Chapter 1. Introduction

1.1. Overview of the Pharmaceutical Outcomes Portfolio

Medications are very frequently used for the treatment and prevention of numerous medical conditions. In 1999, 62% of the U.S. civilian non-institutionalized population had an outpatient drug expense and 2.1 billion prescriptions were purchased with an average of eight prescriptions per person (AHRQ, 2003). Outpatient prescription drug expenses accounted for almost 16% of health care spending, at $94.2 billion (AHRQ, 2003). In addition to the expenditures for medications, the cost of the morbidity and mortality associated with medications was estimated at $76.6 billion in 1995 (Johnson & Bootman, 1995)¹ and $177.7 billion in 2001 (Ernst & Grizzle, 2001)².

AHRQ's Pharmaceutical Outcomes Portfolio has consisted of support for grants through Requests for Applications (RFAs) and has expanded to include support for the Centers for Education and Research on Therapeutics (CERTs) program.³ The overarching program goals of the Pharmaceutical Outcomes Portfolio are:

• Understanding benefits and risks. Expand our knowledge about the benefits and risks and outcomes of pharmacological therapies so that better decisions can be made about how and when to appropriately use pharmaceuticals to improve health.
• Advancing optimal use in clinical practice. Identify opportunities and strategies to increase the likelihood that patients will receive the right treatment at the right time from their health care providers across all practice settings.
• Helping patients and consumers derive maximum benefit. Identify and evaluate strategies for communicating the information that patients and consumers need to make decisions about the appropriate use of therapeutics, in consultation with their health care providers.
• Informing policies. Provide government agencies, managed care organizations, employers and other decision-makers with scientific evidence to inform their decisions and evaluate the policy implications of their decisions.
• Supporting the extension of education and research. Support multi-disciplinary efforts to educate health care providers, researchers and students about how to evaluate the optimal use of therapeutics and apply scientific evidence to practice.

Specific FY'04 Office of Management and Budget (OMB) Program Assessment Rating Tool (PART) review goals for the Pharmaceutical Outcomes Portfolio include:

• Reduce congestive heart failure re-admission rates during the first six months after initial admission by approximately 2% per year through 2014;
• Decrease the inappropriate use of antibiotics in children by approximately 2.5% per year through 2014.
• Reduce hospitalization for upper gastrointestinal by 2% per year through 2014.¹

1.1.1. The CERTs Program

The CERTs program is a national initiative and network of centers funded under cooperative agreements by AHRQ "to conduct research and provide education that advances the optimal use of therapeutics (i.e. drugs, medical devices, and biological products)."⁴

The CERTs concept grew out of a recognition that physicians and other healthcare providers need information more information about prescription and non-prescription medications. Although some information is available through the pharmaceutical industry, continuing medical education programs, professional organizations, and peer-reviewed literature, comparative information about the risks and benefits of new and older agents and about drug interactions is limited.

At the same time that medical products improve the lives of many patients, significant numbers of adverse events and inappropriate product use cause serious impairment to the health of others. Guidance on appropriate product use, prevention of errors and adverse effects, and cost-effective use of new and existing products is limited, indicating that health professionals need more complete information about the drugs and biologics they prescribe, the devices they use and what practices associated with their use need improvement. To address these issues, Congress authorized the CERTs demonstration program as part of the Food and Drug Administration Modernization Act of 1997. AHRQ was given responsibility for administration of the program. AHRQ awarded the first CERTs cooperative agreements in September 1999; the full CERTs program in December of that year was made part of the Healthcare Research and Quality Act of 1999 (Public Law 106-129).

The goals for CERTs were such that AHRQ did not have adequate resources to achieve the goals of the legislation. In order to compensate, the program was designed to allow the program grantees to generate funds from other organizations. Additionally, AHRQ designed the program to allow for continued involvement of government program staff through the cooperative agreement mechanism.

In September of 1999, four CERT research centers and a Coordinating Center were funded and three other centers were funded in 2000. Dr. Hugh Tilson was appointed as the Chairperson of the Steering Committee. The Steering Committee consists of representatives of the private sector, the government, and the grantee institutions. The Steering Committee meets two to four times per year.³

The seven CERTs research centers and their target areas are:

• University of Arizona (Arizona): drug interactions, women's health.
• Duke University Medical Center (Duke): cardiovascular therapies.
• HMO Research Network (HMO): managed care.
• University of Pennsylvania School of Medicine (Penn): anti-infectives.
• University of Alabama at Birmingham (UAB): therapies for musculoskeletal therapies.
• University of North Carolina at Chapel Hill (UNC): pediatrics.
• Vanderbilt University Medical Center (Vanderbilt): Medicaid, vulnerable populations.

In April 2006 AHRQ announced the funding of four additional cooperative agreements with the following CERTs centers: Rutgers, the State University of New Jersey will focus on mental health; the University of Iowa will focus on the elderly; Baylor College of Medicine will focus on consumers and patients; and the Weill Medical College of Cornell University will focus on medical devices.

The Pharmaceutical Outcomes Portfolio consists of both individual grants (different types) and funding of the CERTs centers; however a higher proportion of the research is the result of the CERTs program. The AHRQ RFTO requested data collection methods focused on the CERTs program (i.e. appreciative inquiry and social network analysis). Consequently, the evaluation findings in this report place more emphasis on the CERTs program than on the individual grants.

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1.2. Purpose and Objectives of the Evaluation

In September 2005, AHRQ contracted with Abt Associates to evaluate the AHRQ's Pharmaceutical Outcomes Portfolio for the years 2002 to 2005⁵. The purpose of this evaluation is to analyze the impact of AHRQ's Pharmaceutical Outcomes Portfolio (Portfolio) and to determine if the program is moving toward its goals as described in the RFTO and as clarified by the FY'04 Office of Management and Budget (OMB) Program Assessment Rating Tool (PART) review. The evaluation has six primary objectives:

1. Assess progress of the Portfolio towards meeting Agency and DHHS objectives in the past four years.
2. Assess impact of Portfolio research on state and federal health care policy making.
3. Assess adequacy of Portfolio progress reporting.
4. Assess contribution and role of the Duke Coordinating Center (CC), Steering Committee, program office, and other partners to the CERTs.
5. Identify strengths of the program and most successful or promising research, especially with respect to the PART goals.
6. Assess role of Portfolio relative to other AHRQ and DHHS priorities.

For each of the objectives, study questions were devised to operationalize the evaluation objectives. Appendix 1 displays the study questions and the corresponding evaluation objectives. This evaluation examines the original seven CERTS research centers, the Coordinating Center and individual grantees for the period 2002 through 2005. We refer to this group collectively as the "Portfolio." The four CERTs whose funding began in 2006 are not part of this evaluation. In the balance of this report, we describe the methodology and findings of the evaluation.

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