Fabíola Giordani

Adverse drug events among adult inpatients: a meta-analysis of observational studies

Studies in a number of countries have shown that adverse drug events (ADE) occur frequently among hospital inpatients. The objective of this study was to conduct a systematic review of observational studies of the frequency of ADE in adult inpatients and to examine factors associated with observed heterogeneity in the reported results.

Eventos adversos a medicamentos em hospital terciario: estudo piloto com rastreadores

OBJETIVO : Estimar la frecuencia y caracterizar los eventos adversos a medicamentos en hospital de cuidados terciarios. METODOS : Revision retrospectiva de 128 prontuarios de hospital de Rio de Janeiro, Brasil, en 2007, representando 2.092 pacientes. La herramienta utilizada fue una lista de rastreadores, como antidotos, analisis de laboratorio con resultados anormales, suspension brusca de medicacion y otros. Se extrajo muestra aleatoria simple de los pacientes con 15 anos o mas de edad. Se excluyeron pacientes oncologicos y de obstetricia, y los internados por menos de 48 horas o en la emergencia. Los pacientes con y sin eventos adversos a medicamentos fueron comparados con respecto a las caracteristicas sociales, demograficas y de enfermedades, para evaluar las diferencias entre los grupos. RESULTADOS : Cerca de 70,0% de los prontuarios presentaron por lo menos un rastreador. La capacidad de los rastreadores para identificar eventos adversos a medicamentos fue de 14,4%. La incidencia fue 26,6/100 pacientes. Se identificaron uno o mas eventos adversos a medicamentos en 15,6% de los pacientes. El tiempo mediano de permanencia hospitalaria fue de 35,2 dias para los pacientes con eventos adversos a medicamentos y 10,7 dias para los demas (p<0,01). Las clases de medicamentos mas involucrados fueron los que actuan sobre los sistemas cardiovascular y nervioso y los del tracto digestivo y metabolismo. Los farmacos mas imputados fueron: tramadol, dipirona, glibenclamida y furosemida. Del total de eventos, 82,0% contribuyeron o provocaron danos temporales en el paciente y demandaron intervencion y 6,0% pueden haber contribuido en el obito del paciente. Se estima que el hospital presente, anualmente, 131 eventos de somnolencia y lipotimia, 33 caidas y 33 hemorragias potencialmente asociados a los medicamentos. CONCLUSIONES : Aproximadamente 1/6 de los pacientes internados presento un evento adverso a medicamentos (16,0%). La herramienta estudiada puede ser util como tecnica de monitoreo y evaluacion del resultado de los cuidados a los pacientes internados. La revision de la terapia con psicotropicos merece ser realizada, dada la frecuencia de eventos asociados, como sedacion excesiva, letargo, caida e hipotension.OBJECTIVE To estimate the frequency of and to characterize the adverse drug events at a terciary care hospital. METHODS A retrospective review was carried out of 128 medical records from a hospital in Rio de Janeiro in 2007, representing 2,092 patients. The instrument used was a list of triggers, such as antidotes, abnormal laboratory analysis results and sudden suspension of treatment, among others. A simple random sample of patients aged 15 and over was extracted. Oncologic and obstetric patients were excluded as were those hospitalized for less than 48 hours or in the emergency room. Social and demographic characteristics and those of the disease of patients who underwent adverse events were compared with those of patients who did not in order to test for differences between the groups. RESULTS Around 70.0% of the medical records assessed showed at least one trigger. Adverse drug events triggers had an overall positive predictive value of 14.4%. The incidence of adverse drug events was 26.6 per 100 patients and 15.6% patients suffered one or more event. The median length of stay for patients suffering an adverse drug event was 35.2 days as against 10.7 days for those who did not (p < 0.01). The pharmacological classes most commonly associated with an adverse drug event were related to the cardiovascular system, nervous system and alimentary tract and metabolism. The most common active substances associated with an adverse drug event were tramadol, dypirone, glibenclamide and furosemide. Over 80.0% of events provoked or contributed to temporary harm to the patient and required intervention and 6.0% may have contributed to the death of the patient. It was estimated that in the hospital, 131 events involving drowsiness or fainting 33 involving falls, and 33 episodes of hemorrhage related to adverse drug effects occur annually. CONCLUSIONS Almost one-sixth of in-patients (16,0%) suffered an adverse drug event. The instrument used may prove useful as a technique for monitoring and evaluating patient care results. Psycothropic therapy should be critically appraised given the frequency of associated events, such as excessive sedation, lethargy, and hypotension.

Adverse drug events in hospital: pilot study with trigger tool

OBJETIVO : Estimar la frecuencia y caracterizar los eventos adversos a medicamentos en hospital de cuidados terciarios. METODOS : Revision retrospectiva de 128 prontuarios de hospital de Rio de Janeiro, Brasil, en 2007, representando 2.092 pacientes. La herramienta utilizada fue una lista de rastreadores, como antidotos, analisis de laboratorio con resultados anormales, suspension brusca de medicacion y otros. Se extrajo muestra aleatoria simple de los pacientes con 15 anos o mas de edad. Se excluyeron pacientes oncologicos y de obstetricia, y los internados por menos de 48 horas o en la emergencia. Los pacientes con y sin eventos adversos a medicamentos fueron comparados con respecto a las caracteristicas sociales, demograficas y de enfermedades, para evaluar las diferencias entre los grupos. RESULTADOS : Cerca de 70,0% de los prontuarios presentaron por lo menos un rastreador. La capacidad de los rastreadores para identificar eventos adversos a medicamentos fue de 14,4%. La incidencia fue 26,6/100 pacientes. Se identificaron uno o mas eventos adversos a medicamentos en 15,6% de los pacientes. El tiempo mediano de permanencia hospitalaria fue de 35,2 dias para los pacientes con eventos adversos a medicamentos y 10,7 dias para los demas (p<0,01). Las clases de medicamentos mas involucrados fueron los que actuan sobre los sistemas cardiovascular y nervioso y los del tracto digestivo y metabolismo. Los farmacos mas imputados fueron: tramadol, dipirona, glibenclamida y furosemida. Del total de eventos, 82,0% contribuyeron o provocaron danos temporales en el paciente y demandaron intervencion y 6,0% pueden haber contribuido en el obito del paciente. Se estima que el hospital presente, anualmente, 131 eventos de somnolencia y lipotimia, 33 caidas y 33 hemorragias potencialmente asociados a los medicamentos. CONCLUSIONES : Aproximadamente 1/6 de los pacientes internados presento un evento adverso a medicamentos (16,0%). La herramienta estudiada puede ser util como tecnica de monitoreo y evaluacion del resultado de los cuidados a los pacientes internados. La revision de la terapia con psicotropicos merece ser realizada, dada la frecuencia de eventos asociados, como sedacion excesiva, letargo, caida e hipotension.OBJECTIVE To estimate the frequency of and to characterize the adverse drug events at a terciary care hospital. METHODS A retrospective review was carried out of 128 medical records from a hospital in Rio de Janeiro in 2007, representing 2,092 patients. The instrument used was a list of triggers, such as antidotes, abnormal laboratory analysis results and sudden suspension of treatment, among others. A simple random sample of patients aged 15 and over was extracted. Oncologic and obstetric patients were excluded as were those hospitalized for less than 48 hours or in the emergency room. Social and demographic characteristics and those of the disease of patients who underwent adverse events were compared with those of patients who did not in order to test for differences between the groups. RESULTS Around 70.0% of the medical records assessed showed at least one trigger. Adverse drug events triggers had an overall positive predictive value of 14.4%. The incidence of adverse drug events was 26.6 per 100 patients and 15.6% patients suffered one or more event. The median length of stay for patients suffering an adverse drug event was 35.2 days as against 10.7 days for those who did not (p < 0.01). The pharmacological classes most commonly associated with an adverse drug event were related to the cardiovascular system, nervous system and alimentary tract and metabolism. The most common active substances associated with an adverse drug event were tramadol, dypirone, glibenclamide and furosemide. Over 80.0% of events provoked or contributed to temporary harm to the patient and required intervention and 6.0% may have contributed to the death of the patient. It was estimated that in the hospital, 131 events involving drowsiness or fainting 33 involving falls, and 33 episodes of hemorrhage related to adverse drug effects occur annually. CONCLUSIONS Almost one-sixth of in-patients (16,0%) suffered an adverse drug event. The instrument used may prove useful as a technique for monitoring and evaluating patient care results. Psycothropic therapy should be critically appraised given the frequency of associated events, such as excessive sedation, lethargy, and hypotension.

Interações medicamentosas potenciais entre medicamentos psicotrópicos dispensados

Objetivo Estimar a frequencia e caracterizar as interacoes medicamentosas potenciais entre farmacos psicotropicos sujeitos a controle especial pela portaria 344/98 da Agencia Nacional de Vigilância Sanitaria (Anvisa), os quais foram prescritos e dispensados em uma farmacia publica do Municipio de Cascavel, Parana. Metodos Estudo retrospectivo com desenho seccional foi realizado em uma Farmacia Publica Municipal. A amostra foi composta por prescricoes de medicamentos sujeitos a controle especial, dispensados entre primeiro de julho a 31 de agosto de 2010. As prescricoes retidas na farmacia foram analisadas retrospectivamente e as informacoes, coletadas. As interacoes medicamentosas potenciais foram identificadas em 824 prescricoes. Resultados As prescricoes eram na maioria para pacientes do sexo feminino e com idade entre 19 e 59 anos. Em relacao a especialidade do prescritor, 30,6% foram prescritas por psiquiatra. Em 77,9% das prescricoes identificou-se pelo menos uma interacao medicamentosa potencial. Foram descritas 54 diferentes interacoes medicamentosas potenciais, sendo 34 graves e 20 moderadas. Encontrou-se uma correlacao linear entre medicamentos prescritos e interacoes medicamentosas potenciais (p valor < 0,001). Conclusao O presente estudo identificou uma alta frequencia de interacoes medicamentosas potenciais envolvendo farmacos de controle especial e uma associacao positiva entre o numero de farmacos prescritos com a maior frequencia dessas interacoes.

Eventos adversos a medicamentos en hospital terciario: estudio piloto con rastreadores

OBJETIVO : Estimar la frecuencia y caracterizar los eventos adversos a medicamentos en hospital de cuidados terciarios. METODOS : Revision retrospectiva de 128 prontuarios de hospital de Rio de Janeiro, Brasil, en 2007, representando 2.092 pacientes. La herramienta utilizada fue una lista de rastreadores, como antidotos, analisis de laboratorio con resultados anormales, suspension brusca de medicacion y otros. Se extrajo muestra aleatoria simple de los pacientes con 15 anos o mas de edad. Se excluyeron pacientes oncologicos y de obstetricia, y los internados por menos de 48 horas o en la emergencia. Los pacientes con y sin eventos adversos a medicamentos fueron comparados con respecto a las caracteristicas sociales, demograficas y de enfermedades, para evaluar las diferencias entre los grupos. RESULTADOS : Cerca de 70,0% de los prontuarios presentaron por lo menos un rastreador. La capacidad de los rastreadores para identificar eventos adversos a medicamentos fue de 14,4%. La incidencia fue 26,6/100 pacientes. Se identificaron uno o mas eventos adversos a medicamentos en 15,6% de los pacientes. El tiempo mediano de permanencia hospitalaria fue de 35,2 dias para los pacientes con eventos adversos a medicamentos y 10,7 dias para los demas (p<0,01). Las clases de medicamentos mas involucrados fueron los que actuan sobre los sistemas cardiovascular y nervioso y los del tracto digestivo y metabolismo. Los farmacos mas imputados fueron: tramadol, dipirona, glibenclamida y furosemida. Del total de eventos, 82,0% contribuyeron o provocaron danos temporales en el paciente y demandaron intervencion y 6,0% pueden haber contribuido en el obito del paciente. Se estima que el hospital presente, anualmente, 131 eventos de somnolencia y lipotimia, 33 caidas y 33 hemorragias potencialmente asociados a los medicamentos. CONCLUSIONES : Aproximadamente 1/6 de los pacientes internados presento un evento adverso a medicamentos (16,0%). La herramienta estudiada puede ser util como tecnica de monitoreo y evaluacion del resultado de los cuidados a los pacientes internados. La revision de la terapia con psicotropicos merece ser realizada, dada la frecuencia de eventos asociados, como sedacion excesiva, letargo, caida e hipotension.OBJECTIVE To estimate the frequency of and to characterize the adverse drug events at a terciary care hospital. METHODS A retrospective review was carried out of 128 medical records from a hospital in Rio de Janeiro in 2007, representing 2,092 patients. The instrument used was a list of triggers, such as antidotes, abnormal laboratory analysis results and sudden suspension of treatment, among others. A simple random sample of patients aged 15 and over was extracted. Oncologic and obstetric patients were excluded as were those hospitalized for less than 48 hours or in the emergency room. Social and demographic characteristics and those of the disease of patients who underwent adverse events were compared with those of patients who did not in order to test for differences between the groups. RESULTS Around 70.0% of the medical records assessed showed at least one trigger. Adverse drug events triggers had an overall positive predictive value of 14.4%. The incidence of adverse drug events was 26.6 per 100 patients and 15.6% patients suffered one or more event. The median length of stay for patients suffering an adverse drug event was 35.2 days as against 10.7 days for those who did not (p < 0.01). The pharmacological classes most commonly associated with an adverse drug event were related to the cardiovascular system, nervous system and alimentary tract and metabolism. The most common active substances associated with an adverse drug event were tramadol, dypirone, glibenclamide and furosemide. Over 80.0% of events provoked or contributed to temporary harm to the patient and required intervention and 6.0% may have contributed to the death of the patient. It was estimated that in the hospital, 131 events involving drowsiness or fainting 33 involving falls, and 33 episodes of hemorrhage related to adverse drug effects occur annually. CONCLUSIONS Almost one-sixth of in-patients (16,0%) suffered an adverse drug event. The instrument used may prove useful as a technique for monitoring and evaluating patient care results. Psycothropic therapy should be critically appraised given the frequency of associated events, such as excessive sedation, lethargy, and hypotension.