Attempt to Prepare Artificial Cerebrospinal Fluid in Pursuant to the Product Liability Law.

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  • ＰＬ法施行に基づく院内特殊製剤「人工髄液」作成の試み
  • PLホウ シコウ ニ モトヅク インナイ トクシュ セイザイ ジンコウズイエキ サクセイ ノ ココロミ

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Abstract

At the request of the Department of Neurosurgery, we are providing a special preparation for exclusive use in our hospital. It is artificial cerebrospinal fluid (CSF). The man-made CSF is a solution made similar to human CSF in its composition and is prepared under the aseptic condition. Prior to taking up the task of preparing CSF, we pored over the text of the Product Liability (PL) Law in view of its safety. The defects of products cited by the law included structural defects, functional defects and defects in the way of instructions and caveats. So, a pharmaceutical protocol was drawn out and labels as well as package inserts providing necessary information about the CSF were made. Moreover, we straightened up and improved the workplace environment. All these efforts have resulted in the achievement of homogeneity in the quality of CSF preparations ; protection against bacteria and other contaminants; prevention of accidents due to the commission of errors in the method of use and preparation; and the promotion of proper use of drugs through unification of information. As pharmacists, we can also say with confidence that we have done much for the right use of other medicines dispensed by us through the preparation of protocols, labels and package inserts after carefully examining the PL law.

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