Off -Label Prescribing in Pediatric Inpatients with Pneumonia in a Children’s Hospital
Abstract: Off -label is a term
used in which a drug prescribed outside the offi cial information of the marketing
authorization. Off -label prescribing may occur as the result of several
factors including lackof clinical trials data involving pediatrics and suitable
formulations for medicines commonly prescribed to this fragile population. This
study aimed to estimate the nature and prevalence of off -label prescribing in
pediatric inpatients with pneumonia. A retrospective study was conducted in a
study hospital using medical records from pediatric inpatients with pneumonia
during the period of January-December 2015.Patient and prescribing data were
collected, and drugs were classifi ed as on-label or off -label based on the
Indonesia National Drug Information (IONI) and British National Formulary for
Children (BNFC).Thereafter, off -label drugs were categorized with a
hierarchical system of age, indication, route ofadministration and dosage.
There were 1141 drugs with 77 diff erent types of drug were administered to 207
patient during the study period. The data uncovered that 405 (35.5%) of the
drug prescriptions were used off -label based on IONI, and 319 (28%) of the
drug were used off -label based on BNFC. Based on IONI and BNFC, most off
-label drugs were from anti infection drugs. The prevalence of off –label use
in pediatric inpatients with pneumonia is not high. The off -label prescribing
may not be necessarily be considered irrational, yet this fact reveals that the
use of drugs does not comply with the drug label. Clinical trials for pediatric
drugs are essential to provide complete product information for pediatric use.
Keywords: Off -label drugs,
pneumonia, pediatric, inpatients
Penulis: Hesty Utami
Ramadaniati, Heni Safarini, Aishah A Regine
Kode Jurnal jpfarmasidd180043
