LEGISLATION AND COMBATING FALSIFIED MEDICINES: THE ROLE OF THE PHARMACIST IN PATIENT SAFETY

Abstract

This study aimed to analyze the contribution of current legislation and the role of pharmacists in combating counterfeit medicines and promoting patient safety, considering measures for prevention, detection, and traceability. This is an integrative literature review conducted using the Virtual Health Library (VHL) and PubMed databases, supplemented by regulatory and institutional sources. Studies published between 2020 and 2025 in Portuguese and English—addressing medicine counterfeiting, health legislation, control, traceability, the pharmacist's role, and patient safety—were considered. Following the identification, screening, and eligibility stages, five studies were included. The results demonstrated that medicine counterfeiting poses a significant threat to public health, potentially compromising therapeutic efficacy and causing serious risks to patients. Legislation, traceability mechanisms, and regulatory oversight are fundamental but present challenges regarding inter-sectoral integration and monitoring. Pharmacists emerged as strategic agents in identifying irregularities, verifying product provenance, ensuring traceability, and educating the public. It is concluded that addressing counterfeiting requires integrated and continuous action among public agencies, the industry, healthcare professionals, and the general public, alongside the strengthening of regulatory oversight and health education.