Use of Compounded Bioidentical Hormone Therapy in Menopausal Women: An Opinion Statement of the Women's Health Practice and Research Network of the American College of Clinical Pharmacy

McBane, Sarah; Borgelt, Laura M.; Barnes, Kylie N.; Westberg, Sarah M.; Lodise, Nicole M.; Stassinos, Martha G.

doi:10.1002/phar.1394

Cited by 23 publications

(23 citation statements)

References 67 publications

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“…Most recognized women's health organizations in the United States, including the American Association of Clinical Endocrinologists, the American College of Obstetricians and Gynecologists, the American Society for Reproductive Medicine, The Endocrine Society, The North American Menopause Society, the US Preventive Services Task Force, and the Women's Health Practice and Research Network of the American College of Clinical Pharmacy, have position statements on HT that warn about the lack of scientific evidence supporting the efficacy and safety of CHT. 1 , 9 , 28 , 39 - 41 International organizations such as the International Menopause Society, the Australian Menopause Society, and the British Menopause Society have issued similar guidance. 42 - 44 Both The North American Menopause Society and the American College of Obstetricians and Gynecologists recommend that physicians who are considering prescribing CHT first determine whether an appropriate FDA-approved alternative is available.…”

Section: Discussionmentioning

confidence: 99%

Compounded bioidentical hormone therapy

Pinkerton

Santoro

2015

Menopause

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Objective:Two surveys (Harris and Rose surveys) were conducted to quantify the use of compounded hormone therapy (CHT; or bioidentical hormone therapy) among perimenopausal and postmenopausal women in the United States, to assess women's knowledge of CHT versus Food and Drug Administration (FDA)–approved hormone therapy, and to gather information on menopausal experience.Methods:The Harris survey was administered to 801 women aged 45 to 60 years who had experienced at least one menopausal symptom. The Rose survey was administered to 2,044 women aged 40 years or older who were ever users of hormone therapy. Women were queried about menopausal symptoms, hormone therapy use, and knowledge of CHT. Findings from the Rose survey were extrapolated using US Census Bureau data and prescription claims for FDA-approved hormone therapy to estimate the prevalence of CHT use.Results:According to extrapolations using Rose data, up to 2.5 million US women aged 40 years or older may use CHT annually, accounting for 28% to 68% of hormone therapy prescriptions. Harris data showed that 86% of women surveyed were unaware that CHT products are not FDA-approved. The Rose survey asked a subset of 1,771 women whether their hormone therapy had been personalized based on hormone levels; 21% (378) answered “yes” whereas 27% (476) did not know. In both surveys, most hormone therapy users stated that their physician had recommended the treatment.Conclusions:We estimate that 1 million to 2.5 million US women aged 40 years or older use CHT. The data suggest that many women are unaware that compounded hormones have not been evaluated or approved by the FDA. Providers have an educational opportunity to ensure that women considering hormone therapy understand the risks and benefits of inadequately regulated CHT.

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Section: Discussionmentioning

confidence: 99%

Compounded bioidentical hormone therapy

Pinkerton

Santoro

2015

Menopause

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“…17 These professional organizations state that women should be advised to use FDA-approved products whenever possible instead of CHT regimens, given the wide range of FDA-approved combinations, dosages, and dosage forms of bioidentical HT options. 1 , 12 , 17 , 39 …”

Section: Discussionmentioning

confidence: 99%

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

Pinkerton

Constantine

2016

Menopause

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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.

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“…In addition, a bioethicist evaluation of the Wiley Protocol advertisements found several ethical concerns: the protocol could be classified as human research but did not meet current research standards because it failed to use standard research ethics guidelines (e.g., informed consent, scientific methodology, and investigator expertise) and involved questionable methods of participant enrollment and sources of funding . Evidence does not support a clinical advantage of BHRT over conventional hormone replacement therapies, nor has the safety and efficacy of BHRT been established . Common issues with each of these examples (polypharmacy in compounded topical analgesics and the Wiley Protocol) center on the fact that participants are vulnerable and poorly informed of the risks that come with investigational therapy as well as the fact that appropriate regulation and oversight are lacking.…”

Section: Rational and Irrational Use Of Compounded Medicationsmentioning

confidence: 99%

Rational and irrational use of nonsterile compounded medications

McBane

Coon

Anderson

et al. 2019

J Am Coll Clin Pharm

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Nonsterile compounding is a fundamental component of pharmacy practice, and compounded medications are sometimes essential to optimize a patient's medication therapy. However, controversies surround the rational use of nonsterile compounded medications. Factors including drug cost and availability and the need for a precise dosage or unique formulation may provide a legitimate reason to prepare a compounded medication. Nonetheless, clinical pharmacists should ensure a rational basis for the use of such preparations. The relative paucity of data surrounding the regulation of these formulations, as well as that surrounding their promotion and production, complicates the evaluation of their safety and efficacy. This is especially true when compounded medications are used in special cases that already lack data for the use of commercially available products. Ethical issues also surround the rational use of these nonsterile compounded medications, including the absence of their proven safety and efficacy, the lack of regulation of promotional practices regarding their use, the pricing associated with them, the strategies needed to obtain third‐party coverage for them, and the limited standards in place for the actual production of compounded medications. Indeed, more evidence documenting the safety and efficacy of compounded medications is needed, together with standardization of formulations and better regulation of promotional practices and qualifications of compounding personnel. ACCP supports increased regulation of compounding to promote the appropriate use of these preparations.

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Use of Compounded Bioidentical Hormone Therapy in Menopausal Women: An Opinion Statement of the Women's Health Practice and Research Network of the American College of Clinical Pharmacy

Cited by 23 publications

References 67 publications

Compounded bioidentical hormone therapy

Compounded bioidentical hormone therapy

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

Rational and irrational use of nonsterile compounded medications

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