Serious Adverse Drug Reactions and Safety Signals in Children: A Nationwide Database Study

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.

Suspected Adverse Drug Reactions in Pediatric Cancer Patients in China: An Analysis of Henan Province Spontaneous Reporting System Database

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Potential safety signals for antibacterial agents from the Brazilian national pharmacovigilance database (Vigimed/VigiFlow)

“…Data mining in pharmacovigilance databases may guide 1) additional analytical studies in specific populations that may be more susceptible to ADE occurrence and 2) epidemiologic studies for risk quantification and risk-minimization activities ( Emanuel Raschi, 2016 ). Previous studies from our group found relevant signals of disproportionate reporting in pediatric and oncologic care from the former Brazilian database (Notivisa) ( Barcelos et al, 2019 ; Vieira et al, 2020 ).…”

Data Sources for Drug Utilization Research in Brazil—DUR-BRA Study

“…Systems for active surveillance and projects for detecting signals and monitoring recently approved medications ( Racoosin et al, 2012 ) have been established in other countries. Recent studies involving disproportionality analysis for safety signal screening in children ( Vieira et al, 2020 ) and breast cancer patients ( Barcelos et al, 2019 ) using Notivisa were conducted, demonstrating the potential of this data source. However, Brazil lags behind in terms of research initiatives and decision-making using automated administrative data.…”