ArticleEuropean journal of clinical pharmacology2010
Drug utilization and off-label drug use among Spanish emergency room paediatric patients.
Article in European journal of clinical pharmacology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.
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Who cites it
20 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Use of off-label and unlicenced drugs in hospitalised paediatric patients: a systematic review.European journal of clinical pharmacology · 2015Pooled it
- Off-Label and Unlicenced Medicine Use among Hospitalised Children in South Africa: Practice and Policy Implications.Pharmacy (Basel, Switzerland) · 2023Article
- Factors and Practices Associated with Self-Medicating Children among Mexican Parents.Pharmaceuticals (Basel, Switzerland) · 2022Article
- No Time for Lullabies Tracing down Pharmacological Effects & Uses of H1-Antihistamines in Children Younger than 6 Years.Global pediatric health · 2021Article
- Two decades of off-label prescribing in children: a literature review.World journal of pediatrics : WJP · 2018Review
- Off-Label Medication use in Children, More Common than We Think: A Systematic Review of the Literature.The Journal of the Oklahoma State Medical Association · 2018Article
- Off-label prescriptions in intensive care unit: the Chinese experience.Therapeutics and clinical risk management · 2018Article
- Off-label use of antimicrobials in neonates in a tertiary children's hospital.European journal of clinical pharmacology · 2017Article
- Antihistamines prescribed off-label among paediatric patients at a tertiary care hospital setting in Malaysia.International journal of clinical pharmacy · 2016Observational
- Off-label and unlicensed utilisation of medicines in a French paediatric hospital.International journal of clinical pharmacy · 2015Article
- Off-label prescribing for allergic diseases in children.The World Allergy Organization journal · 2014Article
- Paediatric drug use with focus on off-label prescriptions in Lombardy and implications for therapeutic approaches.European journal of pediatrics · 2013Article
- Evaluation of unlicensed and off-label antiepileptic drugs prescribed to children: Brazilian Regulatory Agency versus FDA.International journal of clinical pharmacy · 2013Article
- Off-label prescribing patterns of antiemetics in children: a multicenter study in Italy.European journal of pediatrics · 2013Article
- Off-label drug prescribing in a Portuguese paediatric emergency unit.International journal of clinical pharmacy · 2013Article
- Off-label and unlicensed drug use in neonatal intensive care units in Turkey: the old-inn study.International journal of clinical pharmacy · 2012Article
- Recent drug history in children visiting a pediatric emergency room and documentation in medical records.European journal of clinical pharmacology · 2011Article
- Prescribing of medicines in the Danish paediatric population outwith the licensed age group: characteristics of adverse drug reactions.British journal of clinical pharmacology · 2011Article
- Physician-pharmacist agreement about off-label use of medications in private clinical settings in Baghdad, Iraq.Pharmacy practiceArticle
- [Drug prescriptions study in the outpatient setting: assessment of off-label uses in children].Atencion primariaArticle
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo describe the use of medicines and to determine the frequency of off-label use in emergency room paediatric patients. PATIENTS AND
methodsA prospective, observational and descriptive study was carried out in the setting of the paediatric emergency room of a Spanish general hospital. Medicines used by children <14 years prior to their emergency room visit were analysed based on information collected from parents/guardians and relatives for each drug prescription. Off-label use was defined as the utilization of a drug at an indication, dosage, frequency or route of administration that differed from the specifications in the Summary of Product Characteristics or by children outside the authorized age group.
resultsThe patient cohort comprised 462 children, among whom 336 children had been prescribed 667 prescriptions. Of the medicines prescribed, 90% fell into only five 5 Anatomical Therapeutic Chemical Classification System groups. The most frequent active principles were ibuprofen and paracetamol. Of a total of 152 different formulations recorded, no paediatric information was provided for 40 formulations, and one formulation was contraindicated in children. Based on the established criteria, 338 prescriptions were off-label: no paediatric information or contraindication in children were available (82 prescriptions); the drug was used for an indication different from the authorized one (111 prescriptions); drug use was inconsistent with age recommendations (16 prescriptions); drug use was inconsistent with dose/frequency (129 prescriptions). Of the 152 formulations, 107 were occasionally used in an off-label manner.
conclusionsAlthough the mean number of drugs used in children is small, off-label use is frequent. Research efforts should target paediatric studies that allow a rational drug use in children.
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Registered trials
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