Guidelines for good pharmacoepidemiology practices (GPP).

Pharmacoepidemiologic studies provide valuable information about the health effects of healthcare products. The ISPE Guidelines for Good Pharmacoepidemiology Practices (GPP) are intended to assist investigators with issues pertaining to the planning, conduct, and evaluation of pharmacoepidemiologic research. The first revision, in 2004 revised and superseded the Guidelines for Good Epidemiologic Practice (GEP) developed in 1996. In that revision, the scope of the guidelines was broadened geographically and conceptually, to reflect ISPE’s international membership, to include risk management and pharmacoeconomic activities, and to address more clearly the role of epidemiologic studies from industry and regulatory perspectives. Specifically, the 2004 revision provided guidance on regulatory reporting requirements as they relate both to individual cases and to aggregate data (see Section ‘Adverse Event Reporting From Pharmacoepidemiology Studies’). The focus of the second revision has been on the use and communication of statistical measures and to add clarification to specific items throughout the document. ISPE recognizes that pharmacoepidemiologic research—the study of the use and effects of healthcare products (e.g., including pharmaceuticals, devices, and vaccines)—has expanded to include clinical, economic, and other health outcomes, requiring study methods that were not covered in previous guidelines. Pharmacoepidemiology is being used increasingly to evaluate health care systems, interventions, and