FDA MedWatch and Patient Safety

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.

• 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

Reporting to MedWatchWhat, When, How and Why

Reporting to MedWatch• What

– All clinical medical products• When

– If serious• How

– Online, or mail/fax/phone• Why

– Every report can make a difference

• 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?

• 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?

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?

• Onlinewww.fda.gov/medwatch

• Phone1-800-FDA-1088

• Fax1-800-FDA-0178

• Mail

Reporting to MedWatch How do I go about reporting?

Reporting to MedWatch How do I go about reporting? (cont.)

Patient

Product

Description of Event or Problem

Reporter

• 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

• 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.)

How MedWatch Sends Safety Information MedWatch e-list notification

• E-mail notification of individuals of new postings on website

• 54,000 subscribers in 2005

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

End of Presentation