 | 28.6 | 42.9 | 3.14 | 0.0 | 0.0 | 0.0 | 14.3 | 85.7 | 3.86 | ||
| 17 | Transfer to large volume bags | Novices | 71.0 | 12.9 | 9.7 | 6.5 | 0.0 | 0.52 | 0.0 | 0.0 | 14.5 | 38.7 | 46.8 | 3.32 |
| Experienced | 0.0 | 0.0 | 14.3 | 42.9 | 42.9 | 3.29 | 0.0 | 0.0 | 0.0 | 0.0 | 100.0 | 4.00 | ||
| 18 | Compounding of cytotoxic preparations | Novices | 80.6 | 9.7 | 6.5 | 3.2 | 0.0 | 0.32 | 0.0 | 1.6 | 27.4 | 53.2 | 17.7 | 2.87 |
| Experienced | 14.3 | 14.3 | 42.9 | 28.6 | 0.0 | 1.86 | 0.0 | 0.0 | 14.3 | 28.6 | 57.1 | 3.43 | ||
| 19 | Differences between horizontal and vertical hoods | Novices | 53.2 | 22.6 | 21.0 | 3.2 | 0.0 | 0.74 | 0.0 | 6.5 | 27.4 | 51.6 | 14.5 | 2.74 |
| Experienced | 14.3 | 0.0 | 42.9 | 14.3 | 28.6 | 2.43 | 0.0 | 0.0 | 28.6 | 14.3 | 57.1 | 3.29 | ||
| 20 | Quality control | Novices | 75.8 | 11.3 | 8.1 | 4.8 | 0.0 | 0.42 | 0.0 | 1.6 | 27.4 | 56.5 | 14.5 | 2.84 |
| Experienced | 14.3 | 0.0 | 42.9 | 14.3 | 28.6 | 2.43 | 0.0 | 0.0 | 14.3 | 28.6 | 57.1 | 3.43 | ||
| 21 | Instructing others | Novices | 82.3 | 9.7 | 6.5 | 1.6 | 0.0 | 0.27 | 4.9 | 6.6 | 31.1 | 42.6 | 14.8 | 2.56 |
| Experienced | 14.3 | 0.0 | 28.6 | 28.6 | 28.6 | 2.57 | 0.0 | 0.0 | 0.0 | 28.6 | 71.4 | 3.71 | ||
Figure 1.
Comprehensive presentation of differences between Novices and Experienced students pre and post course (based on data from Table 1). The vertical rectangles represent a range between the lowest and highest average scores (scale 0 to 4).
Table 2 presents data from the statistical analyses of the differences between pre and post course expertise in aseptic skills for Novices and Experienced students. Novices showed significant pre- vs. postcourse differences in all 21 skills (by both Wilcoxon and randomization tests). Experienced students had statistically significant pre- vs. postcourse differences in proficiency in one skill: appraisal of the quality of sterile admixtures (by the Wilcoxon test). Because of the very small size of the Experienced group, the randomization test showed no significant within-group differences.
Table 2. Pre and post course differences in perceived proficiency in 21 aseptic compounding skills in Novices (n = 62) and Experienced students (n = 7)
| Pre vs. post course | Skills | Pre vs. post course | |||
|---|---|---|---|---|---|
| Wilcoxon test p-values | Randomization test p-values | ||||
| Novices | Experienced | Novices | Experienced | ||
| 0.000 | 0.380 | 1. | Interpretation of parenteral orders | 0.000 | 0.256 |
| 0.000 | 0.660 | 2. | Performing calculations for parenteral compounding | 0.000 | 0.156 |
| 0.000 | 0.180 | 3. | Gowning and hand washing for sterile compounding | 0.000 | 0.070 |
| 0.000 | 0.109 | 4. | Cleaning and disinfecting of the compounding work areas | 0.000 | 0.559 |
| 0.000 | 0.461 | 5. | Laminar airflow hood design and functions | 0.000 | 0.505 |
| 0.000 | 0.679 | 6. | Maintenance of laminar airflow hood and its workbench | 0.000 | 0.241 |
| 0.000 | 0.109 | 7. | Positioning of sterile items inside the compounding work area to assure sterility | 0.000 | 0.496 |
| 0.000 | 0.180 | 8. | Selection of proper size for a syringe for parenteral compounding | 0.000 | 0.397 |
| 0.000 | 0.102 | 9. | Selection of proper size for a needle for parenteral compounding | 0.000 | 0.165 |
| 0.000 | 0.317 | 10. | Aseptic handling of needles and syringes during parenteral compounding | 0.000 | 0.559 |
| 0.000 | 0.066 | 11. | Labeling requirements for compounded parenteral preparations | 0.000 | 0.214 |
| 0.000 | 0.059 | 12. | Selecting expiration date⁎ for sterile compounded preparations | 0.000 | 0.633 |
| 0.000 | 0.180 | 13. | Aseptic breaking of an ampoule | 0.000 | 0.412 |
| 0.000 | 0.157 | 14. | Aseptic withdrawal of ampoule content using a filter needle | 0.000 | 1.000 |
| 0.000 | 0.180 | 15. | Aseptic withdrawal of solution from a vial | 0.000 | 0.462 |
| 0.000 | 0.180 | 16. | Aseptic reconstitution of powdered drugs in a vial | 0.000 | 0.339 |
| 0.000 | 0.109 | 17. | Aseptic transfer of sterile drug solution(s) to bags with large volume solutions | 0.000 | 0.070 |
| 0.000 | 0.066 | 18. | Aseptic compounding of cytotoxic parenteral preparations | 0.000 | 0.106 |
| 0.000 | 0.102 | 19. | Differences between horizontal and vertical laminar airflow hoods | 0.000 | 0.770 |
| 0.000 | 0.039 | 20. | Appraisal of the quality of sterile admixture solutions | 0.000 | 0.492 |
| 0.000 | 0.059 | 21. | Instructing others on proper aseptic compounding techniques and procedures | 0.000 | 0.273 |
⁎ Beyond-use date. |
The results from the statistical analyses of the differences in self-reported skills in aseptic compounding between Novices and Experienced students pre and post course are presented in Table 3. Before the course, statistically significant differences between proficiencies reported by Experienced students and Novices were found in all skills when analyzed with the randomization tests and in 11 skills when analyzed with the Mann–Whitney U test. After the course, these two groups of students differed significantly in eight skills, including five identified with the randomization test and four according to the Mann–Whitney analysis: (1) interpretation of parenteral orders, (2) cleaning and disinfecting of the compounding areas, (3) understanding laminar flow hood design and function, (4) aseptic handling of needles and syringes during compounding, (5) aseptic transfer of sterile drug solutions to bags with larger volumes, (6) selecting beyond-use date for sterile compounded preparations, (7) appraisal of the quality of sterile admixture solution, and (8) instructing others on proper aseptic compounding techniques and procedures.
Table 3. Differences between Novices (n = 62) and Experienced students (n = 7) in perceived proficiency in 21 aseptic compounding skills obtained pre and post course
| Novices vs. experienced | Skill | Novices vs. experienced | |||
|---|---|---|---|---|---|
| Mann–Whitney test p-values | Randomization test p-values | ||||
| Pre course | Post course | Pre course | Post course | ||
| 0.220 | 0.356 | 1. | Interpretation of parenteral orders | 0.000 | 0.020 |
| 0.880 | 0.735 | 2. | Performing calculations for parenteral compounding | 0.032 | 0.615 |
| 0.008 | 0.886 | 3. | Gowning and hand washing for sterile compounding | 0.012 | 0.101 |
| 0.138 | 0.036 | 4. | Cleaning and disinfecting of the compounding work areas | 0.001 | 0.170 |
| 0.089 | 0.208 | 5. | Laminar airflow hood design and functions | 0.004 | 0.045 |
| 0.150 | 0.990 | 6. | Maintenance of laminar airflow hood and its workbench | 0.002 | 0.156 |
| 0.148 | 0.165 | 7. | Positioning of sterile items inside the compounding work area to assure sterility | 0.001 | 0.180 |
| 0.010 | 0.428 | 8. | Selection of proper size for a syringe for parenteral compounding | 0.000 | 0.253 |
| 0.006 | 0.102 | 9. | Selection of proper size for a needle for parenteral compounding | 0.000 | 0.091 |
| 0.000 | 0.892 | 10. | Aseptic handling of needles and syringes during parenteral compounding | 0.000 | 0.023 |
| 0.655 | 0.122 | 11. | Labeling requirements for compounded parenteral preparations | 0.002 | 0.222 |
| 0.819 | 0.047 | 12. | Selecting expiration date⁎ for sterile compounded preparations | 0.008 | 0.767 |
| 0.004 | 0.475 | 13. | Aseptic breaking of an ampoule | 0.000 | 0.181 |
| 0.000 | 0.789 | 14. | Aseptic withdrawal of ampoule content using a filter needle | 0.000 | 0.368 |
| 0.023 | 0.517 | 15. | Aseptic withdrawal of solution from a vial | 0.000 | 0.075 |
| 0.009 | 0.249 | 16. | Aseptic reconstitution of powdered drugs in a vial | 0.000 | 0.054 |
| 0.004 | 0.795 | 17. | Aseptic transfer of sterile drug solution(s) to bags with large volume solutions | 0.000 | 0.019 |
| 0.116 | 0.642 | 18. | Aseptic compounding of cytotoxic parenteral preparations | 0.008 | 0.169 |
| 0.002 | 0.438 | 19. | Differences between horizontal and vertical laminar airflow hoods | 0.000 | 0.142 |
| 0.452 | 0.022 | 20. | Appraisal of the quality of sterile admixture solutions | 0.000 | 0.151 |
| 0.009 | 0.043 | 21. | Instructing others on proper aseptic compounding techniques and procedures | 0.000 | 0.024 |
⁎ Beyond-use date. |
Performance on the theory test pre and post course by Novices and Experienced students
On the pre and post course questionnaires, the students were given the same set of 20 true/false statements that related to the principles of aseptic compounding. Each test query matched one or more of the specific skills (Appendix 1). The number of correct answers on these pre and post course tests obtained by Experienced students and Novices was analyzed. Table 4 shows the between-group and within-group differences in performance on the pre and post course theory test. The between-group analysis showed that before the course, the Experienced students group performed significantly better than Novices on questions related to three areas of competency: (1) aseptic handling of needles and syringes during parenteral compounding, (2) aseptic withdrawal of solutions from a vial, and (3) aseptic reconstitution of powdered drugs in a vial. After the course, Experienced students provided more correct answers than Novices on questions related to eight competencies: (1) interpretation of parenteral orders, (2) positioning of sterile items inside the compounding work area to ensure sterility, (3) aseptic handling of needles and syringes during parenteral compounding, (4) selecting beyond-use date for sterile compounded preparations, (5) aseptic withdrawal of solution from vial, (6) aseptic transfer of sterile drug solutions to bags with large-volume sterile solution, (7) aseptic compounding of cytotoxic parenteral preparations, and (8) appraisal of the quality of sterile admixture solutions. The within-group comparison of the pre and post course performance on the theory test showed that Novices improved significantly in knowledge related to 11 skills, whereas Experienced students made significant improvement in one competency (i.e., cleaning and disinfecting of the compounding work areas).
Table 4. Between-group and within-group differences in performance on the theory test questions related to 21 practical compounding skills
| Test question number(s) | Skill | Novices vs. experienced (between group) | Pre vs. post course (within group) | ||
|---|---|---|---|---|---|
| Precourse | Postcourse | Novices | Experienced | ||
| p-value | p-value | p-value | p-value | ||
| 1 | Interpretation of parenteral orders | 0.1539 | 0.0052 | 0.0032 | 0.9158 |
| 15 | Performing calculations for parenteral compounding | 0.0643 | 0.2177 | 0.0310 | 0.1266 |
| 2, 3 | Gowning and hand washing for sterile compounding | 0.3594 | 0.1711 | 0.0000 | 0.4007 |
| 2, 11, 12 | Cleaning and disinfecting of the compounding work areas | 0.2912 | 0.4207 | 0.0000 | 0.0039 |
| 1, 10 | Laminar airflow hood design and functions | 0.4681 | 0.1010 | 0.1814 | 0.1010 |
| 11 | Maintenance of laminar airflow hood and its workbench | 0.3192 | 0.4168 | 0.4247 | 0.2218 |
| 1, 5, 13 | Positioning of sterile items inside the compounding work area to assure sterility | 0.1735 | 0.0000 | 0.0000 | 0.8898 |
| 4 | Selection of proper size for a syringe for parenteral compounding | 0.4207 | 1.0000 | 0.0000 | 0.9348 |
| 4 | Selection of proper size for a needle for parenteral compounding | 0.4207 | 1.0000 | 0.0000 | 0.9348 |
| 6 | Aseptic handling of needles and syringes during parenteral compounding | 0.0000 | 0.0192 | 0.0000 | 1.0000 |
| 8, 4, 18, 20 | Labeling requirements for compounded parenteral preparations | 0.4602 | 0.4483 | 0.0968 | 0.5313 |
| 19 | Selecting expiration date for sterile compounded preparations | 0.4602 | 0.0192 | 0.1112 | 0.9158 |
| 16 | Aseptic breaking of an ampule | 0.2578 | 0.1539 | 0.0934 | 0.5378 |
| 16 | Aseptic withdrawal of ampule content using a filter needle | 0.2578 | 0.1539 | 0.0934 | 0.5378 |
| 6 | Aseptic withdrawal of solution from a vial | 0.0000 | 0.0192 | 0.0000 | 1.0000 |
| 17 | Aseptic reconstitution of powdered drugs in a vial | 0.0294 | 0.4404 | 0.0000 | 0.0949 |
| 7 | Aseptic transfer of sterile drug solution(s) to bags with large volume sterile solutions | 0.4013 | 0.0052 | 0.0951 | 0.9158 |
| 1 | Aseptic compounding of cytotoxic parenteral preparations | 0.1539 | 0.0052 | 0.0032 | 0.9158 |
| 19, 20 | Differences between horizontal and vertical laminar airflow hoods | 0.4207 | 0.4404 | 0.4404 | 0.9000 |
| 7, 14 | Appraisal of the quality of sterile admixture solutions | 0.4840 | 0.0036 | 0.2177 | 0.9898 |
Discussion
This study attempted to determine whether student pharmacists who had prior work experience with aseptic compounding would achieve greater learning outcomes from a sterile compounding laboratory course. In this research project, pre and post course self-reporting was used as a tool to collect data on the impact of prior experience with skills and knowledge required in compounding of sterile preparations on students' performance in a required sterile compounding laboratory course. Almost 10% of the students in this class reported having experience with aseptic compounding before matriculating to professional pharmacy programs. The significant Experienced students–Novice differences in course competencies identified at the beginning of the course persisted after the course but were much smaller. Although Novices achieved significantly more improvement in learning outcomes on aseptic compounding skills compared with Experienced students, it became apparent that during the laboratory course, the Experienced students were able to outperform Novices in practical skills that required engagement of higher levels of the thinking process and they maintained a better knowledge base related to course competencies.
This research project was based on a laboratory course, with content and delivery methods designed to meet the needs of pharmacy students inexperienced with compounding of sterile preparations. Course objectives covered 21 different competencies, starting with interpretation of orders for parenteral preparations through many specific aseptic techniques, to instructing others on proper aseptic compounding procedures. For Novices, all course activities were new experiences. Analysis of the precourse results showed that the competency level in the Experienced students group was significantly higher than Novices in all practical 21 skills. Furthermore, analysis of the pre and post course questionnaire responses showed that Novices improved in all 21 skills, whereas the Experienced students group improved significantly only in one skill. The within-group comparison of the theory test results pre and post course showed that at the end of the course, Novices improved their knowledge significantly in 11 areas, whereas Experienced students improved their knowledge significantly in only one area. By contrast, the between-group comparison showed that Experienced students had a significantly better knowledge base than Novices in three competency areas before the course and in eight areas after the course. The significantly higher level of competencies (practical skills and theory) demonstrated by Experienced students at the beginning of the course may explain the overall insignificant improvement in Experienced students' learning outcomes. The finding that Novices, who comprised about 90% of the class, improved significantly in course competencies confirms this course's effectiveness and benefits to pharmacy students with no prior experience in compounding of sterile preparations.
There is very little information in the literature on the effect of prior experience(s) on the ability of pharmacy students to master course content. Therefore, this study contributes novel data to an apparently poorly studied topic of prior pharmacy experience and its impact on student performance in pharmacy professional curriculum. Studies that investigated the effect of experience gained by students before starting a professional program on overall student performance in the professional curriculum did not find any significant benefits.2, 3, 4 The lack of significant correlation between prior experience and student performance reported in those studies may be because any type of previous experience in pharmacy,2 dentistry,3 or medicine4 was compared with an overall student's performance. In our research project, we focused on the effect of a finer type of work experience on the learning outcomes in a course with content related closely to students' prior experiences. With this approach, we observed that Experienced students who started the course with a greater amount of skills and knowledge in sterile compounding improved primarily in the skills that required higher-order thinking. Park et al.3 reported that dental students who had dental assisting experience were 2.2 times more likely to earn honors in the initial exposure to preclinical classes. Medical students who had prior clinical experience earned higher scores on subjective evaluations of their performance in surgery.4 Pharmacy students who completed the introductory pharmacy practice experience demonstrated better clinical performance during the advanced pharmacy practice rotations.5 Therefore, it appears that the positive effect of prior professional experience on student academic performance can be demonstrated if more specific kinds of skills and learning outcomes are considered.
Although, according to the results collected from this study, overall the Experienced students might have not benefited as much from this laboratory course as Novices, they achieved learning outcomes not demonstrated by Novices. Students with prior experience self-reported an improvement in appraisal of the quality of sterile admixture preparations and, at the end of the course, they were significantly better than Novices in several competency areas, including interpretation of parenteral orders, understanding laminar airflow hood functions, selecting beyond-use date for sterile compounded preparations, appraisal of the quality of sterile admixtures, and instructing others on proper aseptic compounding techniques and procedures. These competencies indicate that during the learning process in this laboratory course, students who had prior experience were more prepared than Novices to engage in higher levels of the thinking process—analysis, synthesis and evaluation.10 This course, based on practical activities, has given all students—Novices and Experienced—the opportunities to use their higher-order thinking skills. However, as the results of this study suggest, Experienced students were better than Novices in many competencies that involved a more advanced thinking process. Therefore, it might be possible that the prior experience with sterile compounding acquired by students from the Experienced group before they started this course helped them advance their thinking skills to a higher level and apply them in this laboratory course.
The findings from this study point out an important issue of accommodating the learning needs of pharmacy students who, before taking courses in the Doctor of Pharmacy program, acquired many competencies taught in the curriculum. Some student pharmacists before admission to the program work for many years as pharmacy technicians, learning different practical skills and acquiring knowledge related to various aspects of pharmacy practice. These students may have different learning needs not only in the laboratory curricular courses, such as compounding of sterile preparations, but also in introductory and advanced experiential training that comprise 30% of the pharmacy curriculum. Significant differences in skills and knowledge among student pharmacists may be present not only among the group of second-year students investigated in our study but also among the students in different years of the professional pharmacy program. This phenomenon may be common in all schools/colleges of pharmacy and thus should receive more attention from pharmacy educators. It would be of interest to undertake future research studies to further characterize how the effects of diverse kinds of experience gained by students before they start a pharmacy program influence their learning outcomes as professional students.
For students with prior pharmacy work experience, other teaching methods should be explored and adopted to accommodate their learning needs. In an attempt to address the differences in the entry level of skills among students enrolled in this laboratory course, experienced students were invited to serve as student peer-teachers. In six initial laboratory sessions focused on basic techniques, these students provided hands-on instructions to their classmates under the supervision of an instructor. The outcomes of this student-peer teaching pilot experiment were very encouraging11 and its results will be described in a separate publication.
Some limitations in this study are worth noting. The relatively small group of Experienced students and a much bigger group of Novices created a challenge with the statistical analyses and comparisons. In this study, it was impossible to predetermine the size of the groups. The number of students in each group became known after the evaluation of the responses to the precourse questionnaire. Therefore, several nonparametric tests for independence had to be used to statistically evaluate the data because the sample sizes of the two groups varied widely. Also, the questionnaire used in our study provided subjective data that represented students' perceived level of competency in various skills. The abilities to self-evaluate competencies are not universally well-developed among students. However, self-reported measures provided by health professionals and students were reported to be efficient, accurate, and stable.6, 7
There is value in encouraging students to self-report and self-evaluate their skills and knowledge, especially in health professional programs. The ability to self-report allows the students to develop their self-assessment abilities—an element recognized as foundational for continuing professional education and lifelong learning,12, 13 Studies have reported difficulties in accurate self-assessment in pharmacy graduates12 and medical students16 because they either underestimate or overestimate their abilities. For example, in a study of first-year medical students and their assessors, Rees and Shephard14 found gender, overconfidence, lack of self-confidence, and a desire to portray a positive image as reasons behind inaccurate reporting. In our study, we did not control for any factors that might have influenced the quality of the self-reported information. The study did not verify the accuracy of responses but used the self-ranked questionnaire as a tool to collect data needed to describe the differences in perceived level of competencies before and after the course. Even so, in this study, the practical skill ranks reported by students were compared with the number of correct answers on the theory test. Five skills were shown to be significantly improved not only according to the self-reported results but also according to the results from the theory questions. This finding may indicate some credibility of the self-reported data obtained from the second-year student pharmacists.
Students in our study could have differed in the extent to which their self-assessment skills were developed. Austin et al12 suggested a possible association between self-assessment skills and competency. It was reported that Novices were less accurate than Experienced students in judging the difficulty of a problem.15 The present study was not designed to evaluate self-assessment skills among student pharmacists. Nevertheless, it would be of interest to expand this study by including measures of each student's level of self-assessment skills and use it as a variable in analysis of the results. Self-assessment is the cornerstone of maintaining professional competence16; therefore development and improvement of self-assessment skills should be considered a critical element of pharmacy education.
Conclusions
The class of second-year student pharmacists varied significantly in the entry level of skills in aseptic techniques: 9.2% reported previous experience in sterile compounding procedures. The differences between inexperienced and experienced students identified before the course persisted after the course but were much smaller. Because of their prior exposure to aseptic compounding, the Experienced students did not improve their practical skills as much as the Novices. However, after the course, the Experienced students group demonstrated better engagement in higher-order thinking and a better knowledge base than Novices. Recognition of the effects of prior experience may be beneficial to the efficiency of teaching methods as well as for maximizing student learning outcomes. Because this topic appears to be poorly studied, this study contributes to the gap in the literature and may encourage future research in this area of professional pharmacy education. The implications of this study include the need to provide student-centered instructions based on an individual skill level demonstrated at the beginning of a course and underscore possible efforts directed at accommodating the differences in skills and knowledge among students.
Acknowledgments
The authors would like to thank the second-year pharmacy students (Class 2010) enrolled in the first sterile compounding laboratory course (PHAR 777) for their constructive engagement and cooperation.
Appendix 1
Practical skills related to compounding and preparation of sterile parenteral preparations used in pre and post course questionnaire administered to second-year student pharmacists. Students self-ranked their perceived competency level in each skill. Each practical skill except #18 was addressed by at least one question on the theory test administered together with the questionnaire.
| Skill Number | Description of sterile compounding-related skill | Number(s) of matched theory test question⁎ |
|---|---|---|
| 1 | Interpretation of parenteral orders | 1 |
| 2 | Performing calculations for parenteral compounding | 15 |
| 3 | Gowning and hand washing for sterile compounding | 2, 3 |
| 4 | Cleaning and disinfecting of the compounding work areas | 2,11,12 |
| 5 | Laminar airflow hood design and functions | 1,10 |
| 6 | Maintenance of laminar airflow hood and its workbench | 11 |
| 7 | Positioning of sterile items inside the compounding work area to assure sterility | 1,5,13 |
| 8 | Selection of proper size for a syringe for parenteral compounding | 4 |
| 9 | Selection of proper size for a needle for parenteral compounding | 4 |
| 10 | Aseptic handling of needles and syringes during parenteral compounding | 6 |
| 11 | Labeling requirements for compounded parenteral preparations | 8,4,18,20 |
| 12 | Selecting expiration date for sterile compounded preparations | 19 |
| 13 | Aseptic breaking of an ampule | 16 |
| 14 | Aseptic withdrawal of ampule content using a filter needle | 16 |
| 15 | Aseptic withdrawal of solution from a vial | 6 |
| 16 | Aseptic reconstitution of powdered drugs in a vial | 17 |
| 17 | Aseptic transfer of sterile drug solution(s) to bags with large volume sterile solutions | 7 |
| 18 | Aseptic compounding of cytotoxic parenteral preparations | NA |
| 19 | Differences between horizontal and vertical laminar airflow hoods | 1 |
| 20 | Appraisal of the quality of sterile admixture solutions | 19,20 |
| 21 | Instructing others on proper aseptic compounding techniques and procedures | 7,14 |
⁎ Questions from the theory test are presented in Appendix 2. |
Appendix 2
Question statements from the theory test given pre and post course in the sterile compounding laboratory to second-year student pharmacists. The students were asked to answer whether the query statements were true (T) or false (F). Each test statement reflected at least one practical skill (Appendix 1).
| Number | Test statement |
|---|---|
| 1 | Zone of turbulence is created inside the laminar airflow hood all around the objects placed inside the hood. |
| 2 | When washing hands, it is required to scrub hands, nails, wrists, and forearms with a brush, warm water, and bactericidal soap for 10 seconds. |
| 3 | Proper gowning requires dress from the head down. |
| 4 | The larger the gauge, the smaller the needle bore. |
| 5 | All manipulations inside a laminar airflow hood should be performed at least 7.6 centimeters inside the hood to prevent contamination. |
| 6 | Coring is breaking of the needle when pushing it through a vial's stopper with too much force. |
| 7 | Basic aseptic technique should be used when handling parenteral dosage forms but it is not needed for preparation of irrigations. |
| 8 | Admixture solutions do not have to be shown on the compounded preparation's label. |
| 9 | To provide a better sterility it is necessary to swab the needle shaft with 70% alcohol. |
| 10 | The high efficiency particulate air, or HEPA, filter removes 99.97% of particles that are 0.3 μm or larger. |
| 11 | The laminar airflow hood should be cleaned with either 70% alcohol or warm soapy water. |
| 12 | Alcohol (70%) should not be poured onto the surface but rather sprayed. |
| 13 | Your hands should never enter first air. |
| 14 | Flexible plastic bags containing parenteral solutions are packaged in plastic overwraps designed to protect their sterility. |
| 15 | ½NS contains 45 g of sodium chloride per 1000 mL. |
| 16 | Using a filter needle for both withdrawing solution from the ampule and expelling from the syringe will nullify the filtering effect. |
| 17 | Positive pressure that develops when reconstituting powdered drugs within a vial is needed to dissolve the powder. |
| 18 | The total volume of the sterile compounded parenteral preparation should be clearly shown on the label. |
| 19 | For compounded sterile preparations with beyond-use periods less than 24 hours, a beyond-use time is also required. |
| 20 | Parenteral preparations with a cold storage requirement should be stored at 0° to 8°C. |
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PII: S1877-1297(11)00100-6
doi:10.1016/j.cptl.2011.10.008
© 2012 Elsevier Inc. All rights reserved.
Volume 4, Issue 1 , Pages 19-28, January 2012
