Adverse drug reactions in Colombian patients, 2007-2013: Analysis of population databases
Abstract
Introduction: Recognizing adverse drug reactions (ADRs) is becoming more important in clinical practice. Objective: To determine the frequency of adverse drug reactions and ADR suspicions among the population affiliated to the Colombian health system and to describe the drugs, reactions and associated variables. Materials and methods: We revised ADRs and ADRs suspicion databases from drugs dispensed by Audifarma, S.A., both for inpatient and outpatient care from 2007 to 2013. Variables included ADR report date, city, drug, drug’s Anatomical Therapeutic Classification (ATC), ADR severity, ADR type, ADR classification and ADR probability according to the World Health Organization’s definitions. Results: We obtained 5,342 reports for 468 different drugs. The ATC groups with the most reports were anti-infectives for systemic use (25.5%), nervous system agents (17.1%) and cardiovascular system drugs (15.0%). The drugs with the highest number of reports were metamizole (4.2%), enalapril (3.8%), clarithromycin (2.8%), warfarin (2.5%) and ciprofloxacin (2.4%). The most common ADR, classified following the World Health Organization adverse reaction terminology, were: skin and appendages disorders (35.3%), general disorders (14.2%) and gastrointestinal system disorders (11.8%). Overall, 49.4% of the ADRs were classified as “moderate” and 45.1% as “mild”. Conclusion: An increasing number of ADR reports were found coinciding with a worldwide tendency. Differences between inpatient and outpatient ADR reports were found when compared to scientific publications. The information on ADR reports, mainly gathered by the Instituto Nacional de Vigilancia de Medicamentos y Alimentos – Invima, should be made public for academic and institutional use.
Downloads
References
Machado-Alba JE, Moncada-Escobar JC. Reacciones adversas medicamentosas en pacientes que consultaron a instituciones prestadoras de servicios en Pereira, Colombia. Rev Salud Pública (Bogotá). 2006;8:200-8. http://dx.doi.org/10.1590/S0124-00642006000200008
Segura O, Maldonado C. Las reacciones adversas a medicamentos: una aproximación desde el punto de vista económico. Biomédica. 2003;23:401-7. http://dx.doi.org/10.7705/biomedica.v23i4.1234
Salazar N, Jirón M, Escobar L, Tobar E, Romero C. Errores de medicación en pacientes críticos adultos de un hospital universitario. Estudio prospectivo y aleatorio. Rev Med Chile. 2011;139:1458-64. http://dx.doi.org/10.4067/S0034-98872011001100010
Aagaard L, Soendergaard B, Andersen E, Kampmann JP, Hansen EH. Creating knowledge about adverse drug reactions: A critical analysis of the Danish reporting system from 1968 to 2005. Soc Sci Med. 2007;65:1296-309. http://dx.doi.org/10.1016/j.socscimed.2007.04.026
Wiktorowicz M, Lexchin J, Moscou K. Pharmacovigilance in Europe and North America: Divergent approaches. Soc Sci Med. 2012;75:165-70. http://dx.doi.org/10.1016/j.socscimed.2011.11.046.
Moscoso-Veloza SM, Ramírez-Cubillos GF, López-Gutiérrez JJ, Gerena-Useche BE. Reacciones adversas a medicamentos en el Hospital de Suba de Bogotá. Rev Salud Pública (Bogotá). 2006;8:209-17. http://dx.doi.org/10.1590/S0124-00642006000200009
Hasford J, Goettler M, Munter KH, Müller-Oerlinghausen B. Physicians´ knowledge and attitudes regarding the spontaneous reporting system for adverse drug reactions. J Clin Epidemiol. 2002;55:945-50. http://dx.doi.org/10.1016/S0895-4356(02)00450-X
Amariles P, Giraldo N. Método Dáder de seguimiento farmacoterapéutico a pacientes y problemas relacionados con la utilización de medicamentos en el contexto de Colombia. Seguim Farmacoter. 2003;1:99-104.
Du W, Guo JJ, Jing Y, Li X, Kelton CM. Drug safety surveillance in China and other countries: A review and comparison. Value Health. 2008;11(Suppl.1):S130-6. http://dx.doi.org/10.1111/j.1524-4733.2008.00377.x
WHO/Uppsala Monitoring Centre. Vigilancia de la seguridad de los medicamentos. Guía para la instalación y puesta en funcionamiento de un centro de farmacovigilancia. Fecha de consulta: 13 de julio de 2013. Disponible en: http://who-umc.org/graphics/24751.pdf.
Machado-Alba JE, Giraldo-Giraldo C, Moncada-Escobar JC. Farmacovigilancia activa en pacientes afiliados al sistema general de seguridad social en salud. Rev Salud Pública (Bogotá). 2010;12:580-8. http://dx.doi.org/10.1590/S0124-00642010000400005
Magro L, Conforti A, Del Zotti F, Leone R, Iorio ML, Meneghelli I, et al . Identification of severe potential drug- drug interactions using an Italian general-practitioner database. Eur J Clin Pharmacol. 2008;64:303-9. http://dx. doi.org/10.1007/s00228-007-0394-1
García-Ramos SE, Baldominos-Utrilla G. Electronically assisted prescription will minimize drug transcription errors. Farm Hosp. 2011;35:64-9. http://dx.doi.org/10.1016/j.farma.2010.06.002
Calderón-Ospina C, Urbina-Bonilla A. La farmacovigilancia en los últimos 10 años: actualización de conceptos y clasificaciones. Logros y retos para el futuro en Colombia. Médicas UIS. 2011;24:57-73.
Ministerio de la Protección Social. Decreto 1011 de 2006. Diario Oficial. Fecha de consulta: 5 de agosto de 2013. Disponible en: http://www.alcaldiabogota.gov.co/sisjur/normas/Norma1.jsp?i=19975.
Segura O, Pacific H. Tendencias en relación con la farmacovigilancia y la Farmacoepidemiología: un sondeo de opinión entre docentes de farmacología de facultades de medicina colombianas. Acta Med Colomb. 2003;28:112-6.
Cano FG, Rozenfeld S. Adverse drug events in hospitals: A systematic review. Cad Saúde Pública. 2009;25(Suppl.3):S360-72. http://dx.doi.org/10.1590/S0102-311X2009001500003
Tsang C, Majeed A, Aylin P. Routinely recorded patient safety events in primary care: A literature review. Fam Pract. 2012;29:8-15. http://dx.doi.org/10.1093/fampra/cmr050
Tribiño G, Maldonado C, Segura O, Díaz J. Costos directos y aspectos clínicos de las reacciones adversas a medicamentos en pacientes hospitalizados en el servicio de medicina interna de una institución de tercer nivel de Bogotá. Biomédica. 2006;26:31-41. http://dx.doi.org/10.7705/biomedica.v26i1.1392
Budnitz DS, Pollock DA, Mendelsohn AB, Weidenbach KN, McDonald AK, Annest JL. Emergency department visits for outpatient adverse drug events: Demonstration for a national surveillance system. Ann Emerg Med. 2005;45: 197-206. http://dx.doi.org/10.1016/j.annemergmed.2004.09.020
Instituto Nacional de Vigilancia de Medicamentos y Alimentos. Dirección de Medicamentos y Productos Biológicos Grupo de Programas Especiales – Farmaco- vigilancia. Información para profesionales de la salud: Rituximab. 2013. Fecha de consulta: 13 de julio de 2013. Disponible en: http://www.invima.gov.co/images/pdf/farmacovigilancia_alertas/info-seguridad/RITUXIMAB_PROFESIONALES.pdf
Björkman IK, Sanner MA, Bernsten CB. Comparing 4 classification systems for drug-related problems: Processes and functions. Res Social Adm Pharm. 2008;4:320-31. http://dx.doi.org/10.1016/j.sapharm.2007.10.006
Oliveira MP, Novaes MR. Drug-related problems in institutionalized elderly in Brasilia, Brazil. Biomedicine and Aging Pathology. 2011;1:179-84. http://dx.doi.org/10.1016/j.biomag.2011.09.007
Ibáñez L, Laporte JR, Carné X. Adverse drug reactions leading to hospital admission. Drug Saf. 1991;6:450-9.
Ruedy J, Ogilvie R. Adverse events: Past and future. CMAJ. 2004;171:549. http://dx.doi.org/10.1503/cmaj.1040765
Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalizad patients – a meta-analysis of prospective studies. JAMA. 1998;279:1200-5. http://dx.doi.org/10.1001/jama.279.15.1200
Organización Mundial de la Salud. La farmacovigilancia: garantía de seguridad en el uso de los medicamentos. Ginebra: WHO; 2004. Fecha de consulta: 13 de julio de 2013. Disponible en: http://apps.who.int/medicinedocs/pdf/s6166s/s6166s.pdf.
Herxheimer A. Pharmacovigilance on the turn? Adverse reactions methods in 2012. Int J Risk Saf Med. 2013;25:29- 31. http://dx.doi.org/10.3233/JRS-130583
Li Q, Deleger L, Lingren T, Zhai H, Kaiser M, Stoutenborough L, et al . Mining FDA drug labels for medical conditions. BMC Med Inform Decis Mak. 2013;13:53. http://dx.doi.org/10.1186/1472-6947-13-53
Vogel L, Sysak T. Physicians should be paid to report adverse drug reactions, experts say. CMAJ. 2012;184:E409- 10. http://dx.doi.org/10.1503/cmaj.109-4153
Some similar items:
- Elizabeth Borrero, Gabriel Carrasquilla, Neal Alexander, Decentralization and health system reform: What is their impact on malaria incidence in Colombian municipalities? , Biomedica: Vol. 32 (2012): Suplemento 1, Malaria
- Raúl Murillo, Ricardo Cendales, Carolina Wiesner, Marion Piñeros, Sandra Tovar, Effectiveness of cytology-based cervical cancer screening in the Colombian health system , Biomedica: Vol. 29 No. 3 (2009)
- Sandra Lorena Girón, Julio César Mateus, Fabián Méndez, Impact of an open waste disposal site on the occurrence of respiratory symptoms and on health care costs of children , Biomedica: Vol. 29 No. 3 (2009)
- José Joaquín Carvajal, Ligia Inés Moncada, Mauricio Humberto Rodríguez, Ligia del Pilar Pérez, Víctor Alberto Olano, Characterization of Aedes albopictus (Skuse, 1894) (Diptera:Culicidae) larval habitats near the Amazon River in Colombia , Biomedica: Vol. 29 No. 3 (2009)
- Andrés Páez, Gloria Rey, Carlos Agudelo, Alvaro Dulce, Edgar Parra, Hernando Díaz-Granados, Damaris Heredia, Luis Polo, Outbreak of urban rabies transmitted by dogs in Santa Marta, northern Colombia , Biomedica: Vol. 29 No. 3 (2009)
- Patricia Escobar, Katherine Paola Luna, Indira Paola Hernández, César Mauricio Rueda, María Magdalena Zorro, Simon L. Croft, In vitro susceptibility of Trypanosoma cruzi strains from Santander, Colombia, to hexadecylphosphocholine (miltefosine), nifurtimox and benznidazole , Biomedica: Vol. 29 No. 3 (2009)
- Gustavo Pradilla, Julio César Mantilla, Reynaldo Badillo, Human rabies encephalitis by a vampire bat bite in an urban area of Colombia , Biomedica: Vol. 29 No. 2 (2009)
- Mauricio Beltrán, María Cristina Navas, María Patricia Arbeláez, Jorge Donado, Sergio Jaramillo, Fernando De la Hoz, Cecilia Estrada, Lucía del Pilar Cortés, Amalia de Maldonado, Gloria Rey, Seroprevalence of hepatitis B virus and human immunodeficiency virus infection in a population of multiply-transfused patients in Colombia , Biomedica: Vol. 29 No. 2 (2009)
- Rosa Magdalena Uscátegui, Adriana M. Correa, Jaime Carmona-Fonseca, Changes in retinol, hemoglobin and ferritin concentrations in Colombian children with malaria , Biomedica: Vol. 29 No. 2 (2009)
- Claudia M.E. Romero-Vivas, Luis Eduardo Castro, Lila Visbal, Ana María Santos, Esther Díaz, Cutaneous myiasis by Cochliomyia hominivorax (Coquerel) (Díptera Calliphoridae) in Hospital Universidad del Norte, Soledad, Atlántico , Biomedica: Vol. 29 No. 1 (2009)
| Article metrics | |
|---|---|
| Abstract views | |
| Galley vies | |
| PDF Views | |
| HTML views | |
| Other views | |
