# Presentation: 921010

## Slide 1

## 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

**Notes:**
DQRS - Drug Quality Reporting Program

Voluntary reporting program

Div. Of Rx Drug Compliance and Surveillance runs and coordinates the program 

## 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

**Notes:**
Significant heath hazards - Mislabeled products, contaminated 
                products, product mix-ups (wrong product in a container)

Trends - Therapeutic failures for a particular product - same or different
               lots, container defects, product dissolution, product  
               appearance, etc.

## PMST Responsibilities

- Screen all reports
- Potential Health Hazard
- Triage (USP reports)
- ADEs
- Biologics
- Foods
- Devices

**Notes:**
USP reports are forwarded to PMST daily.  Reports concerning Biologics, medical devices, ADEs, and medical foods, are forwarded to the appropriate Center.

ADEs that involve a possible drug quality issue are entered in the DQRS database and, a copy is forwarded to the Division of Pharmacovigilance (HFD-730).,g.g, therapeutic failure.

## 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

## CDER Interaction

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

## 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

## Source of DQRS ReportsFY-00

## Source of DQRS ReportsFY-01

## Total DQRS Reports ReceivedUSP vs MedWatch

- USP program terminated August 31, 2000

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

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

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

## DQRS Primary Defects ReportedFY-00

## DQRS Primary Defects ReportedFY - 01