世界各國針對兒童用藥安全的研究結果顯示,醫院有大部分的藥物都沒有做過兒童適當劑量和副作用的測試,不符合世界衛生組織對兒童用藥的相關說明,屬於兒童禁用的範疇。本研究藉由食品藥物管理局(FDA)藥物許可分類,評估小兒(PICU)及新生兒加護病房(NBCU),醫師處方的藥物型態及其不適當性。研究結果顯示,PICU 屬於未經許可的處方(unlicensed)佔 20.1%,非許可使用範疇(off-label)佔35.4%。NBCU 屬於 unlicensed 約佔 11.9%,off-label 佔 33.2%,其中以處方不適當適應症占大多數。且 unlicensed 藥物中,以心臟血管藥物佔最多(PICU-38.1%,NBCU-59.1%)。而 off-label 藥物,PICU 以心臟血管藥物(27.0%),NBCU 以抗微生物製劑使用(36.2%)佔多數。追蹤一個月內藥物使用情形,病患因服用 amiodarone造成甲狀腺功能低下,為嚴重不良反應。日後,我們應該積極對於目前醫院使用在兒童的藥物執行大規模的檢測與評估,作為以後醫師開立處方的參考,確保兒童用藥安全。

The result of the safety of medication for children around the worldwide country shows that most of drugs were not evaluated about appropriate dosage of children and tested the adverse reactions. These drugs could not be recommended to use in the pediatric field. This study is that to assess the extent of use of drugs inappropriate for children in prescriptions issued in a pediatric intensive care unit (PICU) and newborn care unit (NBCU), according to FDA standards. The results of this study reveal that 20.1% in PICU and 11.9% in NBCU of prescriptions were for unlicensed drugs and 35.4% in PICU and 33.2% in NBCU of prescriptions were for off-label drugs. The most common reason of off-label use is that the medication was prescribed for an inappropriate indication. The analysis of prescriptions base on the BNHI classification of drugs, the higher prevalence of unlicensed uses is cardiovascular drugs (38.1% in PICU and 59.1% in NBCU). The most occurring off-label prescriptions were cardiovascular drugs 27.0% in PICU and antimicrobial drugs 36.2% in NBCU. To follow up the situation of drugs used in these patients, the severe adverse drug reaction was reported that a patient was induced hypothyroidism after taking amiodarone. This result demonstrates the need to encourage further studies on the safety of drugs for pediatric uses.