Medicamentos utilizados en pediatría extrahospitalaria: ¿disponemos de información suficiente?

{ "0" : "Servicio de Pediatría. Consorcio Hospital General Universitario. Consorcio Hospital General Universitario. Valencia. España" , "1" : "Centro de Salud. Aldaia. Consorcio Hospital General Universitario. Valencia. España" , "2" : "Centro de Salud. Tavernes Blanques. Consorcio Hospital General Universitario. Valencia. España" , "3" : "Departamento de Farmacología. Universidad de Valencia. Consorcio Hospital General Universitario. Valencia. España" , "4" : "Unidad de Farmacología Clínica. Consorcio Hospital General Universitario. Valencia. España" , "6" : "Utilización de medicamentos" , "7" : "Información de medicamentos" , "8" : "Uso no autorizado" , "9" : "Niños" , "10" : "Drug use" , "11" : "Drug information" , "12" : "Off-label use" , "13" : "Children"}
Anales de Pediatría (Impact Factor: 0.72). 05/2008; DOI: 10.1157/13120040

ABSTRACT ObjetivoAnalizar los medicamentos que reciben los pacientes pediátricos en el ámbito extrahospitalario y la información disponible sobre los mismos.Pacientes y métodosEstudio transversal, observacional y descriptivo realizado en una muestra de pacientes menores de 14 años atendidos en urgencias del Servicio de Pediatría del Consorcio Hospital General Universitario de Valencia entre junio 2005 y agosto 2006. Se cuantifican y clasifican los medicamentos utilizados antes de acudir a urgencias y se analiza la información sobre su uso que contiene el Vademécum Internacional Medicom y la ficha técnica.ResultadosSe recogió información sobre 462 niños con media de edad de 5,2 años (intervalo de confianza del 95% [IC 95%]: 4,9-5,6). De ellos, 336 reciben 667 medicamentos (152 distintos) que contienen 864 principios activos (161 diferentes). En el 34,3 % de los casos el uso es por automedicación. Los menores de 4 años reciben medicamentos en mayor proporción que los mayores (80,2 y 67,4%, respectivamente). Los pacientes reciben entre 1 y 7 medicamentos (media 2,0). Los que toman 2 o 3 medicamentos son menores que los que toman uno. Cinco grupos terapéuticos de la Clasificación anatómico-terapéutico-química (ATC) incluyen el 93,1% de los medicamentos (R [aparato respiratorio]: 26,5%; M [aparato locomotor]: 23,8%; N [sistema nervioso central]: 22,8 %;J [antiinfecciosos por vía general]: 10,6% y A [aparato digestivo y metabolismo]: 10,0%). Para 40 de los 152 medicamentos no hay información pediátrica en las fuentes consultadas.ConclusionesCasi tres cuartas partes de los niños atendidos en urgencias toman medicamentos antes de acudir a este servicio, en muchos casos por automedicación. La información sobre uso pediátrico de medicamentos es incompleta y presenta incongruencias. Es necesario fomentar la investigación clínica sobre los efectos del tratamiento farmacológico en los niños para mejorar la información sobre su uso.ObjectiveTo analyse the drugs taken in paediatric outpatients and the information available on these drugs.Patients and methodsA cross-sectional, observational, descriptive study was carried out. The study involved a sample of children under 14 years seen in the Emergency Room of the HGUV from June 2005 to August 2006. The medicines they received were quantified and classified, and the information on these drugs available in the Vademecum International Medicom and in the Summary of Product Characteristics, were analysed.ResultsOf the 462 children (mean age 5.2 (95% CI 4.9-5.6)) in-cluded, 336 received 667 medicines (152 different medicines) that contained 864 drugs (161 different drugs). In 34.3 % of the cases it was for self-medication. Children under 4 years received more drugs than the older group (80.2% in the younger group and 67.4% in the older). Patients received from 1 to 7 medicines (mean 2.0). Children receiving 2 or 3 medicines were younger than those who received one. Five therapeutic groups of the Anatomical-Therapeutical-Chemical Classification (ATC) include the 93.1% of the drugs administered (R: 26.5%; M: 23.8%; N: 22.8%; J: 10.6% and A: 10.0%). In the information sources consulted there was no information available on paedi-atric use for 40 of the 152 medicines used.ConclusionsAlmost 75 % of patients seen in the Emergency Room were already receiving drugs before they arrived at the hospital, in many cases as a result of self-medication. The information available on the paediatric use of drugs is deficient. Clinical research is required to study the effects of pharmacological treatment on children and to improve the information on their use.

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    ABSTRACT: Introduction Due to the emergence of new pharmaceutical presentations of ibuprofen (40 mg/ml), an analysis was made on the use of antipyretics in pediatric outpatient in Spain. Patients and methods A cross-sectional, observational, descriptive study was carried out on a sample of children under 14 years old with treated febrile syndrome, seen in the Emergency Room of the Hospital General Universitario de Valencia from November 2012 to January 2013. Results Of the 217 children included, 144 were treated with paracetamol or ibuprofen, 69 received both drugs, and one received paracetamol and metamizol. There were 58.7% of exposures to paracetamol and 40.9% to ibuprofen. The parents decided the use of antipyretics in 63.2% of cases. In 98 exposures the dose was different from that authorized in the labeling of the drug (off-label use). Ibuprofen was used off-label in 40.2% of cases, mostly by underdosing (35.9%). Paracetamol was used off-label in 29.8% of cases, predominantly overdose (26.8%), with the difference being statistically significant. No significant differences were observed in the off-label use in either monotherapy or combined use. There were also no differences when antipyretics prescribed by doctors or given directly by parents were evaluated separately. Conclusions The majority of children with treated febrile syndrome seen in the Emergency Room were receiving antipyretic drugs after a parental decision. Paracetamol is the most commonly used drug and one in three children received it simultaneously with ibuprofen. The antipyretics were used off label in one-third of the cases. Off label use of ibuprofen is increasing, and is probably due to the existence of different pharmaceutical presentations.
    Anales de Pediatría 12/2014; DOI:10.1016/j.anpedi.2014.01.025 · 0.72 Impact Factor
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    ABSTRACT: Off-label drug use is a common practice in paediatrics. The aim of the present study was to estimate the knowledge of Spaniard paediatricians on off-label use. Cross-sectional, multicentre, descriptive and national study from July 2012 to March 2013 using an on-line questionnaire on off-label use in children. An e-mail was sent to paediatricians who were members of the Spanish Association of Paediatrics (AEP) or its Regional or Paediatric Specialties Societies. Out of 673 responses were received, 75.1% of Spanish paediatricians knew the meaning of off-label use, 61% of them prescribed medicines outside the conditions authorised in their Summary of Product Characteristics (SPC) and 47% knew of the importance of noting the off-label use in the medical record. However, just under half of paediatricians informed parents, and only 22% wrote it down in the medical record. Most Spanish paediatricians do not meet current regulations regarding off-label use. This regulation demands: justifying the decisions when off-label use is needed, and to write down in the medical record that, at least an oral consent from the parents has been obtained. This study reveals a fact that Spanish paediatricians must change. Meanwhile, it is a priority to continue with the implementation of consensus and clinical guidelines, to obtain more data on the efficacy and safety of off-label drug use in children, and to incorporate them into the SPC.
    Anales de Pediatría 11/2013; 81(1). DOI:10.1016/j.anpedi.2013.10.004 · 0.87 Impact Factor
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    ABSTRACT: OBJECTIVE: To assess self medication practice among children from a city in the Southern region of Brazil. METHODS: This is a cross-sectional study with a random sample. Initially, Family Health Strategy teams and later the residences that would be visited were raffled. A questionnaire about children and family characteristics and self medication practices was administered to caretakers. Descriptive statistics and chi-square test (p<0.05) were used for data presentation. RESULTS: Child caretakers were interviewed in 83 households. Data from 121 children (aged six months to 14 years) were collected. Among caretakers, 75% said they had practiced self medication; mothers accounted for 95% of these cases. As for self medication situations, convenience (88%), fever (58%) and pain (12%) were the most reported. Acetaminophen (45%) and dipyrone (15%) were the most used drugs. Statistical analysis showed an association between the reuse of old prescriptions and child's age less than seven years and between the use of drugs without prescription from a qualified professional and households with more than four people. CONCLUSIONS: Self medication is a common practice in the surveyed population, especially among children up to seven years of age and conducted primarily by mothers, suggesting the need to develop health education aimed at promoting the rational use of medicines.
    Revista Paulista de Pediatria 09/2010; 28(3):262-268. DOI:10.1590/S0103-05822010000300002

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