Accuracy of Testosterone Concentrations in Compounded Testosterone Products

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.

Variable persistence of serum testosterone in infants and children exposed to topical testosterone

“…10 The testosterone concentration in compounded products can vary greatly. 11 A study investigating testosterone compounds in pharmacies in Toronto, Canada, found that, at best, only 50% of compounded testosterone gels and creams had a testosterone concentration within 20% of that prescribed. 11 Two of the 10 pharmacies had products containing >20% of the prescribed dose.…”

“…11 A study investigating testosterone compounds in pharmacies in Toronto, Canada, found that, at best, only 50% of compounded testosterone gels and creams had a testosterone concentration within 20% of that prescribed. 11 Two of the 10 pharmacies had products containing >20% of the prescribed dose. 11 The most current expenditure data for 2016 on topical testosterone prescribing in Australia totals over $6 million with almost 80 000 prescriptions 5,12 (Table 2).…”

“…11 Two of the 10 pharmacies had products containing >20% of the prescribed dose. 11 The most current expenditure data for 2016 on topical testosterone prescribing in Australia totals over $6 million with almost 80 000 prescriptions 5,12 (Table 2).…”

Minimizing Medication Errors from Electronic Prescription Transmission—Digitizing Compounded Drug Preparations

“…A study of 99 compounded drugs dispensed to 71 patients found an average of 3.5 problems per patient, 4% of which involved major real or potential consequences [5]. Another study in adults identified between 30% and 50% of testosterone preparations compounded by ten compounding pharmacies were within ±20% of the prescribed dose [6]. One report from Belgium, a country that in January 2019 made eRx mandatory, indicated that patients with more complex medical conditions were more likely to want paper prescriptions [7].…”

Primary care use of testosterone therapy to benefit women experiencing distress related to decreased sexual desire after surgical menopause

“…Compounding was widely practiced, but this gave way to prescribing and dispensing of standardized drug products that were rigorously evaluated, manufactured under stringent controls, and approved by federal authorities (Sellers & Utian, 2012 with quality defects such as contaminants and variations in potency and bioavailability (Gass et al, 2015;Sellers & Utian, 2012). In fact, substantial published research, and bodies such as the Institute for Safe Medication Practice Canada (ISMP-Canada), have identified significant issues with the quality of compounded medications (Gass et al, 2015;Grober et al, 2015;Kawano & Ho, 2012;Sellers & Utian, 2012). Grober et al (2015), in a study of ten randomly selected compounding pharmacies in Toronto, reported that significant inaccuracy existed within and between pharmacies, in the compounding of testosterone gels and creams.…”