Ethan D Grober1, Alaina Garbens1, Andrea Božović2,3, Vathany Kulasingam2,3, Majid Fanipour1, Eleftherios P Diamandis2,3,4. 1. Department of Surgery, Division of Urology, Mount Sinai and Women's College Hospital, Toronto, Ontario, Canada. 2. Laboratory Medicine Program, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada. 3. Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada. 4. Samuel Lunenfeld Research Institute and Department of Pathology and Laboratory Medicine, Mount Sinai Hospital, Toronto, Ontario, Canada.
Abstract
OBJECTIVE: This study aims to evaluate the accuracy of the testosterone concentrations within testosterone gels and creams manufactured by compounding pharmacies. METHODS: Ten compounding pharmacies within Toronto area were included. Pharmacies were blinded as to the nature of the study. A standardized prescription for 50 mg of compounded testosterone gel/cream applied once daily was presented to each pharmacy. Two independently compounded batches were analyzed from each pharmacy 1 month apart. Testosterone concentrations in a 5-g sachet of Androgel® 1% (Abbott) and 5-g tube of Testim®1% (Auxilium) were evaluated as controls. Samples were analyzed independently and in a blinded fashion by the Laboratory Medicine Program at the University Health Network. Measurement of testosterone concentration was performed using a modified liquid chromatography tandem mass spectrometry validated for serum testosterone. RESULTS: Compounded formulations included seven gels and three creams with a volume/daily dose ranging from 0.2 mL to 1.25 mL. Product cost ranged from $57.32 to $160.71 for a 30-day supply. There was significant variability both within and between pharmacies with respect to the measured concentration of testosterone in the compounded products. In contrast, the concentration of testosterone within Androgel and Testim was consistent and accurate. Collectively, only 50% (batch 1) and 30% (batch 2) of the compounding pharmacies provided a product with a testosterone concentration within ± 20% of the prescribed dose. Two pharmacies compounded products with >20% of the prescribed dose. One pharmacy compounded a product with essentially no testosterone. CONCLUSIONS: Testosterone concentrations in compounded testosterone products can be variable and potentially compromise the efficacy and safety of treatment.
OBJECTIVE: This study aims to evaluate the accuracy of the testosterone concentrations within testosterone gels and creams manufactured by compounding pharmacies. METHODS: Ten compounding pharmacies within Toronto area were included. Pharmacies were blinded as to the nature of the study. A standardized prescription for 50 mg of compounded testosterone gel/cream applied once daily was presented to each pharmacy. Two independently compounded batches were analyzed from each pharmacy 1 month apart. Testosterone concentrations in a 5-g sachet of Androgel® 1% (Abbott) and 5-g tube of Testim®1% (Auxilium) were evaluated as controls. Samples were analyzed independently and in a blinded fashion by the Laboratory Medicine Program at the University Health Network. Measurement of testosterone concentration was performed using a modified liquid chromatography tandem mass spectrometry validated for serum testosterone. RESULTS: Compounded formulations included seven gels and three creams with a volume/daily dose ranging from 0.2 mL to 1.25 mL. Product cost ranged from $57.32 to $160.71 for a 30-day supply. There was significant variability both within and between pharmacies with respect to the measured concentration of testosterone in the compounded products. In contrast, the concentration of testosterone within Androgel and Testim was consistent and accurate. Collectively, only 50% (batch 1) and 30% (batch 2) of the compounding pharmacies provided a product with a testosterone concentration within ± 20% of the prescribed dose. Two pharmacies compounded products with >20% of the prescribed dose. One pharmacy compounded a product with essentially no testosterone. CONCLUSIONS:Testosterone concentrations in compounded testosterone products can be variable and potentially compromise the efficacy and safety of treatment.
Authors: Sharon J Parish; James A Simon; Susan R Davis; Annamaria Giraldi; Irwin Goldstein; Sue W Goldstein; Noel N Kim; Sheryl A Kingsberg; Abraham Morgentaler; Rossella E Nappi; Kwangsung Park; Cynthia A Stuenkel; Abdulmaged M Traish; Linda Vignozzi Journal: J Womens Health (Larchmt) Date: 2021-04-01 Impact factor: 2.681