Characterization of serious adverse drug reactions as cause of emergency department visit in children: a 5-years active pharmacovigilance study
Abstract Background To describe frequency, preventability and seriousness of adverse drug reactions (ADRs) in children as cause of emergency department (ED) admission and to evaluate the association between specific factors and the reporting of ADRs. Methods A retrospective analysis based on reports...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2018-04-01
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| Series: | BMC Pharmacology and Toxicology |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s40360-018-0207-4 |
| _version_ | 1818180259762143232 |
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| author | Niccolò Lombardi Giada Crescioli Alessandra Bettiol Ettore Marconi Antonio Vitiello Roberto Bonaiuti Anna Maria Calvani Stefano Masi Ersilia Lucenteforte Alessandro Mugelli Lisa Giovannelli Alfredo Vannacci |
| author_facet | Niccolò Lombardi Giada Crescioli Alessandra Bettiol Ettore Marconi Antonio Vitiello Roberto Bonaiuti Anna Maria Calvani Stefano Masi Ersilia Lucenteforte Alessandro Mugelli Lisa Giovannelli Alfredo Vannacci |
| author_sort | Niccolò Lombardi |
| collection | DOAJ |
| description | Abstract Background To describe frequency, preventability and seriousness of adverse drug reactions (ADRs) in children as cause of emergency department (ED) admission and to evaluate the association between specific factors and the reporting of ADRs. Methods A retrospective analysis based on reports of suspected ADRs collected between January 1st, 2012 and December 31st, 2016 in the ED of Meyer Children’s Hospital (Italy). Demographics, clinical status, suspected drugs, ADR description, and its degree of seriousness were collected. Logistic regression was used to estimate the reporting odds ratios (RORs) with 95% confidence intervals (CIs) of potential predictors of ADR seriousness. Results Within 5 years, we observed 834 ADRs (1100 drug-ADR pairs), of whom 239 were serious; of them, 224 led to hospitalization. Patients were mostly treated with one drug. Among patients treated with more than one drug, 78 ADRs presented a potential interaction. The most frequently reported ADRs involved gastrointestinal system. The most frequently reported medication class was antinfectives. Risk of serious ADR was significantly lower in children and infants compared to adolescents (ROR 0.41 [95% CI: 0.27–0.61] and 0.47 [0.32–0.71], respectively), and it was significantly increased in subjects exposed to more than one drug (ROR 1.87 [1.33–2.62] and 3.01 [2.07–4.37] for subjects exposed to 2 and 3 or more drugs, respectively). Gender, interactions and off-label drug use did not influence the risk of serious ADRs. Conclusion Active surveillance in pharmacovigilance might represent the best strategy to estimate and characterize the clinical burden of ADRs in children. |
| first_indexed | 2024-12-11T21:16:56Z |
| format | Article |
| id | doaj.art-86a4ef1653a3407abdc83b998582280d |
| institution | Directory Open Access Journal |
| issn | 2050-6511 |
| language | English |
| last_indexed | 2024-12-11T21:16:56Z |
| publishDate | 2018-04-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Pharmacology and Toxicology |
| spelling | doaj.art-86a4ef1653a3407abdc83b998582280d2022-12-22T00:50:34ZengBMCBMC Pharmacology and Toxicology2050-65112018-04-011911810.1186/s40360-018-0207-4Characterization of serious adverse drug reactions as cause of emergency department visit in children: a 5-years active pharmacovigilance studyNiccolò Lombardi0Giada Crescioli1Alessandra Bettiol2Ettore Marconi3Antonio Vitiello4Roberto Bonaiuti5Anna Maria Calvani6Stefano Masi7Ersilia Lucenteforte8Alessandro Mugelli9Lisa Giovannelli10Alfredo Vannacci11Department of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of FlorenceDepartment of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of FlorenceDepartment of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of FlorenceDepartment of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of FlorenceDepartment of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of FlorenceDepartment of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of FlorenceDepartment of Pharmacy, Anna Meyer Children’s University HospitalDepartment of Emergency Medicine, Anna Meyer Children’s University HospitalDepartment of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of FlorenceDepartment of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of FlorenceDepartment of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of FlorenceDepartment of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of FlorenceAbstract Background To describe frequency, preventability and seriousness of adverse drug reactions (ADRs) in children as cause of emergency department (ED) admission and to evaluate the association between specific factors and the reporting of ADRs. Methods A retrospective analysis based on reports of suspected ADRs collected between January 1st, 2012 and December 31st, 2016 in the ED of Meyer Children’s Hospital (Italy). Demographics, clinical status, suspected drugs, ADR description, and its degree of seriousness were collected. Logistic regression was used to estimate the reporting odds ratios (RORs) with 95% confidence intervals (CIs) of potential predictors of ADR seriousness. Results Within 5 years, we observed 834 ADRs (1100 drug-ADR pairs), of whom 239 were serious; of them, 224 led to hospitalization. Patients were mostly treated with one drug. Among patients treated with more than one drug, 78 ADRs presented a potential interaction. The most frequently reported ADRs involved gastrointestinal system. The most frequently reported medication class was antinfectives. Risk of serious ADR was significantly lower in children and infants compared to adolescents (ROR 0.41 [95% CI: 0.27–0.61] and 0.47 [0.32–0.71], respectively), and it was significantly increased in subjects exposed to more than one drug (ROR 1.87 [1.33–2.62] and 3.01 [2.07–4.37] for subjects exposed to 2 and 3 or more drugs, respectively). Gender, interactions and off-label drug use did not influence the risk of serious ADRs. Conclusion Active surveillance in pharmacovigilance might represent the best strategy to estimate and characterize the clinical burden of ADRs in children.http://link.springer.com/article/10.1186/s40360-018-0207-4PediatricsAdverse eventsSafetyObservational studyPreventabilityDrug interactions |
| spellingShingle | Niccolò Lombardi Giada Crescioli Alessandra Bettiol Ettore Marconi Antonio Vitiello Roberto Bonaiuti Anna Maria Calvani Stefano Masi Ersilia Lucenteforte Alessandro Mugelli Lisa Giovannelli Alfredo Vannacci Characterization of serious adverse drug reactions as cause of emergency department visit in children: a 5-years active pharmacovigilance study BMC Pharmacology and Toxicology Pediatrics Adverse events Safety Observational study Preventability Drug interactions |
| title | Characterization of serious adverse drug reactions as cause of emergency department visit in children: a 5-years active pharmacovigilance study |
| title_full | Characterization of serious adverse drug reactions as cause of emergency department visit in children: a 5-years active pharmacovigilance study |
| title_fullStr | Characterization of serious adverse drug reactions as cause of emergency department visit in children: a 5-years active pharmacovigilance study |
| title_full_unstemmed | Characterization of serious adverse drug reactions as cause of emergency department visit in children: a 5-years active pharmacovigilance study |
| title_short | Characterization of serious adverse drug reactions as cause of emergency department visit in children: a 5-years active pharmacovigilance study |
| title_sort | characterization of serious adverse drug reactions as cause of emergency department visit in children a 5 years active pharmacovigilance study |
| topic | Pediatrics Adverse events Safety Observational study Preventability Drug interactions |
| url | http://link.springer.com/article/10.1186/s40360-018-0207-4 |
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