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January 6, 2016
Prescriptions for Compounded Hormone Therapy
Growing Rapidly Charlottesville, VA—Almost as many prescriptions are written for mostly unregulated compounded hormone therapy for women struggling with menopause symptoms as for medications approved by the FDA, according to a new study. Prescriptions for compounded hormone therapy are reaching an estimated 26 to 33 million a year, approaching the 36 million prescriptions per year for regulated and tested FDA-approved hormone therapy, according to the report published online recently by the journal Menopause. The study, led by University of Virginia researchers, notes that sales of the compounded hormones, estimated at $1.3 to $1.6 billion, are expected to continue to grow 5% to 25% in the next 2 years. While data on sales of FDA-approved medications are easily trackable, the researchers had to analyze data from a Rose Research online survey of U.S. pharmacists at compounding and independent community pharmacies to determine how many of the unregulated products had been dispensed. The survey was completed by nearly 500 respondents—118 compounding and 365 independent community pharmacists—who answered questions about the number of compounded hormone therapy prescriptions filled, the percentage of total volume, the percentages of different types of compounded hormone therapy sold, and what growth they expected for the medications in the next 2 years. The size of the market was based on those responses as well as the average percentage of compounding reported by the National Community Pharmacists Association and the industry market research firm IBISWorld. Background information in the article cites media reports that the compounded products sometimes contain too much of the prescribed estrogens and too little progesterone, an imbalance that has been linked to greater risk of uterine cancer. “On the basis of extrapolated data from numbers of prescriptions reported by pharmacists participating in the survey, the volume of CHT [compound hormone therapy] seems to approach that of Food and Drug Administration (FDA)-approved menopausal hormone therapy, and growth in the CHT market is expected,” the authors write. “Thus, physicians should educate themselves and the women consulting them about the differences between the FDA-approved and the less-tested CHT formulations. More research on the efficacy, safety, and consistency of non-FDA-approved CHT is needed.” The report notes that a perception that compounded formulations are safer than FDA-approved therapies could be driving the increases sales of CHT, especially after a 2002 Women’s Health Initiative trial identified health risks with one type of estrogen-progestogen therapy and prescriptions of all FDA-approved menopausal hormone therapies plummeted. “Despite the increased quality risks and the lack of safety and efficacy data for non-FDA regulated compounded hormone therapy formulations, their use by menopausal women is higher than expected and appears to be continuing to grow,” adds NAMS Executive Director Emeritus Wulf H. Utian, MD, PhD, DSc (Med), executive director emeritus of the North American Menopause Society, which publishes the journal Menopause.
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