Using real-world healthcare data for pharmacovigilance signal detection-the experience of the EU-ADR project

Expert Review of Clinical Pharmacology

Volumn 8, Issue 1, 2014, Pages 95-102

  Patadia, Vaishali K ^a,b   Coloma, Preciosa ^a   Schuemie, Martijn J ^a   Herings, Ron ^c   Gini, Rosa ^d   Mazzaglia, Giampiero ^e   Picelli, Gino ^f   Fornari, Carla ^g   Pedersen, Lars ^h   Van Der Lei, Johan ^a   Sturkenboom, Miriam ^a   Trifirò, Gianluca ^a,i  

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b ASTELLAS PHARMA GLOBAL DEVELOPMENT   (United States)

^c PHARMO INSTITUTE FOR DRUG OUTCOMES RESEARCH   (Netherlands)

^d Osservatorio di Epidemiologia   (Italy)

^e Societa Italiana di Medicina Generale   (Italy)

^f Pedianet Network   (Italy)

^g UNIVERSITY OF MILANO BICOCCA   (Italy)

^h AARHUS UNIVERSITY HOSPITAL   (Denmark)

ⁱ UNIVERSITY OF MESSINA   (Italy)

Author keywords

adverse drug reactions; data mining; electronic health records; EU ADR; FAERS; pharmacovigilance; real world healthcare data; signal detection; spontaneous reporting systems

Indexed keywords

ACUTE HEART INFARCTION; ACUTE KIDNEY FAILURE; ANAPHYLACTIC SHOCK; DATA MINING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG USE; ELECTRONIC MEDICAL RECORD; FOOD AND DRUG ADMINISTRATION; HEART MUSCLE FIBROSIS; HUMAN; LIVER INJURY; MEDICAL DICTIONARY FOR REGULATORY ACTIVITIES; NEUTROPENIA; PANCYTOPENIA; POSTMARKETING SURVEILLANCE; REVIEW; RHABDOMYOLYSIS; SIGNAL DETECTION; UNIFIED MEDICAL LANGUAGE SYSTEM; UPPER GASTROINTESTINAL BLEEDING; VESICULAR RASH; WORLD HEALTH ORGANIZATION; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FACTUAL DATABASE; HEALTH CARE DELIVERY; PROCEDURES; PROSPECTIVE STUDY;

ADVERSE DRUG REACTION REPORTING SYSTEMS; DATABASES, FACTUAL; DELIVERY OF HEALTH CARE; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; HUMANS; PHARMACOVIGILANCE; PROSPECTIVE STUDIES;

EID: 84916925627     PISSN: 17512433     EISSN: 17512441     Source Type: Journal    
DOI: 10.1586/17512433.2015.992878     Document Type: Review

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