American journal of hospital pharmacy
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The stability of succinylcholine chloride injection prepared by a hospital pharmacy was studied under a wide variety of conditions. Batches of succinylcholine chloride injection 10 mg/mL containing sodium chloride, methyl-4-hydroxybenzoate, hydrochloric acid, and water were prepared. Samples were tested for the effect of initial pH (3.0 and 4.2) and sterilization (steam treatment at 100 degrees C for 30 minutes and 121 degrees C for 20 minutes) on stability after three weeks; long-term stability under refrigeration (12, 17, and 23 months of storage at 4 degrees C); and the effect of storage temperature (4-6 degrees C, 20-26 degrees C, 35 degrees C, and 70 degrees C) and light exposure at various intervals up to 12 months. ⋯ The assessments by TLC proved to be more sensitive than the HPLC measurements. Succinylcholine chloride injection sterilized at 100 degrees C for 30 minutes can be stored for up to five months at room temperature if protected from light. The preparation is stable for at least two years under refrigeration.
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The stability of terbutaline sulfate in an extemporaneous oral liquid formulation refrigerated for 55 days was studied. A suspension was prepared by grinding commercially available 5-mg terbutaline sulfate tablets, adding Purified Water, USP, to form a paste, and then adding Simple Syrup, NF. A control solution was prepared from analytical grade terbutaline sulfate powder in Simple Syrup, NF. ⋯ On day 55, the mean percentages of the initial terbutaline sulfate concentrations remaining were 103.8% in the suspension and 91.7% in the solution. Color, odor, and pH of the samples did not change appreciably, and colony counts of bacteria were within acceptable limits. An extemporaneously prepared liquid preparation of terbutaline sulfate in Simple Syrup, NF, is stable under the conditions studied for up to 55 days; however, since microbiological testing was not performed on day 55, it is recommended that the preparation be stored for no longer than 30 days.
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The development and implementation of a code that enables pharmacists to document their clinical interventions in the hospital's computerized patient records is described. To allow data to be entered in patient records from terminals throughout the hospital that are linked to the mainframe computer, a code was developed to summarize each pharmacist recommendation. The coded information is added to the computer entry for the specific drug requiring intervention. ⋯ An additional 17 (6%) of the interventions resulted from physicians' requests for pharmacists' recommendations. In addition to review of all pharmacist clinical interventions, this system allows review of a specific target drug to determine compliance with institutional drug-use guidelines. Through use of the computer program developed at this hospital, information that documents pharmacists' clinical services can be entered directly into patients' records on the hospital's mainframe computer system and retrieved as useful reports.
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Historical Article
An overview of the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations.
The history, purpose, and content of FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book") are described. When cost guidelines established in the 1970s for Medicare reimbursement prompted most states to permit generic drug product selection, an official list of interchangeable drug products was needed. Regulations for determining bioavailability and bioequivalence were published in 1977, and FDA first published Approved Drug Products in 1980. ⋯ Monthly Cumulative Supplements are issued. The Orange Book contains public information and advice, but it is not an official national compendium; FDA has no position on state regulation of drug product selection by pharmacists. The equivalence evaluations do not relieve practitioners from exercising care in prescribing and dispensing products according to patients' individual needs.