Clinical Pharmacy Group, Division of Pharmacology and Pharmacotherapy, Faculty of Pharmacy, University of Helsinki, Helsinki, Finland
HUS Pharmacy, Helsinki University Hospital, Helsinki, Finland.
BMJ Open. 2019 Oct 28;9(10):e032892. doi: 10.1136/bmjopen-2019-032892.
To explore relevant Finnish stakeholders' perceptions on the automatic substitution of biological medicines with particular focus on medication safety and issues that need to be considered to create an appropriate model for automatic biological product substitution.
Qualitative interview study.
Data were collected in semistructured individual (n=17), pair (n=7) and group (n=8) interviews (32 interviews, 62 participants) in 2018. Participants represented a wide range of stakeholders involved in the pharmacotherapy process: community pharmacists (n=8 interviews), authorities (n=7), prescribers (n=7), pharmaceutical industry and wholesalers (n=6), patients/customers (n=2), hospital pharmacists (n=1) and nurses (n=1). Inductive content analysis was performed.
Benefits of automatic substitution were identified as cost savings, more patients receiving biological treatments and enhanced continuity of treatment. Six major risk categories were identified: (1) the patient's medication is interrupted or complicated temporarily or permanently, (2) the patient uses two products with the same active substance, (3) the traceability of the product is compromised, (4) the patient cannot get into healthcare in case of problems, (5) the patient does not receive substitution-related advice from a pharmacy and (6) the patient is distracted by the support material he/she receives. Several risk mitigation measures were commonly mentioned: medication and device counselling by pharmacists (n=23), infrequent substitution interval (n=15) and better knowledge on biosimilars among healthcare providers (n=13).
Automatic substitution of biologics is associated with risks that should be prospectively managed before implementing the procedure. The substitution also introduces new tasks and communication needs to those involved in actual medication use process, particularly to community pharmacists who will be responsible for substitution and counselling the patients.
探讨芬兰相关利益相关者对生物药物自动替代的看法，重点关注药物安全性以及为创建适当的自动生物制品替代模型而需要考虑的问题。
定性访谈研究。
2018 年，通过半结构化个人访谈（n=17）、双人访谈（n=7）和小组访谈（n=8，共 32 次访谈，62 名参与者）收集数据。参与者代表了广泛参与药物治疗过程的利益相关者：社区药剂师（n=8 次访谈）、当局（n=7）、处方者（n=7）、制药业和批发商（n=6）、患者/客户（n=2）、医院药剂师（n=1）和护士（n=1）。采用归纳内容分析法。
自动替代的好处包括节省成本、更多患者接受生物治疗以及提高治疗的连续性。确定了六个主要风险类别：（1）患者的药物暂时或永久中断或复杂化，（2）患者使用两种具有相同活性物质的产品，（3）产品的可追溯性受到损害，（4）患者在出现问题时无法获得医疗保健，（5）患者未从药房获得替代相关建议，（6）患者收到的支持材料分散了注意力。还普遍提到了几种风险缓解措施：药剂师进行药物和设备咨询（n=23）、减少替代间隔（n=15）以及提高医疗保健提供者对生物类似物的认识（n=13）。
生物制剂的自动替代存在风险，在实施该程序之前应前瞻性地进行管理。该替代方案还为实际用药过程中的相关人员引入了新的任务和沟通需求，特别是负责替代和为患者提供咨询的社区药剂师。
