Sistema de farmacovigilancia: conocimiento y actitudes de los médicos del primer nivel de atención y tasa de notificación de efectos adversos para medicación antituberculosis / Pharmacovigilance system: primary care physicians' knowledge and attitudes, and reporting rate of adverse effects caused by anti-tuberculosis drugs

Se realizó un estudio transversal con un componente descriptivo y otro analítico con el fin de describir y analizar la frecuencia de efectos adversos de la medicación antituberculosis y su notificación en los CeSAC del Hospital Parmenio Piñero entre el año 2007 y el año 2014, así como los conocimientos y actitudes de los médicos del primer nivel de atención sobre el sistema de farmacovigilancia. A partir de registros estadísticos y relevamiento de historias clínicas se analizaron variables clínicas y sociodemográficas de pacientes diagnosticados con tuberculosis. Se compararon estos registros con las notificaciones realizadas al Programa de la Ciudad de Buenos Aires. Se entrevistó a los médicos del primer nivel de atención. Se relevaron 562 casos de tuberculosis. Se registraron 242 efectos adversos en 109 pacientes (19%). De éstos, 39% fueron hepáticos, 36% gastrointestinales, y 29% hematológicos. El 63% tuvo efectos adversos leves, el 28% moderados y el 8% graves. En el 7% de los casos el tratamiento debió suspenderse. Requirieron internación 7 casos (19%) y 2 fallecieron (0,36%). Estar desocupado (OR: 3,26 (1,29-8,25)), ser de nacionalidad boliviana (OR: 2,98 (1,32-3,28)) o tener alguna comorbilidad (OR: 3,06 (1,84-5,08)) fueron asociados a una mayor probabilidad de presentar efectos adversos. El 29% de los profesionales encuestados refirió haber notificado un efecto adverso. Los efectos adversos hallados no se notificaron al programa de tuberculosis. Se hace necesario un manejo más eficaz de la información relativa a los efectos adversos de las drogas tuberculostáticas

Pharmacovigilance system: primary care physicians' knowledge and attitudes, and reporting rate of adverse effects caused by anti-tuberculosis drugs

A cross-sectional study with a descriptive and an analytical component was conducted to describe and analyze the incidence of anti-tuberculosis adverse drug effects and its reporting rate at Hospital Parmenio Piñero CeSACs [Centros de Salud y Acción Comunitaria (Community Healthcare Centers)] between 2007 and 2014, as well as the knowledge and attitudes of primary care physicians regarding the pharmacovigilance system. The clinical and socio-demographic variables of patients diagnosed with tuberculosis were analyzed based on statistical records and the assessment of medical records. These records were compared with the reports made to the Program of the City of Buenos Aires. Primary care physicians were interviewed. Five hundred and sixty-two cases of tuberculosis were evaluated. Two hundred and forty-two adverse effects were documented in 109 patients (19%). Of these, 39% were hepatic, 36% were gastrointestinal, and 29% were hematological. Adverse effects were mild in 63% of the patients, moderate in 28% and severe in 8%. Treatment had to be discontinued in 7% of the cases. Seven cases (19%) required hospitalization and two patients passed away (0.36%). Being unemployed [OR: 3.26 (1.29-8.25)], being of Bolivian nationality [OR: 2.98 (1.32-3.28)] or having a comorbidity [OR: 3.06 (1.84-5.08)] was associated with a higher risk of exhibiting adverse effects. Twenty-nine percent of the physicians surveyed mentioned they had reported an adverse effect. The adverse effects found were not reported to the Tuberculosis Program. It is essential to handle the information associated with the adverse effects of tuberculostatic drugs more efficiently.