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Midlife Women’s Health Margery Gass, MD, NCMP Executive Director The North American Menopause Society Consultant, Cleveland Clinic Center for Specialized.

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Presentation on theme: "Midlife Women’s Health Margery Gass, MD, NCMP Executive Director The North American Menopause Society Consultant, Cleveland Clinic Center for Specialized."— Presentation transcript:

1 Midlife Women’s Health Margery Gass, MD, NCMP Executive Director The North American Menopause Society Consultant, Cleveland Clinic Center for Specialized Women’s Health Clinical Professor Case Western Reserve University School of Medicine

2 OBESITY Where to Start? Heart Disease Osteoporosis Alzheimer’s Breast Cancer Mammogram Controversy Over Testing Hormone Therapy

3 Menopause! A normal and natural event Average age 51 (41-55) Symptoms: irregular menses, hot flashes, vaginal dryness ( discomfort with intercourse ) Hot flashes: 75% of women, 25% severe Most effective treatment: hormone therapy

4 Midlife health by age 40455055606570+ ● Final period ● Hot flashes ● Vaginal discomfort ● Heart disease ● Osteoporosis Adapted from Utian 1980; derived from van Keep and Kellerhals 1973

5 Filling in Details Osteoporosis Over Testing Hormone Therapy

6 Off the Radar Osteoporosis Over Testing Hormone Therapy Hormone Compounding

7 Bone Mass by Age & Gend er Katz: Comprehensive Gynecology, 5th ed. Katz Comprehensive Gynecology 5 th Edition Chpt 42, Mosby 2007. ?

8 Ratio of Total Body BMD to Lean Body Mass Across Age Järvinen TL, et al. J Bone Miner Res. 2003;18:1921-1931.

9  Don't do imaging for low back pain within the first 6 weeks unless red flags are present  Don't obtain blood chemistry panels (eg, basic metabolic panel) or urinalyses for screening in asymptomatic, healthy adults  Don't order annual ECGs or any other cardiac screening for asymptomatic, low-risk patients  Use only generic statins when initiating lipid-lowering drug therapy  Don't use DEXA screening for osteoporosis in women under age 65 years or men under 70 years with no risk factors Top 5 “Don’t” List in Internal Medicine http://archinte.ama-assn.org/cgi/content/short/archinternmed.2011.231 http://archinte.ama-assn.org/cgi/content/short/archinternmed.2011.231 Accessed 5-30-2011

10 FRAX - WHO Fracture Risk Assessment Tool Developed by the World Health Organization. FRAX estimates the 10-year probability of fracture. GoogleFRAX www.shef.ac.uk/FRAX

11 5.9 0.6

12 Hormone Therapy  The Women’s Health Initiative has given us 20 years of research in postmenopausal health  Hormone therapy is a viable option for treatment of menopausal symptoms in healthy early postmenopausal women  Hormone therapy is not recommended for long-term use to prevent chronic diseases of aging

13 Rigorous approval process Ongoing monitoring of products Evidenced-based statements on benefits and risks for both the clinician and the patient Medical Societies Recommend FDA-Approved HT

14 Scope of the Problem  The FDA estimated that by 2003 there were 30 million compounded prescriptions written every year  Hormone prescriptions were among the top 3  “Natural” “Safe” “Anti-aging” - No Data

15 Frequently associated with: No studies on efficacy or safety No ongoing monitoring for quality control, purity No consumer information on risks & benefits Unsubstantiated health claims Salivary hormone testing not approved for this purpose http://www.menopause.org/bioidentical.aspx Compounded Bioidentical Hormone Therapy (BHT) = untested generics

16 There are no data about the number of compounded prescriptions being written. Solution:  Require reports on the number of prescriptions filled for each product. Compounded Bioidentical Hormone Therapy (BHT)

17 Compounded drugs do not meet US standards for - establishing safety and efficacy - manufacturing - labeling for safe use Solutions  Require safety and efficacy testing for new combinations  Require class labeling for patients  Require reporting of # of prescriptions filled to determine if it is “manufacturing” Compounded Bioidentical Hormone Therapy (BHT)

18 Not required to report problems associated with drugs they compound Solutions:  Require adverse event reporting  Require all compounding pharmacies to be registered with the FDA

19 Compounded Bioidentical Hormone Therapy (BHT) Federal legislation is critical to protect women and preserve the integrity of our healthcare system

20 The Rest of the Story Osteoporosis Over Testing Hormone Therapy We need to work together….

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