Adaptación transcultural del componente de síntomas gastrointestinales de la escala CTCAE versión 4. 02 / Transcultural adaptation of the component of gastrointestinal symptoms of the CTCAE scale version 4. 02

Resumen Objetivo: Realizar la traducción y adaptación transcultural del componente de síntomas gastrointestinales (SGI) de la escala CTCAE versión 4.02 en pacientes ambulatorios tratados con quimioterapia en el Instituto Nacional de Cancerología en Bogotá. Métodos: Se realizó una búsqueda manual en medios electrónicos de escalas en idioma inglés o español que evaluarán la presencia, frecuencia o intensidad de SGI en pacientes oncológicos. La selección de los ítems fue efectuada por consenso informal de un comité técnico, el cual verificó la concordancia entre los principales SGI descritos en la literatura y los incluidos en la escala, ya que estos podrían afectar el estado nutricional. Posteriormente, para la adaptación transcultural, se siguieron los pasos y recomendaciones del manual ISPOR y del grupo de calidad de vida EORTC. La prueba piloto se efectuó en 30 pacientes seleccionados por conveniencia, quienes cumplieron los criterios de inclusión. Resultados: El 52% eran hombres; la edad promedio fue de 54,2 años (+/- 15,3 años). Los cánceres más frecuentes fueron: colorrectal (28%), estómago (16%) y mama (12%). Los 14 SGI incluidos en la escala fueron experimentados por todos los pacientes, por lo cual se conservaron, y no se requirió adicionar ningún otro. El tiempo promedio de aplicación del instrumento fue de 5 minutos y el 90% de los participantes lo consideró adecuado. Conclusiones: Se generó un instrumento de 14 ítems para medir SGI en pacientes oncológicos ambulatorios sometidos a quimioterapia, el cual es de rápida aplicación y utiliza lenguaje de fácil comprensión para el paciente. Aunque todavía quedan por definir sus propiedades clinimétricas.

Abstract Objective: To carry out the translation and transcultural adaptation of the gastrointestinal symptoms component (GIS) of the CTCAE, scale version 4.02, in outpatient patients treated with chemotherapy at the National Cancer Institute, Bogotá (Colombia). Methods: It was performed a manual search of scales on electronic media, in English or Spanish languages, which will evaluate the presence and intensity of GIS in oncological patients. The selection of the items was made by an informal consensus of a technical committee, which verified the concordance between the main GIS described in the literature and those included in the scale, all of which could affect the nutritional status. For transcultural adaptation, there were followed the steps and recommendations of the ISPOR Handbook, as well as those of the EORTC quality of life group. The pilot test was conducted in 30 patients selected for convenience, who met the inclusion criteria. Results: 52% were men; the average age was 54.2 years (+/-15.3 years). The most frequent cancers were: colorectal (28%), stomach (16%) and breast (12%). The 14 GIS included in the scale were experienced by all patients, so they were retained, and no other addition was required. The average time of application of the instrument was 5 minutes, and 90% of the participants considered it appropriate. Conclusions: A 14-item instrument was generated to measure GIS in cancer patients who undergo outpatient chemotherapy, which is of fast application and uses a language that is easily understood by patients. Its clinimetrics properties remain to be defined.

Evaluation of a method for drug-related problems identification and classification in hospital setting: applicability and reliability.

Background Prescription evaluation by pharmacists has potential to improve pharmacotherapy management. It requires the use of robust methods to identify drug-related problems (DRP), which are important issues in pharmacotherapy. Objective To evaluate the applicability and reliability of Grupo de Investigação em Cuidados Farmacêuticos (GIGUF) method for prescription analysis, identification and classification of drug-related problems in inpatients prescriptions. Setting Department of Medical Clinic of a tertiary and teaching Brazilian hospital. Method An observational and retrospective study of identification and classification of drug-related problems. GIGUF method was used to evaluate prescriptions of hematological patients hospitalized between August and October 2015. The problems were categorized using GICUF-method classification. Three pharmacists performed inter-rater agreement analysis of the method using Kappa. Differences in prevalence of DRP was calculated by age, sex, pharmacotherapy complexity, length of stay and number of drugs. Main outcome measure (a) frequency and characteristics and (b) inter-rater agreement in identification and classification of the drug-related problems. Results A total of 211 problems were identified and 'inadequate dosing' was the most common problem. There was an association between the occurence of a drug-reklated problem and complexity of pharmacotherapy (p = 0.001) and number of drugs used (p = 0.010). The overall inter-rater agreement was moderate (k = 0.44 IC 95% 0.34-0.55) and the problem 'not suitable drug' (k = 0.55 IC 95% 0.44-0.66) had greater inter-rater agreement. Conclusion The method "Evaluation Drug Use Process" was useful for prescription analysis since it made the identification and classification of DRPs possible. The method demonstrated a moderate inter-rater agreement, and can contribute to pharmacotherapy management by hospital pharmacists.

Trends of drug-related poisoning cases attended to at a poison control center. / Tendências de eventos toxicológicos relacionados a medicamentos atendidos por um Centro de Informações Toxicológicas.

INTRODUCTION: Drug-related poisonings have a high impact on morbidity and mortality, representing the first cause of intoxication in Brazil. OBJECTIVE: To describe the trends of cases of drug-related poisonings attended to by a poison control center. METHOD: A quantitative approach (cross-sectional trend study) with data analysis of cases of drug-related poisonings attended to at the Poison Control Center of University Hospital of the State University of Londrina. Data were collected from service notification records for the period 1985 to 2014. For statistical analysis, a simple linear regression model was used. RESULTS: Of the 36,707 cases attended to by the service, 22.5% (n = 8,608) were drug-related poisonings. There was an increase in the proportion of cases for both sexes (R2 = 0.195, p = 0.014) and males (R2 = 0.403, p < 0.001). There was a trend towards a higher proportion of cases involving the analgesic, anti-inflammatory and immunosuppressive drug classes (R2 = 0.521, p = 0.018), antidepressants (R2 = 0.923, p < 0.001) and antipsychotics (R2 = 0.869; p < 0.001). Antibiotics showed a trend toward a lower proportion of cases (R2 = 0.773, p = 0.001). CONCLUSIONS: There was a trend for a higher proportion of cases of drug-related poisonings in males. Also, there was an increased trend towards cases involving analgesics/anti-inflammatories/immunosuppressants, antidepressants and antipsychotics.

INTRODUÇÃO: Os eventos toxicológicos relacionados a medicamentos têm alto impacto na morbimortalidade, representando a primeira causa de intoxicação no Brasil. OBJETIVO: Descrever as tendências de casos de eventos toxicológicos relacionados a medicamentos atendidos por um Centro de Informações Toxicológicas. MÉTODO: Estudo com abordagem quantitativa (transversal e de tendência), com análise dos dados referentes aos casos de eventos toxicológicos relacionados a medicamentos atendidos pelo Centro de Informações Toxicológicas do Hospital Universitário da Universidade Estadual de Londrina. Os dados foram coletados das fichas de atendimento, referentes ao período de 1985 a 2014. Para a análise estatística, utilizou-se um modelo de regressão linear simples. RESULTADOS: Dos 36.707 casos atendidos pelo serviço, 22,5% (n = 8.608) foram eventos toxicológicos relacionados a medicamentos. Houve um aumento da proporção de casos em ambos os sexos (R2 = 0,195; p = 0,014) e no sexo masculino (R2 = 0,403; p < 0,001). Detectou-se tendência de elevação da proporção de casos envolvendo a classe de analgésicos, anti-inflamatórios e imunossupressores (R2 = 0,521; p = 0,018), antidepressivos (R2 = 0,923; p < 001) e antipsicóticos (R2 = 0,869; p < 0,001). Os antimicrobianos apresentaram tendência de redução da proporção de casos (R2 = 0,773; p = 0,001). CONCLUSÕES: Observou-se tendência de aumento da proporção de casos de eventos toxicológicos relacionados a medicamentos no sexo masculino. Também houve aumento nas tendências envolvendo analgésicos/anti-inflamatórios/imunossupressores, antidepressivos e antipsicóticos.

Tendências de eventos toxicológicos relacionados a medicamentos atendidos por um Centro de Informações Toxicológicas / Trends of drug-related poisoning cases attended to at a poison control center

RESUMO: Introdução: Os eventos toxicológicos relacionados a medicamentos têm alto impacto na morbimortalidade, representando a primeira causa de intoxicação no Brasil. Objetivo: Descrever as tendências de casos de eventos toxicológicos relacionados a medicamentos atendidos por um Centro de Informações Toxicológicas. Método: Estudo com abordagem quantitativa (transversal e de tendência), com análise dos dados referentes aos casos de eventos toxicológicos relacionados a medicamentos atendidos pelo Centro de Informações Toxicológicas do Hospital Universitário da Universidade Estadual de Londrina. Os dados foram coletados das fichas de atendimento, referentes ao período de 1985 a 2014. Para a análise estatística, utilizou-se um modelo de regressão linear simples. Resultados: Dos 36.707 casos atendidos pelo serviço, 22,5% (n = 8.608) foram eventos toxicológicos relacionados a medicamentos. Houve um aumento da proporção de casos em ambos os sexos (R2 = 0,195; p = 0,014) e no sexo masculino (R2 = 0,403; p < 0,001). Detectou-se tendência de elevação da proporção de casos envolvendo a classe de analgésicos, anti-inflamatórios e imunossupressores (R2 = 0,521; p = 0,018), antidepressivos (R2 = 0,923; p < 001) e antipsicóticos (R2 = 0,869; p < 0,001). Os antimicrobianos apresentaram tendência de redução da proporção de casos (R2 = 0,773; p = 0,001). Conclusões: Observou-se tendência de aumento da proporção de casos de eventos toxicológicos relacionados a medicamentos no sexo masculino. Também houve aumento nas tendências envolvendo analgésicos/anti-inflamatórios/imunossupressores, antidepressivos e antipsicóticos.

ABSTRACT: Introduction: Drug-related poisonings have a high impact on morbidity and mortality, representing the first cause of intoxication in Brazil. Objective: To describe the trends of cases of drug-related poisonings attended to by a poison control center. Method: A quantitative approach (cross-sectional trend study) with data analysis of cases of drug-related poisonings attended to at the Poison Control Center of University Hospital of the State University of Londrina. Data were collected from service notification records for the period 1985 to 2014. For statistical analysis, a simple linear regression model was used. Results: Of the 36,707 cases attended to by the service, 22.5% (n = 8,608) were drug-related poisonings. There was an increase in the proportion of cases for both sexes (R2 = 0.195, p = 0.014) and males (R2 = 0.403, p < 0.001). There was a trend towards a higher proportion of cases involving the analgesic, anti-inflammatory and immunosuppressive drug classes (R2 = 0.521, p = 0.018), antidepressants (R2 = 0.923, p < 0.001) and antipsychotics (R2 = 0.869; p < 0.001). Antibiotics showed a trend toward a lower proportion of cases (R2 = 0.773, p = 0.001). Conclusions: There was a trend for a higher proportion of cases of drug-related poisonings in males. Also, there was an increased trend towards cases involving analgesics/anti-inflammatories/immunosuppressants, antidepressants and antipsychotics.

Adverse drug events identified in hospitalized patients in Brazil by International Classification of Diseases (ICD-10) code listings.

Studies of adverse drug events (ADEs) are important in order not to jeopardize the positive impact of pharmacotherapy. These events have substantial impact on the population morbidity profiles, and increasing health system operating costs. Administrative databases are an important source of information for public health purposes and for identifying ADEs. In order to contribute to learning about ADE in hospitalized patients, this study examined the potential of applying ICD-10 (10th revision of the International Classification of Diseases) codes to a national database of the public health care system (SIH-SUS). The study comprised retrospective assessment of ADEs in the SIH-SUS administrative database, from 2008 to 2012. For this, a list of ICD-10 codes relating to ADEs was built. This list was built up by examining lists drawn up by other authors identified by bibliographic search in the MEDLINE and LILACS and consultations with experts. In Brazil, 55,604,537 hospital admissions were recorded in the SIH-SUS, between 2008 and 2012, of which 273,440 (0.49%) were related to at least one ADE. The proportions and rates seem to hold constant over the study period. Fourteen out of 20 most frequent ADEs were identified in codes relating to mental disorders. Intoxications figure as the second most frequently recorded group of ADEs in the SIH-SUS, comprising 76,866 hospitalizations. Monitoring of ADEs in administrative databases using ICD-10 codes is feasible, even in countries with information systems under construction, and can be an innovative tool to complement drug surveillance strategies in place in Brazil, as well as in others countries.

Vigilancia de eventos supuestamente atribuidos a la vacunación o inmunización (ESAVI) durante el año 2017 / Surveillance of events supposedly attributed to vaccination or immunization (ESAVI) during 2017

Los Eventos Supuestamente Atribuidos a la Vacunación o Inmunización o ESAVI se definen como todo cuadro clínico que aparece luego de la administración de una vacuna y que supuestamente pueda atribuirse a la misma. Incluye los errores programáticos relacionados con la vacunación. Un ESAVI grave es todo aquel evento que resulte en hospitalización o fallecimiento. Es importante mencionar que un ESAVI, si bien denota una asociación temporal, no implica necesariamente una relación de causa y efecto. La causalidad entre el evento y la vacunación se determinará mediante la investigación del caso. La información aquí presentada surge del análisis de la base de datos de ESAVI del Programa de Inmunizaciones de la Ciudad de Buenos Aires, alimentada por las notificaciones realizadas por efectores públicos y privados de la ciudad. Se incluyen residentes y no residentes de la ciudad, sin realizar distinción entre ellos. Para calcular las tasas se utilizó como denominador las dosis aplicadas en 2017 en la Ciudad de Buenos Aires, tanto a residentes como no residentes. Se cuenta con datos de aquellas vacunas incluidas en el Calendario Nacional de Vacunación del sector público, de la seguridad social y privado. (AU)

Prevalence and characteristics of adverse drug events in Brazil. / Prevalência e características dos eventos adversos a medicamentos no Brasil.

The aim of this study was to describe the prevalence of adverse drug events (ADEs) and associated factors reported by users of medicines in Brazil. This was a cross-sectional population-based study conducted from September 2013 to February 2014 with data from the Brazilian National Survey on Access, Use, and Promotion of Rational Use of Medicines (PNAUM). The study included all individuals that reported the use of medicines and identified, among them, all those reporting at least one problem with the medicine's use. A descriptive analysis was performed to estimate ADE prevalence and 95% confidence intervals (95%CI) among the target variables. Crude and adjusted prevalence ratios were calculated using Poisson regression to investigate factors associated with ADEs. Overall ADE prevalence in Brazil was 6.6% (95%CI: 5.89-7.41), and after multivariate analysis, higher prevalence was associated with female gender, residence in the Central and Northeast regions, consumption of more medicines, "bad" self-rated health, and self-medication. The drugs most frequently reported with ADEs were fluoxetine, diclofenac, and amitriptyline. The most frequent ADEs were somnolence, epigastric pain, and nausea. Most reported ADEs were mild, avoidable, and associated with medicines used frequently by the population. The study provided knowledge on the size of the problem with use of medicines in Brazil.

O presente trabalho tem como objetivo descrever a prevalência e fatores associados a eventos adversos a medicamentos (EAM) referidos por usuários de medicamentos no Brasil. Trata-se de um estudo transversal de base populacional, realizado no período de setembro de 2013 a fevereiro de 2014, com dados coletados na Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos (PNAUM). Foram consideradas todas as pessoas que referiram o uso de medicamentos; entre elas, foram identificadas as que referiram pelo menos um problema com o uso do medicamento. Realizou-se uma análise descritiva para estimar a prevalência e os intervalos de 95% de confiança (IC95%) de EAM entre as variáveis estudadas, e foram calculadas as razões de prevalência bruta e ajustada, pela regressão de Poisson, na investigação dos fatores associados aos EAM. A prevalência de EAM no Brasil foi de 6,6% (IC95%: 5,89-7,41), sendo maior e estatisticamente significante após a realização da análise multivariada, entre pessoas do sexo feminino; residentes nas regiões Centro-oeste e Nordeste; que consumiam maior número de medicamentos; que percebiam seu estado de saúde como "ruim"; e que se automedicavam. Os EAM foram mais relatados para os medicamentos fluoxetina, diclofenaco e amitriptilina. Os EAM mais referidos pelos entrevistados foram sonolência, dor epigástrica e náuseas. Os EAM mais referidos pelos entrevistados foram de natureza leve, considerados evitáveis e estiveram associados a medicamentos de uso frequente pela população. Em razão desse estudo, foi possível conhecer a dimensão do problema ocasionado pelo uso de medicamentos no Brasil.

El presente trabajo tiene como objetivo describir la prevalencia y factores asociados a eventos adversos con medicamentos (EAM), informados por usuarios de medicamentos en Brasil. Se trata de un estudio transversal de base poblacional, realizado durante el período de septiembre de 2013 a febrero de 2014, con datos recogidos en la Encuesta Nacional sobre el Acceso, Utilización y Promoción del Uso Racional de Medicamentos en Brasil (PNAUM). Se consideraron a todas las personas que informaron del uso de medicamentos; entre ellas, se identificaron a las que informaron de por lo menos un problema con el uso del medicamento. Se realizó un análisis descriptivo para estimar la prevalencia y los intervalos de confianza a 95% (IC95%) de EAM entre las variables estudiadas, y se calcularon las razones de prevalencia bruta y ajustada, por la regresión de Poisson, en la investigación de los factores asociados a los EAM. La prevalencia de EAM en Brasil fue de un 6,6% (IC95%: 5,89-7,41), siendo mayor y estadísticamente significante tras la realización del análisis multivariado, entre personas del sexo femenino; residentes en las regiones Centro-Oeste y Nordeste; que consumían un mayor número de medicamentos; que percibían su estado de salud como "malo"; y que se automedicaban. Se informaron de más EAM en medicamentos como: fluoxetina, diclofenaco y amitriptilina. Los EAM más referidos por los entrevistados fueron somnolencia, dolor epigástrico y náuseas. Los EAM más referidos por los entrevistados fueron de naturaleza leve, considerados evitables y estuvieron asociados a medicamentos de uso frecuente por la población. Con motivo de este estudio, fue posible conocer la dimensión del problema ocasionado por el uso de medicamentos en Brasil.

Prevalência e características dos eventos adversos a medicamentos no Brasil / Prevalencia y características de los eventos adversos con medicamentos en Brasil / Prevalence and characteristics of adverse drug events in Brazil

Resumo: O presente trabalho tem como objetivo descrever a prevalência e fatores associados a eventos adversos a medicamentos (EAM) referidos por usuários de medicamentos no Brasil. Trata-se de um estudo transversal de base populacional, realizado no período de setembro de 2013 a fevereiro de 2014, com dados coletados na Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos (PNAUM). Foram consideradas todas as pessoas que referiram o uso de medicamentos; entre elas, foram identificadas as que referiram pelo menos um problema com o uso do medicamento. Realizou-se uma análise descritiva para estimar a prevalência e os intervalos de 95% de confiança (IC95%) de EAM entre as variáveis estudadas, e foram calculadas as razões de prevalência bruta e ajustada, pela regressão de Poisson, na investigação dos fatores associados aos EAM. A prevalência de EAM no Brasil foi de 6,6% (IC95%: 5,89-7,41), sendo maior e estatisticamente significante após a realização da análise multivariada, entre pessoas do sexo feminino; residentes nas regiões Centro-oeste e Nordeste; que consumiam maior número de medicamentos; que percebiam seu estado de saúde como "ruim"; e que se automedicavam. Os EAM foram mais relatados para os medicamentos fluoxetina, diclofenaco e amitriptilina. Os EAM mais referidos pelos entrevistados foram sonolência, dor epigástrica e náuseas. Os EAM mais referidos pelos entrevistados foram de natureza leve, considerados evitáveis e estiveram associados a medicamentos de uso frequente pela população. Em razão desse estudo, foi possível conhecer a dimensão do problema ocasionado pelo uso de medicamentos no Brasil.

Resumen: El presente trabajo tiene como objetivo describir la prevalencia y factores asociados a eventos adversos con medicamentos (EAM), informados por usuarios de medicamentos en Brasil. Se trata de un estudio transversal de base poblacional, realizado durante el período de septiembre de 2013 a febrero de 2014, con datos recogidos en la Encuesta Nacional sobre el Acceso, Utilización y Promoción del Uso Racional de Medicamentos en Brasil (PNAUM). Se consideraron a todas las personas que informaron del uso de medicamentos; entre ellas, se identificaron a las que informaron de por lo menos un problema con el uso del medicamento. Se realizó un análisis descriptivo para estimar la prevalencia y los intervalos de confianza a 95% (IC95%) de EAM entre las variables estudiadas, y se calcularon las razones de prevalencia bruta y ajustada, por la regresión de Poisson, en la investigación de los factores asociados a los EAM. La prevalencia de EAM en Brasil fue de un 6,6% (IC95%: 5,89-7,41), siendo mayor y estadísticamente significante tras la realización del análisis multivariado, entre personas del sexo femenino; residentes en las regiones Centro-Oeste y Nordeste; que consumían un mayor número de medicamentos; que percibían su estado de salud como "malo"; y que se automedicaban. Se informaron de más EAM en medicamentos como: fluoxetina, diclofenaco y amitriptilina. Los EAM más referidos por los entrevistados fueron somnolencia, dolor epigástrico y náuseas. Los EAM más referidos por los entrevistados fueron de naturaleza leve, considerados evitables y estuvieron asociados a medicamentos de uso frecuente por la población. Con motivo de este estudio, fue posible conocer la dimensión del problema ocasionado por el uso de medicamentos en Brasil.

Abstract: The aim of this study was to describe the prevalence of adverse drug events (ADEs) and associated factors reported by users of medicines in Brazil. This was a cross-sectional population-based study conducted from September 2013 to February 2014 with data from the Brazilian National Survey on Access, Use, and Promotion of Rational Use of Medicines (PNAUM). The study included all individuals that reported the use of medicines and identified, among them, all those reporting at least one problem with the medicine's use. A descriptive analysis was performed to estimate ADE prevalence and 95% confidence intervals (95%CI) among the target variables. Crude and adjusted prevalence ratios were calculated using Poisson regression to investigate factors associated with ADEs. Overall ADE prevalence in Brazil was 6.6% (95%CI: 5.89-7.41), and after multivariate analysis, higher prevalence was associated with female gender, residence in the Central and Northeast regions, consumption of more medicines, "bad" self-rated health, and self-medication. The drugs most frequently reported with ADEs were fluoxetine, diclofenac, and amitriptyline. The most frequent ADEs were somnolence, epigastric pain, and nausea. Most reported ADEs were mild, avoidable, and associated with medicines used frequently by the population. The study provided knowledge on the size of the problem with use of medicines in Brazil.

Adverse drug events identified in hospitalized patients in Brazil by International Classification of Diseases (ICD-10) code listings / Eventos adversos a medicamentos identificados em pacientes hospitalizados no Brasil de acordo com códigos da Classificação Internacional de Doenças (CID-10) / Eventos Adversos por Medicamentos identificados en pacientes hospitalizados en Brasil según los listados de códigos de la Clasificación Internacional de Enfermedades (CIE-10)

Studies of adverse drug events (ADEs) are important in order not to jeopardize the positive impact of pharmacotherapy. These events have substantial impact on the population morbidity profiles, and increasing health system operating costs. Administrative databases are an important source of information for public health purposes and for identifying ADEs. In order to contribute to learning about ADE in hospitalized patients, this study examined the potential of applying ICD-10 (10th revision of the International Classification of Diseases) codes to a national database of the public health care system (SIH-SUS). The study comprised retrospective assessment of ADEs in the SIH-SUS administrative database, from 2008 to 2012. For this, a list of ICD-10 codes relating to ADEs was built. This list was built up by examining lists drawn up by other authors identified by bibliographic search in the MEDLINE and LILACS and consultations with experts. In Brazil, 55,604,537 hospital admissions were recorded in the SIH-SUS, between 2008 and 2012, of which 273,440 (0.49%) were related to at least one ADE. The proportions and rates seem to hold constant over the study period. Fourteen out of 20 most frequent ADEs were identified in codes relating to mental disorders. Intoxications figure as the second most frequently recorded group of ADEs in the SIH-SUS, comprising 76,866 hospitalizations. Monitoring of ADEs in administrative databases using ICD-10 codes is feasible, even in countries with information systems under construction, and can be an innovative tool to complement drug surveillance strategies in place in Brazil, as well as in others countries.

Os estudos sobre eventos adversos a medicamentos (EAMs) são importantes para evitar de prejudicar o efeito positivo da farmacoterapia. Os EAMs têm impacto substancial nos perfis de morbidade da população e no aumento dos custos operacionais do sistema de saúde. As bases de dados administrativos representam uma fonte de informação importante para fins de saúde pública em geral e especificamente para identificar os EAMs. No intuito de contribuir para o conhecimento sobre EAMs em pacientes hospitalizados, o estudo examinou a aplicabilidade dos códigos da CID-10 (10ª revisão da Classificação Internacional de Doenças) ao Sistema de Informações Hospitalares do Sistema Único de Saúde (SIH-SUS). O estudo integrou uma avaliação retrospectiva de dados administrativos do SIH-SUS referentes aos anos de 2008 a 2012. Para tanto, foi elaborada uma lista de códigos da CID-10 relacionados a EAMs. A lista foi produzida a partir de uma consulta às listas projetadas por outros autores e identificadas através de uma busca em MEDLINE e LILACS e consultas com especialistas. No Brasil, foram registradas 55.604.537 internações hospitalares no SIH-SUS entre 2008 e 2012, das quais 273.440 (0,49%) estiveram relacionadas a pelo menos um EAM. As proporções e taxas de EAMs permaneceram constantes ao longo do período estudado. Quatorze dos vinte EAMs mais frequentes foram identificados através de códigos relacionados a transtornos psiquiátricos. As intoxicações figuram como o segundo grupo mais frequente de EAMs registrados no SIH-SUS, com 76.866 internações. O monitoramento dos EAMs com o uso dos códigos da CID-10 mostrou ser uma metodologia viável, mesmo em países com sistemas de informação ainda incompletos, e pode ser uma ferramenta inovadora para complementar as estratégias atuais de vigilância farmacológica no Brasil, assim como, em outros países.

Los estudios sobre eventos adversos por medicamentos (EAMs) son importantes, para no comprometer el impacto positivo de la farmacoterapia. Estos eventos tienen un impacto sustancial en los perfiles de morbilidad de la población e incrementan los costes operativos del sistema de salud. Las bases de datos administrativas son una importante fuente de información por motivos de salud pública y para identificar EAMs. Con el fin de contribuir al aprendizaje sobre EAM en pacientes hospitalizados, este estudio examinó el potencial de aplicar códigos CIE-10 (10ª revisión de la Clasificación Internacional de Enfermedades) a una base datos nacional del sistema de salud público (SIH-SUS). Este estudio estuvo constituido por una evaluación retrospectiva de EAMs, en la base de datos administrativa del SIH-SUS, desde 2008 a 2012. Para ello, se desarrolló la lista de la CIE-10 con códigos para EAMs. Esta lista se creó examinando listas diseñadas por otros autores, identificados a través de búsquedas bibliográficas en MEDLINE, LILACS y consultas con expertos. En Brasil, se registraron 55.604.537 admisiones hospitalarias en el SIH-SUS, entre 2008 y 2012, de las cuales 273.440 (0,49%) sufrieron al menos un EAM. Los porcentajes y tasas parecieron mantenerse constantes durante el periodo de estudio. Catorce de los 20 más frecuentes EAMs fueron identificados con códigos relacionados con enfermedades mentales. Las intoxicaciones fueron el segundo grupo registrado más común de EAMs en el SIH-SUS, representando 76.866 hospitalizaciones. La supervisión de EAMs en las bases de datos administrativas, usando los códigos CIE-10, es factible, incluso en países cuyos sistemas de información se encuentran en proceso de construcción, y puede ser un herramienta innovadora como complemento de las actuales estrategias de supervisión sobre medicamentos en Brasil, así como en otros países.

Treatment interruption of biological drugs and tofacitinib in rheumatoid arthritis: A systematic review of case reports

The aim of this study was to evaluate interruption of treatment with biological drugs and tofacitinib due to adverse events in patients with rheumatoid arthritis. A systematic review was performed in the electronic databases MEDLINE, Cochrane, Scopus, CRD, IPA, Lilacs and Scielo. Case reports addressing interruption of treatment due to any adverse event related to abatacept (ABA), adalimumab (ADA), anakinra (ANA), certolizumab pegol (CER), etanercept (ETA), golimumab (GOL), infliximab (IFX), rituximab (RTX), secukinumab (SEC), tocilizumab (TCZ), tofacitinib (TOF) or ustekinumab (UST) in rheumatoid arthritis patients were evaluated. Baseline data, patient profile, previous and current treatments, cause of discontinuation and information on reintroduction of treatment were extracted from the case reports. One hundred and fifty-four studies (154 patients) reported 162 discontinuations of rheumatoid arthritis treatment due to adverse events (ETA = 57; IFX = 46; ADA = 32; TCZ = 13; RTX = 5; ANA = 3; GOL = 2; ABA = 2; TOF = 1; CER = 1; SEC = 0 and UST = 0). The mean age of patients was 56 (± 12.1) years and 82% were female. Seventy-four adverse events were confirmed (related to used drug), and 138 were observed in patients using anti-TNF. The most common adverse events were infections (21%), skin disease (15%), autoimmune disease (13%) and hematological disorders (9%). Case reports are important in the detection of rare adverse events and should be considered in the choice of appropriate therapy for patients.

Efficacy and safety of intravenous laronidase for mucopolysaccharidosis type I: A systematic review and meta-analysis.

OBJECTIVE: To evaluate the efficacy and safety of IV laronidase for MPS I. METHODS: A systematic literature review was performed by searching the ClinicalTrials.gov, MEDLINE/PubMed, EMBASE, LILACS, and Cochrane Library databases, limited to clinical trials published until December 31, 2016. The first inclusion criterion was being a randomized controlled trial (RCT). If < five RCTs were identified, open-label and nonrandomized trials, controlled or uncontrolled (quasi-experimental), including ≥ five patients, and evaluating relevant outcomes defined a priori, would also be included. For meta-analysis, primary inferences were based on random-effects models. Assessment of article quality was performed in accordance with the GRADE criteria. The Cochrane Risk of Bias tool was used to examine the risk of bias for RCTs. RESULTS: The selection phase retrieved 632 articles. During the first phase of selection, 158 had the abstract or full text read for assessment of eligibility, of which nine (two RCTs) were included for qualitative synthesis. Four papers were included in the meta-analysis, which was performed for the following outcomes: occurrence of treatment-emergent or infusion-related adverse events (65%; 95%CI 53, 76), mild in most cases; development of IgG antibodies to laronidase (88%; 95%CI 67, 100); apnea-hypopnea index (not significant-NS), urinary glycosaminoglycans (GAGs) [mean change -65.5 µg/mg creatinine (95%CI -68.8, -62.3)], liver size [mean change -31.03% (95%CI -36.1, -25.9)], left ventricular mass index (LVMI) [mean change -1.8 (95%CI -2.32, -0.25)], and distance covered in the 6-minute walk test (NS). Among the outcomes not included in meta-analysis, we found evidence for benefit of laronidase only on shoulder flexion. CONCLUSIONS: Our findings suggest that IV laronidase effectively reduces urinary GAGs excretion, hepatomegaly and LVMI, and can improve shoulder flexion in MPS I patients. Laronidase appears to be safe in the studied population.

Pharmacotherapeutic follow-up of patients with Chagas disease using benznidazole: drug-related problems and pharmaceutical interventions.

INTRODUCTION: Benznidazole (BNZ) is a drug available for the etiological treatment of Chagas disease. However, this drug is toxic and has a limited effectiveness on the chronic phase of this disease, often leading to poor treatment adherence. METHODS:: This is a descriptive and exploratory study conducted at the Pharmaceutical Care Service for Chagas disease patients of the Federal University of Ceará. Drug-related problems (DRPs) and pharmaceutical interventions (PIs) were classified according to the Second Consensus of Granada. RESULTS:: The average age of patients with Chagas disease was 62 years, with the majority residing in the Ceará countryside (86.7%), and having low education levels (63.3% with elementary school education). Regarding family income, most patients belonged to a household that earned ≤1-2 times the minimum wage per month. Approximately 73% of these patients complied with the BNZ treatment, and nearly 7% underwent therapy interruption after medical evaluation. A total of 189 DRPs were identified, of which 51.9% (n=98) were classified as potential, and 48.1% (n=91) as actual. The most frequent DRPs were related to safety (qualitative safety; n=70; 37%), necessity (non-adherence; n=52; 27.5%), and effectiveness (qualitative effectiveness/non-optimal drug selection; n=45; 23.8%). Among the 216 PIs conducted, the majority were related to patient education (n=168; 77.8%) and pharmacological strategy (n=42; 19.4%). CONCLUSIONS:: This study indicates the need for pharmacotherapeutic monitoring in patients with Chagas because of the high number of therapeutic interventions, DRPs (approximately 3 DRPs/patient), BNZ adherence, and polypharmacy.

Pharmacotherapeutic follow-up of patients with Chagas disease using benznidazole: drug-related problems and pharmaceutical interventions

Abstract INTRODUCTION Benznidazole (BNZ) is a drug available for the etiological treatment of Chagas disease. However, this drug is toxic and has a limited effectiveness on the chronic phase of this disease, often leading to poor treatment adherence. METHODS: This is a descriptive and exploratory study conducted at the Pharmaceutical Care Service for Chagas disease patients of the Federal University of Ceará. Drug-related problems (DRPs) and pharmaceutical interventions (PIs) were classified according to the Second Consensus of Granada. RESULTS: The average age of patients with Chagas disease was 62 years, with the majority residing in the Ceará countryside (86.7%), and having low education levels (63.3% with elementary school education). Regarding family income, most patients belonged to a household that earned ≤1-2 times the minimum wage per month. Approximately 73% of these patients complied with the BNZ treatment, and nearly 7% underwent therapy interruption after medical evaluation. A total of 189 DRPs were identified, of which 51.9% (n=98) were classified as potential, and 48.1% (n=91) as actual. The most frequent DRPs were related to safety (qualitative safety; n=70; 37%), necessity (non-adherence; n=52; 27.5%), and effectiveness (qualitative effectiveness/non-optimal drug selection; n=45; 23.8%). Among the 216 PIs conducted, the majority were related to patient education (n=168; 77.8%) and pharmacological strategy (n=42; 19.4%). CONCLUSIONS: This study indicates the need for pharmacotherapeutic monitoring in patients with Chagas because of the high number of therapeutic interventions, DRPs (approximately 3 DRPs/patient), BNZ adherence, and polypharmacy.

[Comparison of two methods to assess causality of adverse drug reactions]. / Comparación de dos métodos de evaluación de causalidad de sospechas de reacciones adversas a medicamentos (RAM): 2003-2009.

BACKGROUND: Assessment of causality is an essential part of pharmacological surveillance. AIM: To compare the causality assessment of suspected adverse drug reactions (ADRs) using algorithms proposed by Karch-Lasagna (K & L) and the World Health Organization (WHO). MATERIAL AND METHODS: All spontaneous reports of suspected ADRs in a pediatric ward of a regional hospital were included. Causality was categorized as definitive, probable, possible, conditional or unlikely. The agreement between K & L and WHO algorithms was assessed using binomial test proportions and kappa coefficients. RESULTS: One hundred thirty reports of ADRs in 126 patients aged 2 to 11 years were analyzed. The suspected medications were antineoplastic drugs in 59% of cases and antimicrobials in 23%. The most common affected system was the skin and appendages in 35%. Using K & L algorithm, causality was categorized as definitive in 10% of cases, probable in 28.5%, possible in 35.4%, conditional in 23.1% and unlikely in 3.0%. Using WHO algorithm, the figures were 2.3, 34.6, 59.2, 2.3 and 1.5%, respectively. The degree of agreement between K & L and WHO algorithms was 32.3% (kappa = 0.004). CONCLUSIONS: K & L attributed a higher level of ADR causality than WHO algorithm.

Comparación de dos métodos de evaluación de causalidad de sospechas de reacciones adversas a medicamentos (RAM): 2003-2009 / Comparison of two methods to assess causality of adverse drug reactions

Background: Assessment of causality is an essential part of pharmacological surveillance. Aim: To compare the causality assessment of suspected adverse drug reactions (ADRs) using algorithms proposed by Karch-Lasagna (K & L) and the World Health Organization (WHO). Material and Methods: All spontaneous reports of suspected ADRs in a pediatric ward of a regional hospital were included. Causality was categorized as definitive, probable, possible, conditional or unlikely. The agreement between K & L and WHO algorithms was assessed using binomial test proportions and kappa coefficients. Results: One hundred thirty reports of ADRs in 126 patients aged 2 to 11 years were analyzed. The suspected medications were antineoplastic drugs in 59% of cases and antimicrobials in 23%. The most common affected system was the skin and appendages in 35%. Using K & L algorithm, causality was categorized as definitive in 10% of cases, probable in 28.5%, possible in 35.4%, conditional in 23.1% and unlikely in 3.0%. Using WHO algorithm, the figures were 2.3, 34.6, 59.2, 2.3 and 1.5%, respectively. The degree of agreement between K & L and WHO algorithms was 32.3% (kappa = 0.004). Conclusions: K & L attributed a higher level of ADR causality than WHO algorithm.

Possible adverse reactions to herbal products: a study with individuals who resort to popular medicine in the city of Diadema, SP, Brazil.

The present study aimed to investigate the occurrence of adverse reactions (ADRs) related to herbal products (HPs), which are purchased over-the-counter for self-treatment, reported by 100 users. Samples of the HPs related to those ADRs were purchased for their pharmacobotanical identification. The ADRs reported were evaluated based on specialized literature and were analyzed according to causality into probable (PR), possible (PO), unrelated (UR) or unclassifiable (UC); according to expectance into unexpected adverse reaction (UNEX) and expected adverse reaction (EX); seriousness into serious adverse event or reaction (S) and non-serious (NS); and severity into mild (MI), moderate (MO) and severe (SE). Among 100 interviews, five complaints of ADRs were reported in relation to HPs: Senna alexandrina, with a report of cramps (PR; MI; EX; NS); Camellia sinensis, associated with tachycardia (PO; MI; EX; NS); Bauhinia sp., a strong allergic reaction that led to hospitalization (UC; MO; UNEX; S); Picrasma crenata, with several symptoms and hospitalization (UR; MO; UNEX; S); and 21-herb tea, related to an allergic reaction (UC; MI; EX; NS). The strategies used in this study allowed us to carry out an analysis of ADRs attributed to HPs. This analysis could serve as a model in the study of similar cases.

Safety of benzathine penicillin for preventing congenital syphilis: a systematic review.

OBJECTIVE: To estimate the risk of serious adverse reactions to benzathine penicillin in pregnant women for preventing congenital syphilis. METHODS: We searched for clinical trials or cohorts that assessed the incidence of serious adverse reactions to benzathine penicillin in pregnant women and the general population (indirect evidence). MEDLINE, EMBASE, Scopus and other databases were searched up to December 2012. The GRADE approach was used to assess quality of evidence. Absolute risks of each study were calculated along with their 95% confidence intervals (95% CI). We employed the DerSimonian and Laird random effects model in the meta-analyses. RESULTS: From 2,765 retrieved studies we included 13, representing 3,466,780 patients. The studies that included pregnant women were conducted to demonstrate the effectiveness of benzathine penicillin: no serious adverse reactions were reported among the 1,244 pregnant women included. In the general population, among 2,028,982 patients treated, 4 died from an adverse reaction. The pooled risk of death was virtually zero. Fifty-four cases of anaphylaxis were reported (pooled absolute risk = 0.002%; 95% CI: 0%-0.003% I(2) = 12%). From that estimate, penicillin treatment would be expected to result in an incidence of 0 to 3 cases of anaphylaxis per 100,000 treated. Any adverse reactions were reported in 6,377 patients among 3,465,322 treated with penicillin (pooled absolute risk = 0.169%; 95% CI: 0.073%-0.265% I(2) = 97%). The quality of evidence was very low. CONCLUSION: Studies that assessed the risk of serious adverse events due to benzathine penicillin treatment in pregnant women were scarce, but no reports of adverse reactions were found. The incidence of severe adverse outcomes was very low in the general population. The risk of treating pregnant women with benzathine penicillin to prevent congenital syphilis appears very low and does not outweigh its benefits. Further research is needed to improve the quality of evidence.

[Confusions and ambiguities in the classification of adverse events in the clinical research]. / Confusões e ambigüidades na classificação de eventos adversos em pesquisa clínica.

It is quite common to consider the terms ambiguous and confusing as synonyms. Confusing information brings together various data with similar meanings. In ambiguous information, on the other hand, several meanings are assigned to a single word. Excessive information also generates ambiguity; therefore, a concise, clear language is demanded. The term adverse event (AE) is defined as any inconvenient medical occurrence suffered by a subject during a clinical investigation research. Confusion and ambiguity in the use of words may generate relevant consequences in the appraisal of AEs. The objective of this present theoretical study is to harmonize the vocabulary applied in the characterization of risks and in the communication of AEs in clinical research processes. AEs may be classified according to their predictability, frequency, gravity, causality, and severity. Regulatory documents usually address AEs in their severity and causality aspects. Vocabulary conformity in the communication of AEs is an essential step towards avoiding inaccurate use of words with confused or ambiguous meanings.