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CERTs Overview

Fact Sheet


The Centers for Education and Research on Therapeutics (CERTs) program is a national initiative to increase awareness of the benefits and risks of new, existing, or combined uses of therapeutics through education and research. This Overview summarizes the CERTs program.

Purpose / Background / CERTs Implementation / CERTs Impact / Partnerships and Collaboration / CERTs Coordination / More Information


Purpose

The Centers for Education and Research on Therapeutics (CERTs) demonstration program is a national initiative to conduct research and provide education that advances the optimal use of therapeutics (i.e., drugs, medical devices, and biological products). The program consists of 14 research centers and a Coordinating Center and is funded and run as a cooperative agreement by the Agency for Healthcare Research and Quality (AHRQ), in consultation with the U.S. Food and Drug Administration (FDA).

The CERTs receive funds from both public and private sources, with AHRQ providing core financial support. The research conducted by the CERTs program has three major aims:

  1. To increase awareness of both the uses and risks of new drugs and drug combinations, biological products, and devices, as well as of mechanisms to improve their safe and effective use.
  2. To provide clinical information to patients and consumers; health care providers; pharmacists, pharmacy benefit managers, and purchasers; health maintenance organizations (HMOs) and health care delivery systems; insurers; and government agencies.
  3. To improve quality while reducing cost of care by increasing the appropriate use of drugs, biological products, and devices and by preventing their adverse effects and consequences of these effects (such as unnecessary hospitalizations).

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Background

Since 1992, AHRQ has funded studies focused on patient outcomes associated with pharmaceutical therapy. Through this Pharmaceutical Outcomes Program, these studies have addressed many important questions regarding the management of drug prescribing.

The CERTs concept grew out of recognition that, while pharmaceuticals and other medical products improve the lives of many patients, underuse, overuse, adverse events, and medical errors may cause serious impairment to patient health. The following gaps in knowledge remain:

  • Limited comparative information exists on the risks, benefits, and interactions of both new and older agents.
  • Health professionals need guidance on the appropriate, cost-effective use of therapeutics that will, in turn, lead to improved outcomes, error reduction, and prevention of adverse events.

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CERTs Implementation

Because of AHRQ's demonstrated expertise in pharmaceutical outcomes research, it was given responsibility for administering the CERTs demonstration program authorized by Congress as part of the Food and Drug Administration Modernization Act of 1997 (Public Law 105-115).

AHRQ awarded grants to support the first four centers in September 1999, and the full CERTs program was established as part of the Healthcare Research and Quality Act of 1999 (Public Law 106-129).

AHRQ funded 3 additional centers by September 2000 and 4 more in fiscal year 2006, bringing the 2006 total to 11 research centers and 1 Coordinating Center. Expiration of the original awards in 2007 led AHRQ to recompete and expand the number of centers. This resulted in a total of 14 research centers and a new Coordinating Center: 4 research centers added in fiscal year 2006, 6 of the original research centers newly funded in 2007, and 4 new research centers and a new Coordinating Center added in 2007. Each of the 14 research centers focuses on therapies used in a particular population or therapeutic area (select for a list of centers and their emphases). These 14 research centers, a Coordinating Center, a Steering Committee, and numerous partnerships with public and private organizations now make up the CERTs program.

Center Emphasis
Brigham and Women's Hospital (HS016970)
Principal investigator: David Bates, M.D., M.Sc.
Health information technology
Duke University Medical Center (HS016964)
Principal investigator: Eric Peterson, M.D., M.S.
Therapies for heart and blood vessel disorders
HMO Research Network (HS016955)
Principal investigator: Richard Platt, M.D., M.Sc.
Multiple population-based delivery systems
Rutgers, The State University of New Jersey (HS106097)
Principal investigator: Stephen Crystal, Ph.D.
Mental health therapeutics
University of Alabama at Birmingham (HS016956)
Principal investigator: Kenneth G. Saag, M.D., M.Sc.
Musculoskeletal disorders
University of Arizona CERT at The Critical Path Institute (C-Path) (HS017001)
Principal investigator: Raymond L. Woosley, M.D., Ph.D.
Drug interactions, women's health
University of Iowa (HS016094)
Principal investigator: Elizabeth A. Chrischilles, Ph.D.
Therapies for older adults and the effects of aging
Cincinnati Hospital Children's Medical Center (HS016957)
Principal investigator: Carole Lannon, M.D., M.P.H.
Pediatric therapeutics
University of Pennsylvania School of Medicine (HS016946)
Principal investigator: Brian L. Strom, M.D., M.P.H.
Anti-infective therapeutics use and resistance
University of Texas M.D. Anderson Cancer Center and Baylor College of Medicine (Houston CERT) (HS016093)
Principal investigator: Maria E. Suarez-Almazor, M.D., Ph.D.
Consumer education and patient adherence
Vanderbilt University Medical Center (HS016974)
Principal investigator: Wayne A. Ray, Ph.D.
Therapeutics for vulnerable populations
Weill Medical College of Cornell University (HS16075)
Principal investigator: Alvin I. Mushlin, M.D., Sc.M.
Therapeutic medical devices
University of Chicago (HS016967)
Principal investigator: David Meltzer, M.D., Ph.D.
Clinical and economic issues in hospital settings
University of Illinois–Chicago (HS016973)
Principal investigator: Bruce L. Lambert, Ph.D.
Tools for optimizing prescribing

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CERTs Impact

The centers have completed several important projects since their inception. Researchers at the Duke University center examined trends in aspirin use, patient characteristics, and long-term outcomes for aspirin effectiveness in more than 25,000 patients with cardiovascular diseases. They found that the percentage of patients with heart disease who report taking aspirin regularly increased between 1995 and 1999.1

These findings reflect substantial improvements in practice; but additional patients could benefit from this inexpensive, effective treatment that reduces death from heart disease, recurrent heart attacks, and stroke. The U.S. Preventive Services Task Force recommends that clinicians discuss the benefits and risks of aspirin therapy with adults who are at risk for coronary heart disease.

Another CERTs accomplishment is the Web-based International Registry for Drug-Induced Arrhythmias developed by the University of Arizona/C-Path CERT. The information on clinical cases of drug-induced cardiac arrhythmias collected by the registry will be used to develop:

  • Detailed profiles of people most at risk for these arrhythmias.
  • A genetic test that can identify them in advance.

The registry can be accessed online at: http://www.qtdrugs.org.

The University of Arizona /C-Path CERT, in collaboration with FDA's Center for Drug Evaluation and Research, has released its online clinical pharmacology educational module, "Preventable Adverse Drug Reactions: A Focus on Drug Interactions." The module was based on a needs survey sent to all third-year medicine clerkship directors and all medicine residency program directors in the United States. It consists of a set of slides illustrating a sample case, extensive literature references, and self-assessment questions. The module is available at: http://www.fda.gov/cder/drug/drugreactions/default.htm.


1. Califf RM, DeLong ER, Ostbye T, et al. Underuse of aspirin in a referral population with documented coronary artery disease. Am J Cardiol 2002 Mar 15; 89(6):653-61.


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Partnerships and Collaboration

A core value of the CERTs program is the belief that collaboration among groups with different perspectives and resources is critical if the results are to be applicable in "real world" settings. The centers work with public and private collaborators on projects, which allows each center to expand the number of its projects and extend their potential impact.

The CERTs are committed to creating a collaborative environment with other organizations interested in advancing the best use of therapeutics. For that purpose, a "Partnerships to Advance Therapeutics" (PATHs) program was established as an integral part of the CERTs initiative.

Each year, the CERTs host a PATHs meeting of leaders from public and private organizations concerned about the quality and safety of health care. Partners and participants include organizations representing patients, health care providers, government, academia, delivery systems, payers, purchasers, and manufacturers of medical products.

A registry of educational and research projects of PATHs organizations is published and can be accessed through the CERTs Web site at: http://www.certs.hhs.gov/partners/paths/regis.

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CERTs Coordination

The CERTs Coordinating Center is located at the Kaiser Foundation Center for Health Research. Directed by Mark C. Hornbrook, Ph.D., the Coordinating Center helps support the work of the research centers by enhancing cross-center synergy and disseminating findings from the research conducted by the centers.

A Steering Committee, organized by the Coordinating Center, serves in an advisory capacity to the CERTs program. Steering Committee members include representatives from each center, the Federal Government (AHRQ, FDA, and the National Institutes of Health), the private sector, and consumer groups. In addition, work groups of representatives from all centers address broad issues related to the CERTs effort, such as public-private partnerships.

AHRQ's Center for Outcomes and Evidence oversees the CERTs program and provides technical assistance and research support.

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More Information

More information on the CERTs program is available from:

Anne Trontell, M.D., M.P.H.
Program Director, Centers for Education and Research in Therapeutics
Center for Outcomes and Effectiveness Research, AHRQ
Phone: (301) 427-1607
Fax: (301) 427-1640
E-mail: Anne.Trontell@ahrq.hhs.gov

Carmen Kelly, Pharm.D., R.Ph.
Project Officer, CERTs Coordinating Center
Center for Outcomes and Effectiveness Research, AHRQ
Phone: (301) 427-1513
E-mail: Carmen.Kelly@ahrq.hhs.gov

In addition, the CERTs program welcomes input about the types of research and education needed to better address costs, effectiveness, and safety issues related to the use of therapeutics. Comments may be sent to CERTs program staff at AHRQ or to:

Judy Donald
Project Manager
CERTs Coordinating Center
Kaiser Foundation Center for Health Research
E-mail: Judy.L.Donald@kpchr.org

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AHRQ Publication No. 08-P009-EF
Current as of January 2008


Internet Citation:

Centers for Education and Research on Therapeutics (CERTs) Overview: Fact Sheet. AHRQ Publication No. 08-P009-EF, January 2008. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/clinic/certsovr.htm


 

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