Large differences in neonatal drug use between NICUs are common practice: time for consensus?

Flint, Robert B.; Beek, Floor van; Andriessen, Peter; Zimmermann, Luc J. I.; Liem, Kian D.; Reiss, Irwin K M; Groot, Ronald de; Tibboel, Dick; Burger, David M.; Simons, Sinno

doi:10.1111/bcp.13563

Cited by 35 publications

(40 citation statements)

References 29 publications

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“…This was similar finding with that of study reports from Iran and Italy [3,24]. However, it was different from a study conducted in Netherlands which reported that blood products were the top class of medicines used in an off-label manner [20]. The difference might be related with difference in disease status.…”

Section: Discussionsupporting

confidence: 81%

“…Accordingly, the overall off-label medicine use in ACSH NICU was found to be 67.58%. This was higher compared to several study findings elsewhere in the globe which reported off-label medicine use in the range of 23 to 62% [3,4,9,11,13,14,[20][21][22][23]. However, it was slightly lower compared to a study from India which reported an off-label prescription of 70% [2].…”

Section: Discussioncontrasting

confidence: 75%

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

et al. 2020

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Background: Off-label drug use refers to the use of medicines outside of their marketing authorization with respect to dose, dosage form, route of administration, indication or age. Off-label/unlicensed drug use significantly associated with adverse drug reactions and medication errors in neonates and critically ill neonates are more vulnerable to these problems. Objective: To assess the prevalence and associated factors with off-label and unlicensed drug use in neonatal intensive care unit of Ayder Comprehensive Specialized Hospital. Methods: A cross-sectional study was conducted from March 01,2019 to April 30, 2019 in neonatal intensive care unit of Ayder Comprehensive Specialized Hospital. Neonates admitted for 24 h and took at least one medicine were included in the study. Data was collected from prescription and medical charts. The off-label and license status of the medicine was verified based on European medicine Agency electronic medicine compendium. Data was analyzed by SPSS version 21.0. Binary and multivariate logistic regression was done to assess the predictors of offlabel/unlicensed medicine use at p-value ≤0.05 significance level. Result: A total of 364 medicines prescribed for 122 neonates were analyzed. The prevalence of off-label and unlicensed drug use was 246 (67.58%), and 86 (23.63%) respectively. Of the total 122 neonates, 114(93.44%), and 57(46.72%) of them were exposed to at least one off-label and unlicensed drug respectively. Antibiotics were the most commonly prescribed off-label and unlicensed drugs. No statistically significant association was found between demographic as well as health related variables with off-label/unlicensed medicine use at p-value of ≤0.05 significance level. Conclusion: Off-label and unlicensed medicine use was high among neonates admitted to intensive care unit of the hospital. Selecting the safest medicines for such vulnerable patients is crucial to promote rational prescribing and better therapeutic benefit.

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Section: Discussionsupporting

confidence: 81%

Section: Discussioncontrasting

confidence: 75%

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

et al. 2020

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“…Propofol is considered one of the acceptable options, despite being off-label for use in newborns, gaps in knowledge regarding optimal dosing and concerns about safety 12. Because of its rapid onset and recovery, and its ease of use, propofol as a sedative for endotracheal intubation has been implemented into clinical practice in several neonatal intensive care units (NICUs) 13–17. Previous trials studying propofol have shown conflicting results on sedative effect and concerning effects on blood pressure 16–19…”

Section: Introductionmentioning

confidence: 99%

Propofol for endotracheal intubation in neonates: a dose-finding trial

Kort

Prins

Reiss

et al. 2020

Arch Dis Child Fetal Neonatal Ed

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ObjectiveTo find propofol doses providing effective sedation without side effects in neonates of different gestational ages (GA) and postnatal ages (PNA).Design and settingProspective multicentere dose-finding study in 3 neonatal intensive care units.PatientsNeonates with a PNA <28 days requiring non-emergency endotracheal intubation.InterventionsNeonates were stratified into 8 groups based on GA and PNA. The first 5 neonates in every group received a dose of 1.0 mg/kg propofol. Based on sedative effect and side effects, the dose was increased or decreased in the next 5 patients until the optimal dose was found.Main outcome measuresThe primary outcome was the optimal single propofol starting dose that provides effective sedation without side effects in each age group.ResultsAfter inclusion of 91 patients, the study was prematurely terminated because the primary outcome was only reached in 13% of patients. Dose-finding was completed in 2 groups, but no optimal propofol dose was found. Effective sedation without side effects was achieved more often after a starting dose of 2.0 mg/kg (28%) than after 1.0 mg/kg (3%) and 1.5 mg/kg (9%). Propofol-induced hypotension occurred in 59% of patients. Logistic regression analyses showed that GA and PNA did not predict effective sedation or the occurrence of hypotension.ConclusionsEffective sedation without side effects is difficult to achieve with propofol and the optimal dose in different age groups of neonates could not be determined. The sedative effect of propofol and the occurrence of hypotension are unpredictable and show large inter-individual variability in the neonatal population.

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“…The most comprehensive studies conducted in the United States based on national datasets showed that antibioticsampicillin and gentamicin were the most commonly used medicines [5,6]. European studies have covered single countries, single centers or only selected therapeutic groups like antibiotics [7,8]. Due to methodological variabilities between-country comparisons are complicated.…”

Section: Introductionmentioning

confidence: 99%

Drug prescription pattern in European neonatal units

Mesek

Nellis

Lass

et al. 2018

Preprint

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BackgroundHospitalized neonates receive the highest number of drugs compared to all other age groups, but consumption rates vary between studies depending on patient characteristics and local practices. There are no large scale international studies on drug use in neonatal units. We aimed to describe drug use in European neonatal units and characterize its associations with geographic region and gestational age (GA). MethodsA one-day point prevalence study (PPS) was performed as part of the European Study of Neonatal Exposure to Excipients (ESNEE) from January to June 2012. All neonatal prescriptions and demographic data were registered in a web-based database. The impact of GA and region on prescription rate were analyzed with logistic regression. ResultsIn total, 21 European countries with 89 neonatal units participated. Altogether 2173 prescriptions given to 726 neonates were registered. The 10 drugs with the highest prescription rate were multivitamins, vitamin D, caffeine, gentamicin, amino acids for parenteral nutrition, phytomenadione, ampicillin, benzylpenicillin, fat emulsion for parenteral nutrition and probiotics. The six most commonly prescribed ATC groups (alimentary tract and metabolism, blood and blood-forming organs, systemic anti-infectives, nervous, respiratory and cardiovascular system) covered 98% of prescriptions. GA significantly affected the use of all commonly used drug groups. Geographic region influenced the use of alimentary tract and metabolism, blood and blood-forming organs, systemic anti-infectives, nervous and respiratory system drugs. ConclusionsWhile GA-dependent differences in neonatal drug use were expected, regional variations (except for systemic anti-infectives) indicate a need for cooperation in developing harmonized evidence-based guidelines and suggest priorities for collaborative work.

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Large differences in neonatal drug use between NICUs are common practice: time for consensus?

Cited by 35 publications

References 29 publications

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

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

Propofol for endotracheal intubation in neonates: a dose-finding trial

Drug prescription pattern in European neonatal units

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