Department of Pharmacy Practice, Butler University College of Pharmacy and Health Sciences, Indianapolis, IN, USA.
VPS Consulting, North Potomac, MD, USA.
Am J Health Syst Pharm. 2021 Jun 7;78(12):1047-1056. doi: 10.1093/ajhp/zxab048.
This review provides an overview of the proceedings of the symposium "Tackling the Challenges of Nanomedicines: Are We Ready?" organized by the International Pharmaceutical Federation (FIP) Hospital Pharmacy Section and Non-Biological Complex Drugs (NBCDs) Working Group at the 2019 FIP World Congress of Pharmacy and Pharmaceutical Sciences. Debate centered on reasons underlying the current complex regulatory landscape for nanomedicines and their follow-on products (referred to as nanosimilars) and the pivotal role of hospital pharmacists in selecting, handling, and guiding usage of nanomedicines and nanosimilars.
The evaluation and use of nanomedicines are recognized among scientific, pharmaceutical, and regulatory bodies as complex. Interchangeability and substitutability of nanomedicines and nanosimilars are confounded by a lack of pharmaceutical and pharmacological equivalence, reflecting the inherent complex nature of these drug products and manufacturing processes. Consequences include implications for clinical safety and efficacy and, ultimately, comparability. Local regulatory approvals of some nanomedicines have occurred, but there is no standard to ensure streamlined evaluation and use of consistent measures of therapeutic equivalence of reference products and their nanosimilars. Hospital pharmacists are expected to be experts in the selection, handling, and substitution of nanomedicines and familiarize themselves with the limitations of current methods of assessing pharmaceutical and clinical equivalence of nanosimilars in order to ensure informed formulary decision-making and eventual patient benefit.
Supportive guidance for pharmacists focusing on the substitutability and/or interchangeability of nanomedicines and their nanosimilars is needed. Current FIP guidance for pharmacists on therapeutic interchange and substitution should be extended to include nanomedicines and nanosimilars.
本综述概述了国际药学联合会（FIP）医院药学分会和非生物复杂药物（NBCDs）工作组在 2019 年 FIP 世界药学和药物科学大会上组织的专题讨论会“应对纳米药物的挑战：我们准备好了吗？”的会议内容。讨论的焦点是纳米药物及其后续产品（称为纳米类似物）当前复杂监管格局的背后原因，以及医院药剂师在选择、处理和指导纳米药物和纳米类似物使用方面的关键作用。
科学、制药和监管机构都认识到纳米药物的评估和使用很复杂。由于缺乏药学和药理学等效性，纳米药物和纳米类似物的可互换性和可替代性变得复杂，这反映了这些药物产品和制造工艺的固有复杂性。其结果包括对临床安全性和疗效的影响，最终影响到可比性。一些纳米药物已经获得了当地的监管批准，但没有标准来确保参考产品及其纳米类似物的治疗等效性的评估和使用的一致性措施。医院药剂师应成为选择、处理和替代纳米药物的专家，并熟悉当前评估纳米类似物药学和临床等效性的方法的局限性，以确保明智的处方决策并最终使患者受益。
需要为药剂师提供支持性指导，重点关注纳米药物及其纳米类似物的可替代性和/或可互换性。目前 FIP 关于药剂师治疗互换和替代的指南应扩展到包括纳米药物和纳米类似物。
