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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.
• 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 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
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
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