Unlicensed and off label drug use in paediatric wards: prospective study

Turner, Sean; Longworth, Alexandra; Nunn, Anthony J; Choonara, Imti

doi:10.1136/bmj.316.7128.343

Cited by 294 publications

(204 citation statements)

References 7 publications

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“…Em alguns países, existem relatos de alta prevalência de utilização de medicamentos não aprovados ou off-label (OL), tanto em consultórios, unidades de internação e unidades cirúrgicas quanto em unidade de tratamento intensivo pediátrica e neonatal (UTIN), na maioria das vezes devido ao desconhecimento dos prescritores quanto a essas peculiaridades [4][5][6][7][8] . As prescrições OL definem medicamentos prescritos de forma diferente daquela orientada na bula em relação ao grupo etário, à dose, à frequência do uso, à apresentação, à via de administração ou à indicação para uso em crianças.…”

Section: Use Of Off-label and Unlicensed Drugsunclassified

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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Section: Use Of Off-label and Unlicensed Drugsunclassified

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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“…[9][10][11] The objective of the present report is to describe our prospective experience in children with chronic kidney diseases who were administered amlodipine for 16 weeks as part of their pharmacological treatment of arterial hypertension. The report includes 16 patients enrolled in a trial published in part earlier.…”

Section: Journal Of Human Hypertension (2001) 15 387-391mentioning

confidence: 99%

Antihypertensive efficacy of amlodipine in children with chronic kidney diseases

et al. 2001

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In adults the calcium antagonist amlodipine given once a day has proved to be an attractive addition to the antihypertensive armamentarium. The present report describes our experience in 43 paediatric outpatients (26 boys and 17 girls, aged between 1.1 and 19, median 9.8 years) with chronic kidney diseases. The patients were given amlodipine for 16 weeks as part of their antihypertensive treatment. Before amlodipine arterial pressure was 150 (142-163)/90 (84 -95) mm Hg (median and interquartile range). Six patients withdrew from amlodipine because of oedema, flushing or headache. In the remaining patients amlodipine 7.7 (6.9-9.4) mg/m 2 body surface area once a day significantly decreased arterial pressure by 17 (13-22)/10 (7-13) mm Hg. The

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“…O conceito de medicamentos não apropriados para crianças envolve uma variedade de condições, gerando inclusive superposição das nomenclaturas relatadas [2][3][4][5][6][7][8] . Algumas das referências consultadas permitem concluir que o termo não aprovado (not approved) considera medicamentos não aprovados para uso como um todo, não aprovados para uso em crianças, contra-indicados para uso em crianças, manufaturados no hospital, modificados no hospital, ou sem dosagem específica para crianças [2][3][4]8 .…”

Section: Introductionunclassified

Prescription of drugs not appropriate for children in a Pediatric Intensive Care Unit

Carvalho¹,

Carvalho²,

Alievi³

et al. 2003

J Pediatr (Rio J)

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Objective: To assess the extent of use of drugs not appropriate for children in prescriptions issued in a tertiary pediatric intensive care unit (PICU), according to FDA standards. Methods:Observational cross-sectional study. The prescriptions issued to all patients admitted to the PICU at Hospital de Clínicas de Porto Alegre, Brazil, over a six-week period were assessed. Patients' age, sex, weight, prior disease, reason for admission to the PICU and pediatric index of mortality (PIM) were recorded, as were all drugs prescribed, their indications, presentations, doses, frequencies and means of administration. Adequacy for prescription of drugs in three pediatric age ranges was defined according to USA Food and Drug Administration (FDA) approval classification, based on the USP DI 2001 drug reference database.Results: Data were obtained in the months of July and August 2002, on different days, for six consecutive weeks, based on prescriptions issued to 51 patients in 54 admissions to the PICU. Median patient age was 10.5 months; 61% of patients were male. Two thirds of patients (65%) presented prior disease. 87% of admissions were due to clinical reasons, of which 57% were respiratory complaints. A total of 747 prescription items were registered, with prevalence of 10.5% for nonapproved uses and 49.5% for off-label uses. No statistically significant difference was found in the distribution of prevalence of irregular prescription either by the three age ranges or by level of severity of disease at admission (according to PIM risk categories). Conclusion:The high prevalence of prescription of drugs not appropriate for children confirms, in the Brazilian context, the inadequate and inadvertent use of drugs either not approved or offlabel for PICU use. This demonstrates the need to encourage further studies on the quality, efficacy and safety of drugs for pediatric use. ResumoObjetivo: Avaliar a extensão do uso de medicamentos não apropriados para crianças em prescrições de uma unidade de tratamento intensivo pediátrica (UTIP) terciária, de acordo com os padrões estabelecidos pela FDA.Métodos: Estudo transversal, observacional, baseado na avaliação das prescrições de todos os pacientes admitidos na UTIP do Hospital de Clínicas de Porto Alegre, no período de seis semanas consecutivas. Foram considerados idade, sexo, peso, doença prévia, motivo de admissão na UTIP, e PIM (pediatric index of mortality) dos pacientes, e todos os medicamentos prescritos e suas indicações, com as respectivas apresentações, doses, freqüências e vias de administração. O critério de adequação na prescrição dos medicamentos seguiu a classificação de aprovação da FDA, baseada no catálogo de informações de medicamentos USP DI 2001, em três faixas etárias pediátricas.Resultados: Os dados foram obtidos nos meses de julho e agosto de 2002, em diferentes dias, de seis semanas consecutivas, baseados nas prescrições de 51 pacientes em 54 admissões de UTIP. A mediana de idade dos pacientes foi 10,5 meses, sendo 61% do sexo masculino. Dois terç...

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Unlicensed and off label drug use in paediatric wards: prospective study

Cited by 294 publications

References 7 publications

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

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

Antihypertensive efficacy of amlodipine in children with chronic kidney diseases

Prescription of drugs not appropriate for children in a Pediatric Intensive Care Unit

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