Prescribing of medicines in the Danish paediatric population outwith the licensed age group: characteristics of adverse drug reactions.
Br J Clin Pharmacol
; 71(5): 751-7, 2011 May.
Article
em En
| MEDLINE
| ID: mdl-21241353
ABSTRACT
AIM:
To identify adverse drug reactions (ADRs) associated with off-label prescribing of medicines in a paediatric population.METHODS:
We analysed spontaneous ADR reports for children from ages 0 to 17 years submitted to the Danish national ADR database from 1998 to 2007. We defined off-label prescribing as prescriptions outside the licensed age group. Off-label ADRs were categorized by therapeutic group, age of child, type and severity. The unit of analysis was one ADR.RESULTS:
We analysed 4388 ADRs for children reported in the national database. Approximately 17% of reported ADRs were associated with off-label use, 60% of them serious. More than one half of off-label ADRs were reported in adolescents. Serious ADRs due to off-label prescribing are more likely to be reported for hormonal contraceptives (ATC group G), anti-acne preparations (ATC group D) and allergens (ATC group V).CONCLUSION:
One-fifth of all ADRs reported over a decade in Danish children was associated with off-label prescribing, and serious ADRs due to off-label prescribing were primarily present in three therapeutic groups sex hormones, dermatologicals and allergens. There is a need for more research into the prescribing of these medicines in the teenage population, as well as tighter reporting and monitoring of ADRs for medicines prescribed off-label in the paediatric population.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
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Uso Off-Label
Tipo de estudo:
Etiology_studies
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Observational_studies
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Prognostic_studies
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Risk_factors_studies
Limite:
Adolescent
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Adult
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Child
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Child, preschool
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Female
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Humans
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Infant
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Male
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Newborn
País/Região como assunto:
Europa
Idioma:
En
Revista:
Br J Clin Pharmacol
Ano de publicação:
2011
Tipo de documento:
Article
País de afiliação:
Dinamarca