Off label and unlicensed drug use among French office based paediatricians

Chalumeau, Martin; Tréluyer, Jean Marc; Salanave, Benoît; Assathiany, R.; Chéron, Guy; Crocheton, Nicolas; Rougeron, C; Mares, Marie‐Louise; Breart, Gérard; Pons, Guillaume

doi:10.1136/adc.83.6.502

Cited by 154 publications

(130 citation statements)

References 24 publications

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“…7-12 Only 1 study has described the extent of this in Australia. 2 Unlicensed and off-label prescribing practices also have been described in European office-based pediatric practice, 13 primary care, 14 -17 and pediatric intensive care. 18 Five European studies have described such prescribing in neonates.…”

Section: Discussionmentioning

confidence: 99%

Unlicensed and Off-Label Drug Use in an Australian Neonatal Intensive Care Unit

2002

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ABSTRACT. Objectives. To determine the extent of unlicensed and off-label drugs prescribed in the level 3 neonatal intensive care unit (NICU) at the Royal Women's Hospital, Melbourne, Australia.Methods. A prospective cohort study was conducted of all infants who were admitted to the NICU during a 10-week period. Each drug prescribed was evaluated in relation to the licensed approved uses to determine whether the drug was administered in a licensed manner or was unlicensed or used in an off-label manner.Results. There were a total of 101 admissions involving 97 infants. A total of 1442 prescriptions were administered; 42% were licensed, 11% were unlicensed, and 47% were off-label. Twenty-one percent were off-label for 2 or more reasons. Eighty percent of infants received either an unlicensed or an off-label prescription or both; this proportion rose to 93% of extremely low birth weight infants.Conclusions. This is the largest study performed of unlicensed and off-label drug use in the NICU. This practice remains widespread despite clear recommendations to improve this undesirable situation. The attendant risks to infants and prescribers remain. It is time for legislation to be introduced to govern this area.

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Section: Discussionmentioning

confidence: 99%

Unlicensed and Off-Label Drug Use in an Australian Neonatal Intensive Care Unit

2002

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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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“…A prescrição de medicamentos não-licenciados ou de uso não-padronizado em crianças é uma realidade condicionada por fatores tais como ausência de produtos licenciados para pacientes pediátricos, carência de apresentações farmacológicas de uso mais flexível e prevalência elevada de medicamentos comercializados sem informação sobre a dose para crianças [1][2][3][4] . Tais dificuldades tornam o uso de medicamentos em crianças menos seguro e com resultados menos previsíveis e confiáveis do que aquele que ocorre em adultos.…”

Section: Introductionunclassified

Lack of drug preparations for use in children in Brazil

Costa¹,

Rey²,

Coêlho³

2009

J Pediatr (Rio J)

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Objective: To identify drugs which are not suited for pediatric use in Brazil.Methods: A descriptive study involving the development of a national list of unlicensed and off-label medications for pediatric use (problem drugs in pediatrics, PDP) through a literature review, a comparison among sources of the Brazilian pharmaceutical industry, and a survey with pediatricians. Drugs coded at the Anatomic Therapeutic Chemical (ATC) classification system were analyzed regarding licensing status in Brazil and recommendations/indications in pediatrics, based on the following reference sources: the list of licensed drugs of the Brazilian National Health Surveillance Agency (2005), the Brazilian Dictionary of Pharmaceutical Specialties (2005Specialties ( -2007 and the website www.bulas.med.br. Results:Our literature search returned 126 PDP, but 24 drugs were excluded due to absence of national reference. To compose the final list, 24 other drugs referred by pediatricians were added. Of the 126 PDP, 23 drugs were not licensed in the country for use in children; and of the 103 licensed drugs, 24 presented age-related restrictions for pediatric use. The pharmaceutical list included 42 therapeutic groups and 68 subgroups. The groups containing larger numbers of PDP were: antibiotics for systemic use (15), antiepileptics (8), antiasthmatics (7), and analgesics (7). The most frequent problems were: inappropriate dosage (35), unlicensed for pediatric use (28), age-related restrictions (23). Conclusions:The lack of pediatric drug formulations in Brazil shows a profile similar to that observed in other countries, which involves a wide range of clinically important products. This study brings a contribution to the evaluation of the needs and priorities that support the development of suitable medicines for the pediatric patient. (7) e analgésicos (7). Os problemas mais frequentes foram: dosagem inapropriada (43), forma farmacêutica inadequada (35), não-licenciamento para uso pediátrico (28), restrições de faixa etária (23). J Pediatr (Rio J) Conclusões:A carência de medicamentos desenvolvidos para uso em crianças envolve ampla gama de produtos clinicamente importantes. Algumas dessas formulações e dosagens já comercializadas em outros países não são disponibilizadas no mercado brasileiro sem nenhuma justificativa plausível.J Pediatr (Rio J). 2009;85(3):229-235: Uso de medicamentos, pediatria, farmacoepidemiologia, formulações pediátricas, erros de medicação, preparações farmacêuticas, formas de dosagem. Lack of drug preparations for use in children in Brazil IntroduçãoA prescrição de medicamentos não-licenciados ou de uso não-padronizado em crianças é uma realidade condicionada por fatores tais como ausência de produtos licenciados para pacientes pediátricos, carência de apresentações farmacológicas de uso mais flexível e prevalência elevada de medicamentos comercializados sem informação sobre a dose para crianças 1-4 . Tais dificuldades tornam o uso de medicamentos em crianças menos seguro e com resultados menos previsí...

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Off label and unlicensed drug use among French office based paediatricians

Cited by 154 publications

References 24 publications

Unlicensed and Off-Label Drug Use in an Australian Neonatal Intensive Care Unit

Unlicensed and Off-Label Drug Use in an Australian Neonatal Intensive Care Unit

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

Lack of drug preparations for use in children in Brazil

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