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Incorporating Quality Assurance in Pharmaceutical Compounding-related Courses in the PharmD Curricula

Author(s):  Hossain Mohammad Faisal, Levesque Dan, Frye John, Rashid Mamoon

Issue:  Jul/Aug 2020 - Volume 24, Number 4
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Abstract:  The art and the skill set of compounding fulfill the important need of tailor-made pharmaceuticals for use by both institutions and individual  patients. Over the last 20 years, there have been more than 200 adverse events involving compounded products; infections, poisonings, contaminations, and dosing inaccuracies have been problematic. The probability of a correlation between the lack of institutional training and number of serious events could be significant. This survey was an endeavor at fundamental cause analysis and proactive management in relation to the PharmD Curricula as a means of error prevention. A questionnaire was sent to the pharmacy school faculty (department chairs, dean/assistant deans, and pharmaceutical science faculty) across the country. The survey responses were received from 78 participants. The questionnaire evaluated the respondent’s overall knowledge and approach toward the subject in their curriculum. The survey results show 38.9% faculty agree that their college’s curricula lacks sufficient training in microbiological testing, and 16.7% faculty agree their college does not provide sufficient training in nonsterile and sterile compounding (as per United States Pharmacopeia Chapters <795> and <797>). A majority of faculty agree on the implementation of quality assurance in compounding courses (as per United States Pharmacopeia Chapter  <1163>) as either an elective (62.5%) or mandatory class (43.3%), and most of the participants (85.1%) think there is a need to teach quality assurance as continuing education to practicing pharmacists. The survey data suggest a general desire for enhancement of compounding course curriculum, which could reduce the number of adverse events related to compounding. The data also suggests a necessity for the implementation of continuing education programs for practicing pharmacists and academic faculty across the country.

Related Keywords: Mohammad Faisal Hossain, PhD, Dan Levesque, DC, John Frye, RPh, Mamoon Rashid, PhD, pharmacy education, PharmD curriculum, pharmacy school faculty, survey, compounding error prevention, compounding guidelines, drug safety, microbiological testing, microbial contamination, sterile compounding, compounded sterile preparations, quality assurance, adverse effects, continuing pharmacy education, U.S. Food and Drug Administration, FDA, current good manufacturing processes, United States Pharmacopeia Chapter <1163>, USP, sterility testing, endotoxin testing, preservative effectiveness testing, microbial limit testing

Related Categories: LEGAL, PEER-REVIEWED, QUALITY CONTROL, PHARMACY EDUCATION, PROFESSIONAL ISSUES

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