在SARS-CoV-2大流行封锁期间分配抗癌研究药物:在肿瘤中心的经验

J. Villa, C. Jemos, M. Milani, E. O. Salé
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引用次数: 0

摘要

背景和重要性参加肿瘤临床试验的患者经常处于危险之中,并且通常居住在远离肿瘤中心的地方。从2020年2月21日起,在SARS-CoV-2造成的封锁期间,肿瘤患者因健康原因被允许旅行,但他们的临床状况、组织困难和COVID-19的风险建议采取审慎的解决方案。AIFA和EMA授权中心采取特殊措施,促进更多周期的分配,并在家中向患者提供治疗。这项工作旨在验证这些解决方案在肿瘤中心的影响。材料与方法采用Excel数据库对1月至6月3日的实验用药数量进行统计分析。分配情况分为三个时期,以评估趋势:2020年2月21日之前(P1)、2月22日至3月3日(P2)和3月19日(开始发货)至封锁结束(P3)的每日静脉(IV)和口服(PO)分配情况,分析注意到的主要问题和发运的治疗药物百分比。结果全期治疗4154例;P1区平均日配药量为39.46 (16.03 PO, 23.43 IV), P2区平均日配药量为40.06 (16.12 PO, 23.94 IV), P3区平均日配药量为38.71 (14.71 PO, 24.00 IV)。P3区平均日配药量为109批,占总配药量的13.72%。P2区的分配人数略有增加,原因是由于担心即将关闭,预计会有访问;随后的减少是由于单次分配/运输的药品数量增加。与封锁前相比,PO治疗略有下降(- 8.23%),而静脉注射治疗在三个时期保持稳定。发生7例转运问题,109例中有4例导致治疗中断。在分析期间未发现治疗错误,可能是由于药物到达时的电话反馈。结论和相关性研究药物运输在降低大流行对治疗连续性的影响方面是有效的,但没有成为最常用的模式。后勤困难造成了4例治疗中断,电话反馈机制限制了治疗错误的风险。参考文献和/或致谢利益冲突无利益冲突
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4CPS-390 Dispensing of anticancer investigational drugs during lockdown for the SARS-CoV-2 pandemic: experience in an oncological centre
Background and importance Patients enrolled in oncology clinical trials are frequently at risk and often live far from the oncology centre. Starting from 21 February 2020, during the lockdown caused by SARS-CoV-2, oncological patients were allowed to travel for health reasons, but their clinical conditions, organisational difficulties and the risk of COVID-19 suggested adopting prudential solutions. Aim and objectives The AIFA and EMA authorised centres to adopt exceptional measures, promoting the dispensation of more cycles and the delivery of therapies to patients at home. This work aims to verify the impact of these solutions in an oncological centre. Material and methods The number of experimental drugs dispensed from January to 3 June were analysed using an Excel database. Dispensations were divided in three periods to evaluate the trend: daily intravenous (IV) and oral (PO) dispensations before 21 February 2020 (P1), between 22 February and 3 March (P2) and from 19 March (start of shipments) until the end of lockdown (P3), analysing the main issues noticed and the percentage of therapies shipped. Results Therapies in the entire period were 4154; mean daily dispensations in P1 was 39.46 (16.03 PO, 23.43 IV), in P2 40.06 (16.12 PO, 23.94 IV) and in P3 38.71 (14.71 PO, 24.00 IV). During P3, 109 shipments of PO medications were delivered, representing 13.72% of the total therapies. The slight increase in dispensations in P2 was due to the anticipation of visits due to the fear of an imminent closure; the subsequent decrease was due to a higher drug quantity dispensed/shipped per single dispensation. PO therapies decreased slightly (−8.23%) compared with the pre-lockdown period, while IV therapies remained steady over the three periods. Seven transport issues occurred, leading to therapeutic discontinuity in 4 of 109 cases. No therapeutic error was detected during the period analysed, probably due to telephone feedback on the arrival of the drugs. Conclusion and relevance Investigational drug shipment was effective in lowering the impact of the pandemic on the therapeutic continuity, without however becoming the most frequently used model. Logistical difficulties produced four cases of therapeutic discontinuity and the telephone feedback mechanism limited the risk of errors in therapy. References and/or acknowledgements Conflict of interest No conflict of interest
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