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Signal Detection of Pediatric Drug-Induced Coagulopathy Using Routine Electronic Health Records
Xiaolu Nie1,2,3, Yuncui Yu4, Lulu Jia4
1Center for Clinical Epidemiology and Evidence-based Medicine, National Center for Children's Health, Beijing Children's Hospital, Capital Medical University, Beijing, China.
Insights
A new method identified 19 drug-induced coagulopathy (DIC) signals in children, including 12 novel associations. These findings highlight potential drug safety concerns and the need for further research in pediatric populations.
Area of Science:
- Pharmacovigilance
- Pediatric Drug Safety
- Clinical Epidemiology
Background:
- Drug-induced coagulopathy (DIC) presents a significant clinical challenge in pediatric populations.
- Effective post-marketing surveillance is crucial for identifying DIC safety signals in children.
- Electronic medical record (EMR) data offers a valuable resource for detecting adverse drug reactions.
Purpose of the Study:
- To develop and apply a two-stage modeling approach to detect potential DIC safety signals in children using EMR data.
- To identify specific drugs associated with an increased risk of coagulopathy in pediatric patients.
- To assess the novelty of identified DIC signals by comparing them with existing literature.
Main Methods:
- Extracted EMR data from Beijing Children's Hospital (2009-2020).
- Employed a two-stage method involving crude incidence calculation and propensity score-matched retrospective cohort analysis.
- Utilized conditional logistic regression to estimate odds ratios (OR) and 95% confidence intervals (CI) for drug-associated coagulopathy.
Main Results:
- Identified 19 positive associations between drugs and DIC.
- Detected three new DIC signals in both children and adults: omeprazole (OR: 2.23), chlorpheniramine (OR: 3.04), and salbutamol sulfate (OR: 1.36).
- Identified twelve new DIC signals specifically in children, including meropenem (OR: 3.38), cefoperazone sulbactam (OR: 2.80), and fluconazole (OR: 2.11).
Conclusions:
- The developed two-stage algorithm successfully identified nineteen DIC safety signals, with twelve being novel in the pediatric population.
- The findings underscore the importance of continuous drug safety monitoring in children.
- Further population-based studies and mechanistic research are recommended to validate these identified DIC safety signals.
Abstract:
Background: Drug-induced coagulopathy (DIC) is a severe adverse reaction and has become a significantly increased clinical problem in children. It is crucial to the detection of the DIC safety signal for drug post-marketing scientific supervision purposes. Therefore, this study aimed to detect potential signals for DIC in children using the routine electronic medical record (EMR) data. Methods: This study extracted EMR data from Beijing Children's Hospital between 2009 and 2020. A two-stage modeling method was developed to detect the signal of DIC. We calculated the crude incidence by mining cases of coagulopathy to select the potential suspected drugs; then, propensity score-matched retrospective cohorts of specific screened drugs from the first stage were constructed and estimated the odds ratio (OR) and 95% confidence interval (CI) using conditional logistic regression models. The current literature evidence was used to assess the novelty of the signal. Results:In the study, from a total of 340 drugs, 22 drugs were initially screened as potentially inducing coagulopathy. In total, we identified 19 positive DIC associations. Of these, potential DIC risk of omeprazole (OR: 2.23, 95% CI: 1.88-2.65), chlorpheniramine (OR:3.04, 95% CI:2.56-3.60), and salbutamol sulfate (OR:1.36, 95% CI:1.07-1.73) were three new DIC signals in both children and adults. Twelve associations between coagulopathy and drugs, meropenem (OR: 3.38, 95% CI: 2.72-4.20), cefoperazone sulbactam (OR: 2.80, 95% CI: 2.30-3.41), fluconazole (OR: 2.11, 95% CI: 1.71-2.59), voriconazole (OR: 2.82, 95% CI: 2.20-3.61), ambroxol hydrochloride (OR: 2.12, 95% CI: 1.74-2.58), furosemide (OR: 2.36, 95% CI: 2.08-2.67), iodixanol (OR: 2.21, 95% CI: 1.72-2.85), cefamandole (OR: 1.82, 95% CI: 1.56-2.13), ceftizoxime (OR: 1.95, 95% CI: 1.44-2.63), ceftriaxone (OR: 1.95, 95% CI: 1.44-2.63), latamoxef sodium (OR: 1.76, 95% CI: 1.49-2.07), and sulfamethoxazole (OR: 1.29, 95% CI: 1.01-1.64), were considered as new signals in children. Conclusion: The two-stage algorithm developed in our study to detect safety signals of DIC found nineteen signals of DIC, including twelve new signals in a pediatric population. However, these safety signals of DIC need to be confirmed by further studies based on population study and mechanism research.
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