RT Journal Article
T1 Estudio de las prescripciones farmacológicas en niños a nivel de atención primaria: evaluación de los usos off-label o fuera de ficha técnica.
T2 Drug prescriptions study in the outpatient setting: assessment of off-label uses in children
A1 Blanco-Reina, Encarnación
A1 Vega-Jiménez, M Auxiliadora
A1 Ocaña-Riola, Ricardo
A1 Márquez-Romero, Elisa Isabel
A1 Bellido-Estévez, Inmaculada
K1 Off-label
K1 Prescripciones fuera de ficha técnica
K1 Niños
K1 Atención primaria
AB 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 MEASUREMENTSsociodemographics 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.
PB Elsevier
SN 0212-6567
YR 2015
FD 2015-06
LK http://hdl.handle.net/10668/1947
UL http://hdl.handle.net/10668/1947
LA es
NO Blanco-Reina E, Vega-Jiménez MA, Ocaña-Riola R, Márquez-Romero EI, Bellido-Estévez I. Estudio de las prescripciones farmacológicas en niños a nivel de atención primaria: evaluación de los usos off-label o fuera de ficha técnica. Aten Primaria. 2015; 47(6):344-350.
NO JOURNAL ARTICLE;
DS RISalud
RD Apr 7, 2025