Healthcare As Individual As You


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Women are as unique as their fingerprints, inside and outside. It is this fundamental premise that prompted Marla Ahlgrimm R. Ph. nearly 30 years ago to develop her revolutionary approach to helping women balance their unique hormone fingerprint, bioidentically, one woman at a time, with The Restore® Program. Learn why and how in this presentation.

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Healthcare As Individual As You

  1. 1. Healthcare as individual as you!
  2. 2. OBJECTIVES <ul><li>Understand the benefits of Hormone Therapy </li></ul><ul><li>Understand the benefits of customized Bio-identical Hormone Therapy (BHT) </li></ul><ul><li>Understand the benefits of saliva and urine testing and monitoring to help customize proper BHT dosing </li></ul>
  3. 3. HORMONE THERAPY <ul><li>An approach featuring the introduction of hormones into the body with the goal of stabilizing, or reversing, the body’s natural hormone decline during perimenopause, menopause and post-menopause. </li></ul>
  4. 4. Hormone Therapy <ul><li>A hot media topic PAST… </li></ul>
  5. 5. And Also a Concern of the Present
  6. 6. <ul><li>This information </li></ul><ul><li>IS VERY CONFUSING!!! </li></ul><ul><li>Hormone Therapy is one of the most important and difficult decisions that a women makes. </li></ul>
  7. 7. Today’s Women Are… <ul><li>Hungry for credible, solid information </li></ul><ul><li>Inundated with health information </li></ul><ul><li>Searching for a source they can trust </li></ul><ul><li>Excited to learn about new health options </li></ul><ul><li>Active participants in their own health </li></ul><ul><li>Seeking more personalized health care </li></ul>
  8. 8. Common Concerns… <ul><li>Should I take hormones or not? </li></ul><ul><li>How do I know which ones are right for me? </li></ul><ul><li>How much should I take? </li></ul><ul><li>How long should I be on hormone replacement? </li></ul>
  9. 9. The Role of Hormones Throughout a Woman’s Life <ul><li>Conception </li></ul><ul><li>Puberty </li></ul><ul><li>Reproductive years </li></ul><ul><li>Perimenopause </li></ul><ul><li>Menopause and beyond </li></ul>
  10. 10. If You’re on Hormone Therapy (HT)… <ul><li>Do you know your cholesterol rate? </li></ul><ul><li>Has your doctor ordered a bone mineral density (BMD) test? </li></ul>
  11. 11. Continued Demand for Bio-Identical Hormone Therapy to Treat Menopause <ul><li>73% Increase in women aged 45-54 </li></ul><ul><li>60% of all women are post-menopausal </li></ul><ul><li>5,000 women enter menopause each day </li></ul>
  12. 12. Continued Demand for Bio-Identical Hormone Therapy to Treat PMS Symptoms <ul><li>Effects about 70-90% of women during childbearing years </li></ul><ul><li>30-40% Have sever symptoms </li></ul><ul><li>7-10% Have disabling symptoms </li></ul>
  13. 13. Hormones can influence: <ul><li>Brain </li></ul><ul><li>Breasts </li></ul><ul><li>Bones </li></ul><ul><li>Sex Drive </li></ul><ul><li>Appetite </li></ul><ul><li>Bladder </li></ul><ul><li>Skin </li></ul><ul><li>Menstrual Cycle </li></ul><ul><li>Metabolism </li></ul><ul><li>Memory </li></ul><ul><li>Lungs </li></ul><ul><li>Hair </li></ul><ul><li>Energy Level </li></ul><ul><li>Fertility </li></ul><ul><li>Sleep </li></ul>
  14. 14. Conventional Hormone Therapy (HT) <ul><li>One size fits all </li></ul><ul><li>No consideration for individual needs or how well a woman feels on standard dosages </li></ul><ul><li>Limited dosing/formulation options </li></ul><ul><li>Is “FDA Approved” </li></ul>
  15. 15. Assumptions Addressed by Individualized Bio-Identical Hormone Therapy <ul><li>One size does NOT fit all </li></ul><ul><li>Each woman’s hormonal profile is as unique as her fingerprint </li></ul><ul><li>Every woman produces, absorbs and metabolizes hormones differently </li></ul><ul><li>Unlimited dosing/formulation options!! </li></ul>
  16. 16. Hormone Therapy Statistics: Conventional Therapy <ul><li>Despite the benefits, women discontinue Hormone Therapy </li></ul><ul><li>50% stop within 1 year </li></ul><ul><li>80% stop within 3 years </li></ul><ul><li>40% never even fill a second, different prescription </li></ul>
  17. 17. Why Women Stop Hormone Therapy <ul><li>Most women stop treatment due to symptoms of under dosing or side effects of over dosing </li></ul><ul><li>Effects may include </li></ul><ul><ul><li>Depression </li></ul></ul><ul><ul><li>Mood swings </li></ul></ul><ul><ul><li>Fluid retention </li></ul></ul>
  18. 18. There’s a B etter, More Exact Way <ul><li>Measuring exact hormone needs </li></ul><ul><li>Developing a prescription customized to those levels </li></ul><ul><li>Using natural, bio-identical hormones with fewer side effects </li></ul>
  19. 19. <ul><li>The Cornerstone of Successful Hormone Therapy is: </li></ul><ul><li>Bio-Identical Hormones (identical to what the body makes naturally) </li></ul>
  20. 20. The Restore ® Program Protocol <ul><li>Listen to symptoms </li></ul><ul><li>Test for low hormone levels </li></ul><ul><li>Diagnose </li></ul><ul><li>Treat (prescribe) only for diagnosed deficiencies </li></ul><ul><li>Monitor ongoing results </li></ul><ul><li>Re-test and adjust as part of ongoing treatment </li></ul>
  21. 21. What are natural hormones? <ul><li>Specific USP prescription pharmaceuticals regulated by the FDA </li></ul><ul><li>Not health foods or herbal extracts </li></ul>
  22. 22. What are natural hormones? <ul><li>Plant derived (not an extract) </li></ul><ul><li>Chemically bio-identical to hormones produced in the body </li></ul><ul><li>Key factor is molecular structure, not source </li></ul><ul><ul><li>i.e. Estradiol, USP is natural whether a capsule, tablet or patch. </li></ul></ul>
  23. 24. Hormones -> Receptors = Perfect Fit <ul><li>To be most effective, a hormone must fit perfectly with receptors located on cells, like a key fits a lock </li></ul>
  24. 25. Metabolism <ul><li>Natural, Bio-Identical Hormones </li></ul><ul><ul><li>The human body HAS enzymes that can metabolize </li></ul></ul><ul><li>Synthetic Hormones </li></ul><ul><ul><li>The human body may LACK enzymes to metabolize </li></ul></ul><ul><ul><ul><li>Side effects </li></ul></ul></ul><ul><ul><ul><li>Potency concerns </li></ul></ul></ul><ul><ul><ul><li>Duration of action concerns </li></ul></ul></ul>
  25. 26. A Closer Look at Some Bio-Identical Hormones <ul><li>ESTRADIOL (E2 + E3) </li></ul><ul><li>PROGESTERONE </li></ul><ul><li>TESTOSTERONE </li></ul>
  26. 27. Estradiol <ul><li>• Most potent of the three main estrogens </li></ul><ul><li>• Receptor sites in 300+ places, e.g. bladder, vaginal tract, brain, skin, bone </li></ul><ul><li>• Slows memory and bone loss and colon cancer </li></ul><ul><li>• Considered the “up hormone”, increases anxiety, irritability, mood swings </li></ul>
  27. 28. Estradiol <ul><li>Range in serum levels of estradiol </li></ul><ul><li>12 hours (+/- 2) after dose of conjugated estrogens and micronized estradiol. </li></ul><ul><li>Dose Max. (pg/ml) Min. (pg/ml) Range (pg/ml) </li></ul><ul><li>Conjugated estrogens </li></ul><ul><li>0.6725 mg n=5 268 88 180 </li></ul><ul><li>1.35 mg n=4 452 220 232 </li></ul><ul><li>Micronized estradiol </li></ul><ul><li>0.5 mg n=48 350 5 375 </li></ul>
  28. 29. Equilin <ul><li>From PRE gnant MAR e (horse) ur IN e </li></ul><ul><li>Component of Premarin </li></ul><ul><li>Metabolite 17- hydroxy-equilenin has potent estrogen stimulatory effects on uterus and breast tissue </li></ul><ul><li>Eight times more potent than bio-Identical hormones </li></ul><ul><li>Equilin can exert its effects for up to 13 weeks. </li></ul>
  29. 30. Estrogen Molecules Equilin Estrone Estradiol
  30. 31. Progesterone <ul><li>For gestation, produced in last half of menstrual cycle </li></ul><ul><li>Sedative/brain </li></ul><ul><li>Makes the estrogen receptor less sensitive to over stimulation of the breast and uterus </li></ul><ul><li>Used for fertility, PMS and postpartum depression </li></ul><ul><li>Does not interfere with estrogens effect on HDL/LDL ratio </li></ul><ul><li>Releases the smooth muscle in the coronary arteries of the heart </li></ul>
  31. 32. Progesterone: Natural v. Synthetic <ul><li>Medroxyprogesterone, a synthetic </li></ul><ul><li>progesterone, is not a perfect fit for the cell receptors throughout the body </li></ul>
  32. 33. Progesterone: Natural vs. Synthetic Medroxyprogesterone acetate mutes beneficial effects of estradiol on HDL cholesterol Medroxyprogesterone Progesterone
  33. 34. Medroxyprogesterone Acetate <ul><li>Does not support pregnancy </li></ul><ul><li>Increases PMS </li></ul><ul><li>Increases fluid retention, irritability, depression </li></ul><ul><li>Reduces estrogen benefit on HDL/LDL ratio </li></ul><ul><li>Increased risk of coronary artery spasm/ constriction of heart vessels. </li></ul>
  34. 35. Women and Testosterone <ul><li>Women produce this “male” hormone: </li></ul><ul><li>At 1/10th male levels </li></ul><ul><li>Which enhances bone/muscle, vitality, energy </li></ul><ul><li>The synthetic version: Estratest (methyltestosterone) </li></ul>
  35. 36. How Much is Enough/Too Much? <ul><li>Would you be able to tell how much you need? </li></ul>
  36. 37. Hormone Levels Over Time <ul><li>The critical issues: </li></ul><ul><li>Knowing how levels of key hormones decline over time </li></ul><ul><li>Determining what is needed to bring them into optimum balance </li></ul>
  37. 38. Women in Their 20s <ul><li>At their peak of health </li></ul><ul><li>Have no worry about osteoporosis, memory loss, heart disease, energy </li></ul>
  38. 39. Women in Their 30s <ul><li>Estrogen levels stay the same and progesterone levels fall </li></ul><ul><li>Experience heavy menstrual bleeding and spotting </li></ul><ul><li>Have increased PMS symptoms, anxiety, irritability, mood swings, cyclic breast tenderness, weight gain </li></ul>
  39. 41. Women in Their 40s <ul><li>Perimenopause: estradiol levels start to fall; progesterone continues to fall </li></ul><ul><li>Hot flashes, sleep disturbances, urinary stress / incontinence, breast tenderness </li></ul><ul><li>Periods may become lighter </li></ul><ul><li>Testosterone levels remain the same as estrogen levels which are falling, resulting in acne, oily skin, and unwanted hair growth </li></ul>
  40. 43. Women in Their 50s <ul><li>Estrogen and progesterone levels fall to very low levels and testosterone levels begin to decline as well. </li></ul><ul><ul><li>• Experience hot flashes, sleep disturbances </li></ul></ul><ul><ul><li>• Loss of libido, energy, memory, bone </li></ul></ul><ul><ul><li>• Skin/hair becomes dry </li></ul></ul>
  41. 45. Women in Their 60s and Beyond <ul><li>• Testosterone levels can be normal range </li></ul><ul><li>• Exercise </li></ul><ul><li>Menopause symptoms usually stabilize </li></ul>
  42. 47. Why Customized Therapy? <ul><li>Hormone levels fluctuate (during days and years) </li></ul><ul><li>One size does not fit all </li></ul><ul><li>Unlimited dosing options </li></ul><ul><li>Formulations ONLY available at specialized compounding pharmacies </li></ul>
  43. 48. Daily Hormonal Changes Testosterone pg/ml Saliva Time 5 am 0 5 10 15 20 25 30 35 40 9 am 12 pm 4 pm 10 pm 45
  44. 49. Monthly Hormonal Changes
  45. 50. Yearly Hormonal Changes DHEA and Testosterone Ranges of Women Saliva Hormone pg/ml Age (years) 20-29 DHEA Testosterone 30-39 40-49 50-59 60-69 70-79 80-89 0 25 50 75 100 125 150 175 200
  46. 51. Hormone Level <ul><li>How does my prescriber know what hormones I need and how much to prescribe? </li></ul><ul><li>SALIVA TESTING </li></ul><ul><li>URINE TESTING </li></ul><ul><li>SYMPTOMS </li></ul>
  47. 52. SALIVA TESTING <ul><li>Precise results </li></ul><ul><ul><li>Validated as a diagnostic medium </li></ul></ul><ul><ul><li>Measures the unbound, biologically active, “free” hormones (1-10% of total hormones) </li></ul></ul><ul><ul><li>Samples collected at specific times of day </li></ul></ul>
  48. 53. Benefits of Saliva Testing <ul><li>Convenient </li></ul><ul><ul><li>Noninvasive </li></ul></ul><ul><ul><li>Easily collected at patient’s home </li></ul></ul><ul><ul><li>Patient mails sample directly to lab </li></ul></ul><ul><li>Economical </li></ul><ul><ul><li>Less expensive than serum </li></ul></ul><ul><ul><li>Covered by insurance plans and Medicare when prescribed </li></ul></ul>
  49. 54. Five Key Hormones <ul><li>The best Saliva Tests measure 5 hormones: </li></ul><ul><li>Estradiol </li></ul><ul><li>Progesterone </li></ul><ul><li>Testosterone </li></ul><ul><li>DHEA </li></ul><ul><li>Cortisol </li></ul>
  50. 55. Case Study: 49-year-old Female Hysterectomy w/o ovaries - Rx Tri Est 2.5 mg/gm, Progesterone 50 mg/gm cream 1 gram daily <ul><li> Normal Initial </li></ul><ul><li>Saliva Range Test </li></ul><ul><li> </li></ul><ul><li>Estradiol 0.2 - 5.0 pg/ml 36.5 pg/ml </li></ul><ul><li>Progesterone 0.01 - 0.5 ng/ml 1.2 ng/ml </li></ul><ul><li>Testosterone 5 - 21 pg/ml 9 pg/ml </li></ul><ul><li>DHEA 40 - 150 pg/ml 50 pg/ml </li></ul>
  51. 56. Case Study: 49-year-old Female (follow-up) Hysterectomy w/o ovaries - Rx Tri Est 2.5 mg/gm, Progesterone 50 mg/gm cream 1 gram daily <ul><li> Normal Initial </li></ul><ul><li>Saliva Range Test 3 months </li></ul><ul><li>Estradiol 0.2 - 5.0 pg/ml 36.5 pg/ml 3.2 pg/ml </li></ul><ul><li>Progesterone 0.01 - 0.5 ng/ml 1.2 ng/ml 0.44 ng/ml </li></ul><ul><li>Testosterone 5 - 21 pg/ml 9 pg/ml 8 pg/ml </li></ul><ul><li>DHEA 40 - 150 pg/ml 50 pg/ml 42 pg/ml </li></ul>Rx Bi Est 2.5 mg daily and Progesterone 150 mg capsule (1 daily)
  52. 57. URINE TESTING <ul><li>URINE NTx (N-telopeptides) </li></ul><ul><li>Precise results </li></ul><ul><ul><li>Specific to bone type I collagen </li></ul></ul><ul><ul><li>Measures Cross-linked N-telopeptides </li></ul></ul><ul><ul><li>Quantitative measure of osteoclastic resorption activity (measures rate of bone loss) </li></ul></ul><ul><ul><li>Evaluate response in 3 months to antiresorptive therapy </li></ul></ul>
  53. 58. Benefits of Urine Testing <ul><li>Convenient </li></ul><ul><ul><li>1st or 2nd morning void </li></ul></ul><ul><ul><li>Patient mails sample directly to lab </li></ul></ul><ul><li>Economical </li></ul><ul><ul><li>Less expensive than BMD </li></ul></ul><ul><ul><li>Covered by most insurance plans and Medicare </li></ul></ul><ul><ul><li>Gives patients time to be proactive </li></ul></ul><ul><ul><li>Response can be evaluated after 3 months! </li></ul></ul>
  54. 59. Bone Resorption <ul><li>Urine sample analyzed using: </li></ul><ul><ul><ul><li>NTx, Dpd or CTx </li></ul></ul></ul><ul><ul><ul><li>Measures breakdown products, rate of bone loss </li></ul></ul></ul><ul><ul><ul><li>Adds new dimension to BMD </li></ul></ul></ul><ul><li>Allows patient to be proactive </li></ul>
  55. 60. Bone Remodeling Process Fragments of excavated bone collagen are released into body fluids 3 Bone Formation - Osteoblasts deposit new collagen to fill excavated pits 4 When resorption and formation are in balance, there is no net change in bone mass Bone Resorption - Osteoclasts excavate small pits in bone 2 1
  56. 61. A Decrease in NTx in Response to HT Indicates Gain in Bone Mass Mean NTx values throughout the study Mean percent change in BMD from baseline Chesnut et al., Am J Med. 1997;102:29-37. 40 20 0 1 3 6 12 0 1 2 3 BMD NTx Months Baseline 60 38
  57. 62. Case Study: 52-year-old female Hysterectomy w/o ovaries: Premarin 1.25 mg/1 daily Normal Initial Saliva Range Test Estradiol 0.2 - 5.0 pg/ml 1.60 pg/ml Progesterone 0.01 - 0.5 ng/ml 0.08 ng/ml Testosterone 5 - 21 pg/ml 7.70 pg/ml DHEA 40 - 150 pg/ml 126.00 pg/ml Cortisol 5 - 15 ng/ml (AM) 4.0 0 ng/ml (AM) Urine - NTx < 38 nM BCE 53.70 nM BCE Rx: Bi Est 2.5 mg capsule 2x daily Fosamax 10 mg daily
  58. 63. Case study: 52-year-old female (follow-up) Hysterectomy w/o ovaries: Premarin 1.25 mg/1 daily Normal Initial 3 Mos. Saliva Range Test Later Estradiol 0.2 - 5.0 pg/ml 1.60 pg/ml 4.2 pg/ml Progesterone 0.01 - 0.5 ng/ml 0.08 ng/ml Testosterone 5 - 21 pg/ml 7 .70 pg/ml DHEA 40 - 150 pg/ml 26.00 pg/ml Cortisol 5 5- 15 ng/ml (AM) 4.00 ng/ml (AM) Urine - NTx < 38 nM BCE 53.7 nM BCE 19.8 nMBCE Rx: Bi Est 2.5 mg capsule 2x daily Fosamax 10 mg daily
  59. 64. Urine Testing is Most Beneficial When Used in Combination With BMD ***Urine testing does not diagnose osteoporosis but is measures the rate of bone loss CHOLESTEROL MONITORING (measured in Practitioner’s Office)
  60. 65. Laboratory Results <ul><li>Test results show hormonal “snapshot” </li></ul><ul><li>Consider patient’s history and lifestyle </li></ul><ul><li>Determine the following: </li></ul><ul><ul><li>Specific hormones required </li></ul></ul><ul><ul><li>Appropriate dosage </li></ul></ul><ul><ul><li>Proper “form” to achieve results </li></ul></ul>
  61. 66. Achieving Optimal Health <ul><li>Choices for HRT are influenced by: </li></ul><ul><li>Route of administration </li></ul><ul><li>Dosage form </li></ul><ul><li>Absorption and metabolism </li></ul><ul><li>Formulation and compounding </li></ul><ul><li>Patient variability </li></ul><ul><li>Health Conditions </li></ul>
  62. 67. Individualized Hormone Management <ul><li>Move from “one-size-fits-all” to individualized hormone management program for each patient. </li></ul>
  63. 68. Individualized Prescriptions <ul><li>Traditionally, Hormone Therapy (HT) offers a standardized, “one-size-fits-all” approach, but…” </li></ul><ul><ul><li>All women are not alike, and </li></ul></ul><ul><ul><li>One size does not fit all! </li></ul></ul>
  64. 69. Hormone Profile Each woman’s hormonal profile is as unique as a fingerprint!
  66. 71. Early PMS Treatment <ul><li>PMS identified in Europe, mid 1970’s </li></ul><ul><li>Treated with natural progesterone </li></ul><ul><li>Not available in the U.S. </li></ul>
  67. 72. Madison Pharmacy Associates <ul><li>Founded in 1982 </li></ul><ul><li>First pharmacy in America to specialize in women’s health </li></ul><ul><li>National organization serving women’s health needs throughout their lifetimes </li></ul><ul><li>First organization to define and develop treatment options for Premenstrual Syndrome (PMS) </li></ul>
  68. 73. Madison Pharmacy Associates <ul><li>Began with one patient </li></ul><ul><li>Expanded to address continuum of care in women’s health: perimenopause and menopause, infertility, bioidentical hormone therapy </li></ul>
  69. 74. Our First Patient <ul><li>Experienced severe depression, half of the month </li></ul><ul><li>Was told her symptoms were “all in her head” </li></ul><ul><li>Based on work in Europe, we worked with her doctor to formulate a custom prescription </li></ul><ul><li>Result: successfully mitigated symptoms </li></ul>
  70. 75. Word of Mouth <ul><li>PMS as a diagnosis was legitimized </li></ul><ul><li>Word began to spread around the country that there was a prescriptive solution for PMS </li></ul><ul><li>Madison Pharmacy Associates began a comprehensive program of education and support for patients and providers </li></ul><ul><li>Madison Pharmacy Associates grew to become Women’s Health America, Inc. </li></ul>
  71. 76. Women’s Health America, Inc. <ul><li>“ We combine the very latest in pharmaceutical science and laboratory technology with traditional values in health care: listening to patients and responding to their individual needs ” </li></ul>
  72. 77. Women’s Health America, Inc.
  73. 78. The HRT Solution by Marla Ahlgrimm, R. Ph.
  74. 79. Our Clinical Objectives <ul><li>Evaluate the adequacy of prescribed bioidentical Hormone Therapy </li></ul><ul><li>Monitor, and maintain patient’s hormone levels in a therapeutic range </li></ul><ul><li>Avoid side effects of overdosing and consequences of under-dosing </li></ul>
  75. 80. The Restore ® Program Bio-Identical Hormone Replacement and Intervention Program <ul><li>Comprehensive approach to care, integrating: </li></ul><ul><ul><li>Leading laboratory technology (saliva and urine testing) </li></ul></ul><ul><ul><li>Individualized bioidentical hormone prescriptions </li></ul></ul><ul><ul><li>Ongoing monitoring and case management </li></ul></ul><ul><ul><li>OPTIONAL PROGRAM </li></ul></ul>
  76. 81. CONCLUSION <ul><li>A better understanding of customized, bioidentical Hormone Therapy </li></ul><ul><li>An understanding of how a specialty compounding pharmacy can help you with your patients’ Hormone Therapy needs </li></ul>
  77. 82. Restore ® : Changing Health Care “ One Unique Woman at a Time”
  78. 83. Specialized Pharmacy Services
  79. 84. <ul><li> </li></ul>1-800-558-7046 WOMEN’S HEALTH AMERICA, Inc. 1289 Deming Way Madison, WI 53725-9690