[Pilot study evaluating the ratio of adverse drug reactions related to antimicrobials over their consumption in...

Area of Science:

• Pharmacovigilance
• Infectious Diseases
• Hospital Pharmacy

Background:

• Antimicrobial stewardship programs aim to optimize drug use and minimize adverse events.
• Understanding the prevalence and patterns of adverse drug reactions (ADRs) is crucial for patient safety.
• Mother-child hospitals present unique challenges in antimicrobial use and ADR monitoring.

Purpose of the Study:

• To assess the use of antimicrobials and the prevalence of associated adverse drug reactions.
• To identify specific antimicrobials with a higher-than-average risk of ADRs.
• To inform targeted interventions within an antimicrobial stewardship program.

Main Methods:

• A retrospective, descriptive study was conducted over a one-year period (April 2012-March 2013).
• Adverse drug reactions were quantified using the ratio of ADRs per 10,000 defined daily doses or 10,000 days of therapy.
• Severity of ADRs was assessed using Common Terminology Criteria for Adverse Events.

Main Results:

• Out of 570 total ADRs, 100 (17.5%) were related to antimicrobials, affecting 96 patients.
• Five antimicrobials showed significantly higher-than-average ADR ratios: piperacillin, valganciclovir, ceftriaxone, acyclovir, and liposomal amphotericin B.
• Specific ADR ratios and confidence intervals were calculated for targeted risk management.

Conclusions:

• The study identified key antimicrobials requiring focused attention for ADR prevention and management.
• Calculated ADR ratios provide a data-driven approach for antimicrobial stewardship initiatives.
• Targeting high-risk antimicrobials can enhance patient safety in pediatric and obstetric settings.