Case Study Ensuring Level-Three-Risk Compounded Sterile Products Are Safe The pharmacy department of Miracle Hospital has a very large at-home intravenous program providing sterile dosage 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 no preservatives, as it is to be administered intrathecally. Since the beginning of this program, there have been no incidents with this preparation. In the last month, however, five patients reported experiencing high fever with chills, and in almost all cases, the patients were found to be hypotensive following the administration of bupivacaine. They had never before experienced such symptoms. Certain independent laboratory tests revealed that the preparation was pyrogenic. What is a “pyrogenic” preparation, and what are the common adverse effects? (Napra 3.2) Where could have such harmful agents come from? (Napra 3.2) Could such agents have been eliminated from the preparation by using sterile 0.22-micron membrane filtration? (Napra 3.2, 3.3) How could these agents be eliminated from the preparation? (Napra 3.2, 3.3)
Case Study Ensuring Level-Three-Risk Compounded Sterile Products Are Safe
The pharmacy department of Miracle Hospital has a very large at-home intravenous program providing sterile dosage 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 no preservatives, as it is to be administered intrathecally. Since the beginning of this program, there have been no incidents with this preparation. In the last month, however, five patients reported experiencing high fever with chills, and in almost all cases, the patients were found to be hypotensive following the administration of bupivacaine. They had never before experienced such symptoms. Certain independent laboratory tests revealed that the preparation was pyrogenic.
- What is a “pyrogenic” preparation, and what are the common adverse effects? (Napra 3.2)
- Where could have such harmful agents come from? (Napra 3.2)
- Could such agents have been eliminated from the preparation by using sterile 0.22-micron membrane filtration? (Napra 3.2, 3.3)
- How could these agents be eliminated from the preparation? (Napra 3.2, 3.3)
Step by step
Solved in 3 steps
