The Korea National Disability Registration System (KNDRS) was established in 1989 to provide social welfare benefits based on predefined criteria for disability registration and an objective medical assessment using a disability grading system. Disability registration requires (1) a medical examination by a qualified specialist physician and (2) a medical advisory meeting to review the degree of disability. Medical institutions and specialists for the diagnosis of disabilities are legally stipulated, and medical records for a specified period are required to support the diagnosis. The number of disability types has gradually expanded, and 15 disability types have been legally defined. As of 2021, 2.645 million people were registered as disabled, accounting for approximately 5.1% of the total population. Among the 15 disability types, disabilities of the extremities account for the largest proportion (45.1%). Previous studies have investigated the epidemiology of disabilities using data from the KNDRS, combined predominantly with data from the National Health Insurance Research Database (NHIRD). Korea has a mandatory public health insurance system that covers the entire Korean population, and the National Health Insurance Services manages all eligibility information, including disability types and severity ratings. In short, the KNDRS-NHIRD is a significant data resource for research on the epidemiology of disabilities.

Objectives: With the growing interest in big data, regulatory agencies in United States, Japan, and Europe are showing active movements to use RWD and RWE to manage drug safety and development activation. Along with the global movements, it is necessary to establish a basic system for utilizing RWD based drug lifecycle data for drug safety management in Korea. The purpose of this study is to review and find implication of the collection and utilization of drug lifecycle data in the U.S., Japan, and Europe.Methods: In order to investigate the current status and contents of each country’s system, we searched the websites of each country’s regulatory agency and related agencies, and collected and investigated related laws, papers, and reports. We compared and analyzed focusing on solving regulatory problems that may occur in the drug lifecycle or exploring the safety and potential effects of drugs in drug lifecycle phases.Results: Based on FDA Sentinel 5-year plan and MID-NET, the U.S. and Japan are accelerating the generation of real data and real evidence for regulatory decision-making in post-marketing safety management. In Europe, various clinical field-specific projects have been undertaken to assess the effectiveness and safety of drugs due to disease. Various research cases using drug lifecycle data collected from drug safety management systems in each country have been represented.Conclusions: By identifying drug safety management systems and cases of drug lifecycle data utilization in various countries, we expect to serve as a stepping stone for discussions on the direction and utilization plan to efficiently develop drug safety management systems in Korea.

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Few studies have examined the association between disability and chronic obstructive pulmonary disease (COPD). We compared the trends in the annual COPD prevalence between people with and without disabilities, and examined the association between disability and COPD. We linked the National Health Information Database (2008–2017) with the National Disability Registration Database, which includes more than 2 million people with disabilities every year. In the 2017 dataset, people with disabilities had a higher prevalence of COPD than those without disabilities (30.6% vs. 12.5%, P < 0.001). The age-standardized prevalence rate of COPD among people without disabilities increased from 4.2 in 2008 to 10.9% in 2017 (change of 6.7%), whereas that among those with disabilities increased from 7.0 to 17.1% (change of 10.1%). In multivariate analysis, compared to people without disabilities, those with disabilities had a higher probability of having COPD (adjusted odds ratio, 1.42; 95% confidence interval 1.42–1.43). The results of subgroup analysis by disability characteristics suggested that disabilities due to failure of an organ, such as the kidney, lung, heart, or liver, and severe disabilities were particularly vulnerable to COPD. In conclusion, people with disabilities are more likely to have COPD compared to people without disabilities. Further longitudinal studies that examine cause-and-effect relationship between disability and COPD are needed to clarify this relationship and to further investigate any potential negative effects associated with the coexistence of these conditions.