<?xml version="1.0" encoding="ISO-8859-1"?><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
<front>
<journal-meta>
<journal-id>0120-0011</journal-id>
<journal-title><![CDATA[Revista de la Facultad de Medicina]]></journal-title>
<abbrev-journal-title><![CDATA[rev.fac.med.]]></abbrev-journal-title>
<issn>0120-0011</issn>
<publisher>
<publisher-name><![CDATA[Universidad Nacional de Colombia]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S0120-00112017000300411</article-id>
<article-id pub-id-type="doi">10.15446/revfacmed.v65n3.57439</article-id>
<title-group>
<article-title xml:lang="en"><![CDATA[Off-label use of psychotropic drugs beyond officially approved indications in Colombia]]></article-title>
<article-title xml:lang="es"><![CDATA[Uso de psicofármacos en indicaciones no aprobadas por la agencia regulatoria nacional de Colombia]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Fletscher-Covaleda]]></surname>
<given-names><![CDATA[Paola Marcela]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[López-Gutiérrez]]></surname>
<given-names><![CDATA[José Julián]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Machado-Duque]]></surname>
<given-names><![CDATA[Manuel]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Machado-Alba]]></surname>
<given-names><![CDATA[Jorge]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Audifarma S.A  ]]></institution>
<addr-line><![CDATA[Bogotá D.C]]></addr-line>
<country>Colombia</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,Universidad Nacional de Colombia  ]]></institution>
<addr-line><![CDATA[Bogotá D.C]]></addr-line>
<country>Colombia</country>
</aff>
<aff id="Af3">
<institution><![CDATA[,Universidad Tecnológica de Pereira  ]]></institution>
<addr-line><![CDATA[Pereira ]]></addr-line>
<country>Colombia</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>09</month>
<year>2017</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>09</month>
<year>2017</year>
</pub-date>
<volume>65</volume>
<numero>3</numero>
<fpage>411</fpage>
<lpage>415</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://www.scielo.org.co/scielo.php?script=sci_arttext&amp;pid=S0120-00112017000300411&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.co/scielo.php?script=sci_abstract&amp;pid=S0120-00112017000300411&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.co/scielo.php?script=sci_pdf&amp;pid=S0120-00112017000300411&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="en"><p><![CDATA[Abstract  Introduction: Off-label use of psychotropic drugs is a common practice. In Colombia, no information is available in this regard.  Objective: To describe off-label use of psychoactive drugs in a health promoting entity (EPS in Spanish) in Bogotá D.C.  Materials and methods: Cross sectional, observational study (prescription-indication), including a random sample of patients prescribed with psychotropic drugs between January and June 2010. Sociodemographic, clinical, pharmacological and concordance variables were evaluated (correlation between use indication and approved indication). Multivariate analyzes were performed looking for an association with off-label prescriptions.  Results: 420 evaluated patients had a mean age of 44.2±18.8 years, with female predominance (67.9%). Off-label prescription was found in 58.6-59.8% of cases. 84.3% of the prescriptions were delivered by general practitioners. The main psychoactive drugs prescribed for conditions such as tension headaches and insomnia were amitriptyline (n=128, 86.7% of off-label use), trazodone (n=93, 88.2%) and fluoxetine (n=66, 36.4%). The multivariate analysis found that being a young adult (OR=1.99, 95%CI: 1.06-3.70; p=0.030), being treated by general medicine (OR=3.40, 95%CI: 1.507.67; p=0.003) and being prescribed with amitriptyline (OR=11.38; 95%CI: 5.06-25.58; p&lt;0.001) or trazodone (OR = 13.08; 95%CI: 5.23-32.68; p&lt;0.001) increased the likelihood of receiving an off-label prescription.  Conclusions: Psychotropic drugs in Bogotá are used, to a great extent, as off-label in indications other than those officially approved. Thus, it is important to strengthen education and control to achieve a rational, effective and safe use of drugs.]]></p></abstract>
<abstract abstract-type="short" xml:lang="es"><p><![CDATA[Resumen  Introducción. El uso de psicofármacos por fuera de las indicaciones aprobadas (off-label) es una práctica común, de la cual no se tiene información en Colombia.  Objetivo. Describir el uso off-label de psicofármacos en una entidad promotora de salud de Bogotá D.C.  Materiales y métodos. Estudio observacional de prescripción-indicación con una muestra aleatoria de pacientes prescritos con psicofármacos entre enero y junio de 2010. Se evaluaron variables sociodemográficas, clínicas, farmacológicas y de concordancia y se realizaron análisis multivariados buscando asociación con prescripciones no aprobadas.  Resultados. Los 420 pacientes evaluados tenían una edad promedio de 44.2±18.8 años, con predominio femenino (67.9%). Se encontró prescripción no aprobada en 58.6-59.8% de los casos; el 84.3% de las formulas fueron hechas por medicina general. Los principales psicofármacos en indicaciones como cefalea tensional e insomnio fueron amitriptilina (n=128; 86.7% de uso no aprobado), trazodona (n=93; 88.2%) y fluoxetina (n=66; 36.4%). En el análisis multivariado se halló que ser un adulto joven (OR=1.99; IC95%: 1.06-3.70; p=0.030), ser tratado por medicina general (OR=3.40; IC95%: 1.50-7.67; p=0.003) y ser formulado con amitriptilina (OR=11.38; IC95%: 5.06-25.58; p&lt;0.001) o trazodona (OR=13.08; IC95%: 5.23-32.68; p&lt;0.001) aumentan la probabilidad de recibir una prescripción no aprobada.  Conclusiones. En la aseguradora estudiada, los psicofármacos son utilizados en una importante proporción de indicaciones no aprobadas por las autoridades regulatorias, por lo cual es importante fortalecer la educación y el control para el empleo de los medicamentos de manera racional, efectiva y segura.]]></p></abstract>
<kwd-group>
<kwd lng="en"><![CDATA[Off-Label Use]]></kwd>
<kwd lng="en"><![CDATA[Psychotropic Drugs]]></kwd>
<kwd lng="en"><![CDATA[Pharmacoepidemiology]]></kwd>
<kwd lng="en"><![CDATA[Colombia (MeSH)]]></kwd>
<kwd lng="es"><![CDATA[Uso fuera de lo indicado]]></kwd>
<kwd lng="es"><![CDATA[Psicotrópicos]]></kwd>
<kwd lng="es"><![CDATA[Farmacoepidemiología]]></kwd>
<kwd lng="es"><![CDATA[Colombia (DeCS)]]></kwd>
</kwd-group>
</article-meta>
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