Pattern and extent of off-label and unlicensed drug use in neonatal intensive care units in Iran

Abstract

BackgroundMany 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.MethodsThis 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).ResultsIn 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.ConclusionsThe 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.

Off-label and unlicensed drug use in Ayder comprehensive specialized hospital neonatal intensive care unit

“…Pediatric patients are treated with medicines that are not tested for safety and efficacy or their uses are frequently supported by low quality of evidence for safety and efficacy [1,2]. The situation is worse when the patients are neonates, due to their unique physiology where the pharmacokinetic evidence of medicines in older patients cannot be extrapolated [3]. Therefore, in the absence of standard prescribing information about the medicine, clinicians might be forced to prescribe medicines in unlicensed or off-label manner [2,4].…”

“…Off-label medicine use refers to the use of medicines outside of their marketing authorization (product license) with respect to dose, dosage form, route of administration, indication or age [2,3]. Unlicensed use refers to a medicine that does not have a marketing authorization (not authorized and licensed in a country), does not have suitable formulation in the market or extemporaneously prepared products (i.e.…”

“…Unlicensed use refers to a medicine that does not have a marketing authorization (not authorized and licensed in a country), does not have suitable formulation in the market or extemporaneously prepared products (i.e. modified administration of licensed products) [3,[5][6][7][8]. Off-label and unlicensed medicine use is not necessarily incorrect and has to be considered when there is no other option, but it does cause risks and complications to the patient's condition [3,9].…”

“…Off-label and unlicensed medicine use in the newborn increases the risk of adverse drug reaction (ADR), medication errors and misuse [3,10]. According to a literature review by Cuzollin in 2014, the risk of ADRs due to off-label/unlicensed drug use in pediatric population comprised of neonates is reported to be in the range of 23 to 60%, indicating the association of off-label/ unlicensed drug use with increased risk of ADRs.…”

“…Despite the increased risk of medication error and ADRs, the incidence of off-label/unlicensed medicine is highest among neonates admitted to NICU. For instance many studies reported off-label/unlicensed drug exposure in NICU patients in the range of 38 to 99.5% [3,9,[11][12][13][14] and 1.9% up to 24% [3,11,[14][15][16] respectively.…”