The Observational Medical Outcomes Partnership (OMOP) is a public-private partnership designed to help improve the monitoring of drugs for safety. The partnership is conducting a two-year initiative to research methods that are feasible and useful to analyze existing healthcare databases to identify and evaluate safety and benefit issues of drugs already on the market.

OMOP draws on the expertise and resources of the pharmaceutical industry, academic institutions, non-profit organizations, the Food and Drug Administration (FDA) and other federal agencies. It is funded and managed through the Foundation for the National Institutes of Health.

America’s drug-approval process is world-renowned for its rigorous standards on safety and effectiveness, but even with pre-market clinical trials involving thousands of people, it cannot possibly uncover everything about a drug’s performance that may occur once it is in use by a much larger and diverse population.

The FDA’s Adverse Event Reporting System (AERS) relies primarily on voluntary, spontaneous reporting of suspected drug safety issues by health professionals, patients and consumers. OMOP is one of a number of activities that is laying the groundwork for a supplemental approach that is systematic, proactive and cost-effective. Utilizing databases of patient medical records and health insurance claims, researchers are developing and testing various analytical methods for their ability to detect and evaluate drug safety issues over time.

The series of studies include assessing different types of data from across the United States, developing tools and methods to analyze the databases and evaluating how analyses can contribute to decision-making. Together, these studies provide the objective evidence needed to inform best practices for using such data.

OMOP promotes transparency by placing all information of interest in the public domain as quickly as possible. A publicly accessible website is utilized to communicate the research and maintain awareness for consumers, patients and providers.  

Partners
The Foundation for NIH
U.S. Food & Drug Administration (FDA)
PhRMA

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