Building an active medical product safety surveillance system in Taiwan: Adaptation of the US Sentinel System common data model structure to the National Health Insurance Research Database in Taiwan

被引：14

作者：

Huang, Kelly ^{[1
]}

Lin, Fang-Ju ^{[1
,2
,3
]}

Ou, Huang-Tz ^{[4
]}

Hsu, Chien-Ning ^{[5
,6
]}

Huang, Ling-Ya ^{[1
]}

Wang, Chi-Chuan ^{[1
,2
,3
]}

Toh, Sengwee ^{[7
,8
]}

机构：

[1] Natl Taiwan Univ, Coll Med, Sch Pharm, Room 202,33,Linsen S Rd, Taipei 100, Taiwan

[2] Natl Taiwan Univ, Coll Med, Grad Inst Clin Pharm, Taipei, Taiwan

[3] Natl Taiwan Univ Hosp, Dept Pharm, Taipei, Taiwan

[4] Natl Cheng Kung Univ, Inst Clin Pharm & Pharmaceut Sci, Tainan, Taiwan

[5] Kaohsiung Chang Gung Mem Hosp, Dept Pharm, Kaohsiung, Taiwan

[6] Kaohsiung Med Univ, Coll Pharm, Kaohsiung, Taiwan

[7] Harvard Med Sch, Dept Populat Med, Boston, MA 02115 USA

[8] Harvard Pilgrim Hlth Care Inst, Boston, MA USA

来源：

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY | 2021年 / 30卷 / 01期

关键词：

common data model; pharmacoepidemiology; pharmacovigilance; sentinel initiative; Taiwan;

D O I：

10.1002/pds.5168

中图分类号：

R1 [预防医学、卫生学];

学科分类号：

1004 ; 120402 ;

摘要：

Purpose Using real-world data to support regulatory decision has become a global movement. However, a robust platform for active surveillance of medical product safety has not been established in Taiwan. Methods Following the common data model structure of the U.S. Food and Drug Administration's Sentinel System, we built the Taiwan Sentinel Data Model (TSDM) using the National Health Insurance Research Database with longitudinal claims data from 23 million individuals, linked death and cause of death data from a national registry, and linked electronic health record data from a delivery system. We examined the conversion of the TSDM using the Sentinel Data Quality Review and Characterization Programs in a sample of sex- and age-stratified cohort of 3 million individuals. Results The TSDM fulfilled the requirements of data quality assurance. Only about 6% of sex and 0.0007% of birth year were missing, and <0.001% of date data had illogical values. Conclusions The TSDM-converted database could be a valuable data resource for domestic pharmacovigilance analysis in Taiwan and cross-country evaluation.

引用

页码：97 / 101

页数：5