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Comparing recurrent antibiotic prescriptions in children treated with a brand name or a generic formulation

Daniele Piovani1, Antonio Clavenna, Massimo Cartabia

  • 1Department of Public Health, Laboratory for Mother and Child Health, IRCCS-Istituto di Ricerche Farmacologiche "Mario Negri", Milan, Italy.

Pharmacoepidemiology and Drug Safety
|June 10, 2014
PubMed

Insights

Children using generic antibiotics showed similar safety and effectiveness compared to brand-name antibiotics, with no significant differences in recurrent prescriptions or hospital admissions. These findings support the use of generic antibiotics in pediatric care.

Area of Science:

  • Pediatric pharmacology
  • Drug safety and effectiveness
  • Antibiotic utilization

Background:

  • Antibiotic resistance and treatment efficacy are critical in pediatric care.
  • Understanding the comparative outcomes of generic versus brand-name antibiotics is essential for clinical practice and healthcare policy.

Purpose of the Study:

  • To compare the rates of recurrent prescriptions and hospital admissions in children (<18 years) treated with generic versus brand-name antibiotic formulations.
  • To evaluate safety and effectiveness outcomes across different age strata and specific antibiotics.

Main Methods:

  • Observational study using a database of reimbursed prescriptions in the Lombardy Region, Italy (February-April 2010).
  • Defined recurrent prescription as an antibiotic prescription within 28 days of an index prescription.
  • Calculated rates of recurrent prescriptions and hospital admissions for generic/brand name antibiotics (amoxicillin, amoxicillin clavulanate, clarithromycin, cefaclor) across age groups (0-5, 6-11, 12-17 years).
  • Used Cochran-Mantel-Haenszel test for age-adjusted outcome comparisons.

Main Results:

  • 17.5% of children received at least one recurrent prescription.
  • Slightly lower rate of recurrent prescriptions observed with generic antibiotics (OR 0.96; 95%CI 0.93-0.98) compared to brand-name.
  • No significant difference in overall hospital admission rates between children treated with brand-name (1.01%) or generic (1.03%) antibiotics (p=0.43).
  • A slightly higher hospital admission rate was noted for brand-name amoxicillin clavulanate (p=0.002), but not for other antibiotics.

Conclusions:

  • Pediatric patients treated with generic antibiotics experienced comparable safety and effectiveness outcomes to those on brand-name antibiotics.
  • The study provides evidence supporting the safety and efficacy of generic antibiotic use in children.
  • No significant differences in key clinical outcomes warrant consideration for generic antibiotic prescribing in pediatric populations.
Abstract

Keywords:
anti-bacterial agentschilddrug utilisationdrugs, genericpharmacoepidemiologyprescriptionsrecurrence

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