The CEP-Conep System in 2020: confronting COVID-19, challenges and lessons learned.

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.

Use of antimicrobials in pediatric wards of five Brazilian hospitals.

The use of antimicrobials (AMs) in pediatric infections is common practice and use may be inappropriate leading to antimicrobial resistance. Off-label AM use is also common in this group and can result in drug-related problems. There is lack of DUR data in Brazil and in Latin America, specially for AM pediatric use.

Psychoactive substance consumption after the Fundão dam mine tailing disaster in Minas Gerais State, Brazil.

Disasters cause changes in morbidity, mortality, and medicine use. Brazil is one of the main producers of mineral ores at great environmental cost. Mine tailings are stored in dams and ruptures have led to major disasters.

The incorporation of the 3HP regimen for tuberculosis preventive treatment in the Brazilian health system: a secondary-database nationwide analysis.

Introduction: The recommendation of rifampin-based shorter - and safer - regimens for tuberculosis preventive treatment (TPT) is progressively replacing monotherapy with isoniazid by different countries. The Brazilian Ministry of Health (MoH) approved the incorporation of the Rifapentine + isoniazid regimen (3HP) at the end of 2020, with free distribution in the Brazilian Unified Health System (SUS) started from the last quarter of 2021. The objectives were to describe the implementation of the IL-TB System (Information System of TPT Notification) and uptake of Rifapentine + isoniazid (3HP) and Isoniazid (6H or 9H) in Brazil.

Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison.

Biosimilars are biological medicines highly similar to a previously licensed reference product and their licensing is expected to improve access to biological therapies. This study aims to present an overview of biosimilars approval by thirteen regulatory authorities (RA). The study is a cross-national comparison of regulatory decisions involving biosimilars in Argentina, Australia, Brazil, Chile, Canada, Colombia, Europe, Hungary, Guatemala, Italy, Mexico, Peru and United States.

Marketing authorisation and pricing of FDA-approved cancer drugs in Brazil: a retrospective analysis.

Background: Most cancer drugs enter the US market first. US Food and Drug Administration (FDA) approvals of new cancer drugs may influence regulatory decisions in other settings. The study examined whether characteristics of available evidence at FDA approval influenced time-to-marketing authorisation (MA) in Brazil, and price differences between the two countries.

[Data processing of the Brazilian National System of Controlled Product Management for drug utilization research with antimicrobials].

The Brazilian National System of Controlled Product Management (SNGPC) stores data on the dispensing of manufactured and compounded drugs and pharmaceutical inputs, whether controlled and antimicrobial, based on the records of private pharmacies and drugstores. This study assessed the quality of SNGPC data from the dispensing records of manufactured antibiotics, aiming to propose their use in drug utilization researchs (DURs), with a descriptive and retrospective design, analyzing the raw dataset of the SNGPC from January 2014 to December 2020. A total of 475,805,207 drug-dispensing records were collected.

First use of antineoplastic agents in women with breast cancer in the state of Rio de Janeiro, Brazil.

Breast cancer is the most common cancer, except for non-melanoma skin cancer, among women in Brazil and worldwide. Breast cancer treatment involves surgery, radiotherapy and chemotherapy, which is used in 70% of patients. This study analyzes the utilization of antineoplastic agents among women undergoing their first round of chemotherapy in Brazil's public health system (SUS) in the state of Rio de Janeiro.

Adverse Drug Reactions to Anti-infectives in Hospitalized Children: A Multicenter Study in Brazil.

Introduction: Adverse drug reactions (ADRs) to anti-infectives affect especially hospitalized children and contribute to increased morbidity, mortality, length of stay, and costs in healthcare systems.

Objective: To assess ADRs associated with anti-infective use in Brazilian hospitalized children.

Methods: A prospective cohort study was conducted in 5 public hospitals over 6 months.

Consumption of antidepressants and economic austerity in Brazil.

Objective: To describe consumption of antidepressants in Brazil through dispensing data from pharmacy retail outlets, in between 2011 and 2017, and explore the relationship between consumption patterns and changing economic context during this period.

Methods: A time-series analysis of dispensing data from pharmacy retail outlets was carried out considering 10 commonly used antidepressants. DDDs/1000 inhabitants/year for each drug were calculated for each quarter.

Public procurement of antineoplastic agents used for treating breast cancer in Brazil between 2013 and 2019.

Background: Breast cancer is the most common cancer among women in Brazil and the country's public health care system is the main care provider. Timely treatment can increase the chance of cure, prevent metastasis and improve quality of life. Effective public procurement of antineoplastic agents can therefore improve access to drug therapy.

Data Sources for Drug Utilization Research in Brazil-DUR-BRA Study.

In Brazil, studies that map electronic healthcare databases in order to assess their suitability for use in pharmacoepidemiologic research are lacking. We aimed to identify, catalogue, and characterize Brazilian data sources for Drug Utilization Research (DUR). The present study is part of the project entitled, "Publicly Available Data Sources for Drug Utilization Research in Latin American (LatAm) Countries.

[Strategies adopted to ensure the rights of people with cancer in the Brazilian Unified Health System (SUS)].

This study was based on Giddens' Structuration Theory and aimed to analyze strategies adopted to ensure the rights of people with cancer in five Brazilian municipalities, anchored on the experience of managers and health professionals within the Brazilian Unified Health System (SUS). A multiple-case study design was conducted. The municipality was the unit of analysis and oncology care-certified facilities were established as analytical sub-units.

Data sources for drug utilization research in Latin American countries-A cross-national study: DASDUR-LATAM study.

Purpose: Drug utilization research (DUR) contributes to inform policymaking and to strengthen health systems. The availability of data sources is the first step for conducting DUR. However, documents that systematize these data sources in Latin American (LatAm) countries are not known.

COVID-19 and the medicines regulation challenges in times of pandemic.

The SARS-CoV-2 pandemic has brought challenges related to prevention, protection and care. Coping strategies, such as social distancing, individual protection for the population and workers, increase in the number of intensive care beds, provision of human resources and equipment are necessary actions. However, there are yet no specific effective and safe medicines that justify their use.

Knowledge and risk perception of vulnerable women on Zika virus infection at primary health care level in Brazil.

Vulnerable low-income groups were most affected by Zika virus (ZIKV)-related neurologic syndrome during the 2014-2016 outbreak in Brazil. Major ZIKV infection response took place in Primary Health Care (PHC), including prevention strategies and risk communication. We aimed to detect knowledge and beliefs, as well as knowledge gaps among vulnerable women at the PHC level.

[Profile of antineoplastic medication among indigenous people treated in the Brazilian Unified National Health System].

Brazil has an estimated 900,000 indigenous people (0.4% of the country's population), belonging to more than 300 different ethnic groups. However, information is scarce on cancer epidemiology and the antineoplastic drugs used in treatment of these individuals.

An ontology of Pharmaceutical Services in the pages of Journal Ciência & Saúde Coletiva.

Pharmaceutical Services (PS) is a growing field which has established itself over the last 25 years in Brazil through scientific publications. This work investigates the evolution of the field in the Brazilian periodical Journal Ciência & Saúde Coletiva. We conducted a scoping review of relevant literature produced in four separate periods (1996-2003, 2004-2010, 2011-2015, and 2016-2019).

Public financing of human insulins in Brazil: 2009-2017.

Background: From 2006 to 2017, the Brazilian federal government provided free of charge traditional insulins for diabetes treatment. This involved public tendering by the Department of Health Logistics of the Ministry of Health (DLOG-MOH) and the reimbursement after direct contracting for supply with commercial private retailers (Brazilian Popular Pharmacy Program - PFPB).

Objective: We aim to describe the budget of the Brazilian federal government committed to for the acquisition of insulin, as well as corresponding prices and treatment availability from 2009 to 2017.