More Patient Education Needed on Compounded Hormone Therapy

Given the growing number of women taking a custom-compounded hormone therapy (CHT), a new study published in Menopause highlighted a greater need for patient education on the formulations.

The researchers’ objective was to find out more about the use of CHT among perimenopausal and postmenopausal US women and their knowledge of CHT and FDA-approved hormone therapy (HT).

Around 800 women aged 45 to 60 years who had experienced at least 1 menopausal symptom took the Harris poll, while approximately 2050 women aged ≥40 years who had used HT completed the Rose survey. Among these women, 21% reported having used personalized CHT. The Rose group was asked about their menopausal symptoms, HT use, and knowledge of CHT.

Based on census data, between 1 million to 2.5 million women aged ≥40 years may use CHT each year, which means CHT could account for 28% to 68% of all HT prescriptions.

Lack of knowledge on CHT was revealed by the fact that 76% of the women in the Harris survey said they did not know whether bioidentical HT compounded at specialty pharmacies were FDA-approved, and 10% said the products were FDA-approved. Only 14% correctly responded that they were not FDA-approved.

Among the Rose survey takers, a subset of 1771 women were asked whether their HT was personalized based on hormone levels, to which 27% responded that they did not know.

The study authors surmised that some women might choose CHT over FDA-approved HT due to CHT’s popularity on the Internet and the thought that it might be safer and more natural than commercially manufactured HT.

“The data suggest that many women are unaware that compounded hormones have not been evaluated or approved by the FDA,” the study authors concluded. “Providers have an educational opportunity to ensure that women considering HT understand the risks and benefits of inadequately regulated CHT.”

Jill Drury, PharmD, a clinical pharmacy specialist, told Pharmacy Times that educating patients about their medications—including risks and benefits—proves useful for adherence, decision-making, safety, and personal liability for one’s health.

“Pharmacists have an obligation to educate patients on all approved and unapproved medications, especially including compounded products,” Dr. Drury told Pharmacy Times. “Although prescribed by a health care provider, many compounded products are not clearly labeled nor are they accompanied with a plethora of patient-friendly educational reading materials. CHT ingredients and amounts can vary from provider to prescription—just like a grandmother's secret family recipe.”

Dr. Drury pointed out that pharmacists’ ultimate role is to ensure the safe and effective use of medications, and it is their responsibility to be accessible medical resources within the community.

Although both the Harris and Rose groups reported that they were most likely to get their HT products from a local pharmacy, Bill Mixon, RPh, MS, a member of the FDA’s Pharmacy Compounding Advisory Committee, told Pharmacy Times in an exclusive interview that some patients may receive compounded bioidentical hormone replacement therapy (BHRT) via the mail without direct pharmacist involvement, which may lead them to feel that they have not been adequately educated.

Dr. Mixon also pointed out that it is not accurate to label compounded BHRT as not FDA-approved.