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Improved drug safety through intensive pharmacovigilance in hospitalized pediatric patients

Alan O Vázquez-Alvarez1, Lorena Michele Brennan-Bourdon2, Ana Rosa Rincón-Sánchez3

  • 1Instituto de Terapéutica Experimental y Clínica (INTEC). Departamento de Fisiología. Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, Guadalajara, Jalisco, Mexico.

BMC Pharmacology & Toxicology
|December 9, 2017
PubMed

Insights

Intensive pharmacovigilance effectively detected adverse drug reactions in hospitalized children. This approach improved drug safety by identifying probable and certain reactions, particularly with antibiotics, and reducing preventable harm.

Area of Science:

  • Pediatric pharmacovigilance
  • Drug safety research
  • Clinical pharmacology

Background:

  • Adverse Drug Reactions (ADRs) pose a significant risk in pediatric hospital settings.
  • Effective pharmacovigilance strategies are crucial for identifying and mitigating these risks.
  • Previous research highlighted the need for enhanced monitoring in pediatric populations.

Purpose of the Study:

  • To detect and analyze Adverse Drug Reactions (ADRs) in hospitalized pediatric patients.
  • To evaluate the effectiveness of Intensive Pharmacovigilance (IPV) in improving pediatric drug safety.
  • To identify specific drug classes and risk factors associated with ADRs in children.

Main Methods:

  • A prospective 6-month cross-sectional study was conducted in a pediatric hospital in Mexico.
  • Inclusion criteria encompassed hospitalized children aged 1 day to 18 years on at least one medication.
  • ADR detection utilized medical visits, phone calls, and spontaneous reports, with causality assessed using established scales.

Main Results:

  • Out of 1083 admissions, 19 ADRs were recorded, with most classified as probable (68.4%).
  • Antibiotics (AB) and an antiepileptic drug were frequently implicated, with a significant association between AB and ADRs (p < 0.05).
  • Increased hospital stay was linked to ADRs and concomitant medications (p < 0.05); severe ADRs included hemolysis and toxic epidermal necrolysis.

Conclusions:

  • Intensive Pharmacovigilance (IPV) proved effective for ADR prevention, detection, and treatment in hospitalized pediatric patients.
  • The intensive monitoring approach significantly amplifies ADR detection rates.
  • This strategy directly contributes to the overall improvement of drug safety in pediatric care.
Abstract

Keywords:
Adverse drug reactionDrug safetyIntensive pharmacovigilancePharmacovigilance

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