Reacciones adversas no descritas en embarazadas de Cuba / Non-described adverse reactions in pregnant women in Cuba

Introducción: el perfil de seguridad de los medicamentos en las embarazadas es incompleto, porque estas se excluyen de los ensayos clínicos. El propósito de la Farmacovigilancia es detectar reacciones adversas nuevas a medicamentos. Objetivo: caracterizar las reacciones adversas no descritas en embarazadas en Cuba. Método: se realizó un estudio descriptivo y transversal. El universo fue las reacciones adversas medicamentosas en embarazadas registrada en la base de datos del sistema de Farmacovigilancia cubano, la muestra fue de 126 reacciones no descritas reportadas de 2003 a 2012. Las variables fueron datos demográficos, reacción adversa, gravedad, sistema de órganos, medicamento, grupo farmacológico, nivel de atención y notificador; se consideró reacción adversa medicamentosa no descrita, aquella que no aparece en el Formulario Nacional de Medicamentos. El análisis estadístico fue descriptivo. Resultados: las reacciones adversas no descritas predominaron en gestantes de 20 a 30 años (57 por ciento), con edad gestacional sin precisar (77 por ciento). El 2003 fue el año de mayor reporte (26,0 por ciento). Las reacciones indeseables más frecuentes fueron cefalea, taquicardia y náuseas (7,9 por ciento), las moderadas (52,3 por ciento), que afectaron el sistema nervioso central (21,4 por ciento), producidas por antimicrobianos (23 por ciento), Prenatal® (14,2 por ciento) y fármacos con categoría de riesgo B (33 por ciento) en el embarazo, reportadas más por médicos (67 por ciento) del nivel secundario de salud (56 por ciento). Conclusiones: las reacciones adversas medicamentosas no descritas en embarazadas representaron una pequeña proporción de las notificadas en la década estudiada, con características similares a las reacciones adversas descritas solo para gravedad, categoría de riesgo del fármaco en embarazo y profesional notificador(AU)

Introduction: The safety profile of drugs in pregnant women is incomplete because they are excluded from the clinical assays. The purpose of pharmacosurveillance is to detect new adverse drug reactions. Objective: To characterize the non-described adverse reactions in pregnant women in Cuba. Method: A descriptive and cross-sectional study was conducted and the universe of study was adverse drug reactions in pregnant women reported to the database of the Cuban pharmacosurveillance system. The sample was made up of 126 non described reactions reported from 2003 to 2012. The variables were demographic data, adverse reaction, severity, system of organs, medication, pharmacological group, level of care and notification. Non described adverse reaction was considered as that one not included in the National Formulary of Drugs. The statistical analysis was descriptive. Results: Non described adverse reactions predominated in pregnant women aged 20 to 30 years (57 percent), with imprecise gestational age (77 percent). The most reported year (26 percent) was 2003. The most common undesirable reactions were headache, tachycardia and nauseas (7.9 percent), the mild reactions (52.3 percent) affected the central nervous system (21.4 percent) caused by antimicrobials (23 percent), Prenatal® (14.2 percent) and risk B drugs (33 percent) in pregnancy reported more by physicians (67 percent) of the secondary health care level (56 percent). Conclusions: Adverse drug reactions which are not described in pregnant women represented a small portion of the notified ones in the studied decade, with similar characteristics to those of described adverse reactions in terms of severity, category of drug risk in pregnancy and notifying professional(AU)

Concentração regional do valor bruto de produção da banana do Paraná, Brasil ( 1995 a 2010) / Regional concentration of banana production gross value in Paraná, Brazil (1995-2010)

Este estudo analisou o grau de concentração do valor bruto da produção de banana no estado do Paraná, no período 1995-2010. Os dados utilizados estão disponíveis no Instituto Paranaense de Desenvolvimento Econômico e Social. O grau de concentração foi determinado por meio da Razão de Concentração, do Índice de Herfindahl-Hirschman e do Índice de Theil. No período estudado, foi observado um crescimento médio anual de 12,92% a.a. no valor bruto de produção da banana no Paraná; os polos de produção de banana se encontram na Região Metropolitana de Curitiba e a mesorregião do Norte Pioneiro; a razão de concentração municipal foi moderadamente alta a muito alta e, em nível microrregional, foi ainda mais concentrada; o índice de Herfindahl-Hirschman apresentou concentração com grandezas similares nos níveis mesorregional e microrregional. Enquanto indicador, o municipal apontou leve concentração; o índice de Theil mostrou concentração estacionária nos níveis microrregional e municipal e indicou concentração em nível de mesorregião.

The degree of concentration of banana production gross value in Paraná State was studied in the 1995-2010 period. The data base is available at IPARDES - Paraná Institute of Economic and Social Development. The degree of concentration was determined by the Concentration Ratio, the Herfindahl-Hirschman Index and the Theil Index. In the period studied, an average annual growth of 12.92% in the value of banana production in Paraná was observed; the poles of banana production are the Metropolitan region of Curitiba and the Norte Pioneiro mesoregion. Concentration Ratio was moderately high to very high at municipal level, and even higher at micro-region level; the Herfindahl-Hirschman Index showed similar magnitudes at mesoregional and microregional levels for concentration, while the municipal indicator shows a slight concentration. The Theil index showed stationary concentration levels in the microregional and municipal region and indicated the municipal mesoregion concentration.