Detecting pharmacovigilance signals combining electronic medical records with spontaneous reports: A case study of conventional disease-modifying antirheumatic drugs for rheumatoid arthritis

Liwei Wang, Majid Rastegar-Mojarad, Zhiliang Ji, Sijia Liu, Ke Liu, Sungrim Moon, Feichen Shen, Yanshan Wang, Lixia Yao, John Manley III Davis, Hongfang D Liu

Research output: Contribution to journalArticle

2 Scopus citations


Multiple data sources are preferred in adverse drug event (ADEs) surveillance owing to inadequacies of single source. However, analytic methods to monitor potential ADEs after prolonged drug exposure are still lacking. In this study we propose a method aiming to screen potential ADEs by combining FDA Adverse Event Reporting System (FAERS) and Electronic Medical Record (EMR). The proposed method uses natural language processing (NLP) techniques to extract treatment outcome information captured in unstructured text and adopts case-crossover design in EMR. Performances were evaluated using two ADE knowledge bases: Adverse Drug Reaction Classification System (ADReCS) and SIDER. We tested our method in ADE signal detection of conventional disease-modifying antirheumatic drugs (DMARDs) in rheumatoid arthritis patients. Findings showed that recall greatly increased when combining FAERS with EMR compared with FAERS alone and EMR alone, especially for flexible mapping strategy. Precision (FAERS + EMR) in detecting ADEs improved using ADReCS as gold standard compared with SIDER. In addition, signals detected from EMR have considerably overlapped with signals detected from FAERS or ADE knowledge bases, implying the importance of EMR for pharmacovigilance. ADE signals detected from EMR and/or FAERS but not in existing knowledge bases provide hypothesis for future study.

Original languageEnglish (US)
Article number875
JournalFrontiers in Pharmacology
Issue numberAUG
StatePublished - Aug 7 2018



  • Adverse drug event
  • Disease-modifying antirheumatic drug (DMARD)
  • Electronic Medical Records (EMR)
  • FDA Adverse Event Reporting System (FAERS)
  • Natural language processing
  • Pharmacovigilance

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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