Safe handling of cytotoxic drugs in the physician's office: a procedure manual model.

PURPOSE/OBJECTIVE: To present a model of an adapted manual of safety procedures designed for education and implementation of standardized cytotoxic drug handling in the private oncology office setting. DATA SOURCES: Published articles, textbook chapters, published technical bulletins and guidelines, research studies identifying risks of occupational exposure and procedural guideline sources for reducing these risks. DATA SYNTHESIS: Most published guidelines on safe handling of cytotoxic drugs address the hospital setting but lack practical guidelines for use within an oncology office. The procedures presented in this model are a composite of several current guidelines offering recommendations for minimizing chronic low-level exposure to cytotoxic drugs. The recommendations are compiled into a procedure manual for office settings. CONCLUSIONS: The mere provision of laminar flow hood equipment in a physician's office is insufficient without a consistent policy for nursing personnel to follow. Such a policy should be established through the development of a standardized manual appropriate for the office that includes procedures required for the equipment. Adapting safety guidelines into an office procedural manual provides a practical and consistent approach to enhancing personal safety for oncology nurses within community office settings. IMPLICATIONS FOR NURSING PRACTICE: With today's rapid expansion of ambulatory chemotherapy services, the need for specialized instruction in the safe handling of cytotoxic drugs has become increasingly apparent. In the course of their duties, private office oncology nurses endure daily exposure to toxic agents, which poses a concern for occupational safety. An established procedure manual standardizes safe work practices for use in training new personnel and evaluating staff exposure to cytotoxic drugs.

Physical compatibility and chemical stability of amphotericin B in combination with magnesium sulfate in 5% dextrose injection.

The physical compatibility and chemical stability of amphotericin B for injection USP (AB) admixed with magnesium sulfate injection USP (MS) in 5% dextrose injection USP (D5W) was evaluated. AB (final concentration of either 40 or 80 micrograms/mL of solution) and MS (final concentration of 0, 2, or 4 mg/mL of solution) were mixed in glass volumetric flasks containing D5W. AB concentration, as quantitated by high-performance liquid chromatography, and visible admixture clarity were monitored at zero, three, and six hours after combining with MS. At the three-hour observation, visible admixture clarity appeared to decrease in all multiple drug combinations and a clear supernatant began to develop as particulates settled to the bottom of the container. MS (final concentration of 4 or 8 mg/mL of solution) and AB (final concentration of 80 micrograms/mL of solution) were prepared in two separate intravenous polyvinyl chloride bags of D5W. The solutions were manually set to infuse via gravity for six hours and mix at the y-site of an intravenous administration set. Samples of the mixture were collected from the terminal end of a primary intravenous administration set at zero, two, four, and six hours after beginning the infusions. Each sample appeared visibly clear and maintained an AB concentration of at least 100 percent of the initial admixture concentration. MS and AB mixed in the same container appeared to be physically incompatible. The same admixture appeared to be physically compatible and chemically stable, in terms of AB, when infused as separate solutions mixed at a y-site of an intravenous administration set.

Stability of procainamide hydrochloride in neutralized 5% dextrose injection.

The stability of procainamide hydrochloride in neutralized 5% dextrose injection was studied. Sixty-four admixtures were prepared by adding either 2 mL (for 0.4% admixtures) or 4 mL (for 0.8% admixtures) of procainamide hydrochloride to 250 mL of 5% dextrose injection in plastic containers. The pH of 32 of these admixtures (16 of each type) was adjusted to 7.5. These 32 admixtures represented the neutralized group, and the remaining 32 represented the control group. The admixtures were stored at either 23-25 degrees C (room temperature) or 5 degrees C (refrigeration) for 24 hours. Procainamide hydrochloride concentrations in each sample were determined by high-performance liquid chromatography immediately after the admixtures were prepared and at various intervals during storage. Procainamide concentrations decreased over time in 5% dextrose injection. The decrease was significantly less for admixtures in neutralized 5% dextrose injection, those stored under refrigeration, and those with an 0.8% concentration of drug. Decreases in procainamide hydrochloride concentrations in the control admixtures might have been caused by procainamide-dextrose complexation. Initial concentrations of procainamide hydrochloride in 5% dextrose injection can be adequately maintained over a 24-hour storage period by neutralizing the 5% dextrose injection or storing the admixture at 5 degrees C. However, because it is impractical to maintain the necessary temperature condition during a 24-hour infusion, neutralization might be the most viable alternative when extended stability of procainamide hydrochloride in 5% dextrose injection is required.

Stability of terbutaline sulfate injection stored in plastic tuberculin syringes.

Terbutaline sulfate injection was drawn up into plastic tuberculin syringes and stored under four conditions: exposed to ambient (fluorescent) light at room temperature (23-25 degrees C) and under refrigeration (2-8 degrees C) and protected from light at room temperature and under refrigeration. The terbutaline sulfate content was determined one, two, three, four, five, six, and seven weeks after initial storage. The analytical method employed was the United States Pharmacopoeia XXI colorimetric procedure. Under all four storage conditions terbutaline sulfate concentration was greater than 90 percent of initial concentration at all time periods.

An updated pKa listing of medicinal compounds.

A tabulated listing of pKa values is presented for 87 medicinal compounds commercially marketed since 1978. Medicinal compounds are listed alphabetically under their respective generic name. The pKa values reported are listed as either acid or base depending upon the ionization characteristics of the functional group corresponding to the respective pKa value.

Effect of hyperbilirubinemia on the pharmacokinetics of diazepam in the rat.

The pharmacokinetics of intravenously-administered diazepam have been studied in heterozygous (non-jaundiced) and homozygous (jaundiced) Gunn rats following single doses of 10 mg/Kg. Plasma concentration time course data from heterozygous and homozygous animals can be described adequately by biexponential equations. A faster plasma clearance rate (Clp) and shorter elimination half life (t 1/2) as well as reduced volumes of distribution [Vp and Vd(area)] were observed in homozygous animals. These potential effects of bilirubin on the distribution and elimination of diazepam should be considered if diazepam is to be used in the therapy of neonatal hyperbilirubinemia.

Additional conclusions on diazepam injectable precipitate: GC-MS confirmation.

The precipitate which forms upon dilution of diazepam injection with aqueous vehicles is shown conclusively to be diazepam and not benzoates. The results are based on GC-MS analysis of the precipitate as compared with a synthetic mixture of benzoic acid-diazepam.