Enhanced Paediatric Pharmacovigilance at the European Medicines Agency: A Novel Query Applied to Adverse Drug Reaction Reports
| العنوان: | Enhanced Paediatric Pharmacovigilance at the European Medicines Agency: A Novel Query Applied to Adverse Drug Reaction Reports |
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| المؤلفون: | Agnes Saint-Raymond, Kevin Blake, Cosimo Zaccaria, Francois Domergue, Benjamin Pelle, Jim Slattery |
| المصدر: | Pediatric Drugs. 18:55-63 |
| بيانات النشر: | Springer Science and Business Media LLC, 2015. |
| سنة النشر: | 2015 |
| مصطلحات موضوعية: | Adult, Pediatrics, medicine.medical_specialty, Databases, Factual, Drug-Related Side Effects and Adverse Reactions, Postmarketing surveillance, 030226 pharmacology & pharmacy, Pharmacovigilance, 03 medical and health sciences, 0302 clinical medicine, Pharmacotherapy, Agency (sociology), medicine, Adverse Drug Reaction Reporting Systems, Humans, Pharmacology (medical), 030212 general & internal medicine, Drug reaction, Child, Intensive care medicine, business.industry, medicine.disease, Pediatrics, Perinatology and Child Health, business, Adverse drug reaction |
| الوصف: | Databases of suspected adverse drug reactions (ADRs) are a cornerstone of pharmacovigilance. With increasing numbers of reports, additional statistical approaches are needed to better use the data.The present study was aimed at elucidating the European Medicines Agency's (EMA) use of a novel 'paediatric' query to analyse the data in its ADR database 'EudraVigilance'.The proportional reporting ratio (PRR) is a measure of disproportionality for which the underlying principle is that a drug-event pair of interest is reported more often than expected relative to an independence model. The EMA's paediatric query, based on PRRs, was applied to the data in EudraVigilance to investigate the extent to which the known association between enalapril and renal toxicity was reflected in reported ADRs comparing children with adults and with adjustment for the effect of multiplicity.The comparison of PRRs for children (14.91, 95% confidence interval [CI] 13.05-17.04) versus adults (2.66, 95% CI 2.52-2.82) confirmed a higher risk of renal ADRs with enalapril when used in children compared with all other medicines and compared with adults.The EMA's paediatric query can be used to highlight an imbalance for a drug-event pair among ADRs for a medicine when used in children and as compared with adults. Applying the query in practice can help the EMA to decide on whether stand-alone paediatric medicine development is warranted, and which, if any, further studies are necessary. Ongoing evaluation of the query is contributing to the development of new methods and guidance. |
| تدمد: | 1179-2019 1174-5878 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5ed6fe13e9f6cf892302231210da35a9Test https://doi.org/10.1007/s40272-015-0154-0Test |
| حقوق: | CLOSED |
| رقم الانضمام: | edsair.doi.dedup.....5ed6fe13e9f6cf892302231210da35a9 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 11792019 11745878 |
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