This paper presents the structuring dimensions of the CEP-Conep System in order to understand the actions promoted by the National Research Ethics Commission in response to demands for the processing and ethical analysis of research protocols related to COVID-19 in 2020. Based on CEP-Conep System public documents, an assessment of legislation, from 1988 to 2020, and its extension in terms of the number of Committees, users, and protocols, from 2012 to 2020 was presented. The minutes of Conep's Ordinary Meetings (RO), for 2020, of a confidential nature, were analyzed, to verify adaptations to the pandemic.
View Article and Find Full Text PDFHuman challenge trials to deliberately infect volunteers with SARS-CoV-2 should inspire wider debates about research ethics and participants' motivations to take part in such studies.
View Article and Find Full Text PDFThis article examines pharmaceutical services and access to essential medicines in Brazil during the 30 years since the advent of Brazil's Unified Health System from a comprehensiveness perspective. The following topics are addressed: the "realignment" of pharmaceutical services; human resources in pharmaceutical services; the essential medicines concept; the rational use of medicines; technological advances and drug manufacturing; and ethical regulation. With a strong regulatory focus and a structural framework centered on the National Medicines Policy, the past three decades represent a mixture of progress and setbacks, considering the national complexities of the healthcare system and the political, economic and social changes that have influenced policy and access to medicines, which is a key concern even in the world's richest countries, as the forums of discussion on global health have demonstrated.
View Article and Find Full Text PDFCien Saude Colet
August 2017
The rational use of medicines (URM) is considered one of the key elements recommended by the World Health Organization (WHO) for pharmaceutical policies. The excessive increase in the use of medicines in many countries has been identified as a major barrier to the achievement of URM and is part of a phenomenon called the 'pharmaceuticalization' of the society. This paper aims to present innitiatives to rationalize the use of methylphenidate and its limits in Brazil, considering the concept of pharmaceuticalization of the society.
View Article and Find Full Text PDFA criterion is a typical tool in the evaluation field that can be defined as a standard-dimension under which the object of an evaluation receives qualitative or quantitative judgments. During an evaluation, several rigorous methodological procedures are involved in development and application of suitable criteria to determine the value of the object being evaluated. This article presents a set of criteria to evaluate user satisfaction with HIV/Aids-related pharmaceutical delivery services.
View Article and Find Full Text PDFBrazil was the first developing country to provide people living with HIV/AIDS (PLWA) with comprehensive, universal, free access to antiretroviral medicines (ARV). Pharmaceutical services are considered a strategic action that has the goal of providing access to rational use of quality medicines while also promoting user satisfaction. User satisfaction is a complex concept, and evaluation models for pharmaceutical services for PLWA were not found in the literature.
View Article and Find Full Text PDFMalaria control in Brazil is based on early diagnosis and adequate and timely treatment as strategies for a rapid and long-lasting cure. Clinical consequences and resistance to antimalarials may arise from problems in prescribing, dispensing and in acceptance of therapeutic regimens by healthcare workers. We studied knowledge and practices, perceptions and attitudes of health workers participating in pharmaceutical services for malaria, regarding the official protocol and the possible flaws in therapy.
View Article and Find Full Text PDFThe objective of this study is to evaluate the psychometric properties of a user satisfaction scale regarding the Brazilian National STD/AIDS Program, specifically related to dispensing AIDS medicines. The scale was developed and applied in a study covering 10 Brazilian States that evaluated the quality of medicine dispensing. The questionnaire was answered by 1,412 people living with HIV and undergoing antiretroviral therapy.
View Article and Find Full Text PDFThis study evaluates access by people living with HIV/AIDS to pharmaceutical care provided by public health care facilities in the city of Rio de Janeiro, Brazil, focusing on availability, accessibility, and accommodation. The evaluation was conducted using the implementation analysis approach, assessing the process of producing intervention outcomes, considering its relationship to the organizational context. A case study was performed in 11 public health facilities selected according to: different health program areas; diverse levels of complexity; and more than 100 HIV/AIDS patients registered.
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