Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency, Tokyo, 100-0013, Japan.
Head Office, Tokushukai Information System Incorporated, Osaka, Japan.
Pharmacoepidemiol Drug Saf. 2019 May;28(5):601-608. doi: 10.1002/pds.4777. Epub 2019 Apr 3.
To examine the potential role of Medical Information Database Network (MID-NET ), a newly established Japanese medical information database network, in postmarketing drug safety assessments through the characterization of its advantages and limitations in five pilot studies.
The pilot studies were designed to address three major objectives in postmarketing drug safety assessments, ie, the examination of actual drug utilization, the impact of safety-related regulatory actions, and drug-associated risks. The five studies were conducted on the following topics: (a) utilization of codeine-containing products and its relationship with respiratory depression, (b) impact of a Dear Healthcare Professional letter on hypocalcemia incidence associated with denosumab (Ranmark ) use, (c) risk of acute myocardial infarction associated with antidiabetic drug use, (d) risk of glucose metabolism disorders associated with atypical antipsychotic drug use, and (e) prospective monitoring of abnormal laboratory test results during new drug prescriptions.
The pilot studies were successfully conducted and demonstrated the value of MID-NET in postmarketing drug safety assessments. In particular, the ability to utilize laboratory test results as objective clinical indicators is a major advantage of this database. Potential limitations include a relatively small sample size and a lack of patient-level data linkages among hospitals.
MID-NET was confirmed to be a valuable database for postmarketing drug safety assessments. The use of laboratory test results to define clinical outcomes may allow more objective and accurate analyses to be conducted. These studies furthered our understanding of the characteristics of MID-NET , including its advantages and limitations.
通过对五个试点研究的优势和局限性进行分析，考察新成立的日本医学信息数据库网络（MID-NET）在药品上市后安全性评估中的潜在作用。
这些试点研究旨在解决药品上市后安全性评估中的三个主要目标，即实际用药情况的考察、与安全性相关的监管措施的影响以及药物相关风险。这五个研究涉及以下主题：（a）含可待因产品的使用情况及其与呼吸抑制的关系，（b）致医护人员信对 denosumab（Ranmark）使用相关低钙血症发生率的影响，（c）抗糖尿病药物使用与急性心肌梗死的相关性风险，（d）非典型抗精神病药物使用与葡萄糖代谢紊乱的相关性风险，以及（e）新药处方中异常实验室检查结果的前瞻性监测。
这些试点研究成功开展，并证明了 MID-NET 在药品上市后安全性评估中的价值。特别是，将实验室检查结果用作客观临床指标的能力是该数据库的主要优势。潜在的局限性包括样本量相对较小以及医院间缺乏患者层面的数据链接。
MID-NET 被证实是一种有价值的药品上市后安全性评估数据库。使用实验室检查结果来定义临床结局可能允许进行更客观和准确的分析。这些研究进一步了解了 MID-NET 的特点，包括其优势和局限性。
