title: Compounded non-FDA-approved menopausal hormone therapy prescriptions have increased: results of a pharmacy survey.
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.
authors.affiliation: 1Midlife Health Center, Department of Obstetrics and Gynecology, University of Virginia Health System, Charlottesville, VA 2EndoRheum Consultants LLC, Malvern, PA.
authors.forename: JoAnn V
authors.initials: JV
authors.lastname: Pinkerton
authors.forename: Ginger D
authors.initials: GD
authors.lastname: Constantine
mesh_terms: D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004339:Drug Compounding; D004345:Drug Industry / Q000331:legislation & jurisprudence; D015914:Estrogen Replacement Therapy / Q000009:adverse effects / Q000379:methods / Q000706:statistics & numerical data; D004967:Estrogens; D005260:Female; D006801:Humans; D020407:Internet; D008593:Menopause; D010595:Pharmacists; D055553:Prescription Drugs; D011372:Progestins; D011795:Surveys and Questionnaires; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
chemical_list: D004967:Estrogens; D055553:Prescription Drugs; D011372:Progestins