ArticleAtencion primaria
[Drug prescriptions study in the outpatient setting: assessment of off-label uses in children].
Article in Atencion primaria. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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Who cites it
3 citing papers in PubMed, 15 citations in OpenAlex.
- Adverse drug reactions in paediatric surgery: prospective study on frequency and risk related factors.BMC pediatrics · 2024Observational
- Off-label Prescription in Paediatric Dermatology: A Retrospective Observational Study in a Tertiary Hospital.Acta dermato-venereologica · 2023Observational
- Factors and Practices Associated with Self-Medicating Children among Mexican Parents.Pharmaceuticals (Basel, Switzerland) · 2022Article
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Authors and funding
5 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveto evaluate the prescription profile and to assess the off-label and unlicensed uses of medicines among non-hospitalised pediatric patients.
designcross-sectional study.
settingpediatric units in two urban health centers and general emergency room (Hospital Materno-Infantil, Málaga). MAIN MEASUREMENTS: sociodemographics variables, reasons for consultation and information about therapeutic medications. The classification of prescriptions was established according to information requirements contained in the Summary of Products Characteristics (SPC).
resultsA total of 388 children were included (a subsample of 105 treated in the emergency room). Four hundred sixty-two prescriptions (involving 74 different active ingredients) were evaluated. Each infant received and average of 1,7 drugs (95% CI: 1,6-1,9). The most prescribed medicines were ibuprofen, paracetamol, amoxicillin-clavulanate and budesonide. The therapeutic group with the greatest variety of drugs was the respiratory group. 27,4% (95% CI: 23,5-31) of prescriptions were off-label and the main cause was different age (60%; 95% CI: 54,1-63), followed by different dose (21,5%; 95% CI: 18-25), different indication (12%; 95% CI: 9,2-15) and different route of administration (7%; 95% CI: 5,4-10).
conclusionsThe rate of off-label uses presents intermediate figures. Around one third of the paediatric outpatients in our sample are exposed to at least one off-label or unlicensed prescription. We should, however, point out that such usage is based on scant official, quality information, although it is not necessarily incorrect. Evidence-based medicine should be encouraged to improve drug therapy in children, as well as following the rules on drugs in special situations.
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