Pattern and extent of off-label and unlicensed drug use in neonatal intensive care units in Iran
| Autor: | Leila Kouti, Amir Kamal Hardani, Seyyed Mohammad Hassan Aletayeb, Kaveh Eslami, Maryam Aletayeb |
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| Rok vydání: | 2018 |
| Předmět: |
Drug
Male NICU medicine.medical_specialty media_common.quotation_subject Iran Demographic data Off-label use 03 medical and health sciences 0302 clinical medicine 030225 pediatrics Intensive care Intensive Care Units Neonatal medicine Humans Dosing interval 030212 general & internal medicine Drug use Medical prescription Drug Approval media_common Retrospective Studies Unlicensed Off-label business.industry lcsh:RJ1-570 Infant Newborn lcsh:Pediatrics Off-Label Use Newborn Drug Utilization Cross-Sectional Studies Pediatrics Perinatology and Child Health Emergency medicine Female business Research Article |
| Zdroj: | BMC Pediatrics BMC Pediatrics, Vol 19, Iss 1, Pp 1-7 (2019) |
| ISSN: | 1471-2431 |
| Popis: | Background Many newborns may need to be hospitalized and receive drugs during the first days of their lives. These drugs are fundamentally prescribed as off-label and unlicensed. This study aimed to investigate the amount of these kinds of drugs administered in the Neonatal Intensive Care Units (NICUs) of Abuzar and Imam Khomeini Teaching Hospitals in Ahvaz, Iran. Methods This was a 3-month descriptive, cross-sectional study with retrospective nature in which 193 hospitalized newborns were studied. Demographic data were extracted from the patients’ files. The drugs were classified as off-label, unlicensed or licensed according to the Pediatric & Neonatal Dosage Handbook (Lexicomp®, 22nd Edition). Results In total, 1049 prescriptions were registered for the 193 hospitalized newborns (term and preterm). For each newborn, the mean numbers of prescriptions and drugs received were 5.4 and 4.5, respectively. The mean numbers of prescriptions and drugs were greater for preterm newborns. Of the total 1049 prescriptions, 38.1% were off-label and 1.9% were unlicensed. Of the 193 newborns, 85% received at least one off-label or unlicensed prescription. Off-label prescriptions were mostly related to dose (44.8%) and dosing interval (36.5%). Most off-label drugs were antibiotics (mainly Gentamicin). Albuterol was used off-label in 100% of the cases. Conclusions The results of the present study show that the prescription of off-label and unlicensed drugs in NICUs is as high in Iran as in other countries. This suggests that it is necessary to provide information to neonatologists to decrease the prescription of off-label and unlicensed drugs. |
| Databáze: | OpenAIRE |
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