Off-label and unlicensed drug treatments in Neonatal Intensive Care Units: an Italian multicentre study

Cuzzolin, Laura; Agostino, Rocco

doi:10.1007/s00228-015-1962-4

Cited by 46 publications

(68 citation statements)

References 36 publications

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“…and Neubert et al . who also found that anti‐infective drugs were the largest ATC class prescribed with a proportion off‐label in relation to neonatal age of 24% and 11%, respectively . For nervous system drugs, these studies found a proportion of 67% and 56% of off‐label prescriptions in relation to neonatal age, which is comparable with our results.…”

Section: Discussionsupporting

confidence: 91%

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

Flint

Beek

Andriessen

et al. 2018

Brit J Clinical Pharma

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AimsEvidence for drug use in newborns is sparse, which may cause large differences in drug prescriptions. We aimed to investigate the differences between neonatal intensive care units (NICUs) in the Netherlands in currently prescribed drugs.MethodsThis multicentre study included neonates admitted during 12 months to four different NICUs. Drugs were classified in accordance with the Anatomical Therapeutic Chemical (ATC) classification system and assessed for on/off‐label status in relation to neonatal age. The treatment protocols for four common indications for drug use were compared: pain, intubation, convulsions and hypotension.ResultsA total of 1491 neonates (GA range 23+6–42+2 weeks) were included with a total of 32 182 patient days, 181 different drugs and 10 895 prescriptions of which 23% was off‐label in relation to neonatal age. Overall, anti‐infective drugs were most frequently used with a total of 3161 prescriptions, of which 4% was off‐label in relation to neonatal age. Nervous system drugs included 2500 prescriptions of which 31% was off‐label in relation to neonatal age. Nervous system drugs, blood and blood forming organs, and cardiovascular drugs showed the largest differences between NICUs with ranges of 919–2278, 554–1465, and 238–952 total prescriptions per 1000 patients per ATC class, respectively.ConclusionsWe showed that drug use varies widely in neonatal clinical practice. The drug classes with the highest proportion of off‐label drugs in relation to neonatal age showed the largest differences between NICUs, i.e. cardiovascular and nervous system drugs. Drug research in neonates should receive high priority to guarantee safe and appropriate medicines and optimal treatment.

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Section: Discussionsupporting

confidence: 91%

“…with 35% in the USA , and Cuzzolin et al . with 34% in Italy . A comforting finding was that the proportion of off‐label prescriptions in relation to neonatal age increased with PMA at start of drug therapy.…”

Section: Discussionmentioning

confidence: 98%

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

Flint

Beek

Andriessen

et al. 2018

Brit J Clinical Pharma

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“…As regards antibiotic choice, our findings are comparable to other Italian NICUs [3, 13], but differ from other Countries [10, 11, 14, 15]. Inter-Country and inter-centre variability in antibiotic choice, dose regimen and intervals in NICUs is commonly reported worldwide [16–18] and a number of factors may explain this difference: (a) the lack of clinical trials performed in this population resulted in deficiency of international guidelines, (b) clinician’s attitude and hospital policy may also play an important role in both the choice of active substances and the pattern of antibiotic use, (c) moreover, the local epidemiology of bacterial infection is an essential factor, as well as previous maternal infections.…”

Section: Discussionsupporting

confidence: 85%

Pattern of drug use among preterm neonates: results from an Italian neonatal intensive care unit

et al. 2017

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BackgroundDrug use in preterm neonates admitted to Neonatal Intensive Care Unit (NICU) has been investigated, so far, in terms of unauthorized or off-label use; very little is known on the use of combinations of different active substances, which is frequently required in this population (prophylaxis of infections, treatment of concomitant diseases). The aim of this study was to describe the most common patterns of drug use in an Italian NICU, focusing on those with nephrotoxic potential.MethodsMedical records of preterm neonates (<37 weeks of gestational age) weighing less than 1,500 g at birth and admitted to an Italian NICU were scrutinized in a 3-year retrospective investigation. Analysis included drug exposure, duration of therapies, co-administration of drugs with potential renal side effects; also daily protein supplement was calculated from parenteral nutrition.ResultsA cohort of 159 preterm neonates was selected; 68 were born weighing less than 1,000 g (extremely low birth weight infants, ELBW, Group A), 91 weighed between 1,000 and 1,500 g at birth (Group B). Compared to Group B, neonates of Group A were more likely to receive pharmacological treatments: the most used drugs were antibiotics (especially ampicillin and amikacin, p = .07 and p < .001, respectively), antifungals (especially fluconazole, p < .001), and diuretics (especially furosemide, p < .001). Analysis of co-administration of drugs with potential nephrotoxicity showed ampicillin and amikacin as the most reported combination (94.1% of Group A and 31.9% of Group B), the combination of furosemide with antibacterials (ampicillin or amikacin) was also frequently reported, with average period of combination shorter than 2 days.ConclusionsELBW infants were exposed to a higher number of drugs compared to other neonates and were more likely to receive associations of drugs with nephrotoxic potential (e.g. furosemide and amikacin), though only for short cycles. Further studies should evaluate the safety profile (especially potential renal side effects) related to most commonly used combinations.

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“…This IRB exempt study took place from October 2017 to December 2017. An English language, cross‐sectional survey was developed by conducting a benchmarking literature review on neonatal DI . The survey contained three sections: demographics, guideline content/DI references, and accessibility and maintenance of guidelines.…”

Section: Methodsmentioning

confidence: 99%

Sources of drug information in neonatal guidelines of low- and middle-income countries†‡

Japs

Dennehy

Stoffella

et al. 2019

International Journal of Pharmacy Practice

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Objective Identify drug information (DI) resources used in neonatal practice guidelines in low‐ and middle‐income countries. Methods Individuals with knowledge of national neonatal guideline development completed a descriptive, cross‐sectional survey. Key findings Eighty‐five per cent (33/39) of respondents fully completed the survey. Physicians from university hospitals in Africa were primary respondents. Forty‐five per cent (15/33) used a single national neonatal guideline. Primary neonatal resources for drug dosing and preparation were as follows: (1) World Health Organization Pocketbook of Hospital Care for Children, (2) Pediatric & Neonatal Dosage Handbook and (3) National Institute for Health and Care Excellence for Infants and Neonatal pathways. Conclusion Low‐ and middle‐income countries with single national neonatal guidelines cite a finite range of DI resources.

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Off-label and unlicensed drug treatments in Neonatal Intensive Care Units: an Italian multicentre study

Abstract: Our results confirm the high prevalence of off-label/unlicensed drug use in the neonatal population and underline a better adherence to indications based on clinical practice, suggesting the need to update information contained in the data sheets of medicines.

Cited by 46 publications

References 36 publications

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

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

Pattern of drug use among preterm neonates: results from an Italian neonatal intensive care unit

Sources of drug information in neonatal guidelines of low- and middle-income countries†‡

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