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CERTs: An ISPE Partner in Improving the Knowledge and Use of Pharmaceuticals through Research and Education
By Hugh Tilson, MD, DrPH, FISPE, and Leanne Madre, JD

Let us introduce an important strategic partner to ISPE, the U.S.-based national program of the Centers for Education and Research on Therapeutics (CERTs).

The CERTs program was authorized in 1997 by the U.S. Congress to improve the quality of health care through the development and communication of evidence about the benefits, risks and appropriate use of drugs, devices and biological products. The Agency for Healthcare Research & Quality (AHRQ), in consultation with the Food and Drug Administration (FDA), formally established the CERTs program in September 1999. Seven research centers, a coordinating center, a steering committee, and numerous partnerships with public and private organizations now make up the CERTs program. Each research center focuses its research and education efforts on a particular patient population or therapeutic area as follows:

Research Center Emphasis
Duke University Medical Center Therapies for disorders of the heart and blood vessels
HMO Research Network Drug use, safety and effectiveness in HMO populations
University of Alabama at Birmingham Therapies for musculoskeletal disorders
University of Arizona Health Sciences Center Drug interactions that result in harm to women
University of North Carolina at Chapel Hill Therapies for children
University of Pennsylvania School of Medicine Therapies for infection; antibiotic drug resistance
Vanderbilt University Medical Center Prescription drug use in a Medicaid population

Partnerships and Collaboration

One core value of the CERTs program is that collaboration between 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 allow them to expand the number and extend the potential impact of projects. In addition, the CERTs are committed to creating a collaborative environment with other organizations interested in advancing the best use of therapeutics. The "Partnerships to Advance Therapeutics" (PATHs) program was established to facilitate public-private partnership activities 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, delivery systems, payers, and manufacturers of medical products, among others. Susana Perez, FISPE, ISPE President, attended this year's PATHs meeting and herself represented ISPE's many potential contributions to the CERTs proposed national strategic plan to improve therapeutics. A registry of educational and research projects of PATHs organizations is published and can be accessed through the CERTs website: www.certs.hhs.gov/partners/paths/regis. The CERTs are pleased that ISPE is an active participant in the PATHs meetings and is included in the PATHs registry.

Collaboration with ISPE

The CERTs and ISPE share a number of common interests, which is not surprising given the role played in the CERTs by several prominent ISPE members. Lynn Bosco, from AHRQ, and a member of the ISPE Board is the CERTs program officer. One of us, Hugh Tilson, FISPE, ISPE founding co-president, is the Chair of the CERTs national steering committee. Brian Strom, FISPE, an ISPE past president is the principal investigator of one of the CERTs research centers, and several other prominent ISPE members are active in the CERTs leadership.

Together the CERTs and ISPE have begun to explore opportunities for collaboration through, for example, participation in each others' meetings. For the past few years, the CERTs Breakfast Roundtable session at the ISPE annual meeting has provided a wonderful opportunity for CERTs and ISPE members to discuss the implications of appropriate product use, prevention of errors, adverse effects; and cost-effective use of new and existing pharmaceuticals for international pharmacoepidemiology and risk management. A notable feature of these highly interactive breakfast events has been consideration of how to establish and maintain contact with similar centers around the world.

Additional information regarding the program can be found on the CERTs website: www.certs.hhs.gov. Also in future issues of the Scribe, ISPE members will have an opportunity to learn more about the work of the individual CERTs research centers. We look forward to sharing this information with you and welcome suggestions regarding potential collaboration opportunities.

[Editor's Note: ISPE will host the 4th Annual CERTs Breakfast Roundtable, 7:00am, August 25, Sofitel Hotel, Bordeaux, France.]


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