Resíduos de antimicrobianos em produtos de origem animal: análise crítica das bulas e avaliação histórica dos programas de monitoramento no Brasil

Abstract

The scarcity of works and the importance of the drug leaflets in the context of the rational use of veterinary drugs and the fact that failure to comply with its precepts can have serious impacts, such as the presence of residues in food of animal origin stimulated this research. This study aimed a critical analysis of the information present in the antimicrobial leaflets registered in Brazil, considering the current legislation and a historical analysis of the monitoring of antimicrobial residues by the official national programs. The drug leaflets of 433 products (intended for poultry, cattle and pigs) available in the Compendium of Veterinary Products of the National Union of the Animal Health Products Industry were checked in relation to the requirements of Decree n° 5,053 of 2004 and of Normative Instruction n° 26 of 2009 of the Ministry of Agriculture Livestock and Supply. The frequencies of conformities were compared by the global chisquare test (X2), being the contrasts evaluated by the approximation to the normal ( = 0.05). In the evaluation of the national programs the 2002-2003, 2004-2005 and 20062007 reports of the PAMVet and the 2002 to 2016 reports of PNCRC Programs were considered, and also the international reference documents that establish maximum residue limits. The requirements VI (warnings, precautions, adverse effects, contraindications, drug interactions and antidotes) and XI (name, address and CNPJ of the registry holding) were considered critical (p <0.05), with 100% of nonconformities (NC), in addition to Art. 20 (summary information on the pharmacodynamics and pharmacokinetics of its active pharmaceutical ingredient (s)) with 98.8% of NC and requirement II (caption VETERINARY USE, written in highlight) with 97.9%. Due to its importance in the context of veterinary drug residues, the result of 12.0% of NC for requirement VIII (grace period) was also of concern. There were no significant differences in the compliance profile of the drug leaflets for most requirements when comparing the informative documents registered before and after the publication of the current legislation (p> 0.05). Although progress in the residue monitoring scopes has been noted by national programs, it has been noted that in the past few years in PAMVet, 14 analytes recommended by the Codex Alimentarius and 53 by the European Union have not been investigated. In turn, in the PNCRC, four analytes of the Codex Alimentarius and 24 of the European Union were not covered. In addition, the presence of 16 analytes registered in the country for poultry, cattle and pigs was verified which were not monitored by national programs. This work demonstrated that is fundamental that the regulatory bodies act in the sense of promoting the adaptation of the drug leaflets to the legislation, as well as improvements in the legal requirements, with the purpose of promoting the rational use of medicines. It is also imperative that the information available online reflect the reality of the products that are in the market. Also, it was realized the need of continuous adaptation of the scopes of the national programs and of the use of screening analytical tools that allow the prospection of the veterinary products used in the food producing animals in the country.