Hospital medication errors in a pharmacovigilance system in Colombia.

OBJECTIVE: this study analyzes the medication errors reported to a pharmacovigilance system by 26 hospitals for patients in the healthcare system of Colombia. METHODS: this retrospective study analyzed the medication errors reported to a systematized database between 1 January 2008 and 12 September 2013. The medication is dispensed by the company Audifarma S.A. to hospitals and clinics around Colombia. Data were classified according to the taxonomy of the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP). The data analysis was performed using SPSS 22.0 for Windows, considering p-values < 0.05 significant. RESULTS: there were 9 062 medication errors in 45 hospital pharmacies. Real errors accounted for 51.9% (n = 4 707), of which 12.0% (n = 567) reached the patient (Categories C to I) and caused harm (Categories E to I) to 17 subjects (0.36%). The main process involved in errors that occurred (categories B to I) was prescription (n = 1 758, 37.3%), followed by dispensation (n = 1 737, 36.9%), transcription (n = 970, 20.6%) and administration (n = 242, 5.1%). The errors in the administration process were 45.2 times more likely to reach the patient (CI 95%: 20.2-100.9). CONCLUSIONS: medication error reporting systems and prevention strategies should be widespread in hospital settings, prioritizing efforts to address the administration process.

Objetivos: analizar los errores de medicacion reportados en un sistema de farmacovigilancia en 26 hospitales para pacientes del sistema de salud de Colombia. Métodos: estudio retrospectivo que evaluo las bases de datos sistematizadas de reportes de errores de medicacion entre el 1 de enero de 2008 y el 12 de septiembre de 2013 de los medicamentos dispensados por la empresa Audifarma S.A a hospitales de Colombia. Se utilizo la clasificacion taxonomica del National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP). El analisis de los datos se realizo mediante SPSS 22.0 para Windows Se determino como nivel de significacion estadistica una p < 0,05. Resultados: se reportaron 9.062 EM en 45 servicios farmaceuticos hospitalarios. El 51,9% (n = 4.707) de los errores realmente se produjeron, de los cuales el 12,0% (n = 567) afectaron al paciente (categorias C a I) y causaron dano (categorias E a I) a 17 (0,36%). El proceso implicado en los EM ocurridos (categorias B a I) con mayor frecuencia fue la prescripcion (n = 1.758, 37,3%), seguido por la dispensacion (n = 1.737, 36,9%), la transcripcion (n = 970, 20,6%) y, por ultimo, la administracion (n = 242, 5,1%). Los errores relacionados con los procesos de administracion aumentaban 45,2 veces el riesgo de que el medicamento erroneo afectara al paciente (IC 95% 20,2-100,9). Conclusiones: es necesario aumentar la cobertura de los sistemas de reporte de errores de medicacion, y crear estrategias para su prevencion, especialmente en la etapa de administracion del medicamento.

Hospital medication errors in a pharmacovigilance system in Colombia / Errores de medicación identificados por un sistema de farmacovigilancia de instituciones hospitalarias en Colombia

Objective: this study analyzes the medication errors reported to a pharmacovigilance system by 26 hospitals for patients in the healthcare system of Colombia. Methods: this retrospective study analyzed the medication errors reported to a systematized database between 1 January 2008 and 12 September 2013. The medication is dispensed by the company Audifarma S.A. to hospitals and clinics around Colombia. Data were classified according to the taxonomy of the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP). The data analysis was performed using SPSS 22.0 for Windows, considering p-values (AU)

Objetivos: analizar los errores de medicación reportados en un sistema de fármacovigilancia en 26 hospitales para pacientes del sistema de salud de Colombia. Métodos: estudio retrospectivo que evaluó las bases de datos sistematizadas de reportes de errores de medicación entre el 1 de enero de 2008 y el 12 de septiembre de 2013 de los medicamentos dispensados por la empresa Audifarma S.A a hospitales de Colombia. Se utilizó la clasificación taxonómica del National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP). El análisis de los datos se realizó mediante SPSS 22.0 para Windows Se determinó como nivel de significación estadística una p<0,05. Resultados: se reportaron 9.062 EM en 45 servicios farmacéuticos hospitalarios. El 51,9% (n=4.707) de los errores realmente se produjeron, de los cuales el 12,0% (n=567) afectaron al paciente (categorías C a I) y causaron daño (categorías E a I) a 17 (0,36%). El proceso implicado en los EM ocurridos (categorías B a I) con mayor frecuencia fue la prescripción (n=1.758, 37,3%), seguido por la dispensación (n=1.737, 36,9%), la transcripción (n=970, 20,6%) y, por último, la administración (n=242, 5,1%). Los errores relacionados con los procesos de administración aumentaban 45,2 veces el riesgo de que el medicamento erróneo afectara al paciente (IC 95% 20,2-100,9). Conclusiones: es necesario aumentar la cobertura de los sistemas de reporte de errores de medicación, y crear estrategias para su prevención, especialmente en la etapa de administración del medicamento (AU)

[Evolution of consumption of high-cost drugs in Colombia]. / Evolución del consumo de medicamentos de alto costo en Colombia.

OBJECTIVE: Determine the patterns of consumption of high-cost drugs (HCD) during the 2005-2010 period in a population of Colombian patients enrolled in the General System of Social Security in Health. METHODS: An observational descriptive study was conducted. The prescription data of formulas of any drug considered to be high-cost dispensed to all users (1 674 517) in 20 cities of Colombia between 2005 and 2010 were analyzed. The anatomical therapeutic classification was considered, and the number of patients as well as monthly invoicing for each drug, the daily dose defined, and the cost per 1 ;000 inhabitants/day were defined. RESULTS: Over the entire study period, the amount invoiced for HCDs increased by 847.4%. Antineoplastic and immunomodulator drugs accounted for 46.3% of the total invoicing. The other drugs were anti-infectives (15.2%), systemic hormonal preparations (9.5%), and drugs for the nervous system (9.1%). Most of these drugs were prescribed at the daily doses defined as recommended by the World Health Organization, but with high costs per 1000 inhabitants/day. CONCLUSIONS: In Colombia a crisis has occurred in recent years due to the high spending generated by the most expensive drugs. The progressive growth of pharmaceutical spending is greater than the increased coverage by the country's health system. The Colombian health system should evaluate how much it is willing to pay for the most expensive drugs for some diseases and what strategies should be implemented to cover these expenses and thus guarantee access to the insured.

Evolución del consumo de medicamentos de alto costo en Colombia / Evolution of consumption of high-cost drugs in Colombia

Objective. Determine the patterns of consumption of high-cost drugs (HCD) during the 2005–2010 period in a population of Colombian patients enrolled in the General System of Social Security in Health. Methods. An observational descriptive study was conducted. The prescription dataof formulas of any drug considered to be high-cost dispensed to all users (1 674 517) in 20 cities of Colombia between 2005 and 2010 were analyzed. The anatomical therapeutic classification was considered, and the number of patients as well as monthly invoicing for each drug, the daily dose defined, and the cost per 1 000 inhabitants/day were defined. Results. Over the entire study period, the amount invoiced for HCDs increased by 847.4%. Antineoplastic and immunomodulator drugs accounted for 46.3% of the totalinvoicing. The other drugs were anti-infectives (15.2%), systemic hormonal preparations (9.5%), and drugs for the nervous system (9.1%). Most of these drugs were prescribed at the daily doses defined as recommended by the World Health Organization, but with high costs per 1 000 inhabitants/day. Conclusions. In Colombia a crisis has occurred in recent years due to the high spending generated by the most expensive drugs. The progressive growth of pharmaceutical spending is greater than the increased coverage by the country’s health system. The Colombian health system should evaluate how much it is willing to pay for the most expensive drugs for some diseases and what strategies should be implemented to cover these expenses and thus guarantee access to the insured.

Objetivo. Determinar el comportamiento del consumo de medicamentos de alto costo (MAC) durante 2005–2010 en una población de pacientes colombianos afiliados al Sistema General de Seguridad Social en Salud. Métodos. Estudio descriptivo observacional; se analizaron datos de prescripción de fórmulas dispensadas desde 2005 a 2010 a todos los usuarios (1 674 517) de algún medicamento considerado de alto costo en 20 ciudades de Colombia. Se consideró la clasificación anatómicaterapéutica y el número de pacientes, así como la facturación mensual por cada medicamento, la dosis diaria definida y el costo por 1 000 habitantes/día. Resultados. En todo el período de estudio, el valor facturado por MAC creció 847,4%. Losantineoplásicos e inmunomoduladores constituyeron 46,3% del total facturado, antinfecciosos 15,2%, preparaciones hormonales sistémicas 9,5% y fármacos para el sistema nervioso 9,1%. La mayoría de estos medicamentos fueron prescritos a las dosis diarias definidas recomendadaspor la Organización Mundial de Salud, pero con altos costos por 1 000 habitantes y día. Conclusiones. En Colombia durante los últimos años se ha presentado una crisis debida al elevado gasto generado por los medicamentos más costosos. El crecimiento progresivo del gasto farmacéutico es mayor que el aumento de la cobertura del sistema sanitario del país. El sistema sanitario colombiano debe evaluar cuánto está dispuesto a pagar por los medicamentosmás costosos para algunas morbilidades y qué estrategias debe implementar para sufragar estos gastos y así garantizar el acceso a los asegurados.

[Antidiabetic drugs prescription patterns among a group of patients in Colombia]. / Patrones de prescripción de antidiabéticos en un grupo de pacientes colombianos.

OBJECTIVES: To identify prescription patterns for diabetes treatment among a group of individuals covered by Colombia's universal health care, the General System for Social Security in Health (SGSSS). METHODS: The study included 7 308 patients covered by SGSSS who had diabetes mellitus type 1 or 2, were of either sex, any age, and had been undergoing treatment for at least three months (May-July 2005) in 19 cities in Colombia. A database was compiled from the medication usage records maintained by the dispensing pharmacy. Data were analyzed using SPSS 13.0 (SPSS Inc., Chicago, Illinois, United States of America). Student's t-test and analysis of variance (ANOVA) were employed to compare quantitative variables, and the chi-square test was applied to compare categorical variables. RESULTS: The patients' mean age was 60.7 +/- 12.7 years. Women made up 56.6% of the group and had a mean age significantly higher than that of the men (P < 0.05). Forty-eight percent of the group had been prescribed one diabetes medication, while 52% had been prescribed from two to four. The medications prescribed were: biguanides (67.5%), sulphonylureas (64.9%), insulin (23.5%), and thiazolidinediones (0.1%). The most common oral combination-therapies were: glibenclamide and metformin (n = 2 847), metformin and insulin (n = 510), glibenclamide and insulin (n = 148), and metformin, insulin, and glibenclamide (n = 288). Of the total, 94.3% had comorbid conditions for which they had been prescribed medication: antihypertensive drugs (in 74.4% of the cases), anti-inflammatories (61.5%), hypolipemiants (45.5%), antiulcer medications (21.0%), psychoactive drugs (16.8%), antimicrobials (14.4%), asthma medication (5.3%), and salicylic acid (2.8%). Prescriptions for comorbid conditions were more common among women than men (95.6% vs. 92.7%, P < 0.001). Undertreatment with certain medications (metformin, thiazolidinediones, alpha-glucosidase inhibitors, and salicylic acid), and overtreatment with others (antiulcer drugs), probably exist. CONCLUSIONS: There are significant differences in oral therapies prescribed for diabetes across the 19 cities studied, but overall, prescription patterns are appropriate. Educational strategies should be developed to address those prescribing practices that are not appropriate, and the clinical results of the medications studied should be explored.