Finding out what drugs are doing to patients

Pharmacoepidemiology is a big word, but it’s a discipline increasingly being called upon to see what can be done about the errors that occur in hospitals, nursing homes, pharmacies, and urgent care centers and in the care delivered at home. Pharmacoepidemiology is defined as the study of the distribution and determinants of drug-related events in populations, and the application of this study to efficacious drug treatments.

Brian Strom, M.D., M.P.H., said several new approaches involving the discipline are being used to try to cut the approximately 98,000 deaths the Institute of Medicine said, in a report in 1999, had been occurring each year because of medical errors. Strom is professor of medicine and director of the Center for Clinical Epidemiology and Biostatistics at the University of Pennsylvania.

One of the new approaches that involves pharmacoepidemiology has been the establishment of seven Centers for Education & Research on Therapeutics (CERTs) at academic centers across the country. One of these centers, the University of Pennsylvania, has studied the effectiveness of retrospective drug utilization review in Medicaid patients, and has done postmarketing drug surveillance studies. Other CERT center projects have involved drug metabolism in children with and without cystic fibrosis, the study of prescribing patterns for psychotropic drugs for adolescents, and establishment of an international registry for drug-induced cardiac arrhythmias.

Strom said the CERTs’ mission is "to conduct research and provide education that will advance the optimal use of drugs, medical devices, and biological products." Other new applications for pharmacoepidemiology, he told the attendees at the American Society for Clinical Pharmacology and Therapeutics annual meeting in Washington, D.C., include studies on the mechanism of action of drugs, patient safety, and risk management initiatives.

The Joint Commission on Accreditation of Healthcare Organizations and the Institute of Medicine are also sponsoring initiatives, Strom said. These include outpatient drug utilization review programs and the use of pharmacoepidemiology to study drug mechanisms.

Strom said the pharmaceutical industry was also increasingly interested in pharmacoepidemiology because it "can not only find problems, but it can document safety and protect against inappropriate accusations about adverse drug reactions." In the future, he said, he sees an increase in useful databases, the use of the discipline in Medicare, and the development of pharmacy-based surveillance programs.

Jean McCann

The author is a clinical writer based in Ohio.

Jean McCann. Finding out what drugs are doing to patients.

Drug Topics

May 19, 2003;147.