Cristiane Roberta Dos Santos Teodoro1, Rosângela Caetano2, Brian Godman3,4,5, André Luís Almeida Dos Reis6, Aurélio de Araújo Maia7, Mariana de Carvalho Barbosa Ramos7, Claudia Garcia Serpa Osorio-de-Castro1. 1. a Department of Pharmaceutical Policies and Pharmaceutical Services , Sergio Arouca National School of Public Health, Oswaldo Cruz Foundation , Rio de Janeiro , Brazil. 2. b Social Medicine Institute , Rio de Janeiro State University , Rio de Janeiro , Brazil. 3. c Strathclyde Institute of Pharmacy and Biomedical Sciences , University of Strathclyde , Glasgow , UK. 4. d Division of Clinical Pharmacology , Karolinska Institutet , Stockholm , Sweden. 5. e Liverpool Health Economics Centre , University of Liverpool Management School , Liverpool , UK. 6. f Coordination of Intellectual Property , Brazilian National Regulatory Agency (ANVISA) , Rio de Janeiro , Brazil. 7. g Department of Health Economics , Investment and Development, Executive Secretariat, Brazilian Ministry of Health , Brasília , Brazil.
Abstract
BACKGROUND: There are safety concerns with using unlicensed medicines across countries including Brazil. Consequently this needs to be evaluated and concerns address if pertinent. AIM: Investigate such purchases by the Brazilian Federal Government from 2004 to 2013. METHODS: Procurement data from a public-access databank that contains procurement information of the Brazilian Federal Government. Each procured item was cross-referenced to its active drug approval status in the Brazilian National Register (DOU). Exploratory analysis and trend measures were performed for the variables for mapping and characterizing the purchases of non-market approved drugs. RESULTS: 614 (0.14%) purchases in ten years corresponding to 64 unlicensed medicines - some of which had orphan drug status - and 48 different active substances; with a growing trend in recent years. Medicines in 51% of purchases were procured before obtaining marketing approval - with eventual refusals occurring in 17.8% and cancellation due to lack of efficacy and/or safety concerns in 1.1%. Health litigation accounted for 81.9% of purchases and growing in recent years. CONCLUSIONS: Overall a low rate of unlicensed medicine use. However there are concerns given the current regulations in Brazil and the recent increase in the use of unlicensed medicines with increased litigation.
BACKGROUND: There are safety concerns with using unlicensed medicines across countries including Brazil. Consequently this needs to be evaluated and concerns address if pertinent. AIM: Investigate such purchases by the Brazilian Federal Government from 2004 to 2013. METHODS: Procurement data from a public-access databank that contains procurement information of the Brazilian Federal Government. Each procured item was cross-referenced to its active drug approval status in the Brazilian National Register (DOU). Exploratory analysis and trend measures were performed for the variables for mapping and characterizing the purchases of non-market approved drugs. RESULTS: 614 (0.14%) purchases in ten years corresponding to 64 unlicensed medicines - some of which had orphan drug status - and 48 different active substances; with a growing trend in recent years. Medicines in 51% of purchases were procured before obtaining marketing approval - with eventual refusals occurring in 17.8% and cancellation due to lack of efficacy and/or safety concerns in 1.1%. Health litigation accounted for 81.9% of purchases and growing in recent years. CONCLUSIONS: Overall a low rate of unlicensed medicine use. However there are concerns given the current regulations in Brazil and the recent increase in the use of unlicensed medicines with increased litigation.
Keywords:
Brazil; drug approval; federal government; procurement; unlicensed medicines
Authors: Ricardo Eccard da Silva; Elisangela da Costa Lima; Maria Rita C G Novaes; Claudia G S Osorio-de-Castro Journal: Front Pharmacol Date: 2020-05-19 Impact factor: 5.810
Authors: Hong Si Nga; Lilian Monteiro Pereira Palma; Miguel Ernandes Neto; Ida Maria Maximina Fernandes-Charpiot; Valter Duro Garcia; Roger Kist; Silvana Maria Carvalho Miranda; Pedro Augusto Macedo de Souza; Gerson Marques Pereira; Luis Gustavo Modelli de Andrade Journal: PLoS One Date: 2021-11-08 Impact factor: 3.240