Compounded Non-FDA-approved Menopausal Hormone Therapy

Results of a Pharmacy Survey

JoAnn V. Pinkerton, MD; Ginger D. Constantine, MD

Disclosures

Menopause. 2016;23(4):359-367. 

In This Article

Abstract and Introduction

Abstract

Objective. From a survey of compounding pharmacists, specific questions regarding compounded menopausal hormone therapy were used to estimate compounded hormone therapy (CHT) prescribing in the United States.

Methods. A national online survey was conducted by Rose Research—a market research company consisting of 12,250 US pharmacists from independent community pharmacies (ICPs) and compounding pharmacies (CPs). Pharmacists who completed the survey and met the prespecified criteria were eligible. Data from the survey were extrapolated to estimate overall CHT prescription volume and annual costs of CHT prescriptions for the United States based upon industry data from the National Community Pharmacists Association and IBISWorld.

Results. Surveys were completed by 483 pharmacies, including 365 ICPs and 118 CPs. On the basis of the survey responses and extrapolated industry data, an estimated 26 to 33 million CHT prescriptions were filled annually, with total sales estimated at $1.3 to $1.6 billion. CPs (vs ICPs) accounted for a higher proportion of CHT prescriptions. More than half of the ICPs (52%) and CPs (75%) expected continued compounding business growth, with most predicting 5% to 25% growth within 2 years, despite the potential effect of restrictive legislation regarding compounding.

Conclusions. On the basis of extrapolated data from numbers of prescriptions reported by pharmacists participating in the survey, the volume of CHT seems to approach that of Food and Drug Administration (FDA)-approved menopausal hormone therapy, and growth in the CHT market is expected. 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.

Introduction

Menopausal hormone therapy (MHT; see Table 1 for glossary of abbreviations), consisting of estrogen with or without a progestogen, is the most effective treatment for vasomotor symptoms (hot flushes and night sweats) and is often prescribed for other sequelae of menopause, such as sleep disturbances, mood, and quality of life; for osteoporosis prevention; and for relief of genitourinary syndrome of menopause (GSM, which encompasses vulvar and vaginal atrophy [VVA]).[1]

Publications from the Women's Health Initiative (WHI), however, reported health risks associated with MHT. As a consequence, women and providers became apprehensive about MHT, and its usage declined dramatically after 2002.[2,3,4,5,6] According to the National Health and Nutrition Examination Survey (NHANES), use of any oral MHT among women aged at least 40 years declined from 22.4% in 1999 to 2002, to 11.9% in 2003 to 2004, and reached a low of 4.7% in 2009 to 2010.[3] Data from the past decade showed a 61% decrease in prescriptions for MHT, from 93 to 36 million.[7] Pharmacy claims data also confirm a marked decline in prescriptions written immediately after publication of the WHI findings,[4,8,9] with one estimate indicating a 68% decline in overall MHT prescriptions between 2001 and 2008,[5] and another citing up to an 85% decline for estrogen–progestins between 2001 and 2005.[6] The decline of Food and Drug Administration (FDA)-approved MHT has slowly abated, with a very slight upturn between 2005 and 2010.[6]

Compounded hormone therapy (CHT), also referred to as "bioidentical hormone replacement therapy" (BHRT), is a marketing term that is not recognized by the FDA.[10] After the WHI reports in 2002, and the 2001 US Supreme Court ruling allowing pharmacies to market compounded products that were unregulated by the FDA,[11] the use of CHT became more prominent, whereas the use of FDA-approved MHT declined.[2,12] Many women consider CHT options to be more "natural" and safer because of unsubstantiated safety and efficacy claims in the media, internet, and from celebrities promoting them as a superior alternative to approved MHT.[2,12,13,14,15]

Prescription data for FDA-approved MHT are tracked and can be quantified, whereas compounded products are not FDA-approved and are thus not tracked. Therefore, surveys and market research studies have been performed in an attempt to understand the prescription numbers, use, and reasons for continued compounding. In a survey of 184 postmenopausal women presenting for consultation at the Mayo Clinic, Iftikhar et al[13] found that 20% reported ever-use and 14% reported current use of CHT. Pinkerton and Santoro[16] reported data from an online survey in 2013 and 2014 among more than 2,800 women aged 40 to 60 years, and extrapolating data from these surveys estimated that 1 to 2.5 million US women use CHT annually, with 21 to 39 million annual CHT prescriptions representing 28% to 68% of overall MHT prescribing, totaling $1 to $2 billion in spending.

Compounded hormone therapy formulations may have unique risks and may contain non-FDA–approved hormones (eg, estriol) or may have undesirable additives or preservatives. They are not monitored by the FDA for purity or dose standardization, and they are not required to carry a package insert (PI); thus they do not include potential warnings/contraindications as is required for FDA-approved MHT.[1,12,15,17] The products have not undergone FDA-approved rigorous studies evaluating efficacy or potential risk,[1,2] and no pharmacokinetic data are available for CHT formulations. Recent consumer online survey data indicate that 86% of consumers were unsure or unaware that these formulations are not FDA-approved,[16] whereas many websites for CHT are claiming better safety than for FDA-approved products.[18] Purported individualization of therapy frequently recommended by compounders via salivary estradiol and progesterone levels remains unproven.[2,12,15] In 2008, the FDA censured seven pharmacies because of unsubstantiated product claims.[2,14,19]

The majority of pharmacies and their professional organizations are dedicated to providing high-quality products.[20,21,22] Compounding pharmacies now have the option of being accredited by the Pharmacy Compounding Accreditation Board (PCAB).[22] The US Pharmacopeial Convention (USP) has developed standards for compounding to "help compounding practitioners adhere to widely acknowledged, scientifically sound procedures and practices, and facilitate the delivery of consistent and good-quality prepared medicines to people who are need of them."[23]

Given that the use and incidence of CHT prescribing seem to have increased,[2,12] and that the population is aging,[24] more research on actual prescribing and use of compounded products is needed.[13] To date, however, few reliable data are available on the extent of prescribing of CHT by US pharmacies and expected future trends.[13,16] Previously published consumer surveys by Pinkerton and Santoro[16] suggest highvolume use of CHT.

Using data from a large internet survey of US pharmacies conducted by Rose Research—a market research firm—and additional data from the National Community Pharmacists Association (NCPA)[25] and IBISWorld,[26] we have estimated the extent of CHT prescribing and overall annual costs.

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