4．Utilization of Real World Data for Post-marketing Pharmacovigilance Activity
- VernacularTitle:４．製造販売後の安全性監視活動におけるリアルワールドデータ活用
- Author:
Makoto MIYAZAKI
1
;
Akihito SHITO
1
;
Eiji FURUTA
1
;
Minoru SHIMODERA
1
Author Information
- Keywords: real world data; pharmacovigilance; Good Post-Marketing Study Practice
- From:Japanese Journal of Pharmacoepidemiology 2019;24(1):31-39
- CountryJapan
- Language:Japanese
- Abstract: Good Post-Marketing Study Practice (GPSP) changed in April 2018, allows pharmaceutical companies to use a real-world data for pharmacovigilance activity. On the other hand, it is known that there are 3 major dimensions of pharmacovigilance： “Monitoring, vigilance, and science：building the best evidence” ,“Regulation, industry, and legal system：ensuring public health” and “Medicine, medicines, and uncertainty : doing good to patients” . Therefore, in this article, we consider how the change of GPSP reflects on the 3 features of pharmacovigilance.In general, it is thought that the change of GPSP contributes pharmacovigilance, considering the 3 features of pharmacovigilance. On the other hand, there are some points to improve pharmacovigilance system：1) how a safety question for pharmacovigilance should be addressed, 2) how information of routine pharmacovigilance should contribute to a safety question to be addressed, 3) how a feasibility assessment (assessment of data source before conducting a formal comparative activity) should be conducted, and 4) a necessity of a variety of methodology and data sources such as descriptive studies and disease registry. These improvements will contribute to global standardization and give us global competence.Overall, it is very difficult to consider the best safety question, data source and methodology from many options. However, it is thought that keep considering them in order to accumulate experiences is important for our ultimate goal, which is to help our patients. We expect more discussions among all the stakeholders together.
