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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. 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 • • • • • 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 … • • • • • • 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? • • • • 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 • 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