Transcript FDA MedWatch and Patient Safety

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
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(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.
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.
Reporting to MedWatch
What, 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
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
Reporting to MedWatch
What exactly do I report?
• Product Quality Problems
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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 is a serious adverse event?
Any event that …
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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
How do I go about reporting?
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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? (cont.)
Patient
Product
Description of Event
or Problem
Reporter
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
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
How MedWatch Sends Safety Information
MedWatch e-list notification
• E-mail notification of
individuals of new
postings on website
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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