Menopausal Hormone Therapy: Compounded Products Making Gains

Kate Johnson

December 23, 2015

The popularity of compounded menopausal hormone therapy in the United States currently rivals that of traditional formulations approved by the US Food and Drug Administration (FDA), raising concerns with the North American Menopause Society (NAMS). The group released the results of a pharmacy survey online December 7 in Menopause.

"Despite the increased quality risks and the lack of safety and efficacy data for non-FDA regulated compounded hormone therapy [CHT] formulations, their use by menopausal women is higher than expected and appears to be continuing to grow," said Wulf H. Utian, MD, PhD, DSc(Med), executive director emeritus of NAMS, in a news release.

The national online survey included 365 independent community pharmacies (ICPs) and 118 compounding pharmacies (CPs).

As previously reported by Medscape Medical News, a consumer survey conducted by NAMS earlier this year showed that 41% of hormone users were choosing CHT over FDA-approved alternatives.

Combining the current survey responses with industry data from the National Community Pharmacists Association and IBISWorld, researchers JoAnn Pinkerton, MD, president of NAMS, and Ginger Constantine, MD, from EndoRheum Consultants, Malvern, Pennsylvania, estimated that between 26 and 33 million prescriptions for CHT are filled annually in the United States, with sales totaling from $1.3 to $1.6 billion.

These numbers approach the 36 million prescriptions and $1 to $2 billion in annual sales for FDA-approved hormone therapy, they note.

Pharmacists indicate in the survey that CHT represents an important percentage of their business, with more than two thirds of pharmacists from ICPs and more than three quarters of those from CPs predicting similar or increased CHT business in the next 2 years, report the researchers.

But NAMS and other professional medical associations have voiced concerns about the safety and efficacy of CHT.

In addition to NAMS, the American Congress of Obstetricians and Gynecologists, the American Association of Clinical Endocrinologists, the American College of Clinical Pharmacy, the Australian Menopause Society, the Endocrine Society, the American Society for Reproductive Medicine, and the US Preventive Services Task Force state that women should be advised to use FDA-approved products whenever possible.

"CHT carries unique risks," write Dr Pinkerton and Dr Constantine, adding that "CHT products do not come with a package insert of indications and potential risks, whereas all FDA-approved estrogen products include this along with the boxed warning based on the findings from the [Women's Health Initiative]."

They conclude, "[P]roviders should educate themselves and the women who visit them about the differences between FDA-approved and less regulated CHT formulations."

TherapeuticsMD funded the study. Dr Pinkerton has received grants and research support (paid to the University of Virginia) from TherapeuticsMD Inc and EndoCeutics Inc and has served as a consultant (fees paid to the University of Virginia) for Pfizer Inc, Noven Pharmaceuticals Inc, TherapeuticsMD Inc, and Shionogi Inc. Dr Constantine consults for pharmaceutical companies including but not limited to Therapeutics MD.

Menopause. Posted online December 7, 2015. Abstract

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