目的：藥物不良事件（Adverse Drug Event；ADE）顧名思義為病人因使用藥物而造成的傷害事件。研究發現約有1020%住院病患遭受過一個或更多需要醫療介入之藥物不良事件。目前監視藥物不良事件之方法，分別為傳統自發性通報系統、加強通報、病例回顧及藥物不良事件電腦化監視系統。許多藥物不良事件之發生與病人之腎功能不全息息相關。希望藉由此分析結果提醒醫療從業人員在開立藥物時，應依照病人之腎功能調整劑量，以確保病人之用藥安全。
方法：藉由某區域教學醫院92及93年度的藥物不良反應自由通報案件，計算各案件病人的肌酸酐清除率後，利用文獻資料評估各案件之藥物劑量是否合理，並且分析其病人之年紀及造成不良事件藥物之藥理分類。
結果：分析通報案件中，92至 93年度藥物不良反應分別24.4%屬用藥疏失。這些可預防性之藥物不良事件發生大部分原因是65歲以上老年人未依照腎功能調整劑量所造成。
結論：老年人的腎功能不良往往會被醫療人員所忽視，主要原因是會被看似正常的肌酸酐檢驗值所蒙蔽，讓醫療人員誤以為其腎功能正常，在開立處方時未依照病人之腎功能調整劑量而造成藥物不良反應之發生。
Preventable adverse drug events are commonly associated with medication errors. Approximately 10-20% inpatients encounter adverse drug events, and therefore need additional medical interventions. Besides, lots of hospitalized patients suffer from renal insufficiency, which is the risk factor associated with adverse drug reaction occurrence, and it can further precipitate their morbidity and mortality. Automatic reporting system for adverse drug reactions and medication errors provides institutions an opportunity for self-inspection this dilemma. The purpose of this study is to evaluate the cause-effect relationship between adverse drug reactions and medication errors. Results can be used to remind all medical staffs regarding the concept, while prescribing, dispensing, or administering medications, dosage adjustment based on patient's renal function is essential. Methods: From January 2003 to December 2004, all ADR records were extracted from a teaching hospital in southern Taiwan. Results: There were total 122 ADR reports assessed. Incidentally, 30 cases (30/122, 25%) were defined as medication error-related ADRs, and were also preventable adverse drug events. The major reasons for causing medication error-related ADRs were as follows: non-performed dosage adjustment based on patient’s renal function (19/30, 63.3%), drug-drug interactions (4/30, 13.3%), noncompliance (4/30, 13.3%), and overdose (3/30, 0%), respectively. Especially, 18 out of 19 non-performed dosage adjustment based on their renal function cases occurred in elderly. The most agents associated with medication error-related ADRs were antimicrobials (12/30, 40%), anticoagulants (3/30, 10%), gout-related agents (3/30, 10%), etc. 70% patients (21/30) received extra medical management to prevent long-term injury, and 23.3% (7/30) patients were admitted to hospital for further treatment.
Conclusions: In clinical practice, if physicians judge renal function before prescribing a prescription for elderly only simply based on their serum creatinine values, some unanticipated ADRs may occur. For safety purpose, we suggest that a patient-specific creatinine clearance calculation or computerized dosage adjustment warning system will be helpful for reducing or preventing these adverse events in the future.
