[Pharmacovigilance implementation and operational conditions in the pharmaceutical industry in São Paulo State, Brazil].
The development of new drugs and limitations of clinical trials have increased the likelihood of adverse drug events. Pharmacovigilance is essential to detect and evaluate adverse drug events, thereby reducing risks and avoiding excessive public health costs. This study focused on the pharmacovigilance programs in the pharmaceutical industry in São Paulo State, Brazil. Data were collected through questionnaires sent electronically to 105 companies, 41.9% of which responded. The main reason for implementing pharmacovigilance programs was to comply with legal requirements, while the main justification for its absence was production limited to herbal remedies, officinal products, and supplements. The article discusses the obstacles to program implementation, resources used, and characteristics of several such programs.


CONCLUSIONS
(a) standardization is the reason for the increasing number of programs and reports, but more specific guidelines are needed; (b) results depend on multi-sector involvement; (c) customer service centers are an important source of reports; and (d) operation of the service requires only modest human and material resources.
Freitas
Márcia Sayuri Takamatsu
MS
Faculdade de Ciências Farmacêuticas, Universidade de São Paulo, São Paulo, Brasil.
Romano-Lieber
Nicolina Silvana
NS
D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D001938:Brazil; D002986:Clinical Trials as Topic; D003258:Consumer Behavior; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D033161:Government Regulation; D006284:Health Plan Implementation; D006801:Humans; D007255:Information Services; D007880:Legislation, Drug; D011795:Surveys and Questionnaires