Regulatory issues on pharmacovigilance in Latin American countries

Pharmacovigilance is responsible for monitoring the safety of medicines in normal clinical use andduring clinical trials. Legal requirements for pharmacovigilance in some Latin American countries (Argentina, Brazil, Chile, Paraguay and Uruguay) were reviewed. Disparities in the legal framework among the countries are observed being those for marketing authorization holders one of the most evident. Theactive rol of the universities and drug information centers for/of pharmacovilance seems to be a positivecommon point. Legal requirements regarding pharmacovigilance of biosimilar medicines, is still a pointto be developed.

Narrativa audiovisual complexa: modular narratives e database narratives

Procura-se nesse trabalho expor as considerações levantadas sobre a modularidade e a temporalidade do filme Pulp Fiction (1994), de Quentin Tarantino, enquadrada por Simons (2008) nas categorias de narrativa audiovisual complexa denominadas modular narratives e database narratives. Com Ricoeur (1983), discutiu-se a sua organização temporal a partir do conceito de tríplice presente em Santo Agostinho, enquanto com Propp (1970) e Cameron (2008) o cará- ter modular dessa narrativa.

Queixas técnicas e eventos adversos a medicamentos notificados em um hospital sentinela do interior de São Paulo, 2009-2010

Objective: to describe technical complaints and adverse drug events reported in a sentinel hospital in São Paulo state in 2009 and 2010. Methods: This is a descriptive study. Information was obtained from the sentinel hospital Risk Management database. Results: we found 199 reports related to drugs: 70.0% were technical complaints, 21.0% ineffective therapy and 9.0% adverse reaction to medication. The pharmacological groups with highest number of reports were: drugs that act on alimentary tract and metabolism (25.1%), the nervous system (25.1%) and anti-infective drugs for systemic use (22.1%). Conclusion: technical complaints and adverse drug events were frequent, despite recognized underreporting. The characterization of these events could inform the adoption of control measures and permanent educational actions in health services in order to prevent their occurrence.