title: Improving postapproval drug safety surveillance: getting better information sooner.
abstract: Adverse drug events (ADEs) are an important public health concern, accounting for 5% of all hospital admissions and two-thirds of all complications occurring shortly after hospital discharge. There are often long delays between when a drug is approved and when serious ADEs are identified. Recent and ongoing advances in drug safety surveillance include the establishment of government-sponsored networks of population databases, the use of data mining approaches, and the formal integration of diverse sources of drug safety information. These advances promise to reduce delays in identifying drug-related risks and in providing reassurance about the absence of such risks.
authors.affiliation: Center for Pharmacoepidemiology Research and Training.
authors.forename: Sean
authors.initials: S
authors.lastname: Hennessy
authors.forename: Brian L
authors.initials: BL
authors.lastname: Strom
mesh_terms: D022126:Access to Information; D016907:Adverse Drug Reaction Reporting Systems; D057225:Data Mining; D064420:Drug-Related Side Effects and Adverse Reactions / Q000209:etiology* / Q000401:mortality; D019317:Evidence-Based Medicine; D006801:Humans; D033181:Information Dissemination; D061214:Patient Safety; D055553:Prescription Drugs / Q000009:adverse effects*; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D018570:Risk Assessment; D012307:Risk Factors
chemical_list: D055553:Prescription Drugs
keywords: adverse drug reaction reporting systems; pharmacoepidemiology; postmarketing; precision medicine; prediction in pharmacology; product surveillance