ArticleDrug safety2015
Useful Interplay Between Spontaneous ADR Reports and Electronic Healthcare Records in Signal Detection.
Article in Drug safety, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 3 of them syntheses that pooled it.
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Who cites it
36 citing papers in PubMed, 3 syntheses or guidelines pooled it, 66 citations in OpenAlex.
- An Awareness of Pharmacovigilance Among Healthcare Professionals Due to an Underreporting of Adverse Drug Reactions Issue: A Systematic Review of the Current State, Obstacles, and Strategy.Current drug safety · 2024Pooled it
- Methods for drug safety signal detection using routinely collected observational electronic health care data: A systematic review.Pharmacoepidemiology and drug safety · 2023Pooled it
- Factors influencing harmonized health data collection, sharing and linkage in Denmark and Switzerland: A systematic review.PloS one · 2019Pooled it
- Active surveillance of drug safety in healthcare data: Sequential monitoring of bacterial and serious urinary tract infection risk in sodium-glucose cotransporter 2 inhibitor users.British journal of clinical pharmacology · 2026Article
- Persistent rise in device-related errors for CGRP monoclonal antibodies: impact of the COVID-19 pandemic and post-pandemic implications.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Pregnant Women and Vaccine Safety in Uganda: Knowledge, Barriers, and Opportunities for Engagement.Vaccines · 2025Article
- Recommendations to Enable Broader Use of Real-World Evidence to Inform Decision-Making Throughout Pharmacovigilance Signal Management.Pharmacoepidemiology and drug safety · 2025Review
- Article
- A pharmacovigilance analysis of abrocitinib-related skin adverse events based on the FDA Adverse Event Reporting System (FAERS).Archives of dermatological research · 2025Article
- Disproportionality analysis of Raynaud's phenomenon associated with calcitonin gene-related peptide inhibitors using the Food and Drug Administration adverse event reporting system.Scientific reports · 2025Article
- An innovative method to strengthen evidence for potential drug safety signals using Electronic Health Records.Journal of medical systems · 2024Article
- A Survey of Pharmacists and Other Healthcare Professionals in Vietnam: Factors Influencing Knowledge and Attitudes Toward Reporting Adverse Drug Reactions.Hospital pharmacy · 2024Article
- Integrating electronic health records with other data sources for postmarket drug safety signal identification: a review.Frontiers in drug safety and regulation · 2024Review
- A discovery and verification approach to pharmacovigilance using electronic healthcare data.Frontiers in pharmacology · 2024Article
- Supporting Pharmacovigilance Signal Validation and Prioritization with Analyses of Routinely Collected Health Data: Lessons Learned from an EHDEN Network Study.Drug safety · 2023Article
- Use of Electronic Health Record Data for Drug Safety Signal Identification: A Scoping Review.Drug safety · 2023Article
- Conducting and interpreting disproportionality analyses derived from spontaneous reporting systems.Frontiers in drug safety and regulation · 2023Review
- Effectiveness of a structured stimulated spontaneous safety monitoring of medicines reporting program in strengthening pharmacovigilance system in Tanzania.Scientific reports · 2022Article
- Detection of Drug-Induced Thrombocytopenia Signals in Children Using Routine Electronic Medical Records.Frontiers in pharmacology · 2021Article
- Adverse drug event presentation and tracking (ADEPT): semiautomated, high throughput pharmacovigilance using real-world data.JAMIA open · 2020Article
Corrections and comments
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Authors and funding
14 authors at 8 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveSpontaneous reporting systems (SRSs) remain the cornerstone of post-marketing drug safety surveillance despite their well-known limitations. Judicious use of other available data sources is essential to enable better detection, strengthening and validation of signals. In this study, we investigated the potential of electronic healthcare records (EHRs) to be used alongside an SRS as an independent system, with the aim of improving signal detection.
methodsA signal detection strategy, focused on a limited set of adverse events deemed important in pharmacovigilance, was performed retrospectively in two data sources-(1) the Exploring and Understanding Adverse Drug Reactions (EU-ADR) database network and (2) the EudraVigilance database-using data between 2000 and 2010. Five events were considered for analysis: (1) acute myocardial infarction (AMI); (2) bullous eruption; (3) hip fracture; (4) acute pancreatitis; and (5) upper gastrointestinal bleeding (UGIB). Potential signals identified in each system were verified using the current published literature. The complementarity of the two systems to detect signals was expressed as the percentage of the unilaterally identified signals out of the total number of confirmed signals. As a proxy for the associated costs, the number of signals that needed to be reviewed to detect one true signal (number needed to detect [NND]) was calculated. The relationship between the background frequency of the events and the capability of each system to detect signals was also investigated.
resultsThe contribution of each system to signal detection appeared to be correlated with the background incidence of the events, being directly proportional to the incidence in EU-ADR and inversely proportional in EudraVigilance. EudraVigilance was particularly valuable in identifying bullous eruption and acute pancreatitis (71 and 42 % of signals were correctly identified from the total pool of known associations, respectively), while EU-ADR was most useful in identifying hip fractures (60 %). Both systems contributed reasonably well to identification of signals related to UGIB (45 % in EudraVigilance, 40 % in EU-ADR) but only fairly for signals related to AMI (25 % in EU-ADR, 20 % in EudraVigilance). The costs associated with detection of signals were variable across events; however, it was often more costly to detect safety signals in EU-ADR than in EudraVigilance (median NNDs: 7 versus 5).
conclusionAn EHR-based system may have additional value for signal detection, alongside already established systems, especially in the presence of adverse events with a high background incidence. While the SRS appeared to be more cost effective overall, for some events the costs associated with signal detection in the EHR might be justifiable.
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