Katherine M Duszynski1, James H Stark2, Catherine Cohet3, Wan-Ting Huang4, Ju-Young Shin5, Edward Chia-Cheng Lai6, Kenneth K C Man7,8, Nam-Kyong Choi9, Alena Khromava10, Tomomi Kimura11, Kui Huang12, Sawaeng Watcharathanakij13, Sonali Kochhar14,15, Robert T Chen16, Nicole L Pratt1. 1. Quality Use of Medicines and Pharmacy Research Centre, Clinical and Health Sciences, University of South Australia, Adelaide, South Australia, Australia. 2. Vaccine Medical, Scientific and Clinical Affairs, Pfizer Inc., New York, New York, USA. 3. Vaccines Clinical Research & Development, GlaxoSmithKline, Wavre, Belgium. 4. Office of Preventive Medicine, Taiwan Centers for Disease Control, Taipei, Taiwan. 5. School of Pharmacy, Sungkyunkwan University, Suwon, South Korea. 6. School of Pharmacy, Institute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine, National Cheng Kung University, Tainan, Taiwan. 7. Research Department of Practice and Policy, UCL School of Pharmacy, London, UK. 8. Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, The University of Hong Kong, Hong Kong. 9. Department of Health Convergence, Ewha Womans University, Seoul, South Korea. 10. Epidemiology and Benefit Risk, Sanofi Pasteur Ltd., Toronto, Ontario, Canada. 11. Astellas Pharma Inc., Northbrook, Illinois, USA. 12. Global Medical Epidemiology, Worldwide Medical and Safety, Pfizer Inc., New York, New York, United States of America. 13. Faculty of Pharmaceutical Sciences, Ubon Ratchathani University, Ubon Ratchathani, Thailand. 14. Global Healthcare Consulting, New Delhi, India. 15. Department of Global Health, University of Washington, Seattle, Washington, USA. 16. Brighton Collaboration, The Task Force for Global Health, Decatur, Georgia, USA.
Abstract
INTRODUCTION: Information regarding availability of electronic healthcare databases in the Asia-Pacific region is critical for planning vaccine safety assessments particularly, as COVID-19 vaccines are introduced. This study aimed to identify data sources in the region, potentially suitable for vaccine safety surveillance. This manuscript is endorsed by the International Society for Pharmacoepidemiology (ISPE). METHODS: Nineteen countries targeted for database reporting were identified using published country lists and review articles. Surveillance capacity was assessed using two surveys: a 9-item introductory survey and a 51-item full survey. Survey questions related to database characteristics, covariate and health outcome variables, vaccine exposure characteristics, access and governance, and dataset linkage capability. Other questions collated research/regulatory applications of the data and local publications detailing database use for research. RESULTS: Eleven databases containing vaccine-specific information were identified across 8 countries. Databases were largely national in coverage (8/11, 73%), encompassed all ages (9/11, 82%) with population size from 1.4 to 52 million persons. Vaccine exposure information varied particularly for standardized vaccine codes (5/11, 46%), brand (7/11, 64%) and manufacturer (5/11, 46%). Outcome data were integrated with vaccine data in 6 (55%) databases and available via linkage in 5 (46%) databases. Data approval processes varied, impacting on timeliness of data access. CONCLUSIONS: Variation in vaccine data availability, complexities in data access including, governance and data release approval procedures, together with requirement for data linkage for outcome information, all contribute to the challenges in building a distributed network for vaccine safety assessment in the Asia-Pacific and globally. Common data models (CDMs) may help expedite vaccine safety research across the region.
INTRODUCTION: Information regarding availability of electronic healthcare databases in the Asia-Pacific region is critical for planning vaccine safety assessments particularly, as COVID-19 vaccines are introduced. This study aimed to identify data sources in the region, potentially suitable for vaccine safety surveillance. This manuscript is endorsed by the International Society for Pharmacoepidemiology (ISPE). METHODS: Nineteen countries targeted for database reporting were identified using published country lists and review articles. Surveillance capacity was assessed using two surveys: a 9-item introductory survey and a 51-item full survey. Survey questions related to database characteristics, covariate and health outcome variables, vaccine exposure characteristics, access and governance, and dataset linkage capability. Other questions collated research/regulatory applications of the data and local publications detailing database use for research. RESULTS: Eleven databases containing vaccine-specific information were identified across 8 countries. Databases were largely national in coverage (8/11, 73%), encompassed all ages (9/11, 82%) with population size from 1.4 to 52 million persons. Vaccine exposure information varied particularly for standardized vaccine codes (5/11, 46%), brand (7/11, 64%) and manufacturer (5/11, 46%). Outcome data were integrated with vaccine data in 6 (55%) databases and available via linkage in 5 (46%) databases. Data approval processes varied, impacting on timeliness of data access. CONCLUSIONS: Variation in vaccine data availability, complexities in data access including, governance and data release approval procedures, together with requirement for data linkage for outcome information, all contribute to the challenges in building a distributed network for vaccine safety assessment in the Asia-Pacific and globally. Common data models (CDMs) may help expedite vaccine safety research across the region.
Authors: Lana Yh Lai; Faaizah Arshad; Carlos Areia; Thamir M Alshammari; Heba Alghoul; Paula Casajust; Xintong Li; Dalia Dawoud; Fredrik Nyberg; Nicole Pratt; George Hripcsak; Marc A Suchard; Dani Prieto-Alhambra; Patrick Ryan; Martijn J Schuemie Journal: Front Pharmacol Date: 2022-03-22 Impact factor: 5.810