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

Gidey, Meles Tekie; Gebretsadkan, Yohannes Gebrehaweria; Tsadik, Afewerki Gebremeskel; Welie, Abraham Gebrezgabiher; Assefa, Brhane Teklebrhan

doi:10.1186/s13052-020-0809-5

Cited by 16 publications

(8 citation statements)

References 22 publications

(62 reference statements)

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“…Two studies collected both retrospective and prospective data [ 5 , 6 ]. Studies were largely based in a single center (52/84) [ 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 ]. Thirty-two studies were based in more than one neonatal unit, ranging from 2 centers (7 studies)...…”

Section: Resultsmentioning

confidence: 99%

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: Resultsmentioning

confidence: 99%

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

Al-Turkait

Szatkowski

Choonara

et al. 2020

IJERPH

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“…Yet little is known about the drugs' potential side effects and adverse events especially in preterm and very preterm neonates. Offlabel drug use is widely reported, although little to no information is available regarding efficacy and safety [40][41][42][43]. Adequate drug use in neonatal care is mostly derived from the available evidence and the medical experience, with wide variations in local policies and newborn characteristics and does not necessarily imply inappropriate drug use.…”

Section: Discussionmentioning

confidence: 99%

Furosemide use in Italian neonatal intensive care units: a national survey

Manfredini¹,

Cerini

Clavenna

et al. 2020

Ital J Pediatr

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Background: Furosemide is approved in full term neonates to treat edema associated with congestive heart failure, cirrhosis and renal diseases. It is often administered off-label in premature neonates, to treat respiratory conditions and at doses greater-than-recommended. We conducted a national survey on behalf of the Neonatal Pharmacotherapy Study Group of the Italian Society of Neonatology (SIN), to investigate its use in Italian neonatal intensive care units (NICUs), in conformity with current guidelines. Methods: Between December 2016 and June 2017, a 14-item multiple-choice online questionnaire was sent to all NICU directors from the SIN directory. Gestational age, route of administration, posology, indications, referenced guidelines, adverse effects monitoring and the presence of Paediatric Cardiology or Cardiosurgery service on site were assessed. A chi-square test was performed 1) to evaluate differences in the distribution of responses between NICUs administering furosemide at doses higher-than-recommended; 2) to compare the proportion of NICUs administering furosemide at high doses in institutions with versus without a Paediatric Cardiology or Cardiosurgery service. Results: The response rate was 50% (57/114). The intravenous and oral routes were chosen primarily; the intravenous administration in single doses predominated over continuous infusion. Its main therapeutic indications were congestive heart failure/overload (94.7%) and oligo-anuria (87.7%) however furosemide was also frequently used for broncopulmonary dysplasia (50.9%) and respiratory distress syndrome and/or transient tachypnea of the newborn (24.6%). In 28/57 NICUs furosemide was administered at doses higher-than-recommended. In most NICUs the same posology was used in term and preterm neonates. Compared to the total sample, a larger proportion of NICUs administering doses greater-than-recommended referenced current literature for reasons to do so (19.3 and 32.1% respectively). The presence of a Paediatric Cardiology or Cardiosurgery service on site did not correlate with the chosen posology. The majority of NICUs performed acoustic test and renal ultrasound for furosemide exposure greater than 2 weeks.

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“…Visto que o paracetamol intravenoso ainda não apresenta dados de segurança e eficácia para recém-nascidos (SILVA et al, 2015). Este medicamento juntamente com o fenobarbital, são os off-label mais utilizados e que estão relacionados à falta de informação sobre o uso em neonatos e as formas farmacêuticas adequadas para a sua utilização (GIDEY et al, 2020).…”

Section: Resultsunclassified