The researchers said unique risks come with compounded HT because of the lack of FDA approval and monitoring.
JoAnn V. Pinkerton
JoAnn V. Pinkerton, MD, of the University of Virginia Health System, andGinger D. Constantine, MD, of EndoRheum Consultants LLC in Malvern, Pennsylvania, evaluated a national online survey of 365 independent community pharmacies and 118 compounding pharmacies to estimate compounded HT prescriptions in the United States. The survey, conducted by Rose Research between October and November 2014, included 12,250 U.S. pharmacists. Survey responders received approximately $17 to $35 in cash or merchandise for their time to complete the survey.
Overall, nonsterile compounded products made up 8.6% (mean) of prescriptions by independent community pharmacies, and 36% (mean) by compounding pharmacies; 16.1% (mean) were compounded HT prescriptions by independent community pharmacies and 25.7% (mean) by compounding pharmacies. Annually, based on survey responses and extrapolated industry data, independent community pharmacies and compounding pharmacies fill an estimated 33 million compounded HT prescriptions, which yields an estimated $1.61 billion in spending on compounded HT each year.
The most common compounded HT was progesterone/progestin, followed by estrogen and progesterone/progestin and 17-beta-estradiol/estrogen. Transdermal gel or lotion was the most common route of administration, followed by oral and vaginal.
“Providers should educate themselves and the women who visit them about the differences between FDA-approved and less regulated [compounded] HT formulations, and the availability of FDA-approved and monitored therapies,” the researchers wrote. “This study also demonstrates the need for more research on the efficacy, safety and consistency of non-FDA-approved [compounded] HT to better understand benefits and risks for our patients and the need for tracking non-FDA-approved menopausal [HTs] to better understand how and why it is being used.” – by Amber Cox
Disclosure: TherapeuticsMD funded the study. Pinkerton reports receiving grant/research support from EndoCeutics and TherapeuticsMD; and consulting for Noven Pharmaceuticals, Pfizer, Shionogi and TherapeuticsMD. Constantine reports consulting for TherapeuticsMD.