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

Pharmacotherapy

Volumn 34, Issue 4, 2014, Pages 410-423

  McBane, Sarah E ^a   Borgelt, Laura M ^b   Barnes, Kylie N ^c   Westberg, Sarah M ^d   Lodise, Nicole M ^e   Stassinos, Martha ^f  

^a UNIVERSITY OF CALIFORNIA SAN DIEGO   (United States)

^b UNIVERSITY OF COLORADO   (United States)

^c UNIVERSITY OF MISSOURI KANSAS CITY   (United States)

^d UNIVERSITY OF MINNESOTA   (United States)

^e ALBANY COLLEGE OF PHARMACY AND HEALTH SCIENCES   (United States)

^f VA NORTHERN CALIFORNIA HEALTH CARE SYSTEM   (United States)

Author keywords

bioidentical hormones; compounding; estrogen; hormone therapy; menopause; progestogen

Indexed keywords

ESTRADIOL; ESTRIOL; ESTROGEN; ESTRONE; PROGESTERONE; TESTOSTERONE;

ATTITUDE TO HEALTH; COMPOUNDED BIOIDENTICAL HORMONE THERAPY; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG SAFETY; FEMALE; HEALTH CARE PERSONNEL; HEALTH CARE PRACTICE; HEALTH CARE QUALITY; HEALTH HAZARD; HORMONAL THERAPY; HUMAN; MATERNAL ATTITUDE; MEDICAL INFORMATION; MENOPAUSAL SYNDROME; PATIENT EDUCATION; QUALITY CONTROL; REVIEW; RISK BENEFIT ANALYSIS; ADULT; DRUG EFFECTS; DRUG FORMULATION; ESTROGEN THERAPY; MENOPAUSE; MIDDLE AGED; WOMEN'S HEALTH;

ADULT; DRUG COMPOUNDING; ESTROGEN REPLACEMENT THERAPY; FEMALE; HUMANS; MENOPAUSE; MIDDLE AGED; PATIENT EDUCATION AS TOPIC; WOMEN'S HEALTH;

EID: 84898837139     PISSN: 02770008     EISSN: None     Source Type: Journal    
DOI: 10.1002/phar.1394     Document Type: Review

References (88)

1. Williams RE, Kalilani L, DiBenedetti DB, et al. Frequency and severity of vasomotor symptoms among peri- and postmenopausal women in the United States. Climacteric 2008; 11: 32-43.
2. North American Menopause Society. The hormone therapy position statement of: The North American Menopause Society. Menopause 2012; 19: 257-71.
3. Anderson GL, Judd HL, Kaunitz AM, et al. Effects of estrogen plus progestin on gynecologic cancers and associated diagnostic procedures: the Women's Health Initiative randomized trial. JAMA 2003; 290: 1739-48.
4. Grady D, Gebretsadik T, Kerlikowske K, Ernster V, Petitti D,. Hormone replacement therapy and endometrial cancer risk: a meta-analysis. Obstet Gynecol 1995; 85: 304-13.
5. Rossouw JE, Anderson GL, Prentice RL, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA 2002; 288: 321-33.
6. Prentice RL, Chlebowski RT, Stefanick ML, et al. Conjugated equine estrogens and breast cancer risk in the Women's Health Initiative clinical trial and observational study. Am J Epidemiol 2008; 167: 1407-15.
7. Beral V, Reeves G, Bull D, Green J,. Breast cancer risk in relation to the interval between menopause and starting hormone therapy. J Natl Cancer Inst 2011; 103: 296-305.
8. Chlebowski RT, Schwartz AG, Wakelee H, et al. Oestrogen plus progestin and lung cancer in postmenopausal women (Women's Health Initiative trial): a post-hoc analysis of a randomised controlled trial. Lancet 2009; 374: 1243-51.
9. Chlebowski RT, Anderson GL, Gass M, et al. Estrogen plus progestin and breast cancer incidence and mortality in postmenopausal women. JAMA 2010; 304: 1684-92.
10. Chlebowski RT, Anderson GL, Manson JE, et al. Lung cancer among postmenopausal women treated with estrogen alone in the women's health initiative randomized trial. J Natl Cancer Inst 2010; 102: 1413-21.
11. Beral V, Bull D, Green J, Reeves G,. Ovarian cancer and hormone replacement therapy in the Million Women Study. Lancet 2007; 369: 1703-10.
12. Lacey JV Jr, Brinton LA, Leitzmann MF, et al. Menopausal hormone therapy and ovarian cancer risk in the National Institutes of Health-AARP Diet and Health Study Cohort. J Natl Cancer Inst 2006; 98: 1397-405.
13. Shumaker SA, Legault C, Rapp SR, et al. Estrogen plus progestin and the incidence of dementia and mild cognitive impairment in postmenopausal women: the Women's Health Initiative Memory Study: a randomized controlled trial. JAMA 2003; 289: 2651-62.
14. Conaway E,. Bioidentical hormones: an evidence-based review for primary care providers. J Am Osteopath Assoc 2011; 111: 153-64.
15. de Villiers TJ, Gass ML, Haines CJ, et al. Global consensus statement on menopausal hormone therapy. Climacteric 2013; 16: 203-4.
16. American College of Obstetricians and Gynecologists. Compounded bioidentical menopausal hormone therapy. Fertil Steril 2012; 98: 308-12.
17. Santen RJ, Allred DC, Ardoin SP, et al. Postmenopausal hormone therapy: An endocrine society scientific statement. J Clin Endocrinol Metab 2010; 95: s1-66.
18. American Medical Association House of Delegates Resolution 706. FDA Oversight of Bio-identical Hormone (BH) Preparations.
19. Pines A, Sturdee DW, Birkhauser MH, Schneider HP, Gambacciani M, Panay N,. IMS updated recommendations on postmenopausal hormone therapy. Climacteric 2007; 10: 181-94.
20. Cobin RHPS, Bledsoe MB, Borg WP, et al. American Association of Clinical Endocrinologists (AACE) Reproductive Medicine Committee Position Statement on Bioidentical Hormones updated 7/15/2007. Available from https://www.aace.com/ files/position-statements/aacebhstatement071507.pdf. Accessed December 9, 2013.
21. Women's International Pharmacy. Female Hormone Therapy Options. Available from http://www.womensinternational.com/dosing.html. Accessed September 27, 2013.
22. Goodman NF, Cobin RH, Ginzburg SB, Katz IA, Woode DE,. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for the diagnosis and treatment of menopause: executive summary of recommendations. Endocr Pract 2011; 17: 1-25.
23. Ruiz AD, Daniels KR, Barner JC, Carson JJ, Frei CR,. Effectiveness of compounded bioidentical hormone replacement therapy: an observational cohort study. BMC Womens Health 2011; 11: 27.
24. Iftikhar S, Shuster LT, Johnson RE, Jenkins SM, Wahner-Roedler DL,. Use of bioidentical compounded hormones for menopausal concerns: cross-sectional survey in an academic menopause center. J Womens Health (Larchmt) 2011; 20: 559-65.
25. U.S. Pharmcopeia. 795: pharmaceutical compounding-nonsterile preparations. Available from http://www.pharmacopeia.cn/v29240/usp29nf24s0-c795. html. Accessed December 9, 2013.
26. Food and Drug Administration. Compounded menopausal hormone therapy questions and answers. Available from http://www.fda.gov/Drugs/ GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm183088.htm. Accessed December 9, 2013.
27. Pharmacy Compounding Accreditation Board. Available from http://www.pcab.org/. Accessed December 9, 2013.
28. International Academy of Compounding Pharmacies. Pharmacy compounding is a well-regulated, safe and legal practice. Available from http://iacprx.org/. Accessed December 9, 2013.
29. Professional Compounding Centers of America. About PCCA. Available from http://www.pccarx.com. Accessed December 9, 2013.
30. U.S. Pharmacopeia. Mission and history. Available from http://www.usp.org/about-usp/our-impact/mission-history. Accessed December 9, 2013.
31. American Psychiatric Association. Diagnostic and statistical manual of mental disorders FEA, VA, American Psychiatric Association, 2013. Available from http://dsm.psychiatryonline.org. Accessed December 9, 2013.
32. West SL, D'Aloisio AA, Agans RP, Kalsbeek WD, Borisov NN, Thorp JM,. Prevalence of low sexual desire and hypoactive sexual desire disorder in a nationally representative sample of US women. Arch Intern Med 2008; 168: 1441-9.
33. Woodis CB, McLendon AN, Muzyk AJ,. Testosterone supplementation for hypoactive sexual desire disorder in women. Pharmacotherapy 2012; 32: 38-53.
34. Krapf JM, Simon JA,. The role of testosterone in the management of hypoactive sexual desire disorder in postmenopausal women. Maturitas 2009; 63: 213-9.
35. Genazzani AR, Stomati M, Valentino V, et al. Effect of 1-year, low-dose DHEA therapy on climacteric symptoms and female sexuality. Climacteric 2011; 14: 661-8.
36. Goel RM, Cappola AR,. Dehydroepiandrosterone sulfate and postmenopausal women. Curr Opin Endocrinol Diabetes Obes 2011; 18: 171-6.
37. Files JA, Ko MG, Pruthi S,. Bioidentical hormone therapy. Mayo Clin Proc 2011; 86: 673-80; quiz 680.
38. Dietary Supplement Health And Education Act of 1994. Available from http://www.health.gov/dietsupp/ch1.htm. Accessed December 9, 2013
39. American College of Obstetricians and Gynecologists (ACOG). Compounded bioidentical menopausal hormone therapy. Available from http://www.acog.org/ Resources-And-Publications/Committee-Opinions/Committee-on-Gynecologic-Practice/ Compounded-Bioidentical-Menopausal-Hormone-Therapy. Accessed December 9, 2013.
40. Lewis JG, McGill H, Patton VM, Elder PA,. Caution on the use of saliva measurements to monitor absorption of progesterone from transdermal creams in postmenopausal women. Maturitas 2002; 41: 1-6.
41. Adams C, Cannell S,. Women's beliefs about "natural" hormones and natural hormone replacement therapy. Menopause 2001; 8: 433-40.
42. Hankinson SE, Willett WC, Manson JE, et al. Plasma sex steroid hormone levels and risk of breast cancer in postmenopausal women. J Natl Cancer Inst 1998; 90: 1292-9.
43. Lippert C, Seeger H, Mueck AO,. The effect of endogenous estradiol metabolites on the proliferation of human breast cancer cells. Life Sci 2003; 72: 877-83.
44. Eden JA, Hacker NF, Fortune M,. Three cases of endometrial cancer associated with "bioidentical" hormone replacement therapy. Med J Aust 2007; 187: 244-5.
45. Rosenthal MS,. Ethical problems with bioidentical hormone therapy. Int J Impot Res 2008; 20: 45-52.
46. North American Menopause Society. Hormone products for postmenopausal use in the United States and Canada. Available from http://www.menopause.org/ publications/clinical-practice-materials/hormone-therapy-charts. Accessed December 9, 2013.
47. Bhavnani BR, Stanczyk FZ,. Misconception and concerns about bioidentical hormones used for custom-compounded hormone therapy. J Clin Endocrinol Metab 2012; 97: 756-9.
48. Sood R, Warndahl RA, Schroeder DR, et al. Bioidentical compounded hormones: a pharmacokinetic evaluation in a randomized clinical trial. Maturitas 2013; 74: 375-82.
49. Patsner B,. Pharmacy compounding of bioidentical hormone replacement therapy (BHRT): a proposed new approach to justify FDA regulation of these prescription drugs. Food Drug Law J 2008; 63: 459-91.
50. Food and Drug Administration. Report: limited FDA survey of compounded drug products. 2009. Available at http://www.fda.gov/Drugs/ GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm155725.htm. Accessed December 9, 2013.
51. Centers for Disease Control and Prevention. Multistate fungal meningitis outbreak investigation. Available from http://www.cdc.gov/hai/outbreaks/ meningitis.html. Accessed December 9, 2013.
52. Summary: 2013 FDA pharmacy inspection assignment. Available from http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ PharmacyCompounding/ucm347722.htm. Accessed December 9, 2013.
53. th Congress, 2013-2015. Available at https://www.govtrack.us/congress/bills/113/ hr3204/text. Accessed December 9, 2013.
54. Barnabei VM, Cochrane BB, Aragaki AK, et al. Menopausal symptoms and treatment-related effects of estrogen and progestin in the Women's Health Initiative. Obstet Gynecol 2005; 105: 1063-73.
55. NIH State-of-the-Science Panel. National Institutes of Health State-of-the-Science Conference statement: management of menopause-related symptoms. Ann Intern Med 2005; 142: 1003-13.
56. Suckling J, Lethaby A, Kennedy R,. Local oestrogen for vaginal atrophy in postmenopausal women. Cochrane Database Syst Rev 2006; Issue 4: CD001500.
57. Cody JD, Jacobs ML, Richardson K, Moehrer B, Hextall A,. Oestrogen therapy for urinary incontinence in post-menopausal women. Cochrane Database Syst Rev 2012; Issue 10: CD001405.
58. Nelken RS, Ozel BZ, Leegant AR, Felix JC, Mishell DR Jr,. Randomized trial of estradiol vaginal ring versus oral oxybutynin for the treatment of overactive bladder. Menopause 2011; 18: 962-6.
59. Raz R, Stamm WE,. A controlled trial of intravaginal estriol in postmenopausal women with recurrent urinary tract infections. N Engl J Med 1993; 329: 753-6.
60. Eriksen B,. A randomized, open, parallel-group study on the preventive effect of an estradiol-releasing vaginal ring (Estring) on recurrent urinary tract infections in postmenopausal women. Am J Obstet Gynecol 1999; 180: 1072-9.
61. Cauley JA, Robbins J, Chen Z, et al. Effects of estrogen plus progestin on risk of fracture and bone mineral density: the Women's Health Initiative randomized trial. JAMA 2003; 290: 1729-38.
62. Jackson RD, LaCroix AZ, Gass M, et al. Calcium plus vitamin D supplementation and the risk of fractures. N Engl J Med 2006; 354: 669-83.
63. Ouyang P, Michos ED, Karas RH,. Hormone replacement therapy and the cardiovascular system lessons learned and unanswered questions. J Am Coll Cardiol 2006; 47: 1741-53.
64. Rossouw JE, Prentice RL, Manson JE, et al. Postmenopausal hormone therapy and risk of cardiovascular disease by age and years since menopause. JAMA 2007; 297: 1465-77.
65. Akhrass F, Evans AT, Wang Y, et al. Hormone replacement therapy is associated with less coronary atherosclerosis in postmenopausal women. J Clin Endocrinol Metab 2003; 88: 5611-4.
66. Barrett-Connor E, Laughlin GA,. Hormone therapy and coronary artery calcification in asymptomatic postmenopausal women: the Rancho Bernardo Study. Menopause 2005; 12: 40-8.
67. Manson JE, Allison MA, Rossouw JE, et al. Estrogen therapy and coronary-artery calcification. N Engl J Med 2007; 356: 2591-602.
68. Margolis KL, Bonds DE, Rodabough RJ, et al. Effect of oestrogen plus progestin on the incidence of diabetes in postmenopausal women: results from the Women's Health Initiative Hormone Trial. Diabetologia 2004; 47: 1175-87.
69. Kanaya AM, Herrington D, Vittinghoff E, et al. Glycemic effects of postmenopausal hormone therapy: the Heart and Estrogen/progestin Replacement Study. A randomized, double-blind, placebo-controlled trial. Ann Intern Med 2003; 138: 1-9.
70. Chlebowski RT, Wactawski-Wende J, Ritenbaugh C, et al. Estrogen plus progestin and colorectal cancer in postmenopausal women. N Engl J Med 2004; 350: 991-1004.
71. Johnson JR, Lacey JV Jr, Lazovich D, et al. Menopausal hormone therapy and risk of colorectal cancer. Cancer Epidemiol Biomarkers Prev 2009; 18: 196-203.
72. Anderson GL, Limacher M, Assaf AR, et al. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial. JAMA 2004; 291: 1701-12.
73. Beral V,. Breast cancer and hormone-replacement therapy in the Million Women Study. Lancet 2003; 362: 419-27.
74. Cushman M, Kuller LH, Prentice R, et al. Estrogen plus progestin and risk of venous thrombosis. JAMA 2004; 292: 1573-80.
75. Manson JE, Hsia J, Johnson KC, et al. Estrogen plus progestin and the risk of coronary heart disease. N Engl J Med 2003; 349: 523-34.
76. FDA. Bioidenticals: sorting myths from facts. Available from http://www.fda.gov/forconsumers/consumerupdates/ucm049311.htm. Accessed December 9, 2013.
77. USP Monograph Certificate Estriol. Available from www.usp.org/pdf/EN/ referenceStandards/certificates/1254508-K0H209.pdf. Accessed December 9, 2013.
78. Sood R, Shuster L, Smith R, Vincent A, Jatoi A,. Counseling postmenopausal women about bioidentical hormones: ten discussion points for practicing physicians. J Am Board Fam Med 2011; 24: 202-10.
79. North American Menopause Society. FAQs Hormone Therapy Basics. Available from http://www.menopause.org/for-women/expert-answers/faqs-hormone-therapy- basics. Accessed December 9, 2013.
80. National Center for Complementary and Alternative Medicine (NCCAM). Menopausal symptoms and complementary health practices. Available from http://nccam.nih.gov/health/menopause/menopausesymptoms?nav=gsa. Accessed December 9, 2013.
81. Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS,. Evidence based medicine: what it is and what it isn't. BMJ 1996; 312: 71-2.
82. Roush K,. Menopausal hormone therapy: what we know now. Am J Nurs 2011; 111: 38-47; quiz 48-9.
83. Sayakhot P, Vincent A, Teede H,. Breast cancer and menopause: perceptions of diagnosis, menopausal therapies and health behaviors. Climacteric 2012; 15: 59-67.
84. Sayakhot P, Vincent A, Teede H,. Breast cancer and menopause: partners' perceptions and personal experiences-a pilot study. Menopause 2012; 19: 916-23.
85. MacLennan AH,. The four harms of harmless therapies. Climacteric 1999; 2: 73-4.
86. MacLennan AH, Sturdee DW,. The "bioidentical/bioequivalent" hormone scam. Climacteric 2006; 9: 1-3.
87. Barrett-Connor E, Slone S, Greendale G, et al. The Postmenopausal Estrogen/Progestin Interventions Study: primary outcomes in adherent women. Maturitas 1997; 27: 261-74.
88. Grady D, Applegate W, Bush T, Furberg C, Riggs B, Hulley SB,. Heart and Estrogen/progestin Replacement Study (HERS): design, methods, and baseline characteristics. Control Clin Trials 1998; 19: 314-35.