A comparison of active adverse event surveillance systems worldwide

Yu Lin Huang, Jinhee Moon, Jodi Segal

Research output: Contribution to journalArticle

Abstract

Post-marketing drug surveillance for adverse drug events (ADEs) has typically relied on spontaneous reporting. Recently, regulatory agencies have turned their attention to more preemptive approaches that use existing data for surveillance. We conducted an environmental scan to identify active surveillance systems worldwide that use existing data for the detection of ADEs. We extracted data about the systems' structures, data, and functions. We synthesized the information across systems to identify common features of these systems. We identified nine active surveillance systems. Two systems are US based - the FDA Sentinel Initiative (including both the Mini-Sentinel Initiative and the Federal Partner Collaboration) and the Vaccine Safety Datalink (VSD); two are Canadian-the Canadian Network for Observational Drug Effect Studies (CNODES) and the Vaccine and Immunization Surveillance in Ontario (VISION); and two are European-the Exploring and Understanding Adverse Drug Reactions by Integrative Mining of Clinical Records and Biomedical Knowledge (EU-ADR) Alliance and the Vaccine Adverse Event Surveillance and Communication (VAESCO). Additionally, there is the Asian Pharmacoepidemiology Network (AsPEN) and the Shanghai Drug Monitoring and Evaluative System (SDMES). We identified two systems in the UK - the Vigilance and Risk Management of Medicines (VRMM) Division and the Drug Safety Research Unit (DSRU), an independent academic unit. These surveillance systems mostly use administrative claims or electronic medical records; most conduct pharmacovigilance on behalf of a regulatory agency. Either a common data model or a centralized model is used to access existing data. The systems have been built using national data alone or via partnership with other countries. However, active surveillance systems using existing data remain rare. North America and Europe have the most population coverage; with Asian countries making good advances.

Original languageEnglish (US)
Pages (from-to)581-596
Number of pages16
JournalDrug Safety
Volume37
Issue number8
DOIs
StatePublished - 2014

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Drug-Related Side Effects and Adverse Reactions
Vaccines
Information Systems
Pharmacoepidemiology
Pharmaceutical Preparations
Pharmacovigilance
Safety
Drug Monitoring
Electronic Health Records
Risk Management
Ontario
North America
Marketing
Immunization
Electronic medical equipment
Research
Population
Risk management
Medicine
Data structures

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology
  • Toxicology
  • Medicine(all)

Cite this

A comparison of active adverse event surveillance systems worldwide. / Huang, Yu Lin; Moon, Jinhee; Segal, Jodi.

In: Drug Safety, Vol. 37, No. 8, 2014, p. 581-596.

Research output: Contribution to journalArticle

Huang, Yu Lin ; Moon, Jinhee ; Segal, Jodi. / A comparison of active adverse event surveillance systems worldwide. In: Drug Safety. 2014 ; Vol. 37, No. 8. pp. 581-596.
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