FDA’s MedWatch Program Outreach to Healthcare Professionals and the Public

1. FDA’s MedWatch ProgramOutreach to Healthcare Professionals and the Public Managing the Risks of Medical Product Use

2. MedWatch our product is safety information • The communication of INFORMATION that leads to improvement in the safe use of medical products used in clinical care • Serious AE’s, product problems and medication errors IN to MedWatch • Timely safety alerts OUT to our audiences

3. MedWatcha change in focus - 1993 to 2003 • 1993 - MedWatch, The FDA Adverse Event Reporting Program • 1998- MedWatch, The FDA Medical Products Reporting and Safety Information Program • 2001 - MedWatch, The FDA Safety Information and Adverse Event Reporting Program

4. MedWatchour mission in 2003 • FDA’s mission:Assure that safe and effective medical products are available to Americans • Safe means that: • Risks are managed • Quality is assured • Health fraud is pursued • Advertising is appropriate • Information is available

5. MedWatchour role in post-marketing risk management • risk identification - MedWatch • gather information • risk evaluation - Office of Drug Safety • evaluate information • risk intervention - Review Divisions • modify product use strategy • risk communication - MedWatch • disseminate new use information

6. MedWatchour outreach strategies • Providing value for HCPs by • improving the timely BROADCASTING OUT of clinically important medical product safety information • to justify • the REPORTING IN of serious and unexpected AE’s and product problems

7. MedWatchour outreach strategies

8. MedWatchour outreach strategies • MedWatch website • E-mail notification to Partners • E-mail notification to MedWatch e-list • Push technologies to handhelds

9. MedWatch websitewww.fda.gov/medwatchlink • Safety Information Retrieval • Adverse Event Reporting for Drugs and Medical Devices • Continuing Education • Regulatory Information

10. MedWatchour websitelink • What’s New • Safety Information • Submit Report • How to Report • Download Forms

11. MedWatchour websitelink What’s New……Weidner’s eyedrops [OTC]Hepatitis A vaccine [biologic]Kava [dietary supplement]Lamicatal [dispensing errors]Inapsine [ Rx drug]

12. MedWatchour websiteSafety InformationSafety Alerts Safety labeling changes

13. Safety Information Retrieval • Dear Healthcare Professional Letters • Safety Labeling Changes • Recalls - class I • Withdrawals • Public Health Advisories • Safety-related labeling changes

14. Safety-related labeling changes but not prompting a Dear Healthcare Professional letter • “Clinically important” safety labeling updates • dosing and administration • interactions • high risk populations • new adverse reaction profile

15. E-mail Notification“join the MedWatch e-list” • MedWatch Partners • 170 organizations [health professionals and consumers] who take alerts and disseminate to their members • MedWatch e-list • 28,000 individuals who sign up at website for brief reminder of posting of all safety alerts, public health advisories, recalls

16. MedWatchReporting Inone form for all voluntaryreporting [1993- present]

17. MedWatchour websiteReport OnlineReport Online

18. Medwatchwhy report? • Each report can make a difference • Even after long use of a product, uncertainties will remain. • Example • Depakote Depakote • approved in 1982 • in 2001, new indications, new populations

19. Medwatchwhat to report • Serious adverse events, product problems and medical errors associated with: • Drugs [Rx and OTC] • Biological products • Medical devices • Dietary supplements and herbal products

20. Medwatchwhat to report • Serious means: • Death • Life-threatening • Hospitalization [either initial or prolonged] • Disability • Congenital anomaly • Intervention required to prevent permanent impairment or damage

21. Medwatchwhat to report • Product problems are: defective or malfunctioning medical products about which there is a concern about quality, performance, or safety

22. Medwatchwhat to report • Examples of product problems • inaccurate or unreadable product labeling • packaging or product mix-up • suspected contamination • questionable stability • defective devices

23. Medwatchwhat not to report • Vaccine-related problems are reported to: • Vaccine Adverse Event Reporting System (VAERS) • Veterinary medicine-related problems are reported to: • www.fda.gov/cvm/index/ade/adetoc.htm

24. Medwatchhow to reach us • www.fda.gov/medwatch • 1-800-FDA-1088 • 1-800-FDA-0178

25. The Future • Computerized Medical Records • the potential to facilitate reporting of suspected serious adverse events • the potential for clinical reminders about: • previous drug reaction history • drug-drug, drug-food interactions • dosage adjustments • new safety alerts

26. The Future • Hand-Helds [PDA’s] • Portable drug reference information • e-Pocrates [650,000 users] • Instant updates of database at time of synchronization • Medication prescribing by PDA wireless linkages • safety information pop-ups during Rx prescribing • Reporting In application loaded in PDA

27. MedwatchIf It’s Serious, We Need To Know • www.fda.gov/medwatch • 1-800-FDA-1088 [phone] • 1-800-FDA-0178 [fax]