Number of unregulated compounded menopausal HT purchases nears number FDA-approved prescriptions

Issue: April 2015

SAN DIEGO — An estimated 26 million to 33 million total prescriptions are filled annually for custom compounded menopausal hormone therapy, approaching the 36 million FDA-approved therapies prescribed, according to research presented at The Endocrine Society annual meeting.

Perspective from Cynthia A. Stuenkel, MD

To help patients understand the potential risk-benefit ratio of unregulated custom compounding, clinicians should familiarize themselves with the differences between the less tested and less regulating and regulated treatment options, according to researchers.

“We learned the amount of FDA-approved menopausal hormone therapy has decreased … but the amount of compounded non-FDA-approved menopausal HT has increased,” JoAnn V. Pinkerton, MD, of University of Virginia, Charlottesville, said in a press conference. “The FDA-approved HT market has stabilized out at about 3.7 million users with a market of about $3 billion to $4 billion. But our estimation of the compounded bioidentical hormone therapy market is 1 million to 2.5 million users, or $1 billion to $2 billion.”

JoAnn V. Pinkerton

Pinkerton, with Ginger D. Constantine, MD, of EndoRheum Consultants LLC, Malvern, Pennsylvania, conducted a survey representing pharmacists that provide compounding services in the U.S.; Rose Research utilized an online survey representing pharmacists that provide compounding services in the United States; Rose Research conducted the survey on behalf of inThought Research and the International Journal of Pharmaceutical Compounding.

Through survey data, compounded HT prescriptions could be estimated and the extrapolated potential trend during the next 2 years assessed; 12,250 e-mail invitations were sent to potential participants, with approximately $17 to $35 in cash or merchandise offered as a reward for completing the survey.

Screening questions were answered by 24%, and 904 responders met the initial criteria of sufficient knowledge about compounding practices, including independent community pharmacies (ICP; < 50 stores, n = 717) or independent compounding pharmacies (CP; (n = 187).

Compounding services were performed at 70% of ICPs and 96% of CPs, based on 685 responses; 483 (365 ICPs and 118 CPs) completed the full survey related to compounding.

“We used industry data to determine the overall numbers and the average percentages of the different types of pharmaceuticals they compounded to come up with an estimation of the nationwide volume and cost,” Pinkerton said.

Considering survey response, numbers of ICPs and CPs in the United States and reported average percentage of compounding from the National Community Pharmacists Association and IBISWorld, up to 26 million to 36 million total custom compounded prescriptions may be filled each year.

“When we extrapolate the results of this survey data, the market may approach $1.3billion to $1.7 billion,” Pinkerton said.

Pharmacists expect stability or continued growth during the next 2 years. The majority of respondents from ICPs (52%) and CPs (75%) predict a 5% to 25% increase during this period.

“It’s important that providers, consumers and women understand the differences between FDA-approved and the less regulated, less tested, compounded products — and some of the unique risks of compounding,” Pinkerton said. – by Allegra Tiver

Reference:

Pinkerton JV. Constantine GD. Poster Board FRI-124. Presented at: The Endocrine Society Annual Meeting; March 5-8, 2015, San Diego.

Disclosure: Pinkerton reports financial relationships with Noven, Pfizer, Shionogi, and TherapeuticsMD (fees to University of Virginia).

Perspective

Cynthia A. Stuenkel, MD

Those in menopausal medicine recall the initial alarming reports from the Women’s Health Initiative in 2002 and the subsequent exodus from menopausal hormone therapy (MHT) by a majority of women and their prescribers. In that vacuum, the evolution of the compounded “bioidentical” hormone replacement therapy (BHRT) enterprise has been nothing short of phenomenal, in spite of a lack of evidence to support efficacy, disconcerting reports regarding inconsistencies in content, lack of manufacturing standards, absence of package labeling outlining risks and benefits, and cautionary statements by prominent medical societies. Furthermore, without federal or state monitored pharmacy records, it was challenging to estimate how many prescriptions were filled. The report by Pinkerton and colleagues informs us that compounded BHRT prescriptions may be close to parity with FDA-approved MHT. We must increase awareness of practitioners and patients of potential safety implications associated with BHRT while reminding them that FDA-approved estradiol and progesterone therapies are preferred.

Cynthia A. Stuenkel, MD

Clinical Professor of Medicine

University of California, San Diego, La Jolla, California

Disclosures: Stuenkel reports being past president for the North American Menopause Society and chair of the writing group for the Endocrine Society Clinical Practice Guideline on Treatment of Menopause Symptoms.