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[Answered]: Case Study TwoCase Study Ensuring Level-Three-Risk…

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Case Study TwoCase Study Ensuring Level-Three-Risk Compounded Sterile Products Are SafeThe pharmacy department of Miracle Hospital has a very large at-home intravenous program providing steriledosage forms to patients being treated in their home. The department is making a special injectable 0.5%bupivacaine for pain control by using nonsterile commercial raw material of bupivacaine powder and nopreservatives, as it is to be administered intrathecally. Since the beginning of this program, there have been noincidents with this preparation. In the last month, however, five patients reported experiencing high fever withchills, and in almost all cases, the patients were found to be hypotensive following the administration ofbupivacaine. They had never before experienced such symptoms. Certain independent laboratory testsrevealed that the preparation was pyrogenic.1. What is a “pyrogenic” preparation, and what are the common adverse effects? (Napra 3.2)2. Where could have such harmful agents come from? (Napra 3.2)3. Could such agents have been eliminated from the preparation by using sterile 0.22-micron membranefiltration? (Napra 3.2, 3.3)4. How could these agents be eliminated from the preparation? (Napra 3.2, 3.3)

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