Evaluation of Pharmaceutical Compounding-Sterile Preparations Practice in Hospital

• Main Authors: Ching-Ju Hsieh, 謝沁如
• Other Authors: Shihn-Sheng Wu
• Format: Others
• Language: zh-TW
• Published: 2014
• Online Access: http://ndltd.ncl.edu.tw/handle/5pvv2f

碩士 === 高雄醫學大學 === 藥學研究所 === 102 === Aim：The study mainly discussed the Compounding-Sterile Preparations of Total Parenteral Nutrition Solutions (TPN), Chemotherapy Preparations (CT) and Radiotherapy Preparations (RT) for better understanding actual processing situation and to further ensure the safety of patients medication. Methods：The study organized questionnaires and site-visit checking forms aiming at the operation environment, personnel training, operation evaluation and S.O.P setting of hospitals for compounding-sterile preparations. The content of “Compounding-Sterile Preparations Operation Environment Questionnaire” was designed and processed in the hospitals which apply all of Total Parenteral Nutrition Solutions ,Chemotherapy Preparations and Radiotherapy Preparations .The site visiting checking points include environment and equipment of compounding area, the setting of S.O.P. and quality control monitoring. Collecting the actual operation situation information nowadays with further data analysis facilitates the understanding of actual processing of compounding-sterile preparations. Results：There are totally 58 hospitals apply Total Parenteral Nutrition Solutions, Chemotherapy Preparations and Radiotherapy Preparations at the same time, one of them refused to take the questionnaire while 57 hospitals information were collected. The questionnaire return-rate was 98%. One of the 57 hospitals refused site visiting and 56 hospitals information were collected. The site-visiting perform rate was 98%. The results indicated that Total Parenteral Nutrition Solutions was operated in strictly controlled environment in 55 hospitals while 2 hospitals operated the compounding in air-conditioning environment. For Chemotherapy Preparations, the procedure was operated under controlled environment in 56 hospitals and one in air-conditioning environment. For Radiotherapy Preparations, 11 hospitals processed in well-controlled environment, 7 in air-conditioning environment, 5 in uncertain environment and 32 hospitals with no response in questionnaires. The results of site visiting indicate that 48 hospitals operated the compounding procedure in controlled environment and one in air-conditioning environment. 56 hospitals operated chemotherapy infusion compounding in controlled environment. Regarding Radiotherapy Preparations, only 8 hospitals responded with actual answers in questionnaires (7 in air-conditioning environment and one in controlled environment) while 32 hospitals purchase the Preparations, 4 without filling in the answers, 6 without intervention and 6 didn’t set the operation location. Conclusion：Due to the present hospitals regulations, the hospitals investigated in the study provided enough aseptic equipment and effective protection for Total Parenteral Nutrition Solutions and Chemotherapy Preparations. The aseptic environment for Radiotherapy Preparations which was not included in the hospital accreditation needed to be improved. However, most hospitals in the study chose out-sourcing and purchased the Radiotherapy Preparations. The operation procedure and environment were unknown. Therefore, it is necessary for the hospitals requiring qualified aseptic environment and compounding procedure.