Off-label drug use in pediatric anesthesia and intensive care according to official and pediatric reference formularies

Doherty, Dermot; Pascuet, Elena; Ni, Andy; Stewart, Paul; Splinter, William M.; Vaillancourt, Régis

doi:10.1007/s12630-010-9395-0

Cited by 25 publications

(20 citation statements)

References 14 publications

(16 reference statements)

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“…The study setting in the majority of cases was a hospital ward (n=11) [19, 21, 23, 25, 29, 30, 33-35, 43, 51] or intensive care unit (n =16) [20, 24, 26-28, 32, 36, 37, 39-41, 45, 46, 48, 50, 52]. The studies were conducted in 18 countries spread across four continents, principally Europe (55.9 %) [19-23, 25, 28-30, 32, 35, 37-39, 41, 43, 44, 48, 49], followed by America (23.5 %) [27,31,34,40,45,47,50,52], Asia (11.8 %) [24,33,36,42,46] and Oceania (5.9 %) [26,51]. The country with most studies was Brazil (14.7 %) [27,34,45,47,50].…”

Section: Characteristics Of Selected Studiesmentioning

confidence: 99%

“…Seven studies omitted to define their exclusion criteria [28,31,32,34,40,43,48] and one study drew none identification of classification criteria [26]. The main drugs excluded from evaluation by the papers were from ATC group (B), blood and blood-forming organs, e.g.…”

Section: Characteristics Of Selected Studiesmentioning

confidence: 99%

“…All studies assessed the extent of off-label prescriptions and two papers reported off-label and unlicensed data as combined [37,46]; the extent of unlicensed prescribing was not assessed by seven studies [31,33,36,38,40,51,52] ( Table 2). The off-label prescription data revealed a high degree of use, rising as high as 70.6 % in one study [35], with a median of 39.0 %, and the use of unlicensed prescriptions rose to 47.9 % [22], with median of 13.0 %.…”

Section: Off-label and Unlicensed Prescriptionsmentioning

confidence: 99%

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Use of off-label and unlicenced drugs in hospitalised paediatric patients: a systematic review

Magalhães

Rodrigues

Roque

et al. 2014

Eur J Clin Pharmacol

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These findings show that: (i) off-label and/or an unlicensed prescribing is widespread among the hospitalised paediatric population worldwide, (ii) there is no consensus on a definition of off-label and/or unlicensed drugs and (iii) preterm newborns receive most off-label and/or unlicensed drugs. By shedding new light on off-label and/or unlicensed drug prescribing, these findings will hopefully contribute to generating new, more effective knowledge about the paediatric population's need for quality drugs that are both safe and efficacious.

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Section: Characteristics Of Selected Studiesmentioning

confidence: 99%

Section: Characteristics Of Selected Studiesmentioning

confidence: 99%

Section: Off-label and Unlicensed Prescriptionsmentioning

confidence: 99%

See 1 more Smart Citation

Use of off-label and unlicenced drugs in hospitalised paediatric patients: a systematic review

Magalhães

Rodrigues

Roque

et al. 2014

Eur J Clin Pharmacol

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“…A dopamina foi igualmente classificada como medicação OL, pois faltam dados sobre a sua segurança a longo prazo nos recém-nascidos expostos, o que está de acordo com outros estudos publicados 16,23 . Trata-se de um dado muito importante, tendo em vista seu uso amplamente difundido em protocolos de manejo de choque no recém-nascido -e a ausência de outros agentes igualmente eficazes e com perfil de segurança aceitável.…”

Section: Classe De Medicamentos Prevalência % -N Medicamentos Mais Frunclassified

Use of off-label and unlicensed drugs in the neonatal intensive care unit and its association with severity scores

Carvalho

Ribeiro²,

Bonilha³

et al. 2012

J Pediatr (Rio J)

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Objective: To analyze the frequency of unlicensed (UL) and offlabel (OL) prescriptions in neonates admitted to the neonatal intensive care unit of a tertiary care hospital and to determine their association with patients' severity. Methods:Observational cohort study including drugs prescribed during hospitalization of neonates over a 6-week period between July and August 2011. The drugs were classified as UL and OL for dose, frequency, presentation, age group, or indication, according to an electronic list of drugs approved by the Food and Drug Administration. Patients were followed until hospital discharge or 31 days of hospitalization, with daily records of the Neonatal Therapeutic Intervention Scoring System (NTISS). Results:We identified 318 prescription items for 61 patients (average of five items/patient); there were only 13 patients with appropriate use of medications (21%). A prevalence of 7.5% was identified for UL prescriptions and 27.7% for OL, and the most prevalent OL use was that related to age group -19.5%. Fifty-seven medications were computedone patient received 10 UL/OL drugs during hospitalization. The prevalence of OL uses was higher in preterm infants < 35 weeks and in those with higher severity scores (p = 0.00). Conclusions:The prevalence of neonates exposed to UL/OL drugs during hospitalization was high, especially for those with higher NTISS scores. Although there is general appreciation that neonates, especially preterm infants, have a high rate of drug use, an assessment including different cultures and countries is still needed to prioritize areas for future research in the pharmacotherapy of this vulnerable population.J Pediatr (Rio J). 2012;88(6):465-70: Drugs, drug labeling, injury severity score, neonatology. ResumoObjetivo: Avaliar a frequência da prescrição de medicamentos de uso não licenciado (UL) e off-label (OL) em recém-nascidos internados em unidade de tratamento intensivo neonatal de hospital de nível terciário e verificar a associação do seu uso com a gravidade dos pacientes.Métodos: Estudo observacional de coorte dos medicamentos prescritos no período de 6 semanas da internação de neonatos, entre julho e agosto de 2011. Os medicamentos foram classificados em UL e OL para dose, frequência, apresentação, faixa etária e indicação, de acordo com bulário eletrônico aprovado pela Food and Drug Administration. Os pacientes foram acompanhados até alta hospitalar ou 31 dias de internação, com registro diário do Neonatal Therapeutic Intervention Scoring System. Resultados:Foram identificados 318 itens de prescrição para 61 pacientes (média de cinco itens/paciente) e apenas 13 pacientes com uso de medicamentos adequados (21%). Identificaram-se prevalên-cias de 7,5% para prescrições UL e de 27,7% para OL. O uso OL mais prevalente foi para medicamentos não padronizados para faixa etária -19,5%. Computaram-se 57 medicações -um paciente recebeu 10 fármacos UL/OL na internação. A prevalência de usos OL foi maior em prematuros < 35 semanas e nos com escores de gravidade mais ele...

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“…Estimates of off-label use in the pediatric population still range from 10 to 65 % [26]. In the PICU, up to 70 % of drugs are unlicensed or off-label [27,28], which reflects the lack of knowledge on drug efficacy and safety in the PICU population [29].…”

Section: The Need For Drug Research In Childrenmentioning

confidence: 99%

Ethics of Drug Research in the Pediatric Intensive Care Unit

et al. 2014

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Critical illness and treatment modalities change pharmacokinetics and pharmacodynamics of medications used in critically ill children, in addition to age-related changes in drug disposition and effect. Hence, to ensure effective and safe drug therapy, research in this population is urgently needed. However, conducting research in the vulnerable population of the pediatric intensive care unit (PICU) presents with ethical challenges. This article addresses the main ethical issues specific to drug research in these critically ill children and proposes several solutions. The extraordinary environment of the PICU raises specific challenges to the design and conduct of research. The need for proxy consent of parents (or legal guardians) and the stress-inducing physical environment may threaten informed consent. The informed consent process is challenging because emergency research reduces or even eliminates the time to seek consent. Moreover, parental anxiety may impede adequate understanding and generate misconceptions. Alternative forms of consent have been developed taking into account the unpredictable reality of the acute critical care environment. As with any research in children, the burden and risk should be minimized. Recent developments in sample collection and analysis as well as pharmacokinetic analysis should be considered in the design of studies. Despite the difficulties inherent to drug research in critically ill children, methods are available to conduct ethically sound research resulting in relevant and generalizable data. This should motivate the PICU community to commit to drug research to ultimately provide the right drug at the right dose for every individual child.

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Off-label drug use in pediatric anesthesia and intensive care according to official and pediatric reference formularies

Cited by 25 publications

References 14 publications

Use of off-label and unlicenced drugs in hospitalised paediatric patients: a systematic review

Use of off-label and unlicenced drugs in hospitalised paediatric patients: a systematic review

Use of off-label and unlicensed drugs in the neonatal intensive care unit and its association with severity scores

Ethics of Drug Research in the Pediatric Intensive Care Unit

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