ArticlePharmacoepidemiology and drug safety2015
Longitudinal medical records as a complement to routine drug safety signal analysis.
Article in Pharmacoepidemiology and drug safety, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.
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Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it.
- A Comparison of Active Pharmacovigilance Strategies Used to Monitor Adverse Events to Antiviral Agents: A Systematic Review.Drug safety · 2024Pooled it
- Recommendations to Enable Broader Use of Real-World Evidence to Inform Decision-Making Throughout Pharmacovigilance Signal Management.Pharmacoepidemiology and drug safety · 2025Review
- Pharmacovigilance and bioethics: the importance of a neglected relationship.Frontiers in drug safety and regulation · 2025Review
- Integrating electronic health records with other data sources for postmarket drug safety signal identification: a review.Frontiers in drug safety and regulation · 2024Review
- 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
- Challenges and opportunities for mining adverse drug reactions: perspectives from pharma, regulatory agencies, healthcare providers and consumers.Database : the journal of biological databases and curation · 2022Article
- Evaluating the performance of temporal pattern discovery: new application using statins and rhabdomyolysis in OMOP databases.BMC medical informatics and decision making · 2022Article
- Adverse drug event presentation and tracking (ADEPT): semiautomated, high throughput pharmacovigilance using real-world data.JAMIA open · 2020Article
- Nintedanib and ischemic colitis: Signal assessment with the integrated use of two types of real-world evidence, spontaneous reports of suspected adverse drug reactions, and observational data from large health-care databases.Pharmacoepidemiology and drug safety · 2020Article
- Exploring the Potential Routine Use of Electronic Healthcare Record Data to Strengthen Early Signal Assessment in UK Medicines Regulation: Proof-of-Concept Study.Drug safety · 2018Article
- Evaluation of Electronic Healthcare Databases for Post-Marketing Drug Safety Surveillance and Pharmacoepidemiology in China.Drug safety · 2018Article
- Useful Interplay Between Spontaneous ADR Reports and Electronic Healthcare Records in Signal Detection.Drug safety · 2015Article
- Longitudinal medical records as a complement to routine drug safety signal analysis.Pharmacoepidemiology and drug safety · 2015Article
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo explore whether and how longitudinal medical records could be used as a source of reference in the early phases of signal detection and analysis of novel adverse drug reactions (ADRs) in a global pharmacovigilance database.
methodsDrug and ADR combinations from the routine signal detection process of VigiBase® in 2011 were matched to combinations in The Health Improvement Network (THIN). The number and type of drugs and ADRs from the data sets were investigated. For unlabelled combinations, graphical display of longitudinal event patterns (chronographs) in THIN was inspected to determine if the pattern supported the VigiBase combination.
resultsOf 458 combinations in the VigiBase data set, 190 matched to corresponding combinations in THIN (after excluding drugs with less than 100 prescriptions in THIN). Eighteen percent of the VigiBase and 9% of the matched THIN combinations referred to new drugs reported with serious reactions. Of the 112 unlabelled combinations matched to THIN, 52 chronographs were inconclusive mainly because of lack of data; 34 lacked any outstanding pattern around the time of prescription; 24 had an elevation of events in the pre-prescription period, hence weakened the suspicion of a drug relationship; two had an elevated pattern of events exclusively in the post-prescription period that, after review of individual patient histories, did not support an association.
conclusionsLongitudinal medical records were useful in understanding the clinical context around a drug and suspected ADR combination and the probability of a causal relationship. A drawback was the paucity of data for newly marketed drugs with serious reactions.
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