Compounded non-FDA–approved menopausal hormone therapy prescriptions have increased

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.

Prescribing of FDA-approved and compounded hormone therapy differs by specialty

“…This report is the third in a series of surveys designed to elucidate the scope of the CHT market in the United States. 17 , 19 The first was a report using prescription claims for FDA-approved HT and US Census data to extrapolate data from surveys of consumers to estimate the number of women using CHT annually at up to 2.5 million, representing 28% to 68% of all HT prescriptions. 17 The second report, using a survey of pharmacists, National Community Pharmacists Association data, and IBISWorld data, concluded that approximately 26 to 33 million CHT prescriptions are filled annually at a cost of between $1.3 and $1.6 billion.…”

“…The objective of this survey was to assess physicians’ prescribing practices of HT, in particular CHT, among US physicians of different specialties. The survey of physicians reported here is the third in a series of three reports on the results of surveys of consumers, 17 compounding pharmacists, 19 and physicians, designed to gain a clearer picture of the size of the CHT market and the reasons behind its growth.…”

Efeitos das terapias na menopausa: uma revisão narrativa da literatura

“…Essa terapia foi amplamente utilizada entre as mulheres até 2002, mas as atitudes das mulheres e dos clínicos mudaram, consideravelmente, nos últimos anos. Estudos concluíram que os efeitos nocivos da TRH excedem os benefícios e o fato ocasionou uma diminuição das prescrições médicas, levando as mulheres a buscar terapias alternativas 14 .…”

A combined, bioidentical, oral, 17β-estradiol and progesterone capsule for the treatment of moderate to severe vasomotor symptoms due to menopause

“…After the Women's Health Initiative (WHI) trial identified potential risks with HT containing synthetic progestin [7], an increasing demand for bioidentical HT containing estradiol (E2) and progesterone (P4) was observed [8] as many women perceive bioidentical HT to be more 'natural' and safer [9][10][11][12]. Since no US Food and Drug Administration (FDA)approved bioidentical combination products were available at that time, many women opted to take unapproved, unregulated compounded HT (CHT; commonly advertised as bioidentical).…”

“…Since no US Food and Drug Administration (FDA)approved bioidentical combination products were available at that time, many women opted to take unapproved, unregulated compounded HT (CHT; commonly advertised as bioidentical). As of 2016, an estimated 33 million prescriptions were filled annually in the US for CHT [8]. However, due to the lack of quality control, unestablished safety and efficacy, and low level of regulatory oversight, medical societies [5,6] and the FDA [13] recommend against the use of CHT.…”