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Solomon Iyasu, MD, MPH Medical Team Leader Division of Pediatric Drug Development Center for Drug Evaluation and Researc

One Year Post Exclusivity Adverse Event Review as Mandated by the Best Pharmaceuticals for Children Act Pediatric Subcommittee of the Anti-infective Drugs Advisory Committee Meeting June 9, 2004. Solomon Iyasu, MD, MPH Medical Team Leader

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Solomon Iyasu, MD, MPH Medical Team Leader Division of Pediatric Drug Development Center for Drug Evaluation and Researc

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  1. One Year Post Exclusivity Adverse Event Review as Mandated by theBest Pharmaceuticals for Children ActPediatric Subcommittee of the Anti-infective Drugs Advisory Committee Meeting June 9, 2004 Solomon Iyasu, MD, MPHMedical Team Leader Division of Pediatric Drug DevelopmentCenter for Drug Evaluation and Research Food and Drug Administration

  2. Acknowledgements • Office of Drug Safety DSRCS: DDRE: -Laura Governale -Mark Avigan -Michael Evans -Renan Bonnel -Toni Piazza-Hepp -Min Chen -Yoon Kong -Charlene Flowers -Aaron Mendelsohn -Lanh Green -David Moeny - Michael Johnston -Gianna Rigoni - Susan Lu - Kathleen Phelan - Joyce Weaver - Jo Wyeth

  3. Overview • Morning Session • One-year post-exclusivity adverse event reviews as mandated by the Best Pharmaceuticals for Children Act, 2002 (section 17) • Fexofenadine ( Allegra) • Topotecan (Hycamtin) • Temozolomide (Temodar) • Ciprofloxacin (Ciloxan) • Moxifloxacin (Vigamox) • Fosinopril (Monopril) • Fentanyl Transdermal System (Duragesic) • Venlafaxine (Effexor, Effexor XR) • Pediatric Update

  4. OverviewPost-marketing Adverse Event Report Review Outline • Background drug information • Indications, relevant safety labeling • Summary of exclusivity clinical studies • Outpatient and inpatient drugs usage review • Review of pediatric post-marketing adverse event reports • Comments/closing remarks • Question and answer

  5. http://www.fda.gov/cder/pediatric/Summaryreview.htm

  6. Overview • Afternoon session • Update on neonatal withdrawal syndrome • Post-marketing reports of neonatal withdrawal syndrome for SSRI/SNRI • Class labeling for SSRI/SNRI • Treatment of depression during pregnancy • Update on congenital eye malformations • Citalopram and newer antidepressants • PREA update • Overview of IOM Report

  7. Postmarketing Drug Adverse Events: Data Source and Limitations • Adverse Event Reporting System (AERS) • Spontaneous and voluntary reporting • Manufacturers report >90% post-marketing AEs • Limitations • Underreporting • Reporting bias • Quality of report • Cannot estimate true incidence rate of events or exposure risk

  8. Outpatient Drug Use: Data Sources and Limitations • IMS Health, National Prescription Audit Plus provides an estimate of the total number of prescriptions dispensed from retail pharmacies in the U.S., but does not provide demographic information on prescription use. • IMS Health, National Disease and Therapeutic Index is a survey based on a sample size of 2000 - 3000 office-based physicians. The small sample size can make these data projections unstable, particularly when use is not prevalent as in the case of the pediatric population.

  9. Outpatient Drug Use: Data Sources and Limitations • IMS Health, National Sales Perspectives™ Retail and Non-Retail does not provide a direct estimate of use but does provide a national estimate of units sold from the manufacturer to various channels of distribution. It does not include demographic information for the patients receiving these products, such as age and gender. The amount of products purchased by these retail and non-retail channels of distribution may be a possible surrogate for use, if we assume that facilities purchase drugs in quantities reflective of actual patient use.

  10. Inpatient Drug Use:Data Sources and Limitations • AdvancePCS, a wholly-owned subsidiary of Caremark Rx, Inc., is based on a large prescription claims database among an insured population of over 75 million patient lives, but data cannot be projected • Premier, Inc. contains inpatient drug use from 450 acute, short-stay, non-federal hospitals. National projection methodology is available but the ability to make accurate national estimates is selective; drug use cannot be linked to diagnosis or procedure; treatments administered at hospital outpatient clinics not included.

  11. Inpatient Drug Use:Data Sources and Limitations • Child Health Corporation of America™ (CHCA) Pediatric Health Information System (PHIS) • Inpatient data from 29 free-standing children’s hospitals with charge level drug utilization data • Not possible to directly link drug use with specific diagnoses or procedures; therefore, associations should be made with caution • Data cannot be projected nationally

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