Evidence map›Paper›PMID 30609923›Full record

ArticleBMC pediatrics2019

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

Leila Kouti, Maryam Aletayeb, Seyyed Mohammad Hassan Aletayeb, Amir Kamal Hardani, Kaveh Eslami

Abstract read
In one paragraph

Article in BMC pediatrics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

  1. Article
  2. Article
  3. Off-label use of medicines in South Africa: a review.Orphanet journal of rare diseases · 2024
    Review
  4. Article
  5. Article
  6. Article
  7. Prescription of off-label and unlicensed medication for newborns hospitalized in the Intensive Care Unit.Revista paulista de pediatria : orgao oficial da Sociedade de Pediatria de Sao Paulo · 2023
    Observational
  8. Inhaled Pharmacotherapy for Neonates: A Narrative Review.Turkish archives of pediatrics · 2022
    Article
  9. Review
  10. Review of Drug Utilization Studies in Neonatal Units: A Global Perspective.International journal of environmental research and public health · 2020
    Review
  11. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Leila KoutiDepartment of Clinical Pharmacy, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
Maryam AletayebStudent Research Committee, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
Seyyed Mohammad Hassan AletayebDepartment of Pediatrics, Faculty of Medicine, Imam Khomeini Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. mohamadhasanaletayeb@yahoo.com.
Amir Kamal HardaniDepartment of Pediatrics, Faculty of Medicine, Abuzar Children's Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
Kaveh EslamiDepartment of Clinical Pharmacy, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Cross-Sectional StudiesDrug ApprovalDrug UtilizationFemaleHumansInfant, NewbornIntensive Care Units, NeonatalIranMaleOff-Label UseRetrospective StudiesDrug useNewbornNICUOff-labelUnlicensed

Identifiers

PMID30609923
PMCPMC6320573

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.