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https://www.arca.fiocruz.br/handle/icict/42661
SERIOUS ADVERSE DRUG REACTIONS AND SAFETY SIGNALS IN CHILDREN: A NATIONWIDE DATABASE STUDY
Children
Spontaneous reports
Off label drug use
Safety signals
Author
Affilliation
Universidade Federal do Rio de Janeiro. Centro de Ciências da Saúde. Faculdade de Farmácia. Rio de Janeiro, RJ, Brasil.
Universidade Federal do Rio de Janeiro. Centro de Ciências da Saúde. Faculdade de Farmácia. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Presidência. Programa de Computação Científica. Rio de Janeiro, RJ, Brasil.
Alder Hey Children's NHS Foundation Trust. Paediatric Medicines Research Unit. Liverpool, England.
Alder Hey Children's NHS Foundation Trust. Paediatric Medicines Research Unit. Liverpool, England.
Universidade Federal do Rio de Janeiro. Centro de Ciências da Saúde. Faculdade de Farmácia. Rio de Janeiro, RJ, Brasil.
Universidade Federal do Rio de Janeiro. Centro de Ciências da Saúde. Faculdade de Farmácia. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Presidência. Programa de Computação Científica. Rio de Janeiro, RJ, Brasil.
Alder Hey Children's NHS Foundation Trust. Paediatric Medicines Research Unit. Liverpool, England.
Alder Hey Children's NHS Foundation Trust. Paediatric Medicines Research Unit. Liverpool, England.
Universidade Federal do Rio de Janeiro. Centro de Ciências da Saúde. Faculdade de Farmácia. Rio de Janeiro, RJ, Brasil.
Abstract
Children are more exposed to inappropriate medicine use and its consequent harms. Spontaneous reporting of suspected Serious Adverse Drug Reactions (SADR) increases knowledge and prevention of pharmacotherapy risk. Disproportionality measures are useful to quantify unexpected safety issues associated with a given drug event pair (signals of disproportionality). This cross-sectional study aimed to assess SADR reporting and safety signals for Brazilian children from 0-12 years old, notified between January 2008 and December 2013 from the Brazilian Surveillance Agency (Notivisa). Information from serious reports (gender and age of the patient, event description, suspected drug) was included. Disproportionality analysis based on Reporting Odds Ratios with a confidence interval of 95% was conducted to identify possible signals of disproportionate reporting (SDR). Almost 30% of 1,977 suspected SADR was related to babies (0-1-year-old). 69% of reports happened with intravenous dosage forms, and 35% of suspected SADR involved off label use according to age. Laronidase, miglustat, imipenem/cilastatin, and clofarabine were involved in six or more suspected deaths among 75 deaths reported. There were 107 SDRs, of which 16 events (15%) were not described in the product labels. There was a relatively higher number of SADRs in Brazilian children compared with studies from other countries. SDRs found, (especially drug-event pairs ‘imipenen/cilastatin–pneumonia’ and ‘laronidase–respiratory insufficiency’) should be investigated more. The reports of SADR with IV dosage forms and OL drug use suggest the need for drug research and the use of better dosage forms for children in Brazil.
Keywords
Serious adverse drug reactionsChildren
Spontaneous reports
Off label drug use
Safety signals
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