ArticleInternational journal of clinical pharmacy2013
Off-label drug prescribing in a Portuguese paediatric emergency unit.
Article in International journal of clinical pharmacy, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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Who cites it
13 citing papers in PubMed.
- Off‑label and unapproved pediatric drug utilization: A meta‑analysis.Experimental and therapeutic medicine · 2024Article
- Off-Label Prescribing in Pediatric Population-Literature Review for 2012-2022.Pharmaceutics · 2023Review
- Off-Label and Unlicenced Medicine Use among Hospitalised Children in South Africa: Practice and Policy Implications.Pharmacy (Basel, Switzerland) · 2023Article
- 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
- Safety and Efficacy of Off-label and Unlicensed Medicines in Children.Journal of Korean medical science · 2018Article
- Off-label use of antimicrobials in neonates in a tertiary children's hospital.European journal of clinical pharmacology · 2017Article
- Use of off-label nephrology-related drugs in hospitalized pediatric patients: a retrospective study.World journal of pediatrics : WJP · 2016Article
- Off-label and unlicensed utilisation of medicines in a French paediatric hospital.International journal of clinical pharmacy · 2015Article
- Clinical setting influences off-label and unlicensed prescribing in a paediatric teaching hospital.PloS one · 2015Article
- Off-label prescribing for allergic diseases in children.The World Allergy Organization journal · 2014Article
- Incidence of unlicensed and off-label prescription in children.Italian journal of pediatrics · 2014Article
- Tailored Assays for Pharmacokinetic and Pharmacodynamic Investigations of Aliskiren and Enalapril in Children: An Application in Serum, Urine, and Saliva.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAGArticle
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Authors and funding
3 authors.
Funding
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Abstract
backgroundMany drugs are prescribed outside the terms of the marketing authorization ("off-label"). Several studies have shown that this is a common practice in various European healthcare settings.
objectiveThis study aimed to quantify and characterize off-label drug prescribing in children admitted to a Portuguese Paediatric Unit (PEU).
settingThis study was conducted in the Paediatric Unit of the university teaching hospital of Cova da Beira Hospital Centre (CHCB), Covilhã, located in the Eastern Central Region of Portugal.
methodA descriptive study was conducted, including a sample of 700 children, randomly selected from those admitted between January to October 2010. Drug prescription was assessed by retrospective review of clinical files.
main outcome measureOff-label prescribing was defined as the utilization of a drug at an indication, age, dosage, frequency or route of administration different from those recommended in the Summary of Product Characteristics (SPC). For purposes of this study only the medicines prescribed to be used after discharge from the hospital were studied.
results364 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 prescribing (28.2 %). The off-label prescriptions comprised mainly drugs acting on the "Respiratory System" and "Anti-infectious agents for systemic use". Amoxicillin/clavulanic acid, paracetamol, amoxicillin, ibuprofen and salbutamol were the five active principles most frequently prescribed off-label.
conclusionThe prevalence of off-label drug prescribing in the Portuguese PEU of CHCB is high, the use in a dose or for an age group not approved in the SPC being the most common reasons for off-label prescription.
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