In recent years the international debate about universality in health has been marked by a polarization between ideas based on a universal system, and notions proposing universal health coverage. The concept of universal coverage has been disseminated by international organizations and has been incorporated into health system reforms in several developing countries, including some in Latin America. This article explores the assumptions and strategies related to the proposal of universal health coverage. Firstly, a comparison is provided of the models of universal health coverage and universal health systems. This is followed by a contextualization of the international debate, including examples of different health systems. Finally, the implications of the proposal of universal coverage for the right to health in Brazil are discussed. The analysis of different concepts of universality and the experiences of different countries shows that health insurance-based models, either social or private, are not as satisfactory as public, universal health systems. Greater understanding about ongoing international projects is essential in order to identify the possibilities represented by the consolidation of the Unified Health System (SUS) in Brazil, as well as the risks of dismantling the SUS.

The distribution of suspected adverse drug reactions reports by sex and age group corresponded to the profile of children hospitalized in Brazil. Data about seriousness and medicines reported may be useful to encourage regulatory actions and improve the safe use of medicines in children.

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Children are more exposed to inappropriate medicine use and its consequent harms. Spontaneous reporting of suspected Serious Adverse Drug Reactions (SADR) increases knowledge and prevention of pharmacotherapy risk. Disproportionality measures are useful to quantify unexpected safety issues associated with a given drug-event pair (signals of disproportionality). This cross-sectional study aimed to assess SADR reporting and safety signals for Brazilian children from 0-12 years old, notified between January 2008 and December 2013 from the Brazilian Surveillance Agency (Notivisa). Information from serious reports (gender and age of the patient, event description, suspected drug) was included. Disproportionality analysis based on Reporting Odds Ratios with a confidence interval of 95% was conducted to identify possible signals of disproportionate reporting (SDR). Almost 30% of 1,977 suspected SADR was related to babies (0-1-year-old). 69% of reports happened with intravenous dosage forms, and 35% of suspected SADR involved off label use according to age. Laronidase, miglustat, imipenem/cilastatin, and clofarabine were involved in six or more suspected deaths among 75 deaths reported. There were 107 SDRs, of which 16 events (15%) were not described in the product labels. There was a relatively higher number of SADRs in Brazilian children compared with studies from other countries. SDRs found, (especially drug-event pairs 'imipenen/cilastatin-pneumonia' and 'laronidase-respiratory insufficiency') should be investigated more. The reports of SADR with IV dosage forms and OL drug use suggest the need for drug research and the use of better dosage forms for children in Brazil.

Resumo Este estudo visou a caracterizar os ensaios clínicos com medicamentos envolvendo crianças e adolescentes brasileiros, registrados nas bases de dados doEste é um artigo publicado em acesso aberto (Open Access) sob a licença Creative Commons Attribution, que permite uso, distribuição e reprodução em qualquer meio, sem restrições, desde que o trabalho original seja corretamente citado.