Safe Medication Practices and Research

Industry

USP assists the pharmaceutical industry in identifying and implementing strategic approaches to product safety management. By drawing on its two national databases, MEDMARX® and the USP-ISMP Medication Errors Reporting Program (MER), USP can provide timely, detailed information on medication errors and adverse drug events. Proactive pharmacovigilence supports the pursuit of safe medications; and to that end, USP supplies detailed information about a product's use in clinical practice, facilitating the evaluation of a product's post-market performance.

Federal Government

Data from USP's national databases may be used by the Food and Drug Administration to validate warning signs received on possible medication error safety problems with drugs and therapeutic biologics. The data is useful internally as part of FDA's pre- and post-marketing safety reviews and may be a source of medication error cases in FDA safety alerts or publications on the occurrence of such errors.

USP Standards

Analyses of data from the MER Program and MEDMARX by HQI routinely support the standards-setting activities of USP Expert Committees and their subcommittees and USP staff.

Research

The Healthcare Quality and Information (HQI) division of USP believes the data residing in its two databases are valuable and unique and, therefore, has worked to make it available to researchers. Already in the second year of a research agreement, HQI and the Johns Hopkins University Bloomberg School of Public Health are currently coordinating 16 focused studies by using MEDMARX data. The HQI Department has provided data to several Agency for Healthcare Research and Quality (AHRQ) Centers for Evaluation and Research on Therapeutics (CERTs) and individual researchers have benefited from access to the databases.