FDA MedWatch and Patient Safety

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FDA MedWatch and Patient Safety
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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.

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Dietary Supplement and Nonprescription Drug
Consumer Protection Act of 2006

• 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.

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Reporting to MedWatchWhat, When, How and Why
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Reporting to MedWatch

• What
• All clinical medical products
• When
• If serious
• How
• Online, or mail/fax/phone
• Why
• Every report can make a difference

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Reporting to MedWatch What products do I report
on?

• Drugs
• Prescription
• Over the Counter
• Medical Devices
• Biologics, except vaccines
• Special Nutritional Products
• Dietary supplements
• Infant formulas
• Medical foods
• Cosmetics

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Reporting to MedWatch What exactly do I report?

• 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

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Reporting to MedWatch What is a serious adverse
event?

• 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

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Reporting to MedWatch How do I go about
reporting?

• Onlinewww.fda.gov/medwatch
• Phone1-800-FDA-1088
• Fax1-800-FDA-0178
• Mail

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Reporting to MedWatch How do I go about
reporting? (cont.)
PatientProductDescription of Event or
ProblemReporter
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What happens to your report when you report a
serious adverse event

• 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

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What happens to your report when you report a
serious adverse event (cont.)

• 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

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How MedWatch Sends Safety Information MedWatch
e-list notification

• E-mail notification of individuals of new
  postings on website
• 54,000 subscribers in 2005

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Have You Had A Reaction?

• Report serious adverse effects to the FDAs
  MedWatch Program
• 1-800-FDA-1088
• by fax at 1-800-FDA-0178
• reporting on-line at http//www.fda.gov/medwatch/
  how.htm

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End of Presentation