American journal of hospital pharmacy
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Food and Drug Administration requirements for reporting adverse drug reactions (ADRs), processing of ADR reports, and actions in response to these reports are described. FDA requires that drug manufacturers report ADRs to the FDA Division of Epidemiology and Surveillance; 90% of the ADR reports received are from manufacturers. Of the remaining 10%, one third are from pharmacists. ⋯ ADR reports may result in requirements for changes in product labeling, "Dear Doctor" letters, requirement of further study by the manufacturer, or withdrawal of the product. Information about ADRs is communicated to health-care practitioners in product labeling and in the literature. Pharmacists are encouraged to report suspected serious and unlabeled reactions to FDA so that the medical community and the public can benefit from current information about drug safety.
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The release of diethylhexyl phthalate (DEHP) from flexible polyvinyl chloride containers into intravenous cyclosporine solutions was studied. Intravenous cyclosporine solution or solutions containing the vehicle Cremophor EL and alcohol in dextrose were prepared in an all-glass system and stored in polyvinyl chloride (PVC) bags. Four samples were obtained at different time intervals, and DEHP content was analyzed by gas chromatography. ⋯ By 48 hours, nearly 33 mg of DEHP had leached into the solution. Intravenous cyclosporine solutions should be prepared in glass containers to minimize patient exposure to DEHP. If plastic bags are used for preparing cyclosporine injections, the injections must be used immediately after preparation.
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The feasibility of implementing a multiple-dose, multiple-flow-rate syringe pump system in a large teaching institution and a community hospital is described. The new syringe pump system was evaluated on medical and surgical wards in each hospital for a period of time sufficient to evaluate 40 courses of therapy in each hospital. At the time the new syringe pump system was implemented, the teaching hospital was using a gravity-dependent bottle and burette system and the community hospital was using a single-dose syringe pump system. ⋯ When the cost of wasted drug was considered, the cost per day of the multiple-dose syringe pump system was substantially less (70%) than the cost per day of the bottle and burette system and approximately the same as the cost per day for the single-dose syringe pump system. The majority of nurses indicated that the new system was easier or no more difficult to use than the existing i.v. infusion system and were in favor of switching to the new system. Implementation of a multiple-dose, multiple-flow-rate syringe pump system may result in cost savings over a traditional bottle and burette system and could complement an existing single-dose syringe infusion system.
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Letter Comparative Study
Differences between two thiopental sodium for injection kits.