Pediatric medication-related incidents in Japan: a nationwide observational study of severity and factors associated with severe patient harm.

چکیده اصلی

UNLABELLED: Children are particularly vulnerable to medication-related harm. However, most previous research has focused on prescribing errors, leaving incidents occurring during downstream stages of the medication-use process insufficiently well characterized. We determined the epidemiology of pediatric medication-related incidents in Japan and examined factors associated with severe patient harm. This retrospective cross-sectional study analyzed nationwide incident reports from the Japan Council for Quality Health Care (JCQHC) Safe Master database involving patients aged 0 to 19 years reported between 2013 and 2024. Incidents were classified by medication-use stage and error type. Severe incidents (severity grade ≥ 3b) were identified, and associated factors were evaluated by multivariable modified Poisson regression to estimate adjusted prevalence ratios (aPRs) and 95% confidence intervals (CIs). Among the 54,310 incident reports, 546 pediatric medication-related incidents were identified, including 178 (32.6%) that were severe. Incidents occurring during preparation and administration accounted for 67.9% of all incidents and were associated with a higher prevalence of severe harm among reported incidents (aPR, 2.03; 95% CI, 1.38-2.98). Extravasation occurred in 35 incidents, of which 29 (82.9%) were severe. Nurse-related incidents were associated with a lower prevalence of severe harm than physician-related incidents (aPR, 0.55; 95% CI, 0.42-0.72). Patient age, time of day, neonatal intensive care unit (NICU) location, physician experience, and workload were not significantly associated with severe harm. CONCLUSION: Preparation and administration were frequently reported medication-use stages and were associated with a higher prevalence of severe harm. Pediatric medication safety strategies should extend beyond prescribing toward system-level interventions targeting preparation, administration, and monitoring. WHAT IS KNOWN: • Children are particularly vulnerable to medication-related harm, and previous pediatric medication safety research has focused predominantly on prescribing errors. • Evidence regarding severe medication-related incidents occurring during downstream medication-use stages remains limited, particularly from nationwide studies. WHAT IS NEW: • In this 12-year nationwide Japanese study, incidents occurring during medication preparation and administration (not prescribing) were associated with a higher prevalence of severe harm among reported incidents. • Severe extravasation occurred predominantly in younger children, highlighting monitoring of intravenous access sites as a key target for pediatric safety.

ترجمه فارسی چکیده

کودکان به‌ویژه در معرض آسیب ناشی از دارو هستند. با این حال، اکثر تحقیقات قبلی بر روی خطاهای تجویز تمرکز داشته‌اند و حوادث رخ‌داده در مراحل پایانی فرآیند استفاده از دارو به‌طور کافی مشخص نشده‌اند. ما epidemiology حوادث دارویی مرتبط با کودکان در ژاپن را تعیین کردیم و عوامل مرتبط با آسیب شدید بیمار را بررسی کردیم. این مطالعه تجدیدنظرشده مقطعی تحلیل گزارش‌های حوادث ملی از پایگاه داده Safe Master شورای ژاپن برای کیفیت مراقبت بهداشتی (JCQHC) شامل بیماران ۰ تا ۱۹ ساله که بین ۲۰۱۳ و ۲۰۲۴ گزارش شده‌اند. حوادث طبقه‌بندی شدند. حوادث شدید (درجه شدت ≥ 3b) شناسایی شدند و عوامل مرتبط با آن‌ها با استفاده از رگرسیون پواسون اصلاح‌شده چندمتغیره ارزیابی شدند. از میان ۵۴،۳۱۰ گزارش حادثه، ۵۴۶ حادثه دارویی مرتبط با کودکان شناسایی شد، از جمله ۱۷۸ (۳۲.۶٪) که شدید بودند. حوادث رخ‌داده در حین آماده‌سازی و تزریق ۶۷.۹٪ از تمام حوادث را تشکیل دادند و با شیوع بالاتر آسیب شدید در گزارش‌ها مرتبط بودند. اکستراواسکولاسیون در ۳۵ حادثه رخ داد، از جمله ۲۹ (۸۲.۹٪) که شدید بودند. حوادث مرتبط با پرستار با شیوع پایین‌تری از آسیب شدید نسبت به حوادث مرتبط با پزشک مرتبط بودند. سن بیمار، زمان روز، محل واحد مراقبت‌های ویژه نوزاد (NICU)، تجربه پزشک و بار کاری به‌طور معناداری با آسیب شدید مرتبط نبودند.

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