The utilization and challenges of Japan's MID-NET ® medical information database network in postmarketing drug safety assessments

A summary of pilot pharmacoepidemiological studies

on behalf of MID-NET project group

研究成果: ジャーナルへの寄稿記事

抄録

Purpose: 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. Methods: 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. Results: 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. Conclusions: 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.

元の言語英語
ページ(範囲)601-608
ページ数8
ジャーナルPharmacoepidemiology and Drug Safety
28
発行部数5
DOI
出版物ステータス出版済み - 5 1 2019

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Information Services
Japan
Databases
Safety
Pharmaceutical Preparations
Glucose Metabolism Disorders
Pharmaceutical Databases
Drug Utilization
Drug Prescriptions
Codeine
Hypocalcemia
Information Storage and Retrieval
Hypoglycemic Agents
Respiratory Insufficiency
Sample Size
Antipsychotic Agents
Myocardial Infarction
Delivery of Health Care
Incidence

All Science Journal Classification (ASJC) codes

  • Epidemiology
  • Pharmacology (medical)

これを引用

@article{f19edff11c734eaaa6da7d09fd7fb8ad,
title = "The utilization and challenges of Japan's MID-NET {\circledR} medical information database network in postmarketing drug safety assessments: A summary of pilot pharmacoepidemiological studies",
abstract = "Purpose: To examine the potential role of Medical Information Database Network (MID-NET {\circledR} ), 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. Methods: 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 {\circledR} ) 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. Results: The pilot studies were successfully conducted and demonstrated the value of MID-NET {\circledR} 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. Conclusions: MID-NET {\circledR} 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 {\circledR} , including its advantages and limitations.",
author = "{on behalf of MID-NET project group} and Kaori Yamada and Maori Itoh and Yoshiaki Fujimura and Michio Kimura and Koichiro Murata and Naoki Nakashima and Naoki Nakashima and Kazuhiko Ohe and Takao Orii and Eizaburo Sueoka and Takahiro Suzuki and Hideto Yokoi and Chieko Ishiguro and Yoshiaki Uyama",
year = "2019",
month = "5",
day = "1",
doi = "10.1002/pds.4777",
language = "English",
volume = "28",
pages = "601--608",
journal = "Pharmacoepidemiology and Drug Safety",
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T1 - The utilization and challenges of Japan's MID-NET ® medical information database network in postmarketing drug safety assessments

T2 - A summary of pilot pharmacoepidemiological studies

AU - on behalf of MID-NET project group

AU - Yamada, Kaori

AU - Itoh, Maori

AU - Fujimura, Yoshiaki

AU - Kimura, Michio

AU - Murata, Koichiro

AU - Nakashima, Naoki

AU - Nakashima, Naoki

AU - Ohe, Kazuhiko

AU - Orii, Takao

AU - Sueoka, Eizaburo

AU - Suzuki, Takahiro

AU - Yokoi, Hideto

AU - Ishiguro, Chieko

AU - Uyama, Yoshiaki

PY - 2019/5/1

Y1 - 2019/5/1

N2 - Purpose: 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. Methods: 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. Results: 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. Conclusions: 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.

AB - Purpose: 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. Methods: 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. Results: 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. Conclusions: 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.

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U2 - 10.1002/pds.4777

DO - 10.1002/pds.4777

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SN - 1053-8569

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