Vermeer Niels S, Spierings Irina, Mantel-Teeuwisse Aukje K, Straus Sabine M J M, Giezen Thijs J, Leufkens Hubert G M, Egberts Toine C G, De Bruin Marie L
Utrecht University, Utrecht Institute for Pharmaceutical Sciences (UIPS), Division of Pharmacoepidemiology and Clinical Pharmacology , Universiteitsweg 99, Utrecht, 3584CG , The Netherlands +31 302537324 ; +31 302539166 ;
Expert Opin Drug Saf. 2015 Jan;14(1):63-72. doi: 10.1517/14740338.2015.972362. Epub 2014 Nov 5.
Traceability is important in the postmarketing surveillance of biologicals, since changes in the manufacturing process may give rise to product- or batch-specific risks. With the expected expansion of the biosimilar market, there have been concerns about the ability to trace individual products within pharmacovigilance databases.
The authors discuss the present challenges in the traceability of biologicals in relation to pharmacovigilance, by exploring the processes involved in ensuring traceability. They explore both the existing systems that are in place for the recording of exposure information in clinical practice, as well as the critical steps involved in the transfer of exposure data to various pharmacovigilance databases.
The existing systems ensure the traceability of biologicals down to the manufacturer within pharmacy records, but do not support the routine recording of batch information. Expected changes in supply chain standards provide opportunities to systematically record detailed exposure information. Spontaneous reporting systems are the most vulnerable link in ensuring traceability, due to the manual nature of data transfer. Efforts to improve the traceability should, in the short term, be focused toward encouraging health professionals and patients to systematically record and report detailed exposure information. Long-term solutions lie in expanding the accessibility to, and increasing the electronic exchange of exposure data.
可追溯性在生物制品上市后监测中很重要，因为生产过程中的变化可能会引发特定产品或批次的风险。随着生物类似药市场的预期扩张，人们对在药物警戒数据库中追踪单个产品的能力表示担忧。
作者通过探讨确保可追溯性所涉及的过程，讨论了生物制品可追溯性在药物警戒方面目前面临的挑战。他们既探讨了临床实践中用于记录暴露信息的现有系统，也探讨了将暴露数据传输到各种药物警戒数据库所涉及的关键步骤。
现有系统可确保生物制品在药房记录中追溯到制造商，但不支持批量信息的常规记录。供应链标准的预期变化为系统记录详细暴露信息提供了机会。自发报告系统是确保可追溯性中最薄弱的环节，因为数据传输是人工操作。短期内，提高可追溯性的努力应集中在鼓励卫生专业人员和患者系统地记录和报告详细暴露信息上。长期解决方案在于扩大暴露数据的可获取性并增加其电子交换。
