Abstract
INTRODUCTION: Pharmacovigilance plays a critical role in ensuring the safety of medicinal products, particularly those under additional monitoring (AM). The European Union (EU) implemented AM in 2012 to enhance post-marketing surveillance. However, its impact on adverse drug reaction (ADR) reporting and pharmacists' role remains insufficiently explored. This scoping review examines the influence of AM label on ADR reporting management, and pharmacists' awareness and involvement in AM medicines. METHODS: A systematic search across four scientific databases (Web of Science, Scopus, Science Direct, and PubMed) and gray literature sources, covering studies published between 2012 and 2024 in the EU, identified 17 relevant studies according to eligibility criteria: AM labeling's impact on pharmacovigilance in the EU. Relevant data (title, year of publication, country, field, design, objective, results) and relation with research questions were charted. RESULTS: AM label alone does not significantly increase ADR reporting rates. However, structured training programs and targeted interventions for healthcare professionals (HCPs), particularly pharmacists, lead to improved ADR reporting and patient safety outcomes. Pharmacists exhibit the highest awareness of AM among HCPs but often underutilize their role in ADR reporting. Different studies demonstrated that pharmacist-led interventions significantly increased ADR notifications. Education campaigns, standardized reporting protocols, and enhanced integration of AM into clinical practice can strengthen AM pharmacovigilance efforts. CONCLUSIONS: This review highlights the need to implement structured AM training programs and develop systematic evaluation frameworks to assess the effectiveness of AM labeling in improving pharmacovigilance practices. Further research is required to optimize AM strategies and reinforce pharmacists' role in post-marketing drug safety.