Condition of sale of non-steroidal anti-inflammatory drugs authorized for marketing in colombia. strategy of rational use

The commercialization status (otc, under medical prescription, under special monitoring or for hospital use only) sets out the circumstances under which it may be publicized and marketed a drug. The otc does not involve consulting the health team, who do not participate in the selection of the drug,...

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Autores:
Solano Roa, Magda Vianneth
Garavito Cárdenas, Giovanny
Tipo de recurso:
Article of journal
Fecha de publicación:
2013
Institución:
Universidad Nacional de Colombia
Repositorio:
Universidad Nacional de Colombia
Idioma:
spa
OAI Identifier:
oai:repositorio.unal.edu.co:unal/49324
Acceso en línea:
https://repositorio.unal.edu.co/handle/unal/49324
http://bdigital.unal.edu.co/42781/
http://bdigital.unal.edu.co/42781/2/
Palabra clave:
agentes antiinflamatorios no esteroides
medicamentos sin prescripción
medicamentos bajo prescripción
aprobación de medicamentos
registro sanitario
Anti-inflammatory agents
non-steroidal (nsaids)
nonprescription drugs
prescription drugs
drug approval
Rights
openAccess
License
Atribución-NoComercial 4.0 Internacional
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oai_identifier_str oai:repositorio.unal.edu.co:unal/49324
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network_name_str Universidad Nacional de Colombia
repository_id_str
dc.title.spa.fl_str_mv Condition of sale of non-steroidal anti-inflammatory drugs authorized for marketing in colombia. strategy of rational use
title Condition of sale of non-steroidal anti-inflammatory drugs authorized for marketing in colombia. strategy of rational use
spellingShingle Condition of sale of non-steroidal anti-inflammatory drugs authorized for marketing in colombia. strategy of rational use
agentes antiinflamatorios no esteroides
medicamentos sin prescripción
medicamentos bajo prescripción
aprobación de medicamentos
registro sanitario
Anti-inflammatory agents
non-steroidal (nsaids)
nonprescription drugs
prescription drugs
drug approval
title_short Condition of sale of non-steroidal anti-inflammatory drugs authorized for marketing in colombia. strategy of rational use
title_full Condition of sale of non-steroidal anti-inflammatory drugs authorized for marketing in colombia. strategy of rational use
title_fullStr Condition of sale of non-steroidal anti-inflammatory drugs authorized for marketing in colombia. strategy of rational use
title_full_unstemmed Condition of sale of non-steroidal anti-inflammatory drugs authorized for marketing in colombia. strategy of rational use
title_sort Condition of sale of non-steroidal anti-inflammatory drugs authorized for marketing in colombia. strategy of rational use
dc.creator.fl_str_mv Solano Roa, Magda Vianneth
Garavito Cárdenas, Giovanny
dc.contributor.author.spa.fl_str_mv Solano Roa, Magda Vianneth
Garavito Cárdenas, Giovanny
dc.subject.proposal.spa.fl_str_mv agentes antiinflamatorios no esteroides
medicamentos sin prescripción
medicamentos bajo prescripción
aprobación de medicamentos
registro sanitario
Anti-inflammatory agents
non-steroidal (nsaids)
nonprescription drugs
prescription drugs
drug approval
topic agentes antiinflamatorios no esteroides
medicamentos sin prescripción
medicamentos bajo prescripción
aprobación de medicamentos
registro sanitario
Anti-inflammatory agents
non-steroidal (nsaids)
nonprescription drugs
prescription drugs
drug approval
description The commercialization status (otc, under medical prescription, under special monitoring or for hospital use only) sets out the circumstances under which it may be publicized and marketed a drug. The otc does not involve consulting the health team, who do not participate in the selection of the drug, its dispensing or therapeutic monitoring. Present work through an observational, descriptive, cross-sectional study from the universe of Colombian drug approvals, identify and describe the variations in the condition of sale of non-steroidal anti-inflammatory drugs. For this pharmacological group, widely consumed in the country, dominated the modality "make and sell", the non-sterile solid dosage forms, the condition of sale under prescription and the enteric route of administration, likewise predominate as active substance diclofenac, followed by ibuprofen and piroxicam. Eight of the active ingredients of this pharmacological group have double condition of sale (otc and under medical prescription) achieving 70% of marketing authorization for nsaids in Colombia. It is evidenced a relationship between the amount of active substance per dosage unit and the commercialization status, a relationship that is not evident with respect to the indication.
publishDate 2013
dc.date.issued.spa.fl_str_mv 2013
dc.date.accessioned.spa.fl_str_mv 2019-06-29T08:35:29Z
dc.date.available.spa.fl_str_mv 2019-06-29T08:35:29Z
dc.type.spa.fl_str_mv Artículo de revista
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dc.identifier.eprints.spa.fl_str_mv http://bdigital.unal.edu.co/42781/
http://bdigital.unal.edu.co/42781/2/
url https://repositorio.unal.edu.co/handle/unal/49324
http://bdigital.unal.edu.co/42781/
http://bdigital.unal.edu.co/42781/2/
dc.language.iso.spa.fl_str_mv spa
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dc.relation.spa.fl_str_mv http://revistas.unal.edu.co/index.php/rccquifa/article/view/45114
dc.relation.ispartof.spa.fl_str_mv Universidad Nacional de Colombia Revistas electrónicas UN Revista Colombiana de Ciencias Químico Farmacéuticas
Revista Colombiana de Ciencias Químico Farmacéuticas
dc.relation.ispartofseries.none.fl_str_mv Revista Colombiana de Ciencias Químico Farmacéuticas; Vol. 42, núm. 2 (2013); 145-168 0034-7418 1909-6356
dc.relation.references.spa.fl_str_mv Solano Roa, Magda Vianneth and Garavito Cárdenas, Giovanny (2013) Condition of sale of non-steroidal anti-inflammatory drugs authorized for marketing in colombia. strategy of rational use. Revista Colombiana de Ciencias Químico Farmacéuticas; Vol. 42, núm. 2 (2013); 145-168 0034-7418 1909-6356 .
dc.rights.spa.fl_str_mv Derechos reservados - Universidad Nacional de Colombia
dc.rights.coar.fl_str_mv http://purl.org/coar/access_right/c_abf2
dc.rights.license.spa.fl_str_mv Atribución-NoComercial 4.0 Internacional
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dc.rights.accessrights.spa.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv Atribución-NoComercial 4.0 Internacional
Derechos reservados - Universidad Nacional de Colombia
http://creativecommons.org/licenses/by-nc/4.0/
http://purl.org/coar/access_right/c_abf2
eu_rights_str_mv openAccess
dc.format.mimetype.spa.fl_str_mv application/pdf
dc.publisher.spa.fl_str_mv Revista Colombiana de Ciencias Químico Farmacéuticas
institution Universidad Nacional de Colombia
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spelling Atribución-NoComercial 4.0 InternacionalDerechos reservados - Universidad Nacional de Colombiahttp://creativecommons.org/licenses/by-nc/4.0/info:eu-repo/semantics/openAccesshttp://purl.org/coar/access_right/c_abf2Solano Roa, Magda Viannethc7e64409-f1ba-4a5a-80a5-35375984a4e2300Garavito Cárdenas, Giovannyeeae3b67-0f79-456d-90c4-935454fb71873002019-06-29T08:35:29Z2019-06-29T08:35:29Z2013https://repositorio.unal.edu.co/handle/unal/49324http://bdigital.unal.edu.co/42781/http://bdigital.unal.edu.co/42781/2/The commercialization status (otc, under medical prescription, under special monitoring or for hospital use only) sets out the circumstances under which it may be publicized and marketed a drug. The otc does not involve consulting the health team, who do not participate in the selection of the drug, its dispensing or therapeutic monitoring. Present work through an observational, descriptive, cross-sectional study from the universe of Colombian drug approvals, identify and describe the variations in the condition of sale of non-steroidal anti-inflammatory drugs. For this pharmacological group, widely consumed in the country, dominated the modality "make and sell", the non-sterile solid dosage forms, the condition of sale under prescription and the enteric route of administration, likewise predominate as active substance diclofenac, followed by ibuprofen and piroxicam. Eight of the active ingredients of this pharmacological group have double condition of sale (otc and under medical prescription) achieving 70% of marketing authorization for nsaids in Colombia. It is evidenced a relationship between the amount of active substance per dosage unit and the commercialization status, a relationship that is not evident with respect to the indication.La condición de comercialización (venta libre, con fórmula médica, bajo control especial o para uso hospitalario exclusivamente) determina las circunstancias en las cuales puede ser publicitado y comercializado un medicamento. La venta libre no involucra una consulta al equipo de salud, quienes no participan de la selección del medicamento, su dispensación ni seguimiento fármaco-terapéutico. El presente trabajo, mediante un estudio observacional descriptivo de corte transversal desarrollado partiendo del universo de registros sanitarios de medicamentos en Colombia, identifica y describe las variaciones en la condición de venta de analgésicos antiinflamatorios no esteroides. Para este grupo farmacológico, de gran consumo en el país, predominan la modalidad de registro "fabricar y vender", las formas farmacéuticas sólidas no estériles, la condición de venta con fórmula médica y la vía de administración enteral; asimismo, predomina como principio activo el diclofenaco, seguido de ibuprofeno y piroxicam. Ocho de los principios activos de este grupo farmacológico poseen doble condición de venta (venta sin prescripción facultativa o libre y venta con fórmula médica) y alcanzan el 70% de las autorizaciones de comercialización de aines en Colombia. Se evidencia una relación entre la cantidad principio activo por unidad posológica y la condición de venta autorizada, relación que no es evidente con respecto a la indicación.application/pdfspaRevista Colombiana de Ciencias Químico Farmacéuticashttp://revistas.unal.edu.co/index.php/rccquifa/article/view/45114Universidad Nacional de Colombia Revistas electrónicas UN Revista Colombiana de Ciencias Químico FarmacéuticasRevista Colombiana de Ciencias Químico FarmacéuticasRevista Colombiana de Ciencias Químico Farmacéuticas; Vol. 42, núm. 2 (2013); 145-168 0034-7418 1909-6356Solano Roa, Magda Vianneth and Garavito Cárdenas, Giovanny (2013) Condition of sale of non-steroidal anti-inflammatory drugs authorized for marketing in colombia. strategy of rational use. Revista Colombiana de Ciencias Químico Farmacéuticas; Vol. 42, núm. 2 (2013); 145-168 0034-7418 1909-6356 .Condition of sale of non-steroidal anti-inflammatory drugs authorized for marketing in colombia. strategy of rational useArtículo de revistainfo:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501http://purl.org/coar/resource_type/c_2df8fbb1http://purl.org/coar/version/c_970fb48d4fbd8a85Texthttp://purl.org/redcol/resource_type/ARTagentes antiinflamatorios no esteroidesmedicamentos sin prescripciónmedicamentos bajo prescripciónaprobación de medicamentosregistro sanitarioAnti-inflammatory agentsnon-steroidal (nsaids)nonprescription drugsprescription drugsdrug approvalORIGINAL45114-216473-1-SM.pdfapplication/pdf560754https://repositorio.unal.edu.co/bitstream/unal/49324/1/45114-216473-1-SM.pdf8fd83fd9c23529f06090be51afb696c3MD51THUMBNAIL45114-216473-1-SM.pdf.jpg45114-216473-1-SM.pdf.jpgGenerated Thumbnailimage/jpeg6462https://repositorio.unal.edu.co/bitstream/unal/49324/2/45114-216473-1-SM.pdf.jpgb918954450c5a54daa6325f8b7c70b17MD52unal/49324oai:repositorio.unal.edu.co:unal/493242023-12-09 23:05:56.703Repositorio Institucional Universidad Nacional de Colombiarepositorio_nal@unal.edu.co