Medical Databases Can Enhance Drug Safety, Report Suggests
Posted: 10-27-2008 : RESEARCH TRIANGLE PARK, N.C.

RESEARCH TRIANGLE PARK, N.C. -- Large electronic databases, such as electronic medical records, can improve drug safety by alerting researchers and policy makers possible adverse health effects of a specific drug, according to a new synthesis by researchers at RTI International.

The paper, published in RTI Press, summarizes the data resources available for detection and evaluation of safety signals for possible adverse events related to drugs, and describes the resources and methods used in drug safety research.

“Public concern over the safety of medicines is increasing, particularly concerns about serious adverse health effects detected after extensive use of products in the general marketplace,” said Patricia Tennis, Ph.D., senior director in epidemiology at RTI Health Solutions, a business unit of RTI. “It’s important that we understand how existing databases can be used effectively to enhance evaluation of drug safety outside of clinical trials.”

According to the researchers, the most relevant and available data resources primarily include anonymized electronic health care claims and electronic medical records and can be used to identify new safety issues and to evaluate known or suspected problems.

The researchers report that in certain circumstances these data resources can be valuable for the relatively cost-effective evaluation of the frequency of serious adverse events in users of specific medications. However, implementation of such research requires a thorough understanding of the strengths and weaknesses of the data sources and the pharmacoepidemiologic methods used for analysis. It also requires understanding of when these data sources will not be useful and when other methods or data resources, such as registries, are required.

“Nevertheless, administrative databases and EMR databases, are extremely valuable tools to help advance our understanding of medication safety in broader populations,” Tennis said.

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RTI International is one of the world's leading research institutes, dedicated to improving the human condition by turning knowledge into practice. Our staff of more than 2,600 provides research and technical services to governments and businesses worldwide in the areas of health and pharmaceuticals, education and training, surveys and statistics, advanced technology, international development, economic and social policy, energy, and the environment. RTI also employs about 1,200 term employees who support projects in more than 40 countries. For more information, visit www.rti.org.