Pediatric non available medicines in Córdoba (Argentina)

FONTANA, D; MAZZIERI M. R.

Encuentro; 2ª Reunión Internacional de Ciencias Farmacéuticas.; 2012

Introduction Since 2006, we are conducting pharmacoepidemiological research about orphan drugs (OD) (1,2) in Cordoba (Argentina) (3,4). Assuming “lack of availability” as indicator of “orphan patients”, different situations could give rise to “non available medicines” (NAM) such as: not marketed drugs (NMD), orphan compounding (OC), off-label use (OL) (3). Health professionals from public and private hospitals of Córdoba city and university have participated in several observational field studies, and NAMs were documented for inpatient and outpatient (3,4). The aim of this work was to identify NAM in children and compare them with the international OD concept (only related to Rare Diseases). Materials and methods To identify NAMs, different activities were carried out between 2007-2012 (Table1). Anatomical-Therapeutical-Chemical code (ATC) (5) was applied to relate them to diseases. Then, according information provided by ANMAT (6) and by using non-deterministic-algorithms, the NAMs were categorized as NMD (non-registered, registered but not marketed, non-registered as monodrugs), OC (non-registered in dose, pharmaceutical forms or route) or OL (non-approved indication, eatery group or route). Whenever possible, the patients were quantified. Results After applying pharmacoepidemiological research (Table1) 503 NAMs (234 different medicines and 199 drugs) were identified and categorized (Table2). Major causes were related to OC and OL. ATC classification: N(25%); A(18%); C(15%); J(10%); M(5%); others(27%). Conclusions The framework of the study, the approach proposed and the interdisciplinary work were of great value for the integral understanding of pediatric NAM in Córdoba. Numerous NAMs were identified in a variety of diseases and situations, not only Rare Diseases. It was noticeable the prevalence of OC and OL situations.