Akademik Veri Yönetim Sistemi
29th European Congress of Clinical Microbiology & Infectious Diseases (ECCMID), Amsterdam, Hollanda, 13 - 16 Nisan 2019, ss.2036
Background: Off-label drug useis comparably often in pediatrics and should be managed attentively in critical
indications. Infectious diseases posea globally important disease burden in pediatric population.This study aimed
to examine off-label drug useapplications by pediatric infectious diseases specialists in Turkey.
Materials/methods:This retrospectivestudy analyzed medical records of off-label drug useapplications that
were madeto theelectronic registry system of Turkish Medicines and Medical Devices Agency by pediatric
infectious diseases specialists for children (<18 years old) in Turkey between 1
st of January and 31
st of December
in 2015.Some demographic characteristics of patients and applying physicians wereexamined with most
commonly drugs and diagnoses.
Results: Pediatric infectious diseases specialists werefound to apply for 127 off-label drug requests, 85.0% of
which wereapproved. Among all applications, 60.6% belonged to boys,and the mean age of patients was 6.3±5.5
years. Around one-third (33.9%) of applications were made by professors,and 89.0% from university hospitals.
The most frequent drugs to be used off-label at ATC-1 category showed “J-antiinfectives for systemic use”
(64.6%), “P-antiparasitic drugs, insecticides,and repellents” (21.3%),and “B- blood and blood forming organs”
(5.5%). At ATC-5 level,valganciclovir (29.9%), pyrimethamine(14.2%),and posaconazole(8.7%) were determined
to bethe most commonly applied drugs.The most common three diagnoses regarding pediatric off-label drug
applications were detected as “B25- cytomegaloviral disease” (26.0%), “P37.1- congenital toxoplasmosis (11.8%),
and”Z20.6- contact with and exposureto HIV" (8.7%).
Conclusions: Pediatric off-label drug useapplications by pediatric infectious diseases specialists seem to be made
most commonly for systemicantiviral agents in cytomegaloviral diseases. Considering probableassociation of this
indication to immunocompromised conditions, further investigation of thekey outputs in terms of pediatric offlabel drug usecould givecritical insights to therelevant stakeholders.