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

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

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

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

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

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

7. MedWatch our outreach strategies

8. n MedWatch website n E-mail notification to Partners n E-mail notification to MedWatch e-list n Push technologies to handhelds

9. MedWatch website www.fda.gov/medwatch link link n Safety Information Retrieval n Adverse Event Reporting for Drugs and Medical Devices n Continuing Education n Regulatory Information

10. MedWatch our website link link link n What’s New n Safety Information n Submit Report n How to Report n Download Forms

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

12. MedWatch our website Safety Information Safety Alerts Safety labeling changes

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

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

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

16. MedWatch Reporting In one form for all voluntary reporting [1993- present]

17. MedWatch our website Report Online Report Online Report Online Report Online

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

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

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

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

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

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

24. Medwatch how to reach us n www.fda.gov/medwatch n 1-800-FDA-1088 n 1-800-FDA-0178

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

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

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