Academic journal article American Journal of Pharmaceutical Education

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

Academic journal article American Journal of Pharmaceutical Education

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

Article excerpt

INTRODUCTION

As the number of patient-specific medicinal therapies increases, pharmaceutical compounding remains a pertinent skill for pharmacists to master. According to the International Academy of Compounding Pharmacists, compounded prescriptions comprise approximately 1% to 3% of the United States' prescription market. (1) Compounding is especially useful for targeting patients who are challenging to treat; specifically pediatric, geriatric, and veterinary patients. (2) Additionally, compounding enables patients to regain access to medications removed from the market because of manufacturer cost burden. Medical professionals and patients rely on pharmacists to compound these products using the highest-quality standards, which are thoroughly outlined in the United States Pharmacopeia/National Formulary (USP/NF), the official compendia of the United States. (2) In an effort to ensure compounding pharmacies are fulfilling these guidelines, the Pharmacy Compounding Accreditation Board was founded. This organization provides a standardized system for evaluating and validating quality-control techniques performed by compounding pharmacies voluntarily seeking accreditation. (3) Even though resources are available to compounders, errors that have the potential to compromise patient safety still occur. The Federal Drug Administration (FDA) performed a limited survey in 2001 in which compounded products from 12 pharmacies across the United States were evaluated using standard quality testing outlined by the USP. Of the 29 samples evaluated for potency testing, 9 (31 %) of the products failed, with concentrations ranging from 59% to 89% of the label claim. (4) In a subsequent 2006 FDA survey, 36 samples from various compounding pharmacies were analyzed for potency of bulk active pharmaceutical ingredient (API) and products containing that active ingredient were compounded. All bulk API samples contained the label claim based on assay results; however, 33% of the compounded products failed potency testing, with drug concentrations ranging from 67.5% to 268.4% of label claim. (5) Although these studies had small sample sizes and significant limitations, their results raised valid concerns regarding the quality of compounded products being dispensed. High-profile compounding errors publicized in the media have revealed the tragic consequences of improper compounding. (6,7) With the recent compounding errors resulting in numerous deaths from contaminated methylprednisolone acetate steroid injections, and the subsequent Drug Quality and Security Act being proposed into legislation, the importance of pharmacists practicing proper quality-assurance procedures has heightened awareness. (8-12) The foundation for accurate compounding must begin at the pharmacyeducation level and resonate with pharmacy students, empowering them to be more cognizant of the proper quality-control procedures and to maintain these high standards throughout their pharmacy careers.

The Accreditation Council of Pharmacy Education Standards requires students to learn the "techniques and principles used to prepare and dispense individual extemporaneous prescriptions." (13) This topic is also addressed by the Center for Advancement of Pharmaceutical Education Outcomes, which maintains that students must "prepare safe and effective dosage forms and perform in-process quality control." (14) To fulfill these requirements, pharmacy colleges and schools have full authority regarding the extent of compounding instruction included in the curriculum and the means by which students are evaluated for "quality control." The boards of pharmacy in Georgia and New York, for example, place a greater emphasis on the art of compounding and require successful completion of a hands-on (wet laboratory) compounding examination for licensure. Both state boards of pharmacy evaluate students based on correctness of calculations, procedure, labeling, visual inspection, and scalar measurements (eg, weight, volume) but do not require analytical testing of the product (A. …

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