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Enhancing Drug Quality Surveillance: FDA's Pharmacist Role

This article delves into the pivotal role of pharmacists in FDA's Drug Quality Reporting System, highlighting their responsibilities in identifying health hazards, detecting industry problems, and operating a centralized reporting system for drug quality.

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Enhancing Drug Quality Surveillance: FDA's Pharmacist Role

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  1. The Pharmacist’s Role in Drug Quality Surveillance: Perspectives from FDA’s Drug Quality Reporting SystemThe Pharmacist’s Role in Drug Product Quality Surveillance: Perspectives from FDA’s Drug Quality Reporting SystemVaiyapuri Subramaniam, Pharm.D., FASHPRalph Jay Schmid, CSORoger Gregorio, CSOFood and Drug AdministrationU.S.A.

  2. Drug QualityReporting System(DQRS) Division of Rx Drug Compliance and Surveillance

  3. 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

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

  5. PMST Responsibilities • Screen all reports • Potential Health Hazard • Triage (USP reports) • ADEs • Biologics • Foods • Devices

  6. 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

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

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

  9. Primary Users of the DQRS Database • District Offices Prepare for GMP Inspection • TIACC Investigating therapeutic failures • Drug Survey Identify drugProgram candidates • Office of Identify problem Compliance firms/products • USP Monograph

  10. Source of DQRS ReportsFY-00

  11. Source of DQRS ReportsFY-01

  12. Total DQRS Reports ReceivedUSP vs MedWatch USP program terminated August 31, 2000

  13. DQRS Reports Resulting In Recalls/Market WithdrawalsRecall Classes FY-96 to FY-01

  14. Recalls/Market Withdrawals Resulting from DQRS ReportsFY-96 to FY-01

  15. Corrections Resulting from DQRSFY-96 thru FY-01

  16. DQRS Primary Defects ReportedFY-00

  17. DQRS Primary Defects ReportedFY - 01

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