Adverse drug reactions in Colombian patients, 2007-2013: Analysis of population databases.

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.

Adverse drug reactions in Colombian patients, 2007-2013: Analysis of population databases / Reacciones adversas a medicamos en una población colombiana, 2007-2013: análisis de bases de datos

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.

Introducción. La detección de las reacciones adversas a medicamentos es cada vez más importante en la práctica clínica. Objetivo. Determinar la frecuencia de reacciones adversas a medicamentos y de los casos sospechosos de tales reacciones, en la población afiliada al Sistema General de Seguridad Social en Salud de Colombia. Materiales y métodos. Se revisaron las bases de datos sistematizadas de reportes de sospecha de reacciones adversas a los medicamentos dispensados por la empresa Audifarma, S.A., para uso ambulatorio y hospitalario, entre 2007 y 2013. Las variables contempladas fueron: la fecha de radicación del reporte, la ciudad, el medicamento, la clasificación anatómica terapéutica del medicamento, la gravedad, el tipo de reacción adversa y su clasificación, así como la de su probabilidad de ocurrir, según las definiciones de la Organización Mundial de la Salud (OMS). Resultados. Se obtuvieron 5.342 reportes de sospecha de reacción adversa a 468 medicamentos diferentes. Los grupos con más reportes fueron los fármacos antiinfecciosos de uso sistémic (25,5 %) y los medicamentos para el sistema nervioso (17,1 %) y para el sistema cardiovascular (15,0 %). Los medicamentos con más reportes fueron: el metamizol (dipirona) (4,2 %), el enalapril (3,8 %), la claritromicina (2,8 %), la warfarina (2,5 %) y la ciprofloxacina (2,4 %). Las reacciones adversas a medicamentos más frecuentes, según la clasificación de la terminología sobre reacciones adversas de la OMS, fueron los trastornos de la piel y anexos (35,3 %), los trastornos generales (14,2 %) y los trastornos del sistema gastrointestinal (11,8 %). El 49,4 % de las reacciones adversas a medicamentos se catalogaron como moderadas y, el 45,1 %, como leves. Conclusiones. Se encontró un incremento de reportes de reacciones adversas a medicamentos en los últimos años, lo que concuerda con la tendencia mundial. Se evidenciaron diferencias entre los reportes hospitalarios y de consulta ambulatoria. La información sobre los reportes de reacciones adversas a medicamentos, sobre todo la recopilada por el Instituto Nacional de Vigilancia de Medicamentos y Alimentos (Invima), debería ser pública para su uso académico e institucional.

Social, cultural and economic factors associated with self-medication.

INTRODUCTION: Self-medication is an increasingly frequent phenomenon worldwide; some studies suggest that there is a relationship with socio-economic and cultural factors. OBJECTIVE: To determine the prevalence of self-medication and its related factors in a Colombian city. MATERIALS AND METHODS: Cross-sectional descriptive study, in Pereira, Colombia. We selected 414 adults using simple randomization sampling with houses used as the observational unit. The IRIS-AM instrument was used to collect the information required. RESULTS: Four hundred and fourteen (414) people were interviewed, 62.6% were females, and mean age was 44 years; 77.5% of the sample had self-medicated at least once in their life and 31.9% during the last month. The most commonly used medications were: analgesics and antipyretics (44.3%), non-steroidal anti-inflammatory drugs and anti-rheumatic medication (36.4%), and anti-histamine medication (8.5%). The most commonly self-medicated symptoms were: headache (55.7%), cold (16.2%) and muscular pain (13.2%). Multivariate analysis revealed an association between self-medication throughout life and storing medications at home, and between a high level of education and having a favorable opinion of self-medication. Storing medications at home and recommending them to others were associated with self-medication during the previous 30 days. CONCLUSION: Self-medication rates were found to be similar to those reported globally, but there is not an established pattern for this practice. Associations were found between social and demographic variables and self-medication, which require further characterization. Intention to self-medicate has not been well-described in other studies, and may be an important indicator which will contribute to future understanding of this phenomenon.

Social, cultural and economic factors associated with self-medication / Factores económicos, sociales y culturales asociados con la automedicación

Introduction: Self-medication is an increasingly frequent phenomenon worldwide; some studies suggest that there is a relationship with socio-economic and cultural factors. Objective: To determine the prevalence of self-medication and its related factors in a Colombian city. Materials and methods: Cross-sectional descriptive study, in Pereira, Colombia. We selected 414 adults using simple randomization sampling with houses used as the observational unit. The IRIS-AM instrument was used to collect the information required. Results: Four hundred and fourteen (414) people were interviewed, 62.6% were females, and mean age was 44 years; 77.5% of the sample had self-medicated at least once in their life and 31.9% during the last month. The most commonly used medications were: analgesics and antipyretics (44.3%), non-steroidal anti-inflammatory drugs and anti-rheumatic medication (36.4%), and anti-histamine medication (8.5%). The most commonly self-medicated symptoms were: headache (55.7%), cold (16.2%) and muscular pain (13.2%). Multivariate analysis revealed an association between self-medication throughout life and storing medications at home, and between a high level of education and having a favorable opinion of self-medication. Storing medications at home and recommending them to others were associated with self-medication during the previous 30 days. Conclusion: Self-medication rates were found to be similar to those reported globally, but there is not an established pattern for this practice. Associations were found between social and demographic variables and self-medication, which require further characterization. Intention to self-medicate has not been well-described in other studies, and may be an important indicator which will contribute to future understanding of this phenomenon.

Introducción. La automedicación es un fenómeno cada vez más frecuente a nivel mundial. Los estudios en este campo sugieren que hay una relación entre la automedicación y diversos factores sociodemográficos y económicos. Objetivo. Determinar la prevalencia de la automedicación y los factores relacionados en Pereira, Colombia. Materiales y métodos. Estudio descriptivo de corte transversal llevado a cabo en la población de Pereira. Se hizo un muestreo aleatorio por afijación proporcional en 414 adultos, y se desarrolló y aplicó la encuesta IRIS-AM ( Instrument for Systematic Data Collection of Self-Medication ). Resultados. Se encuestaron 414 personas, 62,6 % de las cuales eran mujeres; el promedio de edad fue de 44 años. La prevalencia de la automedicación fue de 77,5 % a lo largo de la vida y de 31,9 % en los 30 días previos. Los medicamentos más comúnmente utilizados fueron los analgésicos y antipiréticos (44,3 %), los antiinflamatorios no esteroideos (36,4 %), y los antihistamínicos (8,5 %). Los síntomas que llevaron a la automedicación con mayor frecuencia fueron la cefalea (55,7 %), el resfriado (16,2 %) y el dolor muscular (13,2 %). Los análisis multivariados mostraron asociación entre la automedicación a lo largo de la vida y guardar medicamentos en casa, así como entre tener un nivel superior de escolaridad y estar a favor de la automedicación. Los factores referentes a almacenar medicamentos y recomendarlos a otros se asociaron con la automedicación en los 30 días previos. Conclusiones. La prevalencia de la automedicación hallada en este estudio fue similar a la reportada previamente a nivel mundial; aun así, no existe un patrón establecido para esta práctica. Se evidenciaron las variables sociodemográficas asociadas con la automedicación, las cuales requieren una mejor caracterización. La intención de recurrir a la automedicación ha sido poco estudiada y podría ser un indicador importante para la medición y comprensión de este fenómeno.

An economic analysis of inadequate prescription of antiulcer medications for in-hospital patients at a third level institution in Colombia.

INTRODUCTION: The prescription and costs of antiulcer medications for in-hospital use have increased during recent years with reported inadequate use and underused. AIM: To determine the patterns of prescription-indication and also perform an economic analysis of the overcost caused by the non-justified use of antiulcer medications in a third level hospital in Colombia. MATERIALS AND METHODS: Cross-sectional study of prescription-indication of antiulcer medications for patients hospitalized in "Hospital Universitario San Jorge" of Pereira during July of 2012. Adequate or inadequate prescription of the first antiulcer medication prescribed was determined as well as for others prescribed during the hospital stay, supported by clinical practice guidelines from the Zaragoza I sector workgroup, clinical guidelines from the Australian Health Department, and finally the American College of Gastroenterology Criteria for stress ulcer prophylaxis. Daily defined dose per bed/day was used, as well as the cost for 100 beds/day and the cost of each bed/drug. A multivariate analysis was carried out using SPSS 21.0. RESULTS: 778 patients were analyzed, 435 men (55.9 %) and 343 women, mean age 56.6 +/- 20.1 years. The number of patients without justification for the prescription of the first antiulcer medication was 377 (48.5 %), and during the whole in-hospital time it was 336 (43.2 %). Ranitidine was the most used medication, in 438 patients (56.3 %). The cost/month for poorly justified antiulcer medications was € 3,335.6. The annual estimated cost for inadequate prescriptions of antiulcer medications was € 16,770.0 per 100 beds. CONCLUSION: A lower inadequate prescription rate of antiulcer medications was identified compared with other studies; however it was still high and is troubling because of the major costs that these inadequate prescriptions generates for the institution.

Análisis económico de la prescripción inadecuada de antiulcerosos en pacientes hospitalizados en institución de tercer nivel de Colombia / An economic analysis of inadequate prescription of antiulcer medications for in-hospital patients at a third level institution in Colombia

Introducción: la prescripción y coste de antiulcerosos a nivel hospitalario se incrementaron en años recientes, reportándose usos inadecuados. Objetivo: determinar los patrones de prescripción-indicación y el análisis económico del sobrecoste por uso injustificado de antiulcerosos en un hospital de tercer nivel de atención en Colombia. Materiales y métodos: estudio de corte transversal, de prescripción-indicación de antiulcerosos en pacientes internados en el Hospital Universitario San Jorge de Pereira en julio 2012. Se determinaron: indicación adecuada o inadecuada del primer antiulceroso prescrito y del prescrito durante la hospitalización, apoyados en guías de práctica clínica del Grupo de Trabajo Sector Zaragoza I, del Departamento Gubernamental Australiano de la Salud y los criterios del Colegio Americano de Gastroenterología para profilaxis de úlceras de estrés. Se definió la dosis diaria definida por cama/día, se obtuvo el coste por 100 camas/día y costes de cada medicamento. Se hizo análisis multivariado mediante SPSS 21.0. Resultados: se analizaron 778 pacientes, 435 hombres (55,9 %) y 343 mujeres, edad promedio 56,6 ± 20,1 años. No tenían justificación para la prescripción del primer antiulceroso 377 pacientes (48,5 %), ni durante toda la hospitalización 336 pacientes (43,2 %). Ranitidina fue el más usado en 438 pacientes (56,3 %). El coste/mes por antiulcerosos no indicados fue 3.335,62 Euros. El coste anual estimado por inadecuada prescripción de antiulcerosos fue 16.770,0 Euros por 100 camas. Conclusión: se presentó una menor prescripción inadecuada de antiulcerosos en comparación con otros estudios, sin embargo sigue siendo alta y preocupante por los importantes costes en que incurre la institución para financiar medicamentos que no requieren los pacientes (AU)

Introduction: The prescription and costs of antiulcer medications for in-hospital use have increased during recent years with reported inadequate use and underused. Aim: To determine the patterns of prescription-indication and also perform an economic analysis of the overcost caused by the non-justified use of antiulcer medications in a third level hospital in Colombia. Materials and methods: Cross-sectional study of prescription-indication of antiulcer medications for patients hospitalized in "Hospital Universitario San Jorge" of Pereira during July of 2012. Adequate or inadequate prescription of the first antiulcer medication prescribed was determined as well as for others prescribed during the hospital stay, supported by clinical practice guidelines from the Zaragoza I sector workgroup, clinical guidelines from the Australian Health Department, and finally the American College of Gastroenterology Criteria for stress ulcer prophylaxis. Daily defined dose per bed/day was used, as well as the cost for 100 beds/day and the cost of each bed/drug. A multivariate analysis was carried out using SPSS 21.0. Results: 778 patients were analyzed, 435 men (55.9 %) and 343 women, mean age 56.6 ± 20.1 years. The number of patients without justification for the prescription of the first antiulcer medication was 377 (48.5 %), and during the whole in-hospital time it was 336 (43.2 %). Ranitidine was the most used medication, in 438 patients (56.3 %). The cost/month for poorly justified antiulcer medications was Euros 3,335.6. The annual estimated cost for inadequate prescriptions of antiulcer medications was Euros 16,770.0 per 100 beds. Conclusion: A lower inadequate prescription rate of antiulcer medications was identified compared with other studies; however it was still high and is troubling because of the major costs that these inadequate prescriptions generates for the institution (AU)