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Trends of Oseltamivir Usage in the United States during the 2009 Influenza A (H1N1) Pandemic CDR John K. Iskander LCDR Craig Hales Charbel el-Bcheraoui Robert T. Chen Centers for Disease Control and Prevention Detection of Novel H1N1 Virus • March 2009 • 2 cases of febrile respiratory illness in children (un-related, no pig contact) • Residents of adjacent counties in southern California, ill in late March • Novel swine influenza A (H1N1) virus detected at CDC on April 15th,17th • Both viruses genetically identical • Contain a unique combination of gene segments previously not recognized among swine or human influenza viruses in the United States Retrospective evidence of respiratory illness outbreaks in Mexico (February/March) April 26, 2009 US declares National Public Health Emergency June 11, 2009 WHO declares Global pandemic of novel influenza A (H1N1) virus Pandemic H1N1: Disease burden estimates • In United States, as of 3/13/2010: – 59.98 million cases – 270, 435 hospitalizations – 12, 271 deaths • Mean age of deaths 37 years – Source: CDC website Influenza Antivirals: Background • Treatment of suspected or confirmed influenza with antiviral medications is one important strategy to reduce morbidity and mortality caused by the 2009 pandemic influenza A (H1N1) virus (pH1N1) • The pandemic strain has been susceptible to neuraminidase inhibitors (NAI) such as oseltamivir (> 99% of isolates) • NAI (oseltamivir, zanamivir) antiviral treatment is recommended* as soon as possible for: • All hospitalized patients with suspected, probable, or confirmed 2009 influenza A (H1N1) virus infection • Outpatients with high-risk conditions (including children < 2 years old, pregnant women and women up to 2 weeks post-pregnancy, persons ages 65 and older, persons with chronic conditions - chronic lung disease, diabetes, etc.) with suspected, probable, or confirmed 2009 influenza A (H1N1) virus infection * Current CDC Antiviral Treatment Recommendations for pH1N1 influenza http://www.cdc.gov/H1N1flu/recommendations.htm Objectives • To monitor the usage of influenza antivirals by pH1N1 age-specific risk groups, and to assess related geographic and time trends in the United States • To evaluate effectiveness of CDC guidance on use of antiviral medicines Monitoring of Influenza Antiviral Medication Usage • Through BioSense*, CDC receives anti-infective prescription data from 27,000 pharmacies, representing approximately half of U.S. antiinfective prescription data – Data include patient demographics (age and sex) and pharmacy zip code *For more information see www.cdc.gov/biosense System Description • BioSense receives prescription data from an electronic prescriptions claims provider in all 50 states and Washington, D.C. as well as U.S. territories. Data are updated every 4 hours • The data collected concern all prescriptions for anti-infective medicines and include the specific type (brand) and formulation dispensed • These data cover about 50% of all anti-infective medicines prescribed in the states and represent prescriptions requested at retail pharmacies and approved to be covered by insurance companies – Coverage range for prescription transactions for the 9 census divisions: mean 49.7%, range 42.9-60.7% Pharmacies — 27,000 Active Methods • Rates of antiviral medication prescribing are calculated using population data from the U.S. Census, and are compared with national and regional measures of influenza disease activity – % of visits for influenza-like illness (ILI) assessed through U.S. Outpatient Influenza-like Illness Surveillance Network (ILINet) • We analyzed oseltamivir (Tamiflu®) prescribing data by age groups and federal regions from April through December 2009 Results Nationwide rates of Rx of Oseltamivir by age groups, USA, 2007-2009 Nationwide rates of Oseltamivir prescribing by age groups USA, April-December 2009 DHHS Regions I-X Regional rates of Rx of Oseltamivir by age groups, Federal Region 4, April-December 2009 Regional rates of Rx of Oseltamivir by age groups, Federal Region 9, April-December 2009 Summary of Results of Monitoring • Nationally, highest rates of prescribing were seen shortly after detection of the pandemic in spring of 2009, as well as in September-October of 2009 – Two distinct peaks seen in autumn of 2009 • Children (infants, pre-school age, and school age) were prescribed the medication at the highest rates • Medication prescribing for all ages has sharply decreased since November 2009 Results Details • School-age children (5-18 years) consistently had the highest prescribing rates, with a peak of > 500 prescriptions/100,000 population during September 2009 • Pre-school age children (2-4) had similar prescribing rates, reaching 450/100,000 in both September and October • Patterns of prescribing for infants generally paralleled those seen for older children but with lower peak rates (350/100,000) • After the initial May peak, prescribing rates for working age adults (18-64) and the elderly (65 and over) were < 200 courses/100,000 • Regional prescribing patterns clustered geographically, with prescribing rates in contiguous regions increasing and decreasing synchronously Interpretation of findings • Prescribing rates have been highest overall among pediatric age groups, who are at high risk of H1N1 illness • Lower rates of prescribing for those 65 and over are consistent with low rates of H1N1 disease in this age group • Rates of prescribing were closely related to levels of influenza disease activity, both nationally and regionally • Despite widespread prescribing of oseltamivir, so far no detection of significant levels of viral resistance or new safety concerns Strengths and Limitations • Strengths – – – – Data updated frequently Significant population coverage Ability to generate age adjusted prescribing rates Exploring ability to provide data linked to claims • Limitations – Ecologic analysis; no linkage to patient level diagnostic information – No data from hospital pharmacies – No coverage for self-pay or those with no prescription insurance coverage Conclusions • Prescribing rates were highest overall among pediatric age groups, who are at high risk of H1N1 illness • Rates of prescribing were closely related to levels of influenza disease activity, both nationally and regionally Future (and Present) Uses of Pharmacy and other Drug Utilization Data • Monitoring of both infectious and chronic diseases • Use as denominator data for pharmaceutical safety/adverse event monitoring • Use by Strategic National Stockpile (SNS) to monitor formulation shortages and adjust stockpile distribution Antiviral Adverse Event Monitoring – Comparison by Season* December 31, 2009 Influenza Antiviral-Related Emergency Department Visits, 2006-2007 Season to Present Source: DAWNLive! 180 160 140 No. of Reports 120 100 80 60 40 20 2006-2007 Season 2007-2008 Season *Note: AE data lagtime is 2-3 weeks. Rimantadine 2009 H1N1 Oseltamivir Zanamivir Dec-09 Nov-09 Oct-09 Sep-09 Aug-09 Jul-09 Jun-09 May-09 Apr-09 Mar-09 Feb-09 2008-2009 Season Month-Year Amantadine Jan-09 Dec-08 Oct-08 Nov-08 Sep-08 Jul-08 Aug-08 Jun-08 May-08 Apr-08 Mar-08 Feb-08 Jan-08 Dec-07 Nov-07 Oct-07 Aug-07 Sep-07 Jul-07 Jun-07 Apr-07 May-07 Mar-07 Jan-07 Feb-07 Dec-06 Oct-06 Nov-06 0 Antiviral AE Monitoring and Antiviral Dispensing, December 31, 2009 Influenza Antiviral-Related Emergency Department Visits (DAWN Live! ) and Influenza Antiviral Prescriptions (CDC BioSense), October 2008 - Present 180 1,400.0 160 1,200.0 1,000.0 No. of Reports 120 100 800.0 80 600.0 60 400.0 40 200.0 20 0 0.0 Oct-08 Nov-08 Dec-08 Jan-09 Feb-09 Mar-09 Apr-09 May-09 Jun-09 Jul-09 Aug-09 Sep-09 Oct-09 Nov-09 Dec-09 Month-Year Amantadine Rimantadine Oseltamivir Zanamivir Influenza Antiviral Rx's *Up-to-date through 12/31/09 (DAWN) and 12/26/09 (BioSense). Note: AE data lagtime is 2-3 weeks. No. of Prescriptions (In Thousands) 140 Acknowledgments • Taha Kass-Hout and BioSense staff • CAPT Anthony Fiore, Influenza Division, CDC • CDR Dan Budnitz, Division of Healthcare Quality Promotion, CDC Supplemental Background on BioSense • BioSense is a national program intended to improve the nation’s capabilities for conducting real-time biosurveillance, and enabling health situational awareness through access to existing data from healthcare organizations across the country • BioSense receives, analyzes, and evaluates health data from numerous data sources such as emergency rooms, ambulatory care clinics, and clinical laboratories • For more information: – www.cdc.gov/biosense – http://twitter.com/cdc_biosense Location of BioSense Pharmacies (N≈27,000) Antiviral AE Monitoring and Antiviral Dispensing, December 31, 2009