# Presentation: 720656

-  CERTs and the FDA
- Implementation of FDAMA 409
- Peter K Honig, MD, MPH
- Office of Postmarketing Drug Risk Assessment
- Center for Drug Evaluation and Research
- DIA Annual Meeting
- June 12, 2000

## Institute of Medicine Report on Medical Errors

- Preventable adverse reactions to drugs is single leading cause of hospitalization (19% of preventable errors)
- Medication error accounts for 7,000 deaths/year
- Systems problem
- Misprescribing ---> operating on wrong side of brain
- FDA has responsibility for and control of part of the issue
- FDA has influence over and interest in other parts of the issue

## Managing the Risks From Medical Product Use & Creating a Risk Management Framework 

- http://www.fda.gov/oc/tfrm/1999report.html
- Attempts to Frame FDA’s Role in Medical Product Risk Management
- Useful conceptual framework for addressing the systems analysis and planning remedies
- Managing Risk: Premarket, Postmarket
- Includes Recommendations and Options

## Conceptual Framework

## FDA’s Responsibilities in the Federal Response to the IOM Report: QuIC Response

- Quality Interagency Coordination Task Force (QuIC) Agencies
- AHRQ
- CDC
- FDA
- HCFA
- NIH
- HRSA, NASA, DoD, etc.

## Synopsis of FDA’s Responsibilities

- Leadership Activities
- Quantifying and Learning from Errors
- Setting Performance Standards and Expectations
- Increasing Public Awareness
- Developing Standardized Procedures, Checklists, and Human Factors Research

## Setting Performance Standards and Expectations

- Initiate programs to develop standards for drug names (within one year)
- Initiate development of packaging standards to prevent dosing and drug mix-ups (within 1 year)
- Develop new labeling standards for drugs to highlight potential DDIs (within 1 year)
- Implement Phase II of MedSUN (within 1 year)
- Complete on-line adverse drug reporting system (AERS and e-prompt: within 1 year)

## Setting Performance Standards and Expectations

- Provide increased access to databases linked to healthcare systems (within 1 year)
- Strengthen FDA’s analytic and investigative capacity (within 1 year)
- Strengthen FDA’s outreach activities and collaboration with other Federal agencies (1 year)

## Increasing Public Awareness

- Increase collaborative programs with consumer groups on safety (within one year)
- Meet with public to discuss provision of information on the safe use of drugs (w/in 1 year)

## Centers for Education & Research in Therapeutics (CERTs)

- Original concept
- Not new:  1980 Kennedy report
- 1990s:  Woosley, Ray and others (? FDA funded program)
- 1997:  FDAMA 409 (November 21, 1997)
- The Secretary, acting ... in consultation with [FDA], shall establish a demonstration program.
- ...to conduct state-of-the-art clinical and laboratory research
- ...to increase awareness of new uses of drugs, biologics, devices
- ...to provide objective clinical information to practitioners, pharmacists..
- ...to improve the quality of healthcare while reducing cost through the appropriate use of and prevention of Aes of drugs, biologics, devices.
- ...conduct research on comparative effectiveness and safety.

## CERTs 

- Coordinating Center:  Duke University
- Duke University (Califf)
- University of North Carolina (Campbell)
- Vanderbilt University (Ray)
- Georgetown University (Woosley)
- All to share 7.7 million dollars/3 years
- Public-private partnership
- Industry representation on steering committee
- Lisa Igbuonu-Davis:  Pfizer
- Karen Williams:  National Pharmaceutical Council

## CERTs- Challenges and Opportunities

- CERTs challenges:  Maintaining balance and independence while building core funding & critical mass
- More FY ‘00 money available; more CERTs or shared resources
- Move beyond demonstration projects to functional PROGRAM with PROGRAMATIC GOALS
- Synergies (critical mass) and focus (broad mandate)

## CERTs Opportunities

- CERTs may be in the right place at the right time (IOM report)
- Back to concept of CERTs as a laboratory or ‘window on the world’ for FDA to:
- interface with the system that manages benefit-risk
- see how therapeutics are really being used out there
- test risk communication strategies in modifying prescribing/use of medical products
- understanding the impediments to and maximizing the benefits of available therapeutics
- maximize societal benefits of available therapies
- Woosley offered CERTs as a sentinel surveillance mechanism at Congressional hearings
- Shared data resources accessible to FDA

## CERTs:  State of the Centers

- Addressing critical unmet medical, societal, scientific needs
- Daunting administrative and scientific challenges
- Critical mass being established
- Impressive energy and progress to date
- Excellent working relationship with FDA

## Short List of CERTs/FDA Activities 

- Acquired (drug induced) prolonged QT registry
- Pediatric medication errors (UNC)
- Active surveillance in ERs (UNC)
- Survey of Program Directors and development of teaching module for drug safety and ADR reporting (Georgetown)
- CDRH-Duke projects on coronary stenting

## Short List of CERTs/FDA Activities

- Stakeholders meetings
- Data resource sharing
- Drug utilization
- Population based data
- Testing of effectiveness of risk management programs (dofetilide)
- FDA training fellowship (shared experience)

**Thanks to: **
**Lynn Bosco**
**Hugh Tilson**
**CERTs PIs (Califf, Campbell, Ray, Woosley)**
**And to all of you for listening**

**FDA**

**CERTs**

**AHRQ**