類固醇眼藥水之無菌品質監測計畫

A Survey on the Sterility of Steroid Eye Drops in Taiwan

類固醇眼藥水常用於外眼部的炎症性患者及手術後病患，因眼部組織處於發炎狀態，局部免疫能力不足，若此時使用之眼藥水非無菌狀態，容易導致眼睛感染造成二度傷害。過去曾針對一般眼藥水進行無菌性品質監測，為保障國人用藥品質安全及降低感染風險，監控產品無菌性確有其必要。本研究調查函請直轄市及各縣（市）衛生局配合至轄區內各級醫療院所、製造廠及代理商等針對類固醇眼藥水（市售含betamethasone、fluorometholone、prednisolone及dexamethasone等成分之眼藥水）進行抽查，並依據中華藥典第七版進行無菌性檢驗。104年度共計抽得57件產品（國產37件，輸入20件），結果顯示抽查之57件產品無菌試驗結果全數合格。而監測調查結果發現部分產品外包裝標示有缺失，包括外盒標示之申請商名稱及地址與許可證不符合及未刊載完整製造廠地址，總標示不符合率為20.8%；上述標示不符合之檢體已逐一函送各轄區衛生局進行處辦，並同時副知相關管理單位進行後續追蹤處置，以保障國人之健康及醫療品質。

Steroid eye drops are prescribed for the treatment of inflammation and postoperative recovery. The patient may be immunity depressed around affected place of eye. If the prescribed steroid eye drop is not sterile, it may cause severe damage on eye. In order to ensure the safety of medication, this study aimed to investigate the sterility of steroid eye drops. Fifty seven steroid eye drops (37 were domestic and 20 were imported products) which mainly contained betamethasone, fluorometholone, prednisolone or dexamethasone as drug facts were collected by local health authorities from hospitals, pharmacies and manufactories in Taiwan in 2015. The sterility test was conducted according to the seventh edition of Chinese Pharmacopoeia of Taiwan. The results showed all of the samples were qualified for the sterility test. However, 20.8% samples failed to comply with their labe ling requirements such as incomplete addresses and names under Pharmaceutical Affairs Act. The report of this study had sent to local health authorities for reference, and requested the suppliers and manufactures to recall or correct their products for the purpose of public health protection.