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Risk Intervention Study: Cisapride

Risk Intervention Study: Cisapride. Evelyn M Rodriguez MD, MPH Director, DDREII, OPDRA. Topics for Today’s Discussion. Cisapride: Risk Intervention Case Study Summary / Considerations Future Directions. Cisapride’s Regulatory History. Risk Intervention Study.

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Risk Intervention Study: Cisapride

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  1. Risk Intervention Study: Cisapride Evelyn M Rodriguez MD, MPH Director, DDREII, OPDRA

  2. Topics for Today’s Discussion • Cisapride: Risk Intervention Case Study • Summary / Considerations • Future Directions

  3. Cisapride’s Regulatory History Risk Intervention Study

  4. Cisapride’s Regulatory History • Approved in July 1993 • First reports of Ventricular Arrhythmia with an antifungal drug 12/94 • Multiple Dear Healthcare Practitioner letters that described new contraindications and warnings for specific drugs and conditions

  5. Cisapride’s Regulatory History • Black Box Warning with Contraindication for QT interval prolonging drugs and Cardiovascular and Medical Conditions, 2nd line indication & DHPL 6/98

  6. Study Objective • To describe the impact of the cumulative labeling changes through 6/98 • CYP P450 3A4 Enzyme Inhibitor Drugs • QT Prolonging Drugs • Contraindicated Comorbidities

  7. Automated Databases: Sites A, B, and C Time Periods Before DHPL: 7/97 - 6/98 After DHPL: 7/98 - 6/99 Methods

  8. Study Sites N based on calendar 1998; no material change for any of databases in 1999.

  9. Cohorts Before and After Labeling Changes through 6/98

  10. Results: Contraindicated Drug or Disease

  11. Conclusion • No reduction in contraindicated use was found following labeling changes and DHPL of 6/98

  12. Study Group • FDA Investigators • Diane Wysowski Ph.D., Evelyn M. Rodriguez, Dave Graham M.D., M.P.H. • United Health Group (Site A) • Deborah Shatin, Ph.D., Stephanie D. Schech, Ph.D. • Tennessee Medicaid (Site B) • Walter Smalley, M.D., M.P.H., Jim Daugherty, M.S., Wayne Ray, Ph.D. • Harvard Consortium (Site C) • Jerry Gurwitz, M.D, Susan Andrade, D.Sc., Jackie Cernieux, M.P.H. (Meyers Primary Care Institute, Fallon Healthcare System); Richard Platt, M.D., M.S., Arnold Chan, M.D., Dr.P.H. (Harvard Pilgrim Healthcare, Michael Goodman, Ph.D. (HealthPartners)

  13. Summary / Considerations • Risk Intervention studies are useful to assess the effect of labeling and DHPL • This study suggests labeling fatigue • Other strategies, such as Education targeting Prescribers and Patients, may be useful to encourage the implementation of recommended risk management efforts

  14. Future Directions • Determine • How prescribers interpret information from DHPL & other educational materials • Best format to inform prescribers and patients of drug safety concerns -- PPI, Med Guide, company sales force materials, CME course

  15. Future Directions • Determine • How information, contraindications, and monitoring recommendations are used

  16. Future Directions • Conduct risk intervention studies in multiple databases that reflect the range of health care services delivery systems • Validate the findings in databases with medical record review

  17. Possible Next Steps • Incidence Study for Serious Outcomes • QT Prolongation and Torsades de Pointe difficult to assess (non-specific ICD-9 codes and underreporting) • Sudden Death possible; use unexposed comparator group

  18. Possible Next Steps • Implement Risk Interventions: EKG monitoring, other • Evaluate whether the Risk Interventions (e.g. Education, Labeling) is achieving desired goals

  19. Back Up Slides

  20. Contra-indicated Drugs

  21. Contraindicated Comorbidity Based on (pre/post) persons with 180+ days of enrollment: Site A: 13613/12418; B: 4379/4229; C: 6848/5812

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