Good Practices for Handling Adverse Events Detected through Patient Registries
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Nancy A. Dreyer, MPH, PhD, FISPE Chief of Scientific Affairs and Project Director, Outcome Sciences Inc., and Outcome DEcIDE Center, Cambridge, Massachusetts Neha Sheth, PharmD Senior Director Safety and Risk Management, Pfizer, Ann Arbor, Michigan Anne Trontell, MD, MPH Program Director, Centers for Education and Research in Therapeutics, Agency for Healthcare Research and Quality, Rockville, Maryland Richard E. Gliklich, MD President and Principal Investigator, Outcome Sciences Inc., and Outcome DEcIDE Center, Cambridge, Massachusetts Key Words Registries; Adverse event reporting; SAE Correspondence Address Nancy Dreyer, Outcome, 201 Broadway, Cambridge, MA 02139 (email: [email protected]). This research was conducted by Outcome Sciences Inc. (d/b/a Outcome) under contract to the Agency for Healthcare Research and Quality (Contract No. HSA29020050035I), Rockville, MD. The authors of this article are responsible for its content. No statement may be construed as the official position of the Agency for Healthcare Research and Quality of the US Department of Health and Human Services.
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Good Practices for Handling Adverse Events Detected Through Patient Registries As the number of patient registries for marketed products increases, it is important for investigators and manufacturers to understand the public health responsibilities and potential regulatory requirements for reporting adverse drug events (AEs). Requirements for reporting AEs will vary depending upon sponsorship of the registry (regulated versus nonregulated industry). If registries are spon-
INTRODUCTION Patient registries that collect information about marketed products are being used increasingly for a range of clinical, scientific, and regulatory purposes. When registries purposefully or incidentally identify adverse events (AEs) in the course of data collection, little guidance is available on their systematic processing and reporting. A strategy for identification, processing, and reporting AEs should be developed for registries and derived studies to include understanding of the basic reporting requirements as well as desirable public health practice in the absence of specific regulatory requirements. Reporting requirements vary according to whether an AE is considered serious, already known or expected to be associated with a product, and whether or not there appears to be a reasonable possibility of a causal association. This report addresses the identification, processing, and reporting of AEs for pharmaceutical products that are detected in registries and describes how the process differs according to registry sponsorship. Many of the practices described here were created for a report commissioned by the US Agency for Healthcare Research and Quality (AHRQ) to develop a handbook on patient registries (1). That report was commissioned through AHRQ’s DEcIDE Network (Developing Evidence to Inform Decisions about Effectiveness) in its Effective Health
sored or supported by a regulated entity and AEs are noted in the course of a registry’s d
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