ArticleBritish journal of clinical pharmacology2013
E-pharmacovigilance: development and implementation of a computable knowledge base to identify adverse drug reactions.
Article in British journal of clinical pharmacology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 3 of them syntheses that pooled it.
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Who cites it
17 citing papers in PubMed, 3 syntheses or guidelines pooled it, 38 citations in OpenAlex.
- Safety of Quinolones in Children: A Systematic Review and Meta-Analysis.Paediatric drugs · 2022Pooled it
- Safety of azithromycin in pediatrics: a systematic review and meta-analysis.European journal of clinical pharmacology · 2020Pooled it
- Computational Advances in Drug Safety: Systematic and Mapping Review of Knowledge Engineering Based Approaches.Frontiers in pharmacology · 2019Pooled it
- An Evaluation Benchmark for Adverse Drug Event Prediction from Clinical Trial Results.Scientific data · 2025Article
- A retrospective case-control study on menstrual cycle changes following COVID-19 vaccination and disease.iScience · 2023Article
- Utility of a Laboratory Alert System for Detecting Adverse Drug Reactions in Hospitalised Patients: Hyponatremia and Rhabdomyolysis.Frontiers in pharmacology · 2022Article
- Multicentric study of patients receiving 50 or 100 mSv in a single day through CT imaging-frequency determination and imaging protocols involved.European radiology · 2021Article
- Developing a framework regarding a complex risk based methodology in the evaluation of hazards associated with medicinal products sourced via the internet.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2020Article
- Pathogenetic approach to the treatment of functional disorders of the gastrointestinal tract and their intersection: results of the Russian observation retrospective program COMFORT.BMC gastroenterology · 2019Observational
- Development of a Controlled Vocabulary-Based Adverse Drug Reaction Signal Dictionary for Multicenter Electronic Health Record-Based Pharmacovigilance.Drug safety · 2019Article
- Survivability of hospitalized chronic kidney disease (CKD) patients with moderate to severe estimated glomerular filtration rate (eGFR) after experiencing adverse drug reactions (ADRs) in a public healthcare center: a retrospective 3 year study.BMC pharmacology & toxicology · 2018Observational
- Quality Requirements for Electronic Health Record Systems*. A Japanese-German Information Management Perspective.Methods of information in medicine · 2017Article
- To establish a body of evidence on safety for postmarketing Chinese medicine: A new research paradigm.Chinese journal of integrative medicine · 2017Article
- Risk Factors Associated with the Requirement for Pharmaceutical Intervention in the Hospital Setting: A Systematic Review of the Literature.Drugs - real world outcomes · 2016Review
- Predicting risk of adverse drug reactions in older adults.Therapeutic advances in drug safety · 2016Review
- Article
- Towards a Computable Data Corpus of Temporal Correlations between Drug Administration and Lab Value Changes.PloS one · 2015Article
Corrections and comments
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Authors and funding
8 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsComputer-assisted signal generation is an important issue for the prevention of adverse drug reactions (ADRs). However, due to poor standardization of patients' medical data and a lack of computable medical drug knowledge the specificity of computerized decision support systems for early ADR detection is too low and thus those systems are not yet implemented in daily clinical practice. We report on a method to formalize knowledge about ADRs based on the Summary of Product Characteristics (SmPCs) and linking them with structured patient data to generate safety signals automatically and with high sensitivity and specificity.
methodsA computable ADR knowledge base (ADR-KB) that inherently contains standardized concepts for ADRs (WHO-ART), drugs (ATC) and laboratory test results (LOINC) was built. The system was evaluated in study populations of paediatric and internal medicine inpatients.
resultsA total of 262 different ADR concepts related to laboratory findings were linked to 212 LOINC terms. The ADR knowledge base was retrospectively applied to a study population of 970 admissions (474 internal and 496 paediatric patients), who underwent intensive ADR surveillance. The specificity increased from 7% without ADR-KB up to 73% in internal patients and from 19.6% up to 91% in paediatric inpatients, respectively.
conclusionsThis study shows that contextual linkage of patients' medication data with laboratory test results is a useful and reasonable instrument for computer-assisted ADR detection and a valuable step towards a systematic drug safety process. The system enables automated detection of ADRs during clinical practice with a quality close to intensive chart review.
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