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

ABSTRACT

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.