Pharmacosurveillance in Brazil: Profile of notifications of products based on plant species
DOI:
https://doi.org/10.3395/2317-269x.00248Keywords:
Pharmacosurveillance, Phytotherapy, Medicinal plants, NOTIVISAAbstract
Medicinal plants, used by humans for millennia, constitute a weak link in the therapeutic context, because of the regulation under construction and the indiscriminate use by your taxing of safety. Monitoring and attention to pharmacovigilance is essential for identifying, evaluating, understanding, and preventing undesirable events associated with these products. This study aimed to identify the general profile of notifications for products based on plants species reported as medicinal in the National System of Health Surveillance Notifications (NOTIVISA) from 2008 to 2012 in Brazil. Data were obtained from NOTIVISA and analyzed using EpiInfo software, version 3.5.4 for Windows. A total of 50,824 notifications for medications were analyzed, of which 399 were associated with products based on plant species, with 10 representing complaints of adverse events and 389 representing complaints about techniques. Among the latter, 48.6% corresponded to notifications of “companies without operating permit/product suspected of being unregistered.” Among all fields of the reports analyzed, approximately 50% were not filled out, weakening the process of pharmacosurveillance and constituting an indicator of poor report quality.Downloads
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