ArticleBritish journal of clinical pharmacology2015
The role of electronic healthcare record databases in paediatric drug safety surveillance: a retrospective cohort study.
Article in British journal of clinical pharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.
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Who cites it
11 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Electronic health record-based disease surveillance systems: A systematic literature review on challenges and solutions.Journal of the American Medical Informatics Association : JAMIA · 2020Pooled it
- Pharmacoepidemiological safety studies in children: a systematic review.Pharmacoepidemiology and drug safety · 2016Pooled it
- Transforming Pharmacovigilance With Pharmacogenomics: Toward Personalized Risk Management.Clinical pharmacology and therapeutics · 2025Review
- A Deep Learning Approach to Estimate the Incidence of Infectious Disease Cases for Routinely Collected Ambulatory Records: The Example of Varicella-Zoster.International journal of environmental research and public health · 2022Article
- Detection of pediatric drug-induced kidney injury signals using a hospital electronic medical record database.Frontiers in pharmacology · 2022Article
- Traceability of Pediatric Antibiotic Purchasing Pathways in Italy: A Nationwide Real-World Drug Utilization Analysis.Frontiers in pharmacology · 2020Article
- Exploratory Study of Signals for Asthma Drugs in Children, Using the EudraVigilance Database of Spontaneous Reports.Drug safety · 2020Article
- Developing a Standardization Algorithm for Categorical Laboratory Tests for Clinical Big Data Research: Retrospective Study.JMIR medical informatics · 2019Article
- The Role of European Healthcare Databases for Post-Marketing Drug Effectiveness, Safety and Value Evaluation: Where Does Italy Stand?Drug safety · 2019Review
- From Big Data to Smart Data for Pharmacovigilance: The Role of Healthcare Databases and Other Emerging Sources.Drug safety · 2018Article
- Drug combination therapy increases successful drug repositioning.Drug discovery today · 2016Review
Corrections and comments
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Authors and funding
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimElectronic healthcare record (EHR)-based surveillance systems are increasingly being developed to support early detection of safety signals. It is unknown what the power of such a system is for surveillance among children and adolescents. In this paper we provide estimates of the number and classes of drugs, and incidence rates (IRs) of events, that can be monitored in children and adolescents (0-18 years).
methodsData were obtained from seven population-based EHR databases in Denmark, Italy, and the Netherlands during the period 1996-2010. We estimated the number of drugs for which specific adverse events can be monitored as a function of actual drug use, minimally detectable relative risk (RR) and IRs for 10 events.
resultsThe population comprised 4 838 146 individuals (25 575 132 person years (PYs)), who were prescribed 2170 drugs (1 610 631 PYs drug-exposure). Half of the total drug-exposure in PYs was covered by only 18 drugs (0.8%). For a relatively frequent event like upper gastrointestinal bleeding there were 39 drugs for which an association with a RR ≥4, if present, could be investigated. The corresponding number of drugs was eight for a rare event like anaphylactic shock.
conclusionDrug use in children is rare and shows little variation. The number of drugs with enough exposure to detect rare adverse events in children and adolescents within an EHR-based surveillance system such as EU-ADR is limited. Use of additional sources of paediatric drug exposure information and global collaboration are imperative in order to optimize EHR data for paediatric safety surveillance.
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