Inconsistencies in the quality of the information on package inserts of medicines for veterinary use commercialized in Brazil

This study examines the adequacy, readability, and quality of the information provided on package inserts for veterinary medicines in Brazil. It aims to identify the essential information required in these documents and assess non-compliance with regulatory standards. Initially, a documentary analys...

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Bibliographic Details
Published in:Brazilian Journal of Pharmaceutical Sciences 2024-01, Vol.60
Main Authors: Thomazini, Vanessa Cola, Mantovanelli, Vitória Ribeiro, Dias, Marcela Saager, Ávila, Letycia Fernandes Franklin, Rocha, Vinycius Fernandes da, Guimarães, Nayhara Madeira, Cunha, Gabriel Mendes da, Giuberti, Cristiane dos Santos, Villanova, Janaína Cecília Oliveira
Format: Article
Language:English
Subjects:
Drug dosages
Drug therapy
Manufacturers
Manufacturing
Packaging
Patient safety
Pharmaceuticals
PHARMACOLOGY & PHARMACY
Preventive medicine
Readability
Registration
Regulation
Regulatory agencies
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Summary:This study examines the adequacy, readability, and quality of the information provided on package inserts for veterinary medicines in Brazil. It aims to identify the essential information required in these documents and assess non-compliance with regulatory standards. Initially, a documentary analysis was conducted to identify mandatory information as per Federal Decree No. 5,053/2004 and Normative Instruction No. 26/2009 of the Ministry of Agriculture, Livestock and Supply. Subsequently, 256 package inserts were analyzed to evaluate their suitability using descriptive quantitative analysis. This analysis showed a lack of essential technical and scientific information, necessary for the rational use of veterinary medicines. Mandatory elements supporting the correct use of veterinary medicines and essential information, such as a qualitative description of excipients, equivalence factors, the mass of active pharmaceutical ingredient per volume (when applicable), and information about the customer service center, were absent from these documents. This study found at least one non-conformity in the 252 evaluated package inserts. These findings underscore the significant lack of adherence to established rules and the low quality of technical-scientific information, reducing the comprehension of both prescribers and owners. The authors highlight the need for regulatory agencies to review and improve the guidelines that govern the format and content of package inserts.Keywords:Package insert; Legibility; Health communication; Veterinary pharmacy
ISSN:2175-9790
1984-8250
2175-9790
DOI:10.1590/s2175-97902024e24041