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Authors
Abstract(s)
Introdução: Muitos fármacos são prescritos sem respeitar as recomendações aprovadas
durante a avaliação que antecede a entrada do medicamento no mercado (“off-label”).
Vários estudos mostraram que esta é uma prática comum em diferentes unidades de saúde
nos países europeus.
Objectivo: Quantificar e caracterizar a prescrição de fármacos em regime off-label em
crianças admitidas numa Unidade de Urgência Pediátrica (UP) em Portugal.
Métodos: Realizou-se um estudo descritivo no Serviço de Pediatria do Centro Hospitalar Cova
da Beira (CHCB). Numa amostra de 700 crianças (dos 0 aos 18 anos de idade) seleccionadas
aleatoriamente de todas as admitidas na UP entre Janeiro e Outubro de 2010, foi analisada a
prescrição por consulta retrospectiva dos processos clínicos. A prescrição em regime off-label
foi definida pela utilização de um fármaco numa indicação terapêutica, idade, dose,
frequência ou via de administração diferente das recomendadas no Resumo das
Características do Medicamento (RCM).
Resultados: Neste estudo, foram incluídos 364 rapazes e 336 raparigas, com idades
compreendidas entre os 4 dias e os 18 anos. Dos 724 fármacos prescritos, 32,2% eram offlabel.
Pelo menos um fármaco foi utilizado em regime off-label em 28,1% da população
estudada, o que corresponde a 46,1% das 427 crianças que tiveram prescrição. A “modificação
da dosagem” foi a causa mais comum de prescrição off-label (28,2%). Os sistemas de órgãos
que mais frequentemente motivaram a utilização em regime off-label foram o “Aparelho
Respiratório”, “Anti-infecciosos para uso sistémico”, “Sistema Nervoso”, “Sistema Músculo-
Esquelético” e “Aparelho Digestivo e Metabolismo”. A amoxicilina + ácido clavulânico, o
paracetamol, a amoxicilina, o ibuprofeno e o salbutamol foram as 5 substâncias activas mais
prescritas em regime off-label na população estudada.
Conclusão: A utilização de fármacos em regime off-label na UP é frequente, apesar do
pequeno número de fármacos prescritos. A informação do RCM necessita de ser melhorada de
modo a facilitar as decisões no momento de prescrever. O desenvolvimento de medicamentos
de uso pediátrico deve ser incentivado e enquadrado em termos legislativos de modo a serem
garantidas a segurança, qualidade e eficácia da sua utilização.
Background: Many drugs are prescribed outside the terms of the marketing authorization (“off-label”). Several studies have shown that this is a common practice in various healthcare settings in European countries. Aim: To determine the frequency and nature of off-label drug use in children admitted to a Portuguese paediatric emergency room. Methods: A descriptive study was conducted at the paediatric ward of Centro Hospitalar Cova da Beira (CHCB). In a sample of 700 children (aged 0-18 years) randomly selected from those admitted to the paediatric emergency room, between January and October 2010, we analysed the prescription by retrospective review of clinical files. Off-label use was defined as the utilization of a drug at an indication, age, dosage, frequency and route of administration different from those recommended in the Summary of Product Characteristics (SPC). Results: 364 boys and 336 girls, aged from 4 days to 18 years, were included in this study. Of the 724 medicines prescribed, 32,2% were off-label. At least one drug was used off-label in 28,1% of the studied population, corresponding to 46,1% of the 427 children that received prescriptions. “Alteration in dosage” was the commonest reason for off-label use (28,2%). The Anatomical Therapeutic Chemical Classification System (ATC) groups that were most frequently used in an off-label manner were “Respiratory System”, “Anti-infectious agents for systemic use”, “Nervous System”, “Musculoskeletal System” and “Alimentary System and Metabolism”. Amoxicillin/ clavulanic acid, paracetamol, amoxicillin, ibuprofen and salbutamol were the five commonest active principles used off-label. Conclusion: The off-label use of medicines in the paediatric emergency room is frequent, despite the small average number of drugs prescribed. Information on the SPC needs to be improved in order to facilitate prescribing decisions. Enforcement of legislation and continued incentives are needed to encourage the development of paediatric medicines that ensure the safety, quality and efficacy of their use.
Background: Many drugs are prescribed outside the terms of the marketing authorization (“off-label”). Several studies have shown that this is a common practice in various healthcare settings in European countries. Aim: To determine the frequency and nature of off-label drug use in children admitted to a Portuguese paediatric emergency room. Methods: A descriptive study was conducted at the paediatric ward of Centro Hospitalar Cova da Beira (CHCB). In a sample of 700 children (aged 0-18 years) randomly selected from those admitted to the paediatric emergency room, between January and October 2010, we analysed the prescription by retrospective review of clinical files. Off-label use was defined as the utilization of a drug at an indication, age, dosage, frequency and route of administration different from those recommended in the Summary of Product Characteristics (SPC). Results: 364 boys and 336 girls, aged from 4 days to 18 years, were included in this study. Of the 724 medicines prescribed, 32,2% were off-label. At least one drug was used off-label in 28,1% of the studied population, corresponding to 46,1% of the 427 children that received prescriptions. “Alteration in dosage” was the commonest reason for off-label use (28,2%). The Anatomical Therapeutic Chemical Classification System (ATC) groups that were most frequently used in an off-label manner were “Respiratory System”, “Anti-infectious agents for systemic use”, “Nervous System”, “Musculoskeletal System” and “Alimentary System and Metabolism”. Amoxicillin/ clavulanic acid, paracetamol, amoxicillin, ibuprofen and salbutamol were the five commonest active principles used off-label. Conclusion: The off-label use of medicines in the paediatric emergency room is frequent, despite the small average number of drugs prescribed. Information on the SPC needs to be improved in order to facilitate prescribing decisions. Enforcement of legislation and continued incentives are needed to encourage the development of paediatric medicines that ensure the safety, quality and efficacy of their use.
Description
Keywords
Fármacos off-label - Prescrição Fármacos off-label - Prescrição - Crianças - Unidades de urgência pediátrica Medicamentos off-label - Pediatria
Pedagogical Context
Citation
Publisher
Universidade da Beira Interior