Presentation on theme: "The Pharmacist’s Role in Drug Quality Surveillance: Perspectives from FDA’s Drug Quality Reporting System The Pharmacist’s Role in Drug Product Quality."— Presentation transcript:
The Pharmacist’s Role in Drug Quality Surveillance: Perspectives from FDA’s Drug Quality Reporting System The Pharmacist’s Role in Drug Product Quality Surveillance: Perspectives from FDA’s Drug Quality Reporting System Vaiyapuri Subramaniam, Pharm.D., FASHP Ralph Jay Schmid, CSO Roger Gregorio, CSO Food and Drug Administration U.S.A.
Drug Quality Reporting System (DQRS) Division of Rx Drug Compliance and Surveillance
DQRS Background 1971 - 1988 Drug Product Problem Reporting Program (DPPR) 1988 - Present USP Drug Product Problem Reporting Program (USP Program terminated August 31, 2000) 1988 - 1993 Drug Quality Reporting System (DQRS) 1993 - Present MedWatch Program
Program Objectives Rapidly identify significant health hazards Detect industry problems and trends Operate a centralized reporting system
PMST Responsibilities Screen all reports –Potential Health Hazard Triage (USP reports) –ADEs –Biologics –Foods –Devices
Responsibilities (Cont’d) Evaluation of Reports Collect and Verify Information –Contact reporter –Contact CDER review division Search Information Sources –DQRS database, DPS surveys, response letters –Reference materials, e.g., Facts and Comparisons Classification
Classification of Reports Priority 1 - Imminent or serious health hazard Priority 2 - Potentially significant CGMP Problems Priority 3 - Routine follow-up
Primary Users of the DQRS Database District Offices Prepare for GMP Inspection TIACC Investigating therapeutic failures Drug Survey Identify drug Program candidates Office of Identify problem Compliance firms/products USP Monograph
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