Aagaard Lise, Soendergaard Birthe, Andersen Elin, Kampmann Jens Peter, Hansen Ebba Holme
Section of Social Pharmacy, Department of Pharmacology and Pharmacotherapy, Faculty of Pharmaceutical Sciences (Research Center for Quality in Medicine Use), The Danish Medicines Agency, Denmark.
Soc Sci Med. 2007 Sep;65(6):1296-309. doi: 10.1016/j.socscimed.2007.04.026. Epub 2007 Jun 12.
Data on adverse drug reactions (ADRs) have been collected in Denmark since 1968 and the process is ongoing. This article explores knowledge created by the system, including how the collected data have been used to monitor the safety of licensed drugs. Nonaka's theory of knowledge creation was used to discriminate between tacit and explicit knowledge. A total of 56,802 ADR case reports were received from 1968 to 2005. The analysis shows a rather stable number of ADR cases from 1980, with about 2000 reports per year. The distribution of cases into serious and non-serious ADRs has been one to four throughout the period under study, but with large variations. Analysis of selected ADR cases shows that the system lacked the potential to capture available knowledge. Consequently the ADR reports have had limited value and significance in the process of creating scientific knowledge. Thus, the analysis questions the way available data can become explicit as a basis for regulatory decisions and whether all data can become knowledge, including who decides what knowledge is.
自1968年起，丹麦就开始收集药品不良反应（ADR）数据，且这一过程仍在持续。本文探讨了该系统所产生的知识，包括所收集的数据是如何用于监测已获许可药品的安全性的。运用野中郁次郎的知识创造理论来区分隐性知识和显性知识。1968年至2005年共收到56,802份药品不良反应病例报告。分析表明，自1980年以来，药品不良反应病例数量相当稳定，每年约有2000份报告。在所研究的整个时期内，严重药品不良反应与非严重药品不良反应的病例分布比例为1比4，但存在较大差异。对选定的药品不良反应病例进行分析表明，该系统缺乏获取现有知识的潜力。因此，药品不良反应报告在创造科学知识的过程中价值和意义有限。因此，该分析对现有数据能否明确化以作为监管决策的依据，以及所有数据能否成为知识（包括由谁决定什么是知识）提出了质疑。
