[Pilot study evaluating the ratio of adverse drug reactions related to antimicrobials over their consumption in 2012-2013]

Ann Pharm Fr. 2016 Mar;74(2):165-72. doi: 10.1016/j.pharma.2015.08.001. Epub 2015 Sep 11.
[Article in French]

Abstract

Objectives: As part of our antimicrobials stewardship program, we were interested in the use of antimicrobials and prevalence of adverse drug reactions associated with the use of these drugs.

Methods: The retrospective and descriptive study was conducted over a one year-period between April 1st 2012 and March 31st 2013 in a mother-child Hospital. We determined the ratio: number of adverse drug reactions over 10,000 defined daily dose or 10,000days of therapy. We identified the ratios higher than average for which the confidence interval did not cross the calculated average. The severity of the adverse drug reactions was codified using the Common Terminology Criteria for Adverse Events.

Results: We found 570 adverse drug reactions including 100 (17.5%) adverse drug reactions related to antimicrobials during the financial year 2012-2013. It represented 96 patients. Thus, five antimicrobials, for which the confidence interval does not cross the calculated average value, may be targeted in risk management because they have a higher ratio than average: piperacillin (290 [113-722]), valganciclovir (244 [43-1260]), ceftriaxone (114 [56-234]), acyclovir (76 [26-220]) and liposomal amphotericin B (72 [20-258]).

Conclusion: In a mother-child university hospital, we calculated a ratios of 19 [15-23] and 13 [10-15], it allows us targeting some antimicrobials in our approach to prevention and management of adverse drug reactions.

Keywords: Adverse drug reactions; Antimicrobials stewardship program; Days of therapy; Defined daily dose; Doses définies journalières; Effets indésirables; Nombre de jours de traitement; Programme de gérance des anti-infectieux.

MeSH terms

  • Adolescent
  • Adverse Drug Reaction Reporting Systems
  • Anti-Infective Agents / adverse effects*
  • Child
  • Child, Preschool
  • Drug-Related Side Effects and Adverse Reactions / epidemiology
  • Female
  • France / epidemiology
  • Humans
  • Male
  • Pilot Projects
  • Prevalence
  • Retrospective Studies
  • Risk Management

Substances

  • Anti-Infective Agents