Off-label antibiotic use in children in three European countries

Porta, Alessandro; Esposito, Susanna; Menson, Esse; Spyridis, Νikos; Τσολιά, Μαρία; Sharland, Mike; Principi, Nicola

doi:10.1007/s00228-010-0842-1

Cited by 54 publications

(42 citation statements)

References 41 publications

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“…In a Portuguese NICU, although ampicillin and gentamicin were the most frequently prescribed antibiotics, drug doses and/or frequencies used were clearly different from those specified in the Summary of Product Characteristics [8]. This finding is in line with the results of a previous survey involving 3 European neonatal centers in which an unregistered dose use of antibiotics was recorded in 37.8-51.7% of the prescriptions [8,9].…”

Section: Off-label Use Of Antibioticssupporting

confidence: 83%

Antimicrobial dosing in neonates

Kontou

Sarafidis

Roilides

2017

Expert Review of Clinical Pharmacology

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Section: Off-label Use Of Antibioticssupporting

confidence: 83%

Antimicrobial dosing in neonates

Kontou

Sarafidis

Roilides

2017

Expert Review of Clinical Pharmacology

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“…27 A survey on off-label antibiotic use performed in three European countries describes an unregistered dose use in a range of 37.8% to 51.7% of prescriptions in NICU, so our findings are in line with European reality. 26 There were also statistically significant differences in the use of off-label drugs for gestational age and dose, since it was in preterm infants that these drugs were administered in these conditions. To exemplify, intravenous paracetamol SPC refers that 'data on safety and efficacy are not available for preterm newborns', although the oral paracetamol SPC does not mention the absence of this data and displays dosage for infants weighing less than 4000 g, regardless of gestational age.…”

Section: Approved Drugs In Neonatal Periodmentioning

confidence: 98%

“…Ampicillin and gentamicin were the most prescribed antibiotics, once the empirical therapy for newborns should be based on a combination of ampicillin and an aminoglycoside. 26 Their labels contain information concerning to variable doses according to weight and postnatal age, respectively, but do not consider the variations in pharmacokinetics that occurs with the gestational age at birth time. Gentamicin was also used in a single daily dosing, although SPC solely describes divided doses.…”

Section: Approved Drugs In Neonatal Periodmentioning

confidence: 99%

Off-Label and Unlicensed Drug Use in Neonatology: Reality in a Portuguese University Hospital

et al. 2015

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Results:We analyzed 1011 prescriptions of 84 active substances, made in 218 admissions. In 42.9% of the cases, medicines were used according to Summary of Product Characteristics information; 27.9% of drugs were approved for neonatal period but used in an off-label manner; off-label drugs for neonates were used in 10.1%, whereas those with undetermined approval state and contraindicated were used 6.0% and 8.7% of the cases, respectively. Unlicensed prescriptions accounted for 4.4% of total. Preterm received a higher rate of drugs used according to Summary of Product Characteristics (p < 0.0001), whereas full-term received more off-label drugs for dose/frequency (p < 0.0001) and contra-indicated for neonates (p < 0.012). Discussion: Preterm neonates received a higher median number of drugs, since they stayed longer in the unit. The main reason for off-label prescribing was the use of doses/frequencies of administration different from those stated in the Summary of Product Characteristics, suggesting that updating these documents is necessary. Manipulation of medicines is one of the causes for unlicensed drugs use, emphasizing the lack of appropriate formulations for neonatal age. Conclusion:Progresses have been made to reduce the risks of off-label/unlicensed prescriptions, but competent authorities must continue their efforts to develop safer and more effective drugs for neonatal period.

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“…Since URTIs represent a significant cause of antibiotic overuse contributing to the development of antibiotic resistance, interventions aiming to optimize antibiotic use should target pediatric clinical practice (1,2,4,16,20,21). Factors leading to antimicrobial misuse in children are complex, involving both parental and physician beliefs as well as daily practice constraints (3,9,10).…”

mentioning

confidence: 99%

Decrease of Antibiotic Consumption in Children with Upper Respiratory Tract Infections after Implementation of an Intervention Program in Cyprus

Papaevangelou

Rousounides

Hadjipanagis

et al. 2012

Antimicrob Agents Chemother

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To assess the impact of intervention on antibiotic misuse in children, parents' and pediatricians' knowledge, attitudes, and practices (KAP) concerning antibiotic use were evaluated pre-and postintervention in Larnaca (Cyprus) and Limassol (Cyprus). Concurrently, pediatricians documented upper respiratory tract infection (URTI) visits and pharmacists provided antibiotic consumption data. Intervention was implemented for parents and pediatricians residing in Larnaca. The consumption/URTI incidence index was significantly reduced in Larnaca but not in Limassol. Parental responses to a KAP questionnaire remained unchanged; therefore, antibiotic consumption reduction is attributable to pediatricians' education.

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Off-label antibiotic use in children in three European countries

Cited by 54 publications

References 41 publications

Antimicrobial dosing in neonates

Antimicrobial dosing in neonates

Off-Label and Unlicensed Drug Use in Neonatology: Reality in a Portuguese University Hospital

Decrease of Antibiotic Consumption in Children with Upper Respiratory Tract Infections after Implementation of an Intervention Program in Cyprus

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