Revue de Pharmacovigilance

Abstrait

Active Surveillance on the Use of Antibiotics in Children, Particularly in the Age Group from 0 to 2 Years

Ettore Napoleone, Antonella Lavalle, Cristiana Scasserra and Moreno Ricci

Introduction: Despite the AIFA (Italian Medicines Agency) campaigns, the consumption and prescription unsuitability of pediatric antibiotics is growing (OsMed data from 2013 to 2015) with an increase in both the adverse reactions and bacterial resistance. 70/80% infections of the respiratory tract (0-3 years) are due to a viral infection and not bacterial.

From this point a study has been foreseen to provide, on the one hand, training interventions for Family Pediatricians (FPs) and information for families on the correct use of antibiotics and possible iatrogenic diseases caused by their misuse, and on the other, which formed a territorial survey aimed at the risk-benefit balance.

Materials and methods: The study conducted by 37 Family Pediatricians (FPs) in Molise consists of three phases: 1) in the first phase (retrospective year 2013) we assessed the prevalence of antibiotic prescriptions in the 0 to 2 years age group, the type of antibiotic used and any ADRs; 2) the second phase (2014) was that of training/ information to the FPs and families on prescriptive appropriateness and proper use; 3) in the third phase (year 2015) the Prevalence of prescriptions has been reassessed and the type of antibiotic used and the possible ADRs (after the training phase).

Results: The study showed, in the first phase (2013) that the prevalence of antibiotics prescribed by 37 FP from 0-2 years old (4060 children), was 83% (number of children with at least one prescription: 3339) with a number of prescriptions of 7114 (number of items prescribed: 8367). After training, the year 2015 detected a 56% prevalence (number of children 4116. number of children treated 2327) with a significant decrease (-27%) compared to 83% in 2013. In addition there has been a reduction of 2938 prescriptions (number of prescriptions 4176) and a reduction of 2975 prescribed items (number of items prescribed 5392) with savings of € 18,854.23 (60950.15 EUR in 2013 and 42095.92 EUR in 2015). Finally there was also an improvement in the appropriateness of prescriptions according to the Guide lines: Amoxicillin (38%), followed by Amoxi/clavulanate (29.3%), Macrolides (16.3%), and Cephalosporins (15.2%). There were no ADRs in the two reference years.

Conclusion: Data showed a marked reduction in the prevalence of prescribed antibiotics, a reduction in health care costs and an improvement on prescriptive appropriateness after training courses for the FPs and continuous information to the families on the proper use, and on ADRs related to the abuse of antibiotics in this age group.