J Pharmacoepidemiol Risk Manage.  2022 Mar;14(1):58-68. 10.56142/2022.14.1.58.

Improvement of Re-examination System of New Drugs: A Safety Monitoring Study using Real-World Data on Re-examined Drugs

• Kim MS
• Jeong NY
• Kim Y
• Choi NK

• KMID: 2534675
• DOI: http://doi.org/10.56142/2022.14.1.58

Abstract

Objective
Although the re-examination of the safety profiles of approved drugs including the Drug Use-Results Survey (DURS) is conducted in Korea, the evaluation process is limited due to insufficient data collection. The purpose of this study was to monitor the safety profile of an approved drug using real-world data (RWD) and to check for areas of improvement regarding DURS.
Methods
We selected Bonviva? (ibandronate sodium) as the drug of interest and alendronate as the control drug. Health outcomes included osteonecrosis of the jaw (ONJ), ocular inflammation, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN). We conducted cohort study, sequential cohort study, and case-crossover study using the health insurance claims data of the Health Insurance Review and Assessment service collected between 2007 and 2015.
Results
For the cohort study, 44,313 patients who received ibandronate and 394,193 patients who received alendronate were evaluated and the results showed no statistically significant differences in incidence of ONJ (hazard ratio [HR] = 1.17, 95% confidence interval [CI]: 0.69-1.99). In terms of the sequential matched cohort study, 21,721 patients who received Ibandronate and 211,830 patients who received alendronate were evaluated. The HR of ibandronate was 1.07 (95% CI: 0.98-1.17) in June 2009 and these results were not statistically significant after that. The safety profiles for SJS and TEN could not be determined due to the small number of patients.
Conclusion
This study confirmed that the use of RWD for post-marketing surveillance is able to provide a higher level of safety evidence compared to the conventional DURS. The analysis methods used in this study may buffer the limitations of the existing DURS and contribute to the early identification of safety information.

Keyword

Real-world data; Drug re-examination system; Post-marketing surveillance; Ibandronate