THE IMPACT OF THE FDA TESTOSTERONE SUPPLEMENTATION THERAPY SAFETY ADVISORY ON PRESCRIBING PATTERNS

You have accessJournal of UrologyGeneral & Epidemiological Trends & Socioeconomics: Practice Patterns, Quality of Life & Shared Decision Making I1 Apr 2018MP44-10 THE IMPACT OF THE FDA TESTOSTERONE SUPPLEMENTATION THERAPY SAFETY ADVISORY ON PRESCRIBING PATTERNS Valary Raup, Tyler McClintock, Ramy Abou Ghayda, Alexandra Berger, Allen Seftel, and Martin Kathrins Valary RaupValary Raup More articles by this author , Tyler McClintockTyler McClintock More articles by this author , Ramy Abou GhaydaRamy Abou Ghayda More articles by this author , Alexandra BergerAlexandra Berger More articles by this author , Allen SeftelAllen Seftel More articles by this author , and Martin KathrinsMartin Kathrins More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2018.02.1429AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES On March 3, 2015 the Food and Drug Administration (FDA) released a safety advisory and prescription labeling change which warned of possible cardiovascular side effects of testosterone supplementation therapy (TST). We sought to investigate the effect of the warning on TST prescribing patterns in the Boston metro-area. METHODS We utilized the Research Patient Data Registry, which is a de-identified clinical patient data repository pertaining to eight hospitals in the Boston metro area within Partners Healthcare. We queried the database for men age 45 to 84 years old who were prescribed TST with transdermal or injectable formulations from March 2013 until August 2016. A second query was performed of such patients to quantify the monthly instances in which during which primary diagnosis of hypogonadism was recorded (based on ICD9/10 codes). We three performed separate interrupted time series (ITS) analyses for each TST modality type and monthly visits for hypogonadism, all with respect to the March 2015 safety advisory. We calculated estimates of effect and relative effects for 1, 3, 6, 9, 12, 15, 16 months post-safety advisory. All data analyses were performed with SPSS v20. IRB approval was not necessary due to the de-identified nature of the data. RESULTS The monthly prescription quantities and clinical encounters are demonstrated in Figures 1.1 and 1.2, respectively. The ITS analysis revealed the difference in slope coefficients between pre- and post-safety advisory was -26.5 (p=0.000) for transdermal formulations. The difference in coefficients was -7.5 (p=0.003) for injectable formulations. However, the difference in coefficients for clinical encounters was -3.0 (p=0.260). Limitations of the study were the inability to distinguish between new and renewed prescriptions and the retrospective nature of the database. CONCLUSIONS While the monthly number of interactions resulting in a primary diagnosis of hypogonadism was unchanged, the amount of monthly prescriptions for both injectable and transdermal testosterone formulations decreased significantly following the FDA safety advisory. © 2018FiguresReferencesRelatedDetails Volume 199Issue 4SApril 2018Page: e591 Advertisement Copyright & Permissions© 2018MetricsAuthor Information Valary Raup More articles by this author Tyler McClintock More articles by this author Ramy Abou Ghayda More articles by this author Alexandra Berger More articles by this author Allen Seftel More articles by this author Martin Kathrins More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...