International journal of pharmaceutical compounding
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The intent of United States Pharmacopeia Chapter 797 Pharmaceutical Compounding-Sterile Preparations is to prevent patient harm and fatalities that may result from nonsterility, excessive endotoxin load, large content errors in strength of correct ingredients, or the presence of incorrect ingredients. Understanding the different microbial contamination risk levels involved in compounding sterile preparations, how to appropriately assign those risk levels, and the steps needed to maintain sterility decreases the probability of a contaminated preparation.
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United States Pharmacopeia Chapter 797 Pharmaceutical Compounding-Sterile Preparations pertains to all preadministration manipulations and procedures involved in preparation of sterile compounds for application, implantation, infusion, inhalation, injection, insertion, instillation, or irrigation, including preparation, storage, and transportation. The chapter does not pertain to actual clinical administration of compounded sterile preparations to patients. ⋯ Because the achievement of sterility requires that facilities meet minimum cleanliness standards, that personnel be trained adequately and undergo periodic testing and training in sterilization techniques, and that appropriate principles and practices be applied to sustain solution stability, compliance to Chapter 797 should be the goal of any facility where sterile preparations are compounded. Many pharmacies have already become compliant with Chapter 797, and those that have already met the new standards seem to support them strongly.
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United States Pharmaceopeia Chapter 797 Pharmaceutical Compounding-Sterile Preparations pertains to all preadministration manipulations and procedures involved in preparation of sterile compounds for application, implantation, infusion, inhalation, injection, insertion, installation, or irrigation, including preparation, storage, and transportation. The chapter does not pertain to actual clinical administration of compounded sterile preparations to patients. ⋯ Because the achievement of sterility requires cleaner facilities, trained personnel undergoing periodic testing and training in sterilization, and application of principles and practices to sustain solution stability, compliance to Chapter 797 should be met by any facility where sterile preparations are compounded. Many pharmacies have already become compliant with Chapter 797, and those that have already met the new standards seem to strongly support them.
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The objective of this study was to evaluate the physical and chemical stability of mixtures of undiluted palonosetron hydrochloride 50 micrograms/mL with dacarbazine 4 mg/mL and with methylprednisolone sodium succinate 5 mg/mL in 5% dextrose injection during simulated Y-site administration. Triplicate test samples were prepared by admixing 7.5 mL of palonosetron hydrochloride with 7.5 mL of dacarbazine solution and, separately, methylprednisolone sodium succinate solution. Physical stability was assessed by using a multistep evaluation procedure that included both turbidimetric and particulate measurement as well as visual inspection. ⋯ Within 4 hours, the mixtures of palonosetron hydrochloride and methylprednisolone sodium succinate developed a microprecipitate that became a white precipitate visible to the unaided eye. The precipitate was analyzed and identified as methylprednisolone. Palonosetron hydrochloride is incompatible with methylprednisolone sodium succinate.
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The purpose of this study was to compare the relative severity of nausea and vomiting scores before and after initiation of treatnment regimens in end-of-life cancer patients, and secondarily to evaluate the efficacy of a combination antiemetic preparation (ABHR; lorazepam [Ativan], diphenhydramine [Benadryl], haloperidol [Haldol], and metoclopramide [Reglan] in this patient population. A retrospective analysis of antiemetic use was performed through a systematic chart review of patients with an end-of-life diagnosis of lung, pancreatic, or colorectal cancer whose medications were provided through Hospice Pharmacia. Information collected included patient age and sex; terminal diagnosis; pre- and post-antiemetic nausea and vomiting scores; and initial antiemetic choice. ⋯ All of the agents and preparations were determined to be effective as intial therapy for the management of nausea and vomiting in the end-of-life cancer patient; therefore use of these agents as first-line therapy options in this population appears to be justified. ABHR appears to be at least as efficacious as other first-line monotherapy options investigated. Despite a lack of information on the absolute bioavailability of alternative ABHR dosage forms such as suppositories and topical gels, these also appear to be efficacious and therefore are viable options in the treatment of nausea and vomiting in end-of-life cancer patients.