Federal procurement of unlicensed medicines in Brazil: findings and implications

Cristiane Roberta dos Santos Teodoro, André Luís Almeida dos Reis, Brian Godman, Rosângela Caetano, Claudia Garcia Serpa Osorio-de-Castro

Research output: Contribution to journalArticle

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 65 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.
LanguageEnglish
Pages607-613
Number of pages7
JournalExpert Review of Pharmacoeconomics and Outcomes Research
Volume17
Issue number6
Early online date13 Apr 2017
DOIs
StatePublished - 31 Dec 2017

Fingerprint

Federal Government
Jurisprudence
Brazil
Orphan Drug Production
Drug Approval
Safety
Marketing
Medicine
Databases
Health
Pharmaceutical Preparations

Keywords

  • federal government
  • procurement
  • Brazil
  • medicines
  • licensing

Cite this

Teodoro, Cristiane Roberta dos Santos ; dos Reis, André Luís Almeida ; Godman, Brian ; Caetano, Rosângela ; Osorio-de-Castro, Claudia Garcia Serpa . / Federal procurement of unlicensed medicines in Brazil : findings and implications. In: Expert Review of Pharmacoeconomics and Outcomes Research. 2017 ; Vol. 17, No. 6. pp. 607-613
@article{9be8cbc80bb5409d98b8ad77d355d87a,
title = "Federal procurement of unlicensed medicines in Brazil: findings and implications",
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 65 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 = "federal government, procurement, Brazil, medicines, licensing",
author = "Teodoro, {Cristiane Roberta dos Santos} and {dos Reis}, {Andr{\'e} Lu{\'i}s Almeida} and Brian Godman and Ros{\^a}ngela Caetano and Osorio-de-Castro, {Claudia Garcia Serpa}",
year = "2017",
month = "12",
day = "31",
doi = "10.1080/14737167.2017.1311209",
language = "English",
volume = "17",
pages = "607--613",
journal = "Expert Review of Pharmacoeconomics and Outcomes Research",
issn = "1473-7167",
number = "6",

}

Federal procurement of unlicensed medicines in Brazil : findings and implications. / Teodoro, Cristiane Roberta dos Santos ; dos Reis, André Luís Almeida ; Godman, Brian; Caetano, Rosângela ; Osorio-de-Castro, Claudia Garcia Serpa .

In: Expert Review of Pharmacoeconomics and Outcomes Research, Vol. 17, No. 6, 31.12.2017, p. 607-613.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Federal procurement of unlicensed medicines in Brazil

T2 - Expert Review of Pharmacoeconomics and Outcomes Research

AU - Teodoro,Cristiane Roberta dos Santos

AU - dos Reis,André Luís Almeida

AU - Godman,Brian

AU - Caetano,Rosângela

AU - Osorio-de-Castro,Claudia Garcia Serpa

PY - 2017/12/31

Y1 - 2017/12/31

N2 - 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 65 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.

AB - 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 65 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.

KW - federal government

KW - procurement

KW - Brazil

KW - medicines

KW - licensing

UR - http://www.tandfonline.com/loi/ierp20

U2 - 10.1080/14737167.2017.1311209

DO - 10.1080/14737167.2017.1311209

M3 - Article

VL - 17

SP - 607

EP - 613

JO - Expert Review of Pharmacoeconomics and Outcomes Research

JF - Expert Review of Pharmacoeconomics and Outcomes Research

SN - 1473-7167

IS - 6

ER -