Characterization of MID-NET® Data for Appropriate Drug Safety Assessment： Lessons Learned from Studies Investigating Incidence of Decreased Liver Function in Patients Prescribed Drugs for Pulmonary Arterial Hypertension and Examining Real World Utilization of Biosimilars
- VernacularTitle:MID—NET® データに基づく適切な医薬品安全性評価のためのデータ特性把握 ―肺高血圧症治療薬による肝機能検査値異常発現割合やバイオ後続品の処方実態の検討を通じて―
- Author:
Maki KOMAMINE
1
;
Tomoaki HASEGAWA
1
;
Takashi ANDO
1
;
Yoshiaki UYAMA
1
Author Information
- Keywords: pharmacoepidemiology; electronic health records; pharmacovigilance
- From:Japanese Journal of Pharmacoepidemiology 2022;():28.e1-
- CountryJapan
- Language:Japanese
- Abstract: Objectives：MID-NET® has contributed to post-marketing drug safety assessment through various pharmacoepidemiological studies. To further promote an appropriate use of MID-NET®, this paper describes points to consider in conducting studies utilizing MID-NET® based on results from the two MID-NET® studies.Study design：Cohort study based on the secondary utilization of medical information databaseMethods：In the first study, the incidence of decreased liver function in patients prescribed drugs for pulmonary arterial hypertension was compared with the results from all-case surveillance (primary data collection). In the second study, real world utilization of biosimilar (hereinafter referred to as “BS”) was investigated to understand characteristics of BS prescription in clinical practice. Results：Although the incidence of decreased liver function varied depending on outcome definitions, the proportion on the definition identifying severe cases was similar to that in the all-case surveillance. It suggests that use of multiple outcomes including a definition taking into consideration a degree of severity is important to evaluate study results with robustness appropriately. In the second study, increased trends of BS prescriptions and various patterns of switching (from original biopharmaceutical to BS or from BS to original biopharmaceutical) depending on age and other factors were confirmed. It indicates that considerations about real world utilization of original biopharmaceutical and BS are necessary for future studies targeting BS.Conclusion：These studies further expanded an understanding and knowledge about data characteristics of MID-NET® and provide useful points to consider for promoting appropriate data utilization in future MID-NET® studies.
