1. FDA MedWatch and Patient Safety

2. Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006  The Act defines a ‘serious adverse event’ as one that results in  (i) death,  (ii) a life-threatening experience,  (iii) in-patient hospitalization,  (iv) a persistent or significant disability or incapacity,  (v) a congenital anomaly or birth defect; or requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described above.

3. Mandatory for all DS and nonprescription drug manufacturers or distributors to file serious AERs to MedWatch. According to the Act: –The DS manufacturer, packer, or distributor (the responsible party) must submit to FDA within 15 business days any report received regarding a serious adverse event associated with the DS when the product is used in the US. –Must be accompanied by a copy of the label on or within the retail package of the product. Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006

4. Reporting to MedWatch What, When, How and Why

5. Reporting to MedWatch What –All clinical medical products When –If serious How –Online, or mail/fax/phone Why –Every report can make a difference

6. Drugs Prescription Over the Counter Medical Devices Biologics, except vaccines Special Nutritional Products Dietary supplements Infant formulas Medical foods Cosmetics Reporting to MedWatch What products do I report on?

7. Product Quality Problems Suspect counterfeit Contamination, instability Poor packaging, labeling Defective components Therapeutic failures Serious Adverse Events Drugs, biologics, devices, cosmetics and special nutritional products Reporting to MedWatch What exactly do I report?

8. Any event that … Is fatal Is life-threatening Is permanently/significantly disabling Requires or prolongs hospitalization Causes a congenital anomaly Requires intervention to prevent permanent impairment or damage Reporting to MedWatch What is a serious adverse event?

9. Online www.fda.gov/medwatch Phone 1-800-FDA-1088 Fax 1-800-FDA-0178 Mail Reporting to MedWatch How do I go about reporting?

10. Reporting to MedWatch How do I go about reporting? (cont.) Patient Product Description of Event or Problem Reporter

11. Report captured in a database Database monitored by an FDA professional Review of a case series Consultation with medical review division and manufacturer Further epidemiological studies as needed What happens to your report when you report a serious adverse event

12. FDA can issue: –Boxed Warning Drug-drug, drug-food interaction warnings Monitoring recommendations Dosage adjustments for sub-populations –Contraindications, Warnings, Precautions or Adverse Reactions –Medication Guide What happens to your report when you report a serious adverse event (cont.)

13. How MedWatch Sends Safety Information MedWatch e-list notification E-mail notification of individuals of new postings on website 54,000 subscribers in 2005

14. Have You Had A Reaction? Report serious adverse effects to the FDA’s MedWatch Program: 1-800-FDA-1088 by fax at: 1-800-FDA-0178 reporting on-line at: http://www.fda.gov/medwatch/how.htm

15. End of Presentation