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Patterns of Medication Use and Related Health Care Service Utilization Associated with Vaginal Estrogen Therapy in Medicaid-Enrolled Women

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Patterns of Medication Use and Related Health Care Service Utilization Associated with Vaginal Estrogen Therapy in Medicaid-Enrolled Women Patterns of Medication Use and Related Health Care Service Utilization Associated with Vaginal Estrogen Therapy in Medicaid-Enrolled Women Dissertation Presented in Partial Fulfillment of the Requirements for the Doctor of Philosophy Degree in the Graduate School of the Ohio State University By Marjorie V. Neidecker, MEng, RN Graduate Program in Pharmacy The Ohio State University 2009 Dissertation Committee: Rajesh Balkrishnan, PhD, Advisor Deborah A. Levine, MD, MPH Milap C. Nahata, MS, PharmD Sharon Schweikhart, PhD Copyright by Marjorie V. Neidecker 2009 Abstract Background : Vaginal atrophy, or atrophic vaginitis, is a symptom of menopause experienced by up to 40% to 50% of postmenopausal women. Symptoms include vaginal dryness, itching, and irritation; dyspareunia; successive urinary tract infections; and urinary incontinence. The most effective therapy for atrophic vaginitis is vaginal estrogen, available in cream and tablet forms. Not all forms have received equal acceptance, potentially resulting in sub-optimal medication adherence and persistence. The objective of this study was to understand the medication-taking behavior of vaginal estrogen users in clinical practice and measure associated healthcare utilization and cost outcomes. Methods : Retrospective claims of women enrolled in the North Carolina Medicaid program between January 2003 and December 2007 were analyzed. Inclusion criteria were occurrence of at least one prescription claim for vaginal estrogen and continuous health plan enrollment for 12 months prior to and 12 months following vaginal estrogen initiation. Multivariate regression analyses were used to estimate the effect of form of vaginal estrogen on medication adherence, medication persistence, and health services utilization and cost outcomes. Adherence was measured using the medication possession ratio (MPR); persistence was measured using treatment duration. Additional outcomes ii explored included prescribing provider specialty, proportion of initial prescriptions refilled, and switching to the other form of vaginal estrogen. Covariates included age, race, Charlson Comorbidity Index, mammography, prior and current use of systemic estrogen, and the number of outpatient office visits in the year prior to vaginal estrogen initiation. Results : 1,505 women (30% black, age 40 - 64 years, mean age 53.2 years) met all inclusion criteria. 89.6% of women used vaginal cream products; 10.4% used vaginal tablets. An estimated 23.3% of vaginal estrogen prescriptions were prescribed by obstetrician/gynecologists. Mean MPR was 0.31 for vaginal tablet users; 0.27 for vaginal cream users (p = 0.117). Treatment duration over two years of follow-up was similar for both forms of vaginal estrogen (296 days for vaginal tablets vs. 280 days for vaginal cream, p = 0.607). Tablet users refilled their first prescription at a significantly higher rate (48.8% for vaginal tablets, 35.3% for vaginal cream, p = 0.001) but more often switched to the other form of vaginal estrogen (4.4% vs. 1.7%, p = 0.023). Annual obstetrician/gynecologist and primary care physician costs and vaginal estrogen prescription costs for tablets and creams were similar. Multivariate regression models suggest that use of vaginal tablets compared to vaginal creams is significantly associated with more often refilling the initial prescription (odds ratio 1.77, p = 0.001), higher number of annual vaginal estrogen prescriptions (β = 0.322, p < 0.001), and lower vaginal estrogen prescription costs (β = -0.133, p = 0.019). Conclusion : Women on vaginal tablet therapy were more likely to refill their initial prescription and, although not significant over a 2 year window, to have longer treatment iii duration, indicating a preference for this treatment modality. At the same time, healthcare utilization in terms of physician visits and costs were no higher for vaginal tablet users than vaginal cream users, and were significantly lower in vaginal estrogen prescription costs. iv Dedication To the growing ranks of post-menopausal women. v Acknowledgements My very sincere thanks must first be extended to my advisor, Dr. Rajesh Balkrishnan, Merrell Dow Professor, for inviting me to join his lab and mentoring me through the doctoral program. Along with providing many valuable academic opportunities, he been most encouraging and supportive. He may never fully know the extent of my gratitude for his concern and support during this past very challenging year. I hope this is not the end of our work together, but the beginning of new collaborations to come where I may continue to learn from his expertise. I wish him all the best as he takes his next step forward in his bright and accomplished career. I would also like to thank my dissertation committee members, Drs. Deborah Levine, Milap Nahata, and Sharon Schweikhart for their contributions to this report. Dr. Levine deserves special thanks for her insightful comments on the study methodology and clinical considerations. I am most grateful, too, to Dr. Schweikhart, who several years ago had confidence in my abilities and opened the door to my work in the College of Public Health, eventually leading to this doctoral degree. Several others deserve my thanks. Fabian Camacho, biostatistician and SAS programmer extraordinaire , has been tremendously patient and truly invaluable in guiding me with his expert knowledge through the dataset creation and the statistical vi analyses. Kathy Brooks, in her calm and kind way, has been most helpful in navigating the many administrative pathways required at such a large university. Finally, and most importantly, I would like to extend gratitude from the bottom of my heart to my family for their unwavering support in this circuitous journey. From my mid-life announcement that I would enter the College of Nursing graduate entry program, to my interim work in the College of Public Health, to the completion of this doctoral program in the College of Pharmacy, they have backed me 100 percent. My parents, John and Marie Vermeulen, have encouraged me from the start in their calm and loving way to aim high. My amazing husband, Tom, and wonderful children, Marita, Derek, Peter, and Elise, have sacrificed much in these five years, for which I am forever indebted. I have learned more than they will ever know from the selfless and unconditional love they have shown me. vii Vita November 17, 1960 Born – Columbus, Ohio 1980-81 Industrial Engineering Intern (summers) General Motors, Detroit Diesel Allison Div.; Indianapolis 1982 B.S. Mechanical Engineering Industrial Engineering Concentration University of Notre Dame; Notre Dame, Indiana 1983 M.Eng. Operations Research and Industrial Engineering Cornell University; Ithaca, New York 1982-1984 International Systems Engineer AT&T Bell Laboratories; Holmdel, New Jersey 1984-1985 Logistics Management Consultant Cleveland Consulting Associates; Cleveland, Ohio 1985-1990 Analytic Products Project Manager The Fair, Isaac Companies; San Rafael, California 2006 R.N. licensure, Graduate-Entry Nursing Program The Ohio State University; Columbus, Ohio 2006 Bachelor’s Plus Program in Education Ashland University; Columbus, Ohio 2006 Long-Term Substitute Mathematics Teacher Southwestern City Schools; Grove City, Ohio 2006 - 2007 Research Specialist Center for Health Outcomes, Policy and Evaluation Studies The Ohio State University; Columbus, Ohio viii 2007 Lecturer, College of Public Health The Ohio State University; Columbus, Ohio 2008 Graduate Teaching Associate, College of Pharmacy The Ohio State University; Columbus, Ohio 2008 – present Graduate Research Associate, College of Pharmacy The Ohio State University; Columbus, Ohio Fields of Study Major Field: Pharmacy Minor Field: Nursing ix Table of Contents Abstract ............................................................................................................................... ii Dedication ......................................................................................................................... v Acknowledgements .......................................................................................................... vi Vita .............................................................................................................................. viii Table of Contents .............................................................................................................. x List of Tables .................................................................................................................. xiv List of Figures ................................................................................................................ xvi Chapter 1: Introduction .................................................................................................... 1 1.1 Background ................................................................................................. 1 1.1.1 Atrophic Vaginitis ........................................................................... 1 1.1.2 Vaginal Estrogen ............................................................................. 2 1.2 Importance of Assessing Medication Use Behavior and Need for Research ..................................................................................................................... 3 1.3 Study Objectives ......................................................................................... 4 Chapter 2: Literature Review and Theoretical Framework .............................................
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