Impact of Additional Monitoring on Pharmacovigilance and Pharmacists' Role: A Scoping Review.

IF 2.4 4区医学 Q3 PHARMACOLOGY & PHARMACY

Pharmacoepidemiology and Drug Safety Pub Date : 2025-09-01 DOI:10.1002/pds.70201

Xabier Aizpurua-Arruti, Estíbaliz Goyenechea, Arantxa Isla, Ainhoa Oñatibia-Astibia, Amaia Malet-Larrea, Miguel Ángel Gastelurrutia, María Ángeles Solinís, Ana Del Pozo-Rodriguez

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引用次数: 0

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.

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额外监测对药物警戒和药师角色的影响：范围综述。

引言：药物警戒在确保药品安全方面发挥着关键作用，特别是那些需要额外监测的药品（AM）。欧盟（EU）于2012年实施AM，以加强上市后监督。然而，其对药品不良反应（ADR）报告和药师角色的影响仍未得到充分探讨。本综述探讨了AM标签对ADR报告管理的影响，以及药剂师对AM药物的认识和参与。方法：系统搜索四个科学数据库（Web of Science, Scopus， Science Direct和PubMed）和灰色文献来源，涵盖2012年至2024年在欧盟发表的研究，根据资格标准确定17项相关研究：AM标签对欧盟药物警戒的影响。将相关数据（标题、出版年份、国家、领域、设计、目的、结果）及其与研究问题的关系绘制成图表。结果：单独使用AM标签不会显著增加不良反应报告率。然而，针对医疗保健专业人员（HCPs），特别是药剂师的结构化培训计划和有针对性的干预措施，可以改善不良反应报告和患者安全结果。药师对AM的认识在HCPs中是最高的，但往往没有充分利用他们在ADR报告中的作用。不同的研究表明，药剂师主导的干预措施显著增加了不良反应的通报。教育活动、标准化报告协议以及将AM纳入临床实践可以加强AM药物警戒工作。结论：本综述强调需要实施结构化的人工智能培训计划，并制定系统的评估框架，以评估人工智能标签在改善药物警戒实践方面的有效性。优化AM策略，加强药师在上市后药品安全中的作用，需要进一步的研究。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pharmacoepidemiology and Drug Safety 医学-药学

CiteScore

4.80

自引率

7.70%

发文量

173

审稿时长

3 months

期刊介绍： The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report. Particular areas of interest include: design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology; comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world; methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology; assessments of harm versus benefit in drug therapy; patterns of drug utilization; relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines; evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.