ABSTRACT
Quality assurance is a key element in the process of creating safe and effective preparations. Furthermore, the implementation of quality-assurance measures allows 503A pharmacies to ensure accurate, well-made preparations to their customers. When corrective and preventive measures are not implemented, the risk of errors is increased, like subtherapeutic or supratherapeutic compounded medications. The objective of this article was to demonstrate the importance of quality assurance through the development and validation of the compounding method, preparation characterization, training, implementation of a master formulation record, compounding protocol, and verification to prevent compounding errors. Two groups, comprising of 10 students, compounded lidocaine gel following the quality-assurance guidelines in accordance with United States Pharmacopeia Chapter <1163>. Following the trial, the preparations from both groups were tested to evaluate the content of lidocaine using high-performance liquid chromatography and an ultra-viscosity detector. The study results indicated that the newly developed, validated procedure produced a stable, uniform, highly reproducible (%Assay ± SD; 101.65% ± 1.04), and elegant (clear hydro-alcoholic gel) preparation with a high yield (~98.5%). There was no significant difference observed in the %Assay results obtained from the two groups (%Assay ±SD; P1: 98.76% ±1.01, and P2: 99.02% ±1.39, %Difference: 0.3). Overall, our findings suggest that the implementation of quality assurance could significantly reduce compounding errors and improve both preparation quality and patient safety.
Subject(s)
Pharmacies , Drug Compounding , Humans , Lidocaine , Patient SafetyABSTRACT
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.
