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Goal 1—Outcomes Research (continued)
Promoting Safe and Effective Use of Pharmaceuticals
Prescription and over-the-counter drugs are central to many of the most challenging issues faced in health services delivery and financing today. Expenditures for medications represent a major portion of the health care dollars spent in the United States. Health plans, hospitals, and Federal, State, and local officials are wrestling with questions about which drugs are most effective and how to balance costs with providing the life-saving benefits that medicines offer. For over a decade, AHRQ has funded studies that focus on patient outcomes related to pharmaceutical therapy. Findings from these research projects, such as those shown below, have yielded important insights for the health care system and revealed key issues.
AHRQ research has shown that one of every five elderly Americans living in the community (not in a nursing home) is taking at least one inappropriate medication. AHRQ's research is focusing on ways to reduce such inappropriate prescribing of medicines. One promising approach now being studied involves the use of information technology such as hand-held computers to limit prescribing errors. Other efforts include looking at ways to help clinicians become more aware of the benefits and risks of certain drugs and possible complications from drug interactions.
An AHRQ-funded study published recently in the Journal of the American Medical Association indicates that about one-fifth of the approximately 32 million elderly Americans not living in nursing homes in 1996 used at least one or more of 33 prescription medicines considered potentially inappropriate. Nearly 1 million elderly men and women used at least 1 of 11 medications that a panel of geriatric medicine and pharmacy experts advising the researchers agreed should always be avoided in the elderly. The study highlighted the problem of inappropriate prescribing in the United States and underscored the importance of safe use of prescription medications as a critical component of quality of care.
Publication of these findings led to:
- Creation of the Department of Health and Human Services Working Group for the Secretary's Initiative on Assuring the Appropriate Use of Therapeutic Agents in the Elderly.
- Development of a monitoring system to effectively identify inappropriate medication use. The project is being conducted by the Mississippi quality improvement organization for the Center for Medicare & Medicaid Services' "Medicare Prescription Continuity of Care Project," which is focused on quality of care issues related to prescription drug use in elderly beneficiaries. They are using the "always avoid" medicines identified in the JAMA article as an indicator.
- Approval of the proposal, "Inappropriate Prescribing of Medication for Older Veterans," for funding by the Department of Veterans Affairs. This project will assess patterns and correlates of inappropriate medication use in the VA. By linking VA pharmacy and electronic medical record data, they are developing an algorithm to determine an adjusted rate of inappropriate prescribing that accounts for some of the rare indications for use.
- Development of a medication management indicator for Medicare HEDIS® that focuses on quality of prescribing for the elderly. The indicator was developed by the National Committee for Quality Assurance.
Patients and caregivers shouldn't have to guess which therapies are the best or live in fear that a mistake will be made in treatment. This is the basis of AHRQ's Centers for Education and Research on Therapeutics (CERTs) program, which conducts research and provides education to advance the optimal use of drugs, medical devices, and biological products such as vaccines. AHRQ was given authority to support the CERTs initiative under the Food and Drug Modernization Act of 1997. Between 1999 and 2000, AHRQ established seven centers under the CERTs program, each of which focuses on therapies used in a particular population or therapeutic area.
|Focus of the Centers for Education and Research on Therapeutics (CERTs)|
||Approved drugs and therapeutic devices in cardiovascular medicine.|
|University of Arizona:
||Reduction of drug interactions, particularly in women.|
|University of North Carolina:
||Rational use of therapeutics in pediatric populations.|
||Prescription medication use in the Medicaid managed care population.|
|HMO Research Network:
||Use of large managed care databases to study prescribing patterns, dosing outcomes, and policy input.|
|University of Pennsylvania:
||Antibiotic drug resistance, drug use, and intervention studies.|
|University of Alabama:
||Therapeutics for musculoskeletal disorders|
Although drugs, medical devices, and biological products improve health for thousands of people, side effects, misuse, and overuse of products can seriously impair the health of many others. The facts are:
- Underuse. Many patients potentially could benefit from a therapy but do not receive it. This may be through lack of information, oversight, or in the mistaken belief that the therapy will do them harm.
- Drug/treatment interactions. Studies conducted prior to FDA approval may not test medical products in combination with other therapies often used by the same patients.
- Off-label use. Once approved, drugs and devices often are used for purposes other than those for which they were approved—sometimes these uses are supported by studies, but not always.
- Unexpected side-effects. Some side effects of medical products emerge only after they have been approved for release, when large numbers of people begin to use them.
The CERTs program aims to fill these information gaps by answering important questions that have not been addressed and implementing effective educational interventions for caregivers. The program is also a critical complement to the Food and Drug Administration's (FDA's) postmarketing studies. Participants in the CERTs program—Federal government agencies, academic organizations, managed care organizations, drug and device companies, practitioners, commercial research groups, and consumer groups, among others—are committed to seeking answers together.
Since the program's inception in September 1999, the CERTs have developed a portfolio of more than 120 completed and ongoing studies. Following are a few examples of how the CERTs serve as a trusted national resource for those seeking to improve health through the best use of medical therapies.
- Aspirin is inexpensive, available over-the-counter, and greatly reduces the risk of heart attack, stroke, and related death in people with coronary artery disease (CAD). Similarly, beta-blockers, have been shown to help people with congestive heart failure (CHF). There have been some successes in translating research and research recommendations into practice. For example, a recent study done by the Duke University CERT showed that 87 percent of cardiac patients were using aspirin. This reflects, in part, the adoption of recommendations from the AHRQ-sponsored U.S. Preventive Services Task Force. However, data collected by the Duke University CERT also confirmed that 13 percent of high-risk patients with CAD were not receiving adequate therapy. The people with CAD who were not taking aspirin were almost twice as likely to die within 1 year as those who were taking aspirin. The news was only slightly better for people with CHF who were not taking a beta-blocker; they had 1.5 times the risk of dying compared with people who were taking the medicine. The Duke CERT is now investigating ways to get life-saving medicine to people who need it. Programs to overcome barriers and save lives can be designed once more is understood about why people are not taking these medicines.
- The effectiveness of drugs for women and children with HIV depends on the way patients take the drugs and how their bodies handle the medicine. The University of North Carolina CERT developed a screening test for kids to measure the levels of anti-HIV drugs called protease inhibitors in the bloodstream. The test will determine whether the level of drugs is too high or too low as a result of the way the drug was taken or absorbed. Research on the screening test had an unexpected, important finding: giving anti-HIV drugs with water to babies can speed the passage of the drugs through babies' systems before they have a chance to work. Giving drugs in combination with infant formula greatly improves results. In another case, the test showed high levels of protease inhibitor in a child whose parent had readjusted the dose. Some patients were not getting their drugs at all. In one case, a child's mother was too ill herself to medicate her child, but the problem was only uncovered by the screening test. The test demonstrated that there might be a big difference between what a doctor prescribes and what is at work in the body. Providing this test to HIV-infected individuals can go a long way in ensuring that people are getting the level of drugs they need. The test also may help reduce the incidence of drug-resistant viruses and the cost of caring for patients with HIV.
- Collectively, the CERTs have access to more than 20 unique data sources representing over 50 million people, which they use to conduct population-based studies. Many of these studies have been conducted within Medicaid populations, including drug effects and use, prior authorization for use of nonsteroidal antiinflammatory drugs (NSAIDs), prevention of falls, reimbursement for community providers of long-term care, and evaluation of a nursing-home dispensing change. In addition, studies are underway to gather information that Medicaid programs can use to make coverage and other policy decisions such as drug utilization review, economic effects of beta-blocker therapy in heart failure, efficacy and toxicity of drugs used in pediatric AIDS, prevalence of type-2 diabetes mellitus in children, drug interactions, fractures related to osteoporosis, and other topics. The Vanderbilt CERT, in particular, has a long history of providing technical assistance to the Tennessee Medicaid program under a contract that has been active since 1972.
- Many doctors prescribe antibiotics before dental treatment to reduce the risk of endocarditis (infection of the heart lining and valves). Because conventional wisdom suggests that patients with heart problems are at risk, this preventive measure has been recommended for more than 45 years. The University of Pennsylvania CERT conducted a study to evaluate and quantify the risk of such infection. They found that the incidence of infection remained the same even after the introduction of widespread antibiotic prophylaxis, and that neither dental work in general, nor any individual procedure, was associated with infective endocarditis, with the possible exception of tooth extraction. The study also determined that flossing daily slightly reduced the risk of infection. Efforts are underway to have these findings incorporated into American Heart Association guidelines. These findings will affect an important source of unnecessary antibiotic use.
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Promoting Evidence-Based Health Care
AHRQ's 13 Evidence-based Practice Centers (EPCs) produce evidence reports and technology assessments on clinical and behavioral therapies and technologies that are common, expensive, and significant for Medicare and Medicaid populations. The EPCs systematically review and analyze scientific evidence to develop the reports. During their reviews, the EPCs flag areas where the evidence base is sparse and suggest future research directions.
In 2002, AHRQ awarded 13 new 5-year contracts to continue and expand the work performed by the first group of EPCs initiated in 1997. During the past year, AHRQ also formed a partnership with the Office of Medical Applications of Research (OMAR) at the National Institutes of Health to include EPC systematic reviews on each clinical condition presented at a Consensus Development Conference. OMAR works closely with the NIH Institutes, Centers, and Offices to assess, translate, and disseminate the results of biomedical research that can be used in the delivery of health services. The EPCs will present their topic-specific evidence-based reports to the NIH Consensus Development Conferences to ensure that they have the latest scientific evidence to support their deliberations. These conferences address complex issues of medical importance to health care providers, patients and the general public.
AHRQ funded 16 new evidence topics in 2002; nine of the topics were nominated by private-sector professional societies and providers, and seven of the EPC topics are being funded by other Federal agencies. In addition, AHRQ funded an EPC to continue to support the work of the U.S. Preventive Services Task Force, and several EPCs were funded to continue their work on technology assessments as requested by the Centers for Medicare and Medicaid Services (CMS).
FY 2002 EPC Reports and Technology Assessments
- Islet Cell (cells in the pancreas that make insulin) Transplantation for Diabetes
- Strategies to Improve Minority Health Care Quality
- Treatment of Dementia
- Pharmacological Management of Obesity
- Community-Based Participatory Research
- Health Literacy: Impact on Health Outcomes
- Effective Payment Strategies to Support Quality-Based Purchasing
- Biventricular Pacing (using a pacemaker to pace both pumping chambers of the heart) for Congestive Heart Failure
- Economic Incentives: Impact on Use/Outcomes of Preventive Health Services
- Cross-cutting Quality Measures for Cancer Care
- Sexuality and Reproductive Health Following Spinal Cord Injury
- Training for Rare Public Health Events: Bioterrorism (update of prior report plus development of tool to evaluate bioterrorism preparedness of U.S. hospitals)
- Distance Learning Program – Web-based Curriculum for Dentists
- Regional Models for Bioterrorism Preparedness
- Total Knee Replacement (NIH Consensus Development Conference)
- Efficacy of Behavioral Interventions to Modify Physical Activity
Since the start of the program in 1997, the EPCs have conducted more than 90 systematic reviews and analyses of the literature on a wide spectrum of topics and published the results and conclusions as evidence reports and technology assessments. Some of these reviews are ongoing, and others have been published. Users include doctors, medical and professional associations, health system managers, researchers, consumer organizations, and policymakers. Public- and private-sector organizations use the reports as the basis for developing their own clinical guidelines, performance measures, and other quality improvement tools and strategies. The reports and assessments often are used in formulating reimbursement and coverage policies. Examples include:
- Use of AHRQ evidence reports by the Social Security Administration to determine disability for various conditions, including: end-stage renal disease, infant and childhood impairments, repetitive motion disorders, speech/language disorders, chronic fatigue syndrome, treatment-resistant epilepsy, and multiple sclerosis.
- Use by the Veteran's Administration of the meta-analysis in Testosterone Suppression: Treatment for Prostate Cancer as part of its continuing medical education program.
- Development of a practice guideline by the American Academy of Pediatrics (AAP) based on the evidence report on Diagnosis of Attention-Deficit/Hyperactivity Disorder.
Nominations of topics are solicited routinely through notices in the Federal Register and are accepted on an ongoing basis. Professional organizations, health plans, providers, and others who nominate topics are considered partners and agree to use the evidence reports when they are completed. All EPCs collaborate with other medical and research organizations so that a broad range of experts are included in the development process. AHRQ invites comments from interested parties about the EPC program with respect to what has worked well, what has not worked well, and what changes and improvements could be made. We also are interested in suggestions about new opportunities, such as what steps AHRQ can take to encourage more health care organizations and other relevant groups to translate EPC reports into clinical practice guidelines and related products.
EPC Technology Assessment: Actinic Keratoses
CMS revised its Medicare Coverage Issues Manual to include a national coverage policy permitting coverage for the treatment of actinic keratoses (AK), a common skin condition that is often the precursor of skin cancer. The decision to cover the treatment of AK was based largely on the AHRQ Technology Assessment for Actinic Keratoses Treatment. This assessment suggests that the presence of AK is associated with the development of squamous cell carcinoma (SCC), the second most common skin cancer, more than other factors. SCC has the potential to metastasize and accounts for a large percentage of all non-melanoma skin cancer deaths in the Medicare population.
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Finding the Evidence for Quality Health Care
The National Guideline Clearinghouse™ (NGC), an Internet resource for evidence-based clinical practice guidelines located at http://www.guideline.gov, has been operational for 5 years. The NGC was developed by AHRQ in partnership with the American Medical Association (AMA) and the American Association of Health Plans (AAHP) to be a resource for physicians, nurses, educators, and other health care professionals.
The NGC is designed to promote quality health care by making the latest evidence-based clinical practice guidelines available in one easy-to-access location. The NGC Web site is updated weekly with new and revised guidelines. In addition to its 24-hour access on the Internet, the clearinghouse has many useful features such as standardized abstracts containing information about each guideline and how it was developed, the ability to make guideline comparisons, access to the full text of guidelines or ordering information, and the capability to browse for guideline titles by organization, disease/condition, or treatment/intervention.
Undoubtedly, the NGC's capacity to make vast amounts of information quickly accessible to clinicians is its biggest asset. Before the development of the NGC, clinicians and others who wanted to study or compare guidelines for any medical condition had to contact individual guideline developers to obtain a copy. Users then had to perform their own side-by-side analysis to determine which, if any, of the guidelines they wanted to follow. The usefulness of the NGC the is evidenced by the large number of visits every week by physicians and other health professionals.
Management of chronic asthma. An estimated 14 to 15 million Americans have asthma. It is the most common chronic disease of childhood, affecting approximately 4.8 million children. More than 70,000 people are hospitalized each year for asthma-related conditions, and 5,000 people die annually of asthma.
In early FY 2002, AHRQ published an evidence report on management of chronic asthma. Subsequently, the National Heart, Lung, and Blood Institute's National Asthma Education and Prevention Program used the AHRQ evidence report in formulating and updating NAEPP guidelines for managing the care of adults and children who have this condition. The NAEPP Web site features a link to the AHRQ guideline and summary on management of chronic asthma.
Like all good tools, the NGC is designed to be used according to personal preference. For example, a cardiologist might check to see whether he or she should refer an arthritic patient to a rheumatologist by accessing the American College of Cardiology's guidelines to check compatibility with his or her own practice, or a nursing director of a large inner city clinic might check the childhood immunization guidelines so he or she can provide young mothers with more information about preventive care.
The NGC has more than 1,000 clinical practice guidelines submitted by over 180 health care organizations and other entities. New guidelines are added weekly. Over the past 5 years, NGC has had more than 6 million visitors, processed over 55 million requests, and received more than 120 million "hits" or visits. NGC receives over 60,000 visits each week.
AHRQ does not require NGC visitors to register in order to use the site; however, the third customer satisfaction survey of NGC indicates who uses the site. Physicians were the largest portion of survey respondents (40.6 percent), followed by nurses and/or nurse practitioners (20.5 percent). More than 93 percent of respondents rated their overall satisfaction with NGC as either "fairly satisfied" or "very satisfied" compared with 89 percent for the first annual survey. Respondents also provided many useful comments on how they were using the site in their clinical work. For instance, a number of respondents reported using NGC to identify guidelines for adaptation in their health system or institution and to find the best approach to treating their patients. The results from the third customer satisfaction survey reinforced the high level of satisfaction registered on earlier surveys.
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