LABELING OF DRUG PRODUCTS MARKETED IN BRAZIL: A DISCUSSION ABOUT NON-CONFORMITIES

Abstract

The standardization of the form and content of medicine labels guarantees access to safe information and the rational use of drugs. The current regulations on the labeling of drug products aim to protect the consumer's right, as well as the patient's health. There are few national papers published on the topic and the objective of this work was to contribute to the evaluation of the labeling of drug products, based on Brazilian legal provisions. The labels of 71 drug products were analyzed, grouped into nine therapeutic classes and including 32 different companies/laboratories. Relevant non-conformities were observed in 28% of the sample, which involved 50% of the total companies/laboratories identified in the entire set of products. Non-conformities occurred in oral and parenteral medicines, containing antibiotic, anxiolytic, diuretic, anti-inflammatory, antihypertensive or anesthetic drugs. Among the non-conformities, the failures in devices for traceability were highlighted. Greater adequacy of labels to legal aspects has been observed, however, apart from the limitations of this study, non-conformities in medications that are critical for patient safety were pointed out. The quality control of drug labels is essential for the quality of the final product, contributing to the correct use and to a safe and effective treatment. In addition, it is important that manufacturers consider adopting new resources and technologies aimed at improving the labeling of drug products.