Use of off-label drugs in neonatal intensive care

Alonso, Andrea Sucasas; Ávila-Álvarez, Alejandro; Eiriz, Marina Combarro; Roca, Cristina Martínez; Gómez, Pedro Yáñez; López, A.; Trisac, José Luis Fernández; Díaz, Sonia Pértega

doi:10.1016/j.anpede.2018.12.005

Cited by 10 publications

(25 citation statements)

References 24 publications

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“…Thirty out of the 60 included studies reported the most frequently prescribed pharmacological groups, using different methods in their classification. Most used the WHO-Anatomical Therapeutic Chemical (ATC) classification system (19 of 30 studies) [7,13,[23][24][25]30,32,34,42,43,50,51,59,63,71,73,76]. Four studies listed the pharmacological class of the drugs [10,19,39,47] while Kumar et al (2008) [26] classified the pharmacological groups based on the most frequent indication and the physiological effects of the drug (38).…”

Section: Most Frequently Prescribed Pharmacological Groupsmentioning

confidence: 99%

“…Among the studies that used the WHO-ATC system, anti-infectives for systemic use were the most frequently prescribed pharmacological group in the majority (14 studies) [13,[23][24][25]30,34,42,43,50,51,59,71,73,76]. This was followed by agents for the alimentary tract and metabolism (4 studies) [7,63,65,74] and agents for the central nervous system (1 study) (32). Among the four studies that listed the pharmacological groups according to their pharmacological class, three studies reported that antimicrobials were the most frequently prescribed group [19,39,47] and one study by Ashwin et al (2018) identified that penicillins were the most frequently prescribed [10].…”

Section: Most Frequently Prescribed Pharmacological Groupsmentioning

confidence: 99%

“…Twenty-one studies reported a drug from another therapeutic class as its most frequently used. These were calcium gluconate (2 studies [7,8]), multivitamins (3 studies [44,65,75]), vitamin K (7 studies [14,22,43,45,55,62,76]), caffeine (2 studies [35,71]), chlorhexidine powder (1 study [37]), theophylline (1 study [42]), epinephrine (1 study [78]), parenteral nutrition (1 study [60]), cholecalciferol (1 study [63]) , fentanyl (1 study [32]) and vitamin D (1 study [74]). Of the two studies that reported caffeine as the first most frequently prescribed drug, 86.8% of included infants in Cuzzolin et al (2016) were preterm [71] while Jong et al (2001) did not report the preterm proportion in their cohort [35].…”

Section: Drugsmentioning

confidence: 99%

“…Europe (24 studies) [7,13,20,25,26,29,31,35,37,[42][43][44]50,59,62,63,65,67,68,71,[74][75][76]79] caffeine (18 studies), gentamicin (17 studies), ampicillin (11 studies), furosemide (9 studies), multivitamins (9 studies), vitamin K (11 studies), benzylpenicillin (8 studies), amikacin (6 studies), morphine (5 studies), paracetamol (6 studies)…”

Section: Geographic Region (Number Of Studies) (Ref) Most Frequently mentioning

confidence: 99%

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Review of Drug Utilization Studies in Neonatal Units: A Global Perspective

Al-Turkait

Szatkowski

Choonara

et al. 2020

IJERPH

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Rational prescribing is challenging in neonatology. Drug utilization studies help identify and define the problem. We performed a review of the literature on drug use in neonatal units and describe global variations. We searched databases (EMBASE, CINAHL and Medline) from inception to July 2020, screened studies and extracted relevant data (two reviewers). The search revealed 573 studies of which 84 were included. India (n = 14) and the USA (n = 13) reported the most. Data collection was prospective (n = 56) and retrospective (n = 26), mostly (n = 52) from one center only. Sixty studies described general drug use in 34 to 450,386 infants (median (IQR) 190 (91–767)) over a median (IQR) of 6 (3–18) months. Of the participants, 20–87% were preterm. The mean number of drugs per infant (range 11.1 to 1.7, pooled mean (SD) 4 (2.4)) was high with some reporting very high burden (≥30 drugs per infant in 8 studies). This was not associated with the proportion of preterm infants included. Antibiotics were the most frequently used drug. Drug use patterns were generally uniform with some variation in antibiotic use and more use of phenobarbitone in Asia. This study provides a global perspective on drug utilization in neonates and highlights the need for better quality information to assess rational prescribing.

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Section: Most Frequently Prescribed Pharmacological Groupsmentioning

confidence: 99%

Section: Most Frequently Prescribed Pharmacological Groupsmentioning

confidence: 99%

Section: Drugsmentioning

confidence: 99%

Section: Geographic Region (Number Of Studies) (Ref) Most Frequently mentioning

confidence: 99%

See 2 more Smart Citations

Review of Drug Utilization Studies in Neonatal Units: A Global Perspective

Al-Turkait

Szatkowski

Choonara

et al. 2020

IJERPH

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“…Namun, terdapat penelitian yang menunjukkan bahwa 2,4% peresepan ranitidin ditujukan untuk mengatasi penyakit refluks gastroesofagus (GERD) pada anak-anak dengan usia kurang dari enam bulan dengan menghambat sekresi asam, mengurangi volume dan kandungan asam serta sekresi pepsin (Ferreira, Ibiapina, Machado, & Fagundes, 2012;Piñeiro Pérez et al, 2021;Sucasas Alonso et al, 2019).…”

Section: Hasil Penggunaan Off-label Obat Antagonisunclassified

Review: Penggunaan Off-Label Obat Golongan Antagonis Reseptor Histamin 2

Sari

Febrina

2023

JPS

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Saat ini obat golongan antagonis reseptor histamin 2 (H2) telah banyak digunakan untuk indikasi yang cukup luas termasuk untuk penggunaan sebagai obat off-label. Walaupun berpotensi meningkatkan risiko reaksi obat yang merugikan, pada kondisi tertentu penggunaan obat off-label menjadi satu-satunya pilihan bagi tenaga medis. Review ini bertujuan untuk memberikan gambaran tentang seberapa luas penggunaan off-label obat golongan antagonis reseptor H2 yang meliputi ranitidin, simetidin, famotidin, dan nizatidin. Hasil review ini diharapkan dapat menjadi bahan evaluasi bagi pemerintah, produsen obat, maupun praktisi kesehatan. Metode yang digunakan dalam review ini adalah studi terhadap literatur yang diperoleh melalui beberapa layanan seperti PubMed®, ScienceDirect®, dan Google Scholar. Hasil review ini menunjukkan penggunaan off-label obat golongan antagonis reseptor H2 adalah sebagai upaya kuratif dan preventif untuk mengatasi beberapa penyakit yaitu off-label dalam kategori usia pasien, dosis, dan indikasi.

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Massive presence of off‐label medicines in Danish neonatal departments: A nationwide survey using national hospital purchase data

Gade

Trolle

Mørk

et al. 2022

Pharmacology Res & Perspec

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There is currently insufficient knowledge of gestational age dependent medicine disposition in neonates. Accordingly, the use of off-label medication, i.e., use of medicines outside its approved marketing authorization, is high in the neonatal departments. By using data from the Danish National Pharmaceutical Hospital Purchase Database, we identified the most commonly occurring medications and calculated the on/off-label ratios for premature and term neonates. Data was extracted on ATC level 5 and based on defined daily doses as per WHO. Data covered the 4 high-level NICUs and 10 of 13 of the intermediate/standard level Danish neonatal departments. Of the identified medication, 87% and 70% did not have approved marketing authorization for use in premature and full-term neonates, respectively. Furthermore, one-fifth of the top 100 medicines did not have a (Danish) marketing license. Overall, off-label medication was widespread covering virtually all ATC groups and no ATC group had an off-label level lower than 50% (range 50%-100%). Finally, in 21% of medications, additives from 8 different chemical groups with potential deleterious effects for neonates were identified. In conclusion, off-label medication in the Danish neonatal departments is widespread. The pharmaceutical industry is unlikely to solve this problem, and we may for a very long time be occasionally forced to use off-label medication. Practical solution must therefore come from multidisciplinary clinical and academic collaboration. Use of formulation list as guidance for prescriptions and NICU-friendly galenic formulations may mitigate the problem temporarily while waiting for definitive studies.

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Use of off-label drugs in neonatal intensive care

Cited by 10 publications

References 24 publications

Review of Drug Utilization Studies in Neonatal Units: A Global Perspective

Review of Drug Utilization Studies in Neonatal Units: A Global Perspective

Review: Penggunaan Off-Label Obat Golongan Antagonis Reseptor Histamin 2

Massive presence of off‐label medicines in Danish neonatal departments: A nationwide survey using national hospital purchase data

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