Federal procurement of unlicensed medicines in Brazil; findings and implications.
BACKGROUND
There are safety concerns with using unlicensed medicines across countries including Brazil. Consequently this needs to be evaluated and concerns address if pertinent.


OBJECTIVE
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.
a Department of Pharmaceutical Policies and Pharmaceutical Services , Sergio Arouca National School of Public Health, Oswaldo Cruz Foundation , Rio de Janeiro , Brazil.
Cristiane Roberta Dos Santos
CRDS
Teodoro
b Social Medicine Institute , Rio de Janeiro State University , Rio de Janeiro , Brazil.
Rosângela
R
Caetano
c Strathclyde Institute of Pharmacy and Biomedical Sciences , University of Strathclyde , Glasgow , UK.|d Division of Clinical Pharmacology , Karolinska Institutet , Stockholm , Sweden.|e Liverpool Health Economics Centre , University of Liverpool Management School , Liverpool , UK.
Brian
B
Godman
f Coordination of Intellectual Property , Brazilian National Regulatory Agency (ANVISA) , Rio de Janeiro , Brazil.
André Luís Almeida
ALA
Dos Reis
g Department of Health Economics , Investment and Development, Executive Secretariat, Brazilian Ministry of Health , Brasília , Brazil.
Aurélio de Araújo
AA
Maia
g Department of Health Economics , Investment and Development, Executive Secretariat, Brazilian Ministry of Health , Brasília , Brazil.
Mariana de Carvalho Barbosa
MCB
Ramos
a Department of Pharmaceutical Policies and Pharmaceutical Services , Sergio Arouca National School of Public Health, Oswaldo Cruz Foundation , Rio de Janeiro , Brazil.
Claudia Garcia Serpa
CGS
Osorio-de-Castro
D001938:Brazil; D003132:Commerce / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data; D016208:Databases, Factual; D017277:Drug Approval; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D035082:Federal Government; D006801:Humans; D009965:Orphan Drug Production / Q000191:economics / Q000331:legislation & jurisprudence; D004364:Pharmaceutical Preparations / Q000191:economics*
D004364:Pharmaceutical Preparations
Brazil; drug approval; federal government; procurement; unlicensed medicines