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The Pharmacist’s Role in Drug Quality Surveillance: Perspectives from FDA’s Drug Quality Reporting System The Pharmacist’s Role in Drug Product Quality.

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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:

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3 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.

4 Drug Quality Reporting System (DQRS) Division of Rx Drug Compliance and Surveillance

5 DQRS Background Drug Product Problem Reporting Program (DPPR) Present USP Drug Product Problem Reporting Program (USP Program terminated August 31, 2000) Drug Quality Reporting System (DQRS) Present MedWatch Program

6 Program Objectives Rapidly identify significant health hazards Detect industry problems and trends Operate a centralized reporting system

7 PMST Responsibilities Screen all reports –Potential Health Hazard Triage (USP reports) –ADEs –Biologics –Foods –Devices

8 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

9 Classification of Reports Priority 1 - Imminent or serious health hazard Priority 2 - Potentially significant CGMP Problems Priority 3 - Routine follow-up

10 CDER Interaction Office of Post-marketing DrugRisk Assessment (OPDRA) Review divisions TIACC GWQAP

11 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

12 Source of DQRS Reports FY-00

13 Source of DQRS Reports FY-01

14 Total DQRS Reports Received USP vs MedWatch USP program terminated August 31, 2000

15 DQRS Reports Resulting In Recalls/Market Withdrawals Recall Classes FY-96 to FY-01

16 Recalls/Market Withdrawals Resulting from DQRS Reports FY-96 to FY-01

17 Corrections Resulting from DQRS FY-96 thru FY-01

18 DQRS Primary Defects Reported FY-00

19 DQRS Primary Defects Reported FY - 01


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