Medicamentos com defeitos estão entre nós! Umaanálise do combate aos defeitos em embalagens demedicamentos à luz do Direito Administrativo Sanitárioe do Consumidor

Abstract

Introduction: Providing quality, safe, and effective medicine is the purpose of the production and supply chain; however, errors happen. This work addresses action against defects observed in medicines’ primary and secondary packaging from the perspective of health and consumer administrative legislation and their practical consequences in the consumer relationship. Objective: To demonstrate the contribution of health and consumer administrative legislation, with emphasis on Good Manufacturing Practices (GMP) for medicines and the Consumer Protection Code, ensuring adequate and safe information to patients and how suppliers and consumers can influence the control of defects and safe administration of medicines, before, during, and after sale. Method: Adoption of descriptive and explanatory research, a documental nature bibliographical using checklist for direct observation register, about a qualitative and quantitative approach. Results: It was identified that current resolution about GMP applied at medicines have 34 control mechanisms that contribute to avoiding defects in packaging operations, an advance for patient safety. In addition, in all legislative frameworks analyzed, there was a protection of consumerist principles of transparency in information, objective good faith and security. However, there were gaps in the use and knowledge of information and safety devices in packaging materials. Highlighting the practice of changing medications without regulatory provisions as a problem for communicating product defects to the manufacturer and increasing health risk. Conclusions: Despite legislative evolution to combat defects, consumers and pharmacies need more knowledge, awareness, and adequate use of complaint channels. The return/exchange of medicines is a potential sanitary risk that needs to be confronted and perhaps better regulated.