Petra Czarniak
Curtin University, Australia
Title: Cross-sectional study of the off-label and unlicensed medicine use in a paediatric ward in Indonesia
Biography
Biography: Petra Czarniak
Abstract
Introduction & Objective: Data on the off-label and unlicensed medicines use in paediatric patients in the hospital setting in Indonesia is limited. The objectives of the study were to evaluate the prevalence of off-label and unlicensed prescribing at a paediatric medical ward at Abepura Hospital, Indonesia and to identify which drugs were commonly prescribed off-label or unlicensed.
Method: A retrospective cross-sectional study was conducted to collect data on 200 randomly selected patients in 2014, including data on all drugs prescribed. Drugs were categorized as licensed, off-label or unlicensed, according to their approved Indonesian registration Product Information. Unlicensed drugs/formulations were those not registered in Indonesia.
Results: There were 124 (62.0%) males and 76 (38.0%) females. Of the 200 patients (aged 1 month to 13.2 years), 1961 medicines were administered of which 1807 (92.1%) were licensed and 154 (7.9%) were unlicensed. Of the licensed drugs, 1403 (71.5%) were prescribed off-label. Many drugs (1066; 54.4%) were administered parenteral and every patient was prescribed at least one off-label drug. The most common reason for off-label prescribing was indication (810; 34.6%). The most frequent drug prescribed off-label was ranitidine. Darplex® (Dihydroartemisinin and Piperaquine), which was manufactured but not registered in Indonesia, was the most common drug prescribed unlicensed.
Conclusion: This study revealed a high prevalence of off-label and unlicensed drug use in paediatric patients in this hospital, which raises potential issues of unexpected toxicity and adverse drug effects in children by exposing them to drug treatments or regimens that had not been approved by regulatory authorities.