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Titolo:
Proactive safety surveillance
Autore:
Bortnichak, EA; Wise, RP; Salive, ME; Tilson, HH;
Indirizzi:
Berlex Labs Inc, Corp Epidemiol & Publ Hlth Evaluat, Montville, NJ USA Berlex Labs Inc Montville NJ USA & Publ Hlth Evaluat, Montville, NJ USA US FDA, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA US FDA Rockville MD USA 20857 Drug Evaluat & Res, Rockville, MD 20857 USA Univ N Carolina, Chapel Hill, NC 27515 USA Univ N Carolina Chapel Hill NCUSA 27515 olina, Chapel Hill, NC 27515 USA
Titolo Testata:
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY
fascicolo: 3, volume: 10, anno: 2001,
pagine: 191 - 196
SICI:
1053-8569(200105)10:3<191:PSS>2.0.ZU;2-J
Fonte:
ISI
Lingua:
ENG
Keywords:
proactive safety surveillance; pharmacovigilance; pharmacoepidemiology; drug safety; product safety screening strategies; exploratory data analysis; signal detection;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
21
Recensione:
Indirizzi per estratti:
Indirizzo: Bortnichak, EA Sanofi Synthelabo Inc, 90 Pk Ave,8th Floor, New York, NY 10016 USA Sanofi Synthelabo Inc 90 Pk Ave,8th Floor New York NY USA 10016
Citazione:
E.A. Bortnichak et al., "Proactive safety surveillance", PHARMA D S, 10(3), 2001, pp. 191-196

Abstract

Growth in health information systems presents opportunities to enhance postmarketing safety surveillance of medical products. Spontaneous suspected side effect reports provide the foundation, but we need to 'proactively' improve their quality and our strategies to seek signals. In our more familiar'reactive' mode, we examine hypotheses from inquiries or publicity. Such responsive evaluations remain essential but may miss latent information on unsuspected risks. Efficient techniques to disclose hidden clusters and associations may emerge through adaptation of approaches from industrial quality control and other disciplines. Data-driven techniques like exploratory analysis, control charts, and time series modeling may help in sifting through accumulated data and in screening consecutive submissions to discern hints of new product hazards or of more specific understanding about previouslyidentified potential side effects. We also need to cultivate non-spontaneous data for hypothesis generation as well as testing, the systematic epidemiologic evaluation of questions and concerns. This hypothesis testing function will assume greater importance if proactive safety surveillance methodsyield larger numbers of putatively positive findings. Whether from spontaneous reports or other sources, signals that could have arisen by chance alone usually represent only clues to potential hazards until or unless they can be verified through independent studies. Copyright (C) 2001 John Wiley &Sons, Ltd.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 26/01/20 alle ore 10:08:11