title: Analysis of spontaneous adverse drug reaction (ADR) reports using supplementary information.
abstract: Assessment of safety of newly marketed drugs is an important public health issue. Once the drug is in the market, clinicians and/or health professionals are responsible for recognizing and reporting suspected side effects known as adverse drug reaction (ADR). Such reports are collected in a so-called spontaneous reporting (SR) system. The primary purpose of spontaneous ADR reporting is to provide early warnings or suspicions, which have not been recognized prior to marketing of a drug because of limitations of clinical trials. We shall discuss the existing work to analyze the SR database and their drawbacks and also suggest methodologies to tackle these drawbacks by defining a source population and considering the problem of under-reporting, with the help of supplementary data. Unbiased estimate of population odds-ratio has been obtained and the corresponding asymptotic results are derived.
authors.affiliation: Applied Statistics Unit, Indian Statistical Institute, Kolkata 700108, India.
authors.forename: Palash
authors.initials: P
authors.lastname: Ghosh
authors.forename: Anup
authors.initials: A
authors.lastname: Dewanji
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D056808:Biostatistics / Q000379:methods*; D003404:Creatinine / Q000097:blood; D016572:Cyclosporine / Q000009:adverse effects; D016208:Databases, Factual; D004232:Diuretics / Q000009:adverse effects; D064420:Drug-Related Side Effects and Adverse Reactions; D006333:Heart Failure / Q000209:etiology; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects; D016030:Kidney Transplantation / Q000009:adverse effects; D016013:Likelihood Functions; D015233:Models, Statistical; D009426:Netherlands; D016017:Odds Ratio; D014481:United States; D014486:United States Food and Drug Administration / Q000706:statistics & numerical data
chemical_list: D004232:Diuretics; D007166:Immunosuppressive Agents; D016572:Cyclosporine; D003404:Creatinine