About CERTs
Annual Report Year 1
Year 1 Progress
Developing Knowledge | Managing Risk | Improving Practice | Informing Policies | Program-wide Activities
Developing Knowledge
We are developing knowledge about therapies and how best to use them. Our research examines both basic mechanisms (through clinical pharmacology and genomics research) and medical outcomes.
Children and Adolescents
More than 80 percent of the prescription drugs given to children have not been tested in children and are not labeled for pediatric use. But children are not "small adults." They have different metabolic rates, their bodies are changing rapidly, and their ability to understand and express information varies widely. For these reasons, assessment of therapeutics in children is critical.
We have two projects assessing how drugs move and work in the bodies of children and adolescents, one examining children with cystic fibrosis, and another assessing the levels of drugs called protease inhibitors in the blood of children with human immunodeficiency virus (HIV) infection. The goal is to identify how children's bodies handle drugs differently from adults', which may result in more tailored (and thus more effective) treatment.
Drugs to treat attention deficit/hyperactivity disorder (ADHD) and depression in children have been used more and more in recent years, despite a lack of supporting evidence for their safety and long-term effectiveness. During Year 1, we assessed how the use of these drugs has changed among doctors and patients, in preparation for more detailed future studies.
The incidence of Type 2 diabetes in adolescents may be increasing because of lifestyle changes. We are gathering the data needed to determine whether this is true. The earlier this disease is diagnosed, the sooner treatment can begin.
Adults
Heart disease has been the number-one killer of adults in the United States for all but one of the last 100 years. Although aspirin can save lives in people who have coronary artery disease (CAD), a very common form of heart disease, only about half of them take aspirin regularly. We have examined the use of aspirin in this group, tapping into the resources of a 30-year-old database for cardiovascular disease. We have found that 87 percent of the people in the database have been taking aspirin. This is better than average but still shows room for improvement, especially among women.
We have used similar methods to examine the use of beta-blocking drugs in people who have congestive heart failure (CHF). Compared with aspirin, beta-blockers cost more; they also require a prescription and, until recently, were thought to be harmful to people with CHF. Before beta-blockers can be widely used, then, educational efforts must overcome resistance based on outdated information. Only about 45 percent of the people with CHF in the database have been taking beta-blockers, and the rates of use for the individual drugs known to save lives have been extremely low.
More than 2 billion prescriptions are written in the United States every year, and two thirds of all visits to doctors result in at least one new prescription. Thus people likely are taking more than one drug at a time. Interactions between these drugs can be fatal. In fact, several drugs have been removed from the market because of fatal interactions in recent years. Further, most drugs used by adults have been studied only in men. How women process drugs taken alone or with other drugs is largely unknown.
Our initial efforts in addressing the issue of drug interactions includes studying drug usage and interaction patterns, to identify targets for further testing. This effort involves the use of large databases and collaborations with the FDA.
People over the age of 65 are the fastest-growing segment of the U.S. population, and the older a person gets, the greater the risk of having a heart attack. Several drugs can reduce the risk of death after a heart attack, chief among them aspirin, beta-blockers, and drugs to reduce cholesterol. These drugs might be greatly underused in men and women covered by managed-care plans such as Medicaid, which includes substantial numbers of elderly people.
We are studying the rates of use for these three types of drugs in a large Medicaid population, by physician and hospital, with the goal of identifying targets for future education, including policymakers.