Analysis of Compounded Pharmaceutical Products to Teach ...

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4-17-2014

Analysis of Compounded Pharmaceutical Products to Teach the Analysis of Compounded Pharmaceutical Products to Teach the

Importance of Quality in an Applied Pharmaceutics Laboratory Importance of Quality in an Applied Pharmaceutics Laboratory

Course Course

Alyssa M. Pignato St. John Fisher College

Christine R. Birnie St. John Fisher College, [email protected]

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Analysis of Compounded Pharmaceutical Products to Teach the Importance of Analysis of Compounded Pharmaceutical Products to Teach the Importance of Quality in an Applied Pharmaceutics Laboratory Course Quality in an Applied Pharmaceutics Laboratory Course

Abstract Abstract Objective.Objective. To assess the effectiveness of a product-analysis laboratory exercise in teaching students the importance of quality in pharmaceutical compounding.

Design.Design. Second-year pharmacy students (N=77) participated in a pharmaceutical compounding laboratory exercise and subsequently analyzed their final product using ultraviolet (UV) spectrometry.

Assessment.Assessment. Reflection, survey instruments, and quiz questions were used to measure how well students understood the importance of quality in their compounded products. Product analysis showed that preparations compounded by students had an error range of 0.6% to 140%, with an average error of 23.7%. Students’ reflections cited common sources of error, including inaccurate weighing, contamination, and product loss during both the compounding procedure and preparation of the sample for analysis. Ninety percent of students agreed that the exercise improved their understanding of the importance of quality in compounded pharmaceutical products. Most students (85.7%) reported that this exercise inspired them to be more diligent in their preparation of compounded products in their future careers.

Conclusion.Conclusion. Integrating an analytical assessment during a pharmaceutical compounding laboratory can enhance students’ understanding of quality of compounded pharmaceutical products. It can also provide students a chance to reflect on sources of error to improve their compounding technique in the future.

Disciplines Disciplines Pharmacy and Pharmaceutical Sciences

Comments Comments This article was originally published in American Journal of Pharmaceutical Education, April 2014, 78 (3) 61: https://www.ajpe.org/content/78/3/61

This article is available at Fisher Digital Publications: https://fisherpub.sjfc.edu/doctoral_ext_pub/76

INSTRUCTIONAL DESIGN AND ASSESSMENT

Analysis of Compounded Pharmaceutical Products to Teach theImportance of Quality in an Applied Pharmaceutics Laboratory Course

Alyssa Pignato, BS, PharmD Candidate, and Christine R. Birnie, PhD

Wegmans School of Pharmacy, St. John Fisher College, Rochester, New York

Submitted June 20, 2013; accepted October 9, 2013; published April 17, 2014.

Objective. To assess the effectiveness of a product-analysis laboratory exercise in teaching studentsthe importance of quality in pharmaceutical compounding.Design. Second-year pharmacy students (N577) participated in a pharmaceutical compounding lab-oratory exercise and subsequently analyzed their final product using ultraviolet (UV) spectrometry.Assessment. Reflection, survey instruments, and quiz questions were used to measure how wellstudents understood the importance of quality in their compounded products. Product analysis showedthat preparations compounded by students had an error range of 0.6% to 140%, with an average error of23.7%. Students’ reflections cited common sources of error, including inaccurate weighing, contam-ination, and product loss during both the compounding procedure and preparation of the sample foranalysis. Ninety percent of students agreed that the exercise improved their understanding of theimportance of quality in compounded pharmaceutical products. Most students (85.7%) reported thatthis exercise inspired them to be more diligent in their preparation of compounded products in theirfuture careers.Conclusion. Integrating an analytical assessment during a pharmaceutical compounding laboratorycan enhance students’ understanding of quality of compounded pharmaceutical products. It can alsoprovide students a chance to reflect on sources of error to improve their compounding technique inthe future.

Keywords: compounding, analysis, pharmaceutics, pharmacy practice laboratory

INTRODUCTIONAs the number of patient-specific medicinal thera-

pies increases, pharmaceutical compounding remainsa pertinent skill for pharmacists to master. According tothe InternationalAcademyofCompounding Pharmacists,compounded prescriptions comprise approximately 1%to 3% of the United States’ prescription market.1 Com-pounding is especially useful for targeting patients whoare challenging to treat; specifically pediatric, geriatric,and veterinary patients.2 Additionally, compounding en-ables patients to regain access to medications removedfrom the market because of manufacturer cost burden.Medical professionals and patients rely on pharmacists tocompound these products using the highest-quality stan-dards, which are thoroughly outlined in the United StatesPharmacopeia/National Formulary (USP/NF), the official

compendia of the United States.2 In an effort to ensurecompounding pharmacies are fulfilling these guidelines,the Pharmacy Compounding Accreditation Board wasfounded. This organization provides a standardized systemfor evaluating and validating quality-control techniquesperformed by compounding pharmacies voluntarily seek-ing accreditation.3 Even though resources are available tocompounders, errors that have the potential to compromisepatient safety still occur. The Federal DrugAdministration(FDA) performed a limited survey in 2001 in which com-pounded products from 12 pharmacies across the UnitedStates were evaluated using standard quality testing out-lined by the USP. Of the 29 samples evaluated for potencytesting, 9 (31%) of the products failed, with concentrationsranging from 59% to 89% of the label claim.4 In a subse-quent 2006 FDA survey, 36 samples from various com-pounding pharmacies were analyzed for potency of bulkactive pharmaceutical ingredient (API) and products con-taining that active ingredient were compounded. All bulkAPI samples contained the label claim based on assay re-sults; however, 33% of the compounded products failedpotency testing, with drug concentrations ranging from

Corresponding Author: Christine R. Birnie, PhD, AssociateProfessor and Chair, Department of Pharmaceutical Sciences,St. John Fisher College, Wegmans School of Pharmacy, 3690East Avenue, Rochester, NY 14618. Tel: 585-385-7202. Fax:585-385-5295. E-mail: [email protected]

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67.5% to 268.4% of label claim.5 Although these studieshad small sample sizes and significant limitations, theirresults raised valid concerns regarding the quality of com-pounded products being dispensed. High-profile com-pounding errors publicized in the media have revealedthe tragic consequences of improper compounding.6,7

With the recent compounding errors resulting in numerousdeaths from contaminated methylprednisolone acetatesteroid injections, and the subsequent Drug Quality andSecurity Act being proposed into legislation, the impor-tance of pharmacists practicing proper quality-assuranceprocedures has heightened awareness.8-12 The foundationfor accurate compounding must begin at the pharmacy-education level and resonate with pharmacy students,empowering them to be more cognizant of the properquality-control procedures and tomaintain these high stan-dards throughout their pharmacy careers.

The Accreditation Council of Pharmacy EducationStandards requires students to learn the “techniques andprinciples used to prepare and dispense individual extem-poraneous prescriptions.”13 This topic is also addressedby the Center for Advancement of Pharmaceutical Edu-cation Outcomes, which maintains that students must“prepare safe and effective dosage forms and performin-process quality control.”14 To fulfill these requirements,pharmacy colleges and schools have full authority regard-ing the extent of compounding instruction included in thecurriculumand themeans bywhich students are evaluatedfor “quality control.” The boards of pharmacy in Georgiaand New York, for example, place a greater emphasis onthe art of compounding and require successful completionof a hands-on (wet laboratory) compounding examinationfor licensure. Both state boards of pharmacy evaluatestudents based on correctness of calculations, procedure,labeling, visual inspection, and scalar measurements (eg,weight, volume) but do not require analytical testing ofthe product (A.T. Corigliano, e-mail, January 21, 2013;T.F. Allen, e-mail, November 5, 2012). Interestingly, nostate requires students to provide proof that they are ableto compound products that fulfill USP standards with re-spect to potency and purity.15-17 It is therefore imperativefor pharmacy colleges and schools to take initiative toverify that students are preparing pharmaceutically ele-gant products that fulfill the USP quality standards test-ing. This goal can be accomplished by incorporating ananalytical method in the compounding laboratory.

A survey evaluating the compounding curriculumwithin pharmacy colleges and schools identified the lackof analytical testing in educational compounding labora-tories. Most survey respondents cited direct observationas their primary assessment approach, while only a smallpercentage (8%) of institutions used a quantitative method

to evaluate student preparations.18 Although this studywasnot all-inclusive, it did reflect a trend among pharmacycolleges and schools in the assessment of students’ com-pounded products. Other concerns identified in the liter-ature include students’ retention of compounding skillsand the attenuated role of compounding in academia.19,20

Some institutions have attempted to implement analyticaltesting in the laboratory through changes in course designand assessment.21-27 One study in which the accuracy ofpharmaceutical products compounded by pharmacy stu-dents was evaluated found that 54% of students preparedthe desired potassium permanganate solution within 10%of the intended concentration.27 Students who were un-successful in accurately compounding the solution hadconcentrations ranging from less than 75% to greater than200%. In the same study, 78% of student preparations ofcaffeine citrate solution fell within 10% of the intendedconcentration, with errors ranging from less than 89% tomore than 269% of the required potency. The wide vari-ation in product potency compounded by pharmacy stu-dents mirrors the FDA’s findings on a national level.

Incorporating analytical testing of compounded phar-maceutical products into the pharmacy curriculum givesstudents a sense of accountability for ensuring that theirproducts meet the acceptable quality standards to dispenseto a patient. This study describes the design and implemen-tation of a product-analysis laboratory to teach students theimportance of quality in compounded products. The labo-ratory included preparation of a compounded product, sub-sequent analytical testing, product evaluation, and studentreflection. The impact of the exercise on students’ percep-tions regarding the importance of quality in compoundingwas also recorded.

DESIGNBeginning in the first year of a 4-year doctor of

pharmacy (PharmD) program at St. John Fisher College,Wegmans School of Pharmacy, students were taughtfoundational principles of physical, chemical, and bio-logical mechanisms involved in drug formulation duringthe pharmaceutics course sequence. Students were ex-pected to use this knowledge in a practical setting as partof a 2-semester Applied Pharmaceutics compounding lab-oratory sequence, comprising 2 single-credit-hour coursesoffered during the second year. The courses consisted ofa 1-hour prelaboratory lecture in conjunctionwith a 3-hourlaboratory period consisting of 2 sections. Course evalua-tion comprised of 2 practicals, a cumulative final labora-tory practical, 2 quizzes, and an overall professionalismscore. Final products were assessed by visual inspection,accuracy of calculations, and completeness of compound-ing procedure. Individual laboratory sessions were not

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graded in order to provide students the opportunity torefine their compounding skills and learn from their errorsin a controlled learningenvironment.Course instructors andteaching assistantswere available consistently throughoutthe laboratory sessions to provide feedback and answerstudents’ questions. Faculty members rotated teachingthroughout the semester to provide instructional guidanceon their particular dosage-form specialty.

The product-analysis exercise was incorporated dur-ing the second-semester laboratory course. At the com-pletion of this laboratory session students were expectedto (1) prepare a compounded product with a designatedlevel of precision and accuracy; (2) complete a pharma-ceutical analysis of a compounded product; (3) accuratelyperform calculations related to compounding and dilu-tion; (4) identify sources of error that could have occurredin pharmaceutical compounding and analysis; (5) eval-uate assay results of a compounded product to determineif it met the quality standards necessary to dispense forpatient use; and (6) comprehend the importance of accu-racy and quality in compounded products. These learningoutcomes and the corresponding instruments used toassess them are presented in Table 1. The St. John FisherCollege Institutional Review Board approved this pro-ject as exempt.

Students were provided a packet containing a pre-scription for methimazole 5% in poloxamer lecithinorganogel (PLO), directions for compounding, assayprocedure, and reflection questions during the 1-hourprelaboratory class session held 1 week prior to the labo-ratory exercise. 28,29 (Appendix 1). Studentswere informedthat they would assay their final product to determine po-tency using UV spectroscopy. Supplying the materialsprior to the exercise gave students sufficient time to com-plete the calculations and familiarize themselves with theproduct in anticipation of the analytical process. Studentswere also informed that a bonus point would be added totheir next quiz if their product analysis was found to bewithin an acceptable range.

During the 3-hour laboratory period, students com-pounded the prescription according to the instructionsprovided and removed a 0.5-gram sample for the assay.This sample was serially diluted and filtered before beingplaced in a plastic cuvette and assayed using the UV spec-trophotometer at a wavelength of 252 nm. With the ab-sorbance value obtained from the UV spectrophotometer,students calculated the concentration of the sample de-rived from the product they prepared.

After conducting the assay, students were asked tocomplete the last page of their laboratory exercise, in-cluding a calculationworksheet with reflection questions.Students were instructed to use the Beer-Lambert Law

equation to convert their absorbance value to concentra-tion, perform calculations to determine the concentrationof assayed solution after performing serial dilutions, andcalculate a percentage of error based on their product ver-sus the target concentration. The reflection portion of theexercise required students to evaluate their assay results byindicating whether their product met an appropriate levelof quality required to dispense to their patients. Studentswere also provided an opportunity to reflect on poten-tial sources of error in their compounding or analyticalprocedure.

As per standard procedure for the semester labora-tory, each student then completed a final “check-out”witha teaching assistant or laboratory instructor to review theprescriptionwrite-ups, final products, analysisworksheet,and reflection questions. The teaching assistant/instructorensured that all aspects of the laboratory were completed,during which time the student also had an opportunity toask any additional questions before leaving the laboratory.

EVALUATION AND ASSESSMENTStudents’ product analysis worksheets were collected

and tabulated at the conclusion of the laboratory exercise.Absorbance values were used to determine the final con-centration and percentage error for each sample. Of the77 student products assayed, products ranged in errors from0.6% to 140%, with an average error of 23.7%. Only32 (41.6 %) products prepared by students fell within anacceptable 10% error range. An additional 16 (20.8%)samples fell within the 10% to 20% error range, with theremaining 38% having an error rate of more than 20%.

Written responses identifying sources of errors werecoded to reveal common themes (Table 2). For a responseto be considered a theme, a minimum of 25% of studentshad to have commented on that specific category. Over72% of students discussed some form of measurementerror as a potential source of deviation from the expectedpotency. Examples of these errors included improper cal-ibration of balance, measuring more API than required,andmeasuring an inappropriate amount of gel for the anal-ysis portion. A second theme that more than 61% of stu-dents cited involved errors made during the serial dilutionprocess. Many students commented that loss of productcould have occurred during the stepwise serial dilution oras a result of inadequate dissolution of the product into theassay solvent. Contamination of either the drug source orglassware, including the plastic cuvette, was discussed byover 25% of students. Twenty-five percent of studentsreported that their errormay have occurred during the com-pounding of the gel product. Students mentioned impropermixing, loss of product while removing air bubbles, andcalculation errors as potential sources of inaccuracy.

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When students were asked to reflect onwhether theirproduct was suitable for dispensing based upon the anal-ysis results, a majority (97%) identified less than 10%error as acceptable for dispensing. The remaining 3%indicated an acceptable error of less than 5% and eval-uated their results based on this guideline. As part of a10-question laboratory quiz in the overall course assess-ment, 2 questions pertained to the analysis laboratory.The first was a calculation, similar to that required for thedilution conducted in the laboratory. Of the 75 studentswho completed the quiz, 56 (75.7%) responded correctly

to the open-ended question. The second question askedstudents to explain why accuracy and quality of com-pounded products is an important aspect of pharmaceu-tical compounding. Of the 75 students who responded,100% provided a correct written response, citing eitherpatient safety or medication effectiveness.

To obtain each student’s perspective on the labora-tory, an optional 8-item questionnaire was distributed tostudents at the end of the laboratory period. The volun-tary survey instrument included 7 Likert-scale questionsand 1 open-ended question. Students were instructed to

Table 1. Learning Outcomes and Methods for Assessment in a Laboratory Exercise on Pharmaceutical Compounding

Learning OutcomesMethod of AssessingLearning Outcome Questionnaire Statements

Learning(Bloom’s Taxonomy)

Prepare compounded productswith a level of precisionand accuracy.

Product assay As a result of analyzing my owncompounded products in this lab,I believe I will preparecompounded products moreaccurately in the future.

Application

Complete a pharmaceuticalanalysis on a compoundedproduct.

Successful completion oflaboratory exercise asdocumented by laboratoryinstructor and teachingassistants

As a result of this laboratoryexercise, I now know howpharmaceutical products canbe analyzed for drug content.

Knowledge/application

Accurately perform calculationsrelated to compoundingand dilution

Calculations recordedon laboratory worksheetand assessed by teachingassistants and instructor

By performing the calculationsassociated with this laboratoryexercise, I now feel moreconfident about performingcalculations related tocompounding.

Application

Calculation questionon course quiz

Identify sources of error that canoccur in pharmaceuticalcompounding and analysis.

Reflection question: Whatsources of error may haveoccurred in the preparationor analysis of the product?

This laboratory experience helpedme to think through the sourcesof error that may occur whilecompounding and analyzingcompounded products.

Synthesis

I believe I know where the errorsassociated with my compoundedproduct may have occurred.

Synthesis

Evaluate assay results of acompounded product todetermine if it meets thequality standards necessary todispense to a patient.

Reflection question: What isthe percent error of thisproduct? Based on youranalysis, is the productsuitable to dispense to apatient?

After completing this laboratory,I am more confident in my abilityto evaluate the assay results ofa compounded product.

Evaluation

Comprehend the importanceof accuracy and quality incompounded products

Open-ended questionson course quiz

The laboratory exercise involvingthe assay of the methimazolein PLO gel compounded productI prepared helped me to betterunderstand the importance ofquality in compoundingpharmaceutical products.

Comprehension

Abbreviation: PLO5poloxamer lecithin organogel.

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complete the survey instrument without any personal iden-tifiers to maintain anonymity and to rank their level ofagreement with the statements using a 5-point Likert scale(15strongly disagree, 25disagree, 35neutral, 45agreeand 55strongly agree) (Appendix 1). The survey instru-ment questions were designed to match the learning out-comes for the laboratory exercise (Table 1).

Of the 77 second-year pharmacy students who suc-cessfully completed the product-analysis laboratory,

71 (92.2%) completed the survey instrument and returnedit at the conclusion of the laboratory exercise. The resultswere reported using descriptive statistics (Table 3). Thestudents responded positively to all 7 questions, indicatingthat the laboratory exercises were useful in emphasizingthe importance of quality in compounded products. Ninetypercent (63 of 70) of students agreedor strongly agreed thatthe exercise helped them understand the importance ofquality in compoundingpharmaceutical products. Studentswere also asked an open-ended question to allow them toreflect on any future changes they would make to theircompounding technique based on their experience duringthe exercise. Several responses emphasized taking morecare while compounding, cleaning glassware thoroughlyprior to compounding, and minimizing product loss whilemeasuring and mixing ingredients.

DISCUSSIONPharmaceutical compounding offers a unique niche

in the healthcare arena. It not only provides patients with

Table 2. Summary of Themes in Student Reflection ina Laboratory Exercise on Pharmaceutical Compounding:Potential Sources of Error (N568)

Theme No. (%)

Errors due to inaccurate weighingor measuring of volume

49 (72.1)

Errors involved during serial dilution 42 (61.8)Errors due to contamination of drug

product, glassware, cuvette20 (29.4)

Errors involved in compounding procedure 19 (27.9)

Table 3. Student Responses to a Survey Regarding Evaluation of Methimazole in PLO Gel Product in a Laboratory Exercise onPharmaceutical Compounding

Survey Instrument Question

StronglyDisagree,No. (%)

Disagree,No. (%)

Neutral,No. (%)

Agree,No. (%)

StronglyAgree,No. (%)

NoResponse,

No.Mean(SD)

The laboratory exercise involving the assay ofthe methimzaole in PLO gel compoundedproduct I prepared helped me to betterunderstand the importance of quality incompounding pharmaceutical products.

0 1 (1.4) 6 (8.6) 31 (44.3) 32 (45.7) 1 4.3 (0.7)

As a result of this laboratory exercise, I nowknow how pharmaceutical products can beanalyzed for drug content.

0 2 (2.8) 8 (11.3) 33 (46.5) 28 (39.4) 0 4.2 (0.8)

This laboratory experience helped me to thinkthrough the sources of error that may occurwhile compounding and analyzingcompounded products.

0 1 (1.4) 6 (8.6) 39 (55.7) 24 (34.3) 1 4.2 (0.7)

I believe I know where the errors associatedwith my compounded product mayhave occurred.

1 (1.4) 3 (4.2) 13 (18.3) 34 (47.9) 20 (28.2) 0 4.0 (0.9)

By performing the calculations associatedwith this laboratory exercise, I now feelmore confident about performingcalculations related to compounding.

0 2 (2.8) 10 (14.0) 37 (52.1) 22 (31.0) 0 4.1 (0.8)

After completing this laboratory, I am moreconfident in my ability to evaluate assayresults of a compounded product.

0 2 (2.8) 15 (21.1) 32 (45.1) 22 (31.0) 0 4.0 (0.8)

As a result of analyzing my own compoundedproducts in this lab, I believe I will preparecompounded products more accuratelyin the future.

0 2 (2.9) 8 (11.4) 36 (51.4) 24 (34.3) 1 4.2 (0.7)

Abbreviations: PLO5poloxamer lecithin organogel.

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drug formulations specifically tailored to best suit theirneeds but also can improve patient compliance and healthoutcomes. Unfortunately, compounding errors can havedeleterious effects that overshadow these benefits andhave a lasting impact on the pharmacy profession. It isparamount that pharmacy students realize the responsi-bility they have to their patients concerning quality ofcompounded products. One mechanism of executing thisacademically would be to incorporate an analytical ele-ment to the compounding curriculum.

After compiling the students’ overall error percent-ages, only 32 (41.6 %) products were found to be withinan acceptable 10% error rate. Error percentages rangedfrom 0.6% to greater than 140%. This wide range in po-tencymirrors similar trends seen by the FDAand reportedby other academic institutions.4,5,23,27 Several factorsmay have contributed to the students’ poor analytical per-formance. Although students were provided a bonus-point incentive, their grade was not greatly affected bythe outcome of the product analysis. This may have in-fluenced some students not to put forth their best effortduring the exercise. Also, the unique compounding pro-cedure for this product is more complex than other dosageforms, such as solutions or intravenous admixtures thatcan be easily assayed. This laboratory exercise was pur-posely designed to include analysis of a complex formu-lation toward the end of the compounding course asa means of a near-final assessment for the students. Anal-ysis of a simpler formulation would have likely increasedthe percentage of products that would have been deemedacceptable for dispensing. Additionally, the assay samplepreparation required a 2-step dilution in volumetrics. Thismultiple-step process had the potential to precipitateproduct loss or contamination when conducted by a stu-dent with limited analysis training.

After coding students’ reflection responses, manystudents cited similar rationales for not obtaining a samplewithin an acceptable potency range.Most of the responsesinvolved errors in measurement, measuring either too lit-tle or too much active ingredient. Because this laboratorytook place near the end of the compounding sequence, itwas expected that students would be proficient in basictasks, such as accurate measuring. With the analysis hav-ing no impact on the students’ grade, less care may havebeen taken during the measurement process. A similarstudy determined that student performance significantlyimproved when students were required to remake unac-ceptable products outside of their scheduled laboratorytime.23 This step may be a valid consideration for futureyears in an effort to prompt students to use class timemeaningfully. Students mentioned that the multiple stepsinvolved for both the compounding and assay preparation

created many opportunities for product loss. This partic-ular laboratory procedure incorporated a novel methodfor mixing involving 2 syringes attached by a connectoras the mixing vessel. Students had never been exposed tothis type of compoundingmethod andmay have producedbetter products if had theyfirstmastered the compoundingtechnique. Overall, having students identify their sourcesof error was an important learning outcome to ensure theycould target their weaknesses and correct these errors insubsequent attempts.

Students responded positively on survey items re-garding the analytical laboratory component, agreeingthat this exercise enhanced their understanding of theimportance of quality compounded products and wouldenable them to better prepare accurate products in thefuture. A similar trend in student response was observedin previous research involving pharmaceutical laboratoryanalysis. 24 Most students were able to identify wheretheir errors may have occurred while compounding andresponded favorably to the exercise, with increased con-fidence in compounding-related calculations. An impor-tant aspect was the students’ ability to identify whetherthe product was within an acceptable range for dispens-ing. According to the survey, most students felt betterprepared to evaluate their product quality because of theexercise.

This study has several limitations. The laboratoryhandouts guided students through both the compoundingand analytical procedures. Providing students with onlythe prescription and no other instructional material wouldsimulate a more realistic scenario in which pharmacystudents must take initiative to consult the appropriatecompounding monograph as a resource. Students werealso aware prior to the laboratory that the products wereto be assayed. Blinding students to the analysis portionmay have achieved different results and potentially agreater impact for students regarding their skill level andthe care with which they compounded products. Other in-stitutions might consider implementing an analytical lab-oratory multiple times throughout the semester to providea longitudinal method for tracking student progress, takinginto account the potential cost and time implications. Be-cause this laboratory exercise was a single assessment ofstudents’ ability to prepare quality compounded products,it is unclear whether these attitudes or compounding abil-ities were maintained beyond this laboratory exercise.Measuring student perceptions by means of a preexerciseand postexercise survey instrument might provide a betterindication of students’ evolution of learning after exposureto an analytical method. Regardless of methodology, phar-macy colleges and schools must design pedagogy that willensure students’ understandingof the importanceofquality

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in compounded products. Analytical testing of studentproducts combined with subsequent reflection appears tobe one way to accomplish this outcome.

From an institutional perspective, implementing ananalytical element to a laboratory can be an expensive andtime-consuming undertaking. Institutions might considercollaborating with other departments in the college oruniversity for assays requiringmore advanced instrumen-tation. For the purposes of this study, the UV spectropho-tometer and bulk materials were relatively inexpensiveand already on hand at the institution. Additionally, usingassays developed from previous research at the institutionmay provide an easier transition for classroom implemen-tation. For example, extensive research was previouslyperformed at the Wegmans School of Pharmacy usingmethimazole in PLO, facilitating the development ofthe UV assay method and stability of the formulation.29

Faculty members were familiar with this product andcomfortable applying these methods on a larger scalefor classroom purposes.

The overarching theme of this laboratory exercisewas the importance of quality in compounding. All stu-dents enrolled in the course completed an analytical assayand accurately interpreted whether their product was ap-propriate for dispensing to a patient. Every student effec-tively identified sources of errors and performed thecalculations necessary for compounding and completingthe assay. The open-ended quiz question on the surveyinstrument solidified that students understood that qualityis important for patient safety and medication effective-ness. Student questionnaires correlated students’ percep-tions regarding the measured outcomes. Although somestudents were unable to accurately prepare this com-pounded product within the recommended error range,the impact the exercise had on all participants may havebeen an equally important learning outcome. The exercisecaused them to look beyond the pharmaceutically elegantproducts they had often prepared to evaluate the productsfor drug content. This important aspect of quality in com-pounded products is often marginalized by product ap-pearance and elegance. The result of such negligence canpotentially be fatal to patients and, thus, should be a mo-tivation for educational institutions to consider the addi-tion of analytical methodology in their compoundinglaboratories.

SUMMARYImplementing product analysis in the pharmacy-

compounding curriculum provided students with theopportunity to assess objectively their products for accu-racy. Students were receptive to this laboratory exerciseand able to identify potential sources of error during their

compounding process. This assessment effectively en-abled students to reflect on their compounding skills, un-derstand the importance of compounding quality, andbetter prepare to compound products more accurately intheir future careers.

ACKNOWLEDGEMENTSThe authors thankMarvin Pankaskie for his extensive

contributions in the development of the methimazoleproduct assay.

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Appendix 1.Materials Distributed to Students During the Laboratory Session: (a)Methimazole 0.5% in PLOProcedure; (b) AnalysisProcedure for Methimazole 0.5% in PLO; (c) Evaluation of Methimazole in PLO Gel Product Evaluation

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