TabsDetailsBasic DetailsDate: Tuesday, January 31, 2012Type: PublicationDescription: The Mini-Sentinel Supplement to Pharmacoepidemiology and Drug Safety provides a set of 34 articles that collectively describe the work of the FDA's Mini-Sentinel pilot in its early phase. Each article is also listed individually below. Read More Materials: ReportsThe U.S. Food and Drug Administration's Mini-Sentinel Program: Status and DirectionThe U.S. Food and Drug Administration's Sentinel Initiative: Expanding the Horizons of Medical Product SafetyThe Organizational Structure and Governing Principles of the Food and Drug Administration's Mini-Sentinel Pilot ProgramA Policy Framework for Public Health uses of Electronic Health DataDesign Considerations, Architecture, and Use of the Mini-Sentinel Distributed Data SystemDesign Considerations in an Active Medical Product Safety Monitoring SystemUsing High-Dimensional Propensity Scores to Automate Confounding Control in a Distributed Medical Product Safety Surveillance SystemWhen Should Case-Only Designs be used for Safety Monitoring of Medical Products?Challenges in the Design and Analysis of Sequentially Monitored Postmarket Safety Surveillance Evaluations using Electronic Observational Health Care DataStatistical Approaches to Group Sequential Monitoring of Postmarket Safety Surveillance Data: Current State of the Art for use in the Mini-Sentinel PilotMini-Sentinel's Systematic Reviews of Validated Methods for Identifying Health Outcomes using Administrative and Claims Data: Methods and Lessons LearnedMini-Sentinel's Systematic Reviews of Validated Methods for Identifying Health Outcomes using Administrative and Claims Data: Methods and Lessons LearnedA Systematic Review of Validated Methods for Identifying Cerebrovascular Accident or Transient Ischemic Attack using Administrative DataA Systematic Review of Validated Methods for Identifying Heart Failure using Administrative DataA Systematic Review of Validated Methods for Identifying Atrial Fibrillation using Administrative DataA Systematic Review of Validated Methods for Identifying Ventricular Arrhythmias using Administrative and Claims DataA Systematic Review of Validated Methods for Identifying Venous Thromboembolism using Administrative and Claims DataA Systematic Review of Validated Methods for Identifying Depression using Administrative DataA Systematic Review of Validated Methods for Identifying Suicide or Suicidal Ideation using Administrative or Claims DataA Systematic Review of Validated Methods for Identifying Seizures, Convulsions, or Epilepsy using Administrative and Claims DataA Systematic Review of Validated Methods for Identifying Pancreatitis using Administrative DataA Systematic Review of Validated Methods for Identifying Lymphoma using Administrative DataA Systematic Review of Validated Methods for Identifying Infection Related to Blood Products, Tissue Grafts, or Organ Transplants using Administrative DataA Systematic Review of Validated Methods for Identifying Transfusion-Related Sepsis using Administrative and Claims DataA Systematic Review of Validated Methods for Identifying Transfusion-Related ABO Incompatibility Reactions using Administrative and Claims DataA Systematic Review of Validated Methods for Identifying Erythema Multiforme Major/Minor/Not otherwise specified, Stevens–Johnson Syndrome, or Toxic Epidermal Necrolysis using Administrative and Claims DataA Systematic Review of Validated Methods for Identifying Anaphylaxis, Including Anaphylactic Shock and Angioneurotic Edema, using Administrative and Claims DataA Systematic Review of Validated Methods for Identifying Hypersensitivity Reactions other than Anaphylaxis (Fever, Rash, and Lymphadenopathy), using Administrative and Claims DataA Systematic Review of Validated Methods for Identifying Pulmonary Fibrosis and Interstitial Lung Disease using Administrative and Claims DataA Systematic Review of Validated Methods for Identifying Acute Respiratory Failure using Administrative and Claims DataA Systematic Review of Validated Methods for Identifying Orthopedic Implant Removal and Revision using Administrative DataDesign for Validation of Acute Myocardial Infarction Cases in Mini-SentinelA Protocol for Active Surveillance of Acute Myocardial Infarction in Association with the use of a New Antidiabetic Pharmaceutical AgentThe Food and Drug Administration's Postlicensure Rapid Immunization Safety Monitoring Program: Strengthening the Federal Vaccine Safety EnterpriseAdditional InformationInformationHost: Pharmacoepidemiology and Drug Safety, Volume 21, Issue Supplement S1, January 2012, Pages 1-303ContributorsAuthor(s): Richard Platt MD, MSc; Ryan M. Carnahan PharmD, MS, BCPPCorresponding Author: R. Platt, Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA, USA. Email: Richard_Platt@harvard.eduR. Carnahan, Department of Epidemiology, The University of Iowa College of Public Health, C 21-H General Hospital, 200 Hawkins Dr., Iowa City, IA 52242, USA. Email: ryan-carnahan@uiowa.edu
