Physical compatibility of pemetrexed disodium with other drugs during simulated Y-site administration.

PURPOSE: The physical compatibility of pemetrexed disodium with selected other drugs during simulated Y-site injection was studied. METHODS: A 5 mL sample of pemetrexed disodium 20 mg/mL in 0.9% sodium chloride injection was combined with 5 mL of a solution of each of 79 other drugs. The other test drugs included antineoplastics, antiinfectives, and supportive care drugs used undiluted or diluted in 0.9% sodium chloride injection or 5% dextrose injection. Visual examinations were performed with the unaided eye in normal diffuse fluorescent light at intervals up to four hours after mixing. Combinations with no obvious incompatibility were examined further with a high-intensity monodirectional light source to enhance visualization of small particles and low-level turbidity. The combinations were also evaluated with a turbidimeter at one and four hours. All combinations without visual incompatibility were assessed with a particle sizer-counter. RESULTS: Of the 79 pemetrexed-secondary drug combinations, 55 were compatible for at least four hours. However,mixture with 24 drugs resulted in precipitation (including microprecipitation) and color change. CONCLUSION: Pemetrexed disodium was incompatible with 24 drugs during simulated Y-site administration and should not be administered with them.

Using medium-fill simulation to establish a benchmark microbiological contamination rate for low-risk-level compounding.

A benchmark contamination rate for prefilled syringe compounding was determined by using a medium-fill-simulation method. One thousand thirty-five 1-mL tuberculin syringes were aseptically filled with 0.9 mL of sterile soybean-casein digest medium and capped. These syringes were placed into clear nonsterile plastic bags and incubated at 35 degrees C for seven days, then inspected for cloudiness or colony formation indicative of bacterial growth. The operation was performed by two certified pharmacy technicians in an ISO Class 5 vertical-airflow biological safety cabinet in a typical inpatient pharmacy compounding area over two days. The technicians wore protective garments and gloves and followed standard procedures of preparing sterile injections. The adequacy of the methodology was verified by using four syringes that contained deliberately contaminated medium and incubating them along with 15 aseptically prepared syringes at 35 degrees C for seven days. Colony formation in the four syringes containing contaminated medium was directly observed and differentiated from the control syringes, which confirms the validity of the method. No bacterial growth was detected in any of the 1035 medium-filled syringes studied. Therefore, the contamination rate for aseptic compounding operation was less than 0.1%. Medium-fill-simulation testing of 1035 prefilled tuberculin syringes yielded no contamination. A contamination rate of less than 0.1% should be achievable and expected for this type of low-risk pharmacy preparation after pharmacies validate their own compounding operation.

Stability of three cephalosporin antibiotics in AutoDose Infusion System bags.

OBJECTIVE: To evaluate the physical and chemical stability of three commonly used cephalosporin antibiotic solutions packaged in AutoDose Infusion System bags stored and evaluated at appropriate intervals for up to 7 days at 23 degrees C and up to 30 days at 4 degrees C. SETTING: Laboratory. INTERVENTIONS: The test samples were prepared by adding the required amount of the cephalosporin antibiotic to the AutoDose Infusion System bags and diluting to the target concentration with 0.9% sodium chloride injection. MAIN OUTCOME MEASURES: Physical stability and chemical stability based on drug concentrations initially and at appropriate intervals over periods of up to 7 days at 23 degrees C and up to 30 days at 4 degrees C. RESULTS: All of the cephalosporin admixtures were clear when viewed in normal fluorescent room light and with a Tyndall beam. Measured turbidity and particulate content were low and exhibited little change. The cefazolin sodium-containing samples were colorless throughout the study. The admixtures with ceftazidime and ceftriaxone sodium had a slight yellow tinge initially, and the room temperature samples turned a frank yellow color after 5 days. The refrigerated samples did not change color. High-performance liquid chromatography analysis showed that cefazolin sodium and ceftriaxone sodium remained stable for 30 days and ceftazidime remained stable for 7 days at 4 degrees C. At room temperature, losses were much more rapid. Cefazolin sodium and ceftriaxone sodium retained at least 90% of their initial concentrations through 7 days and 5 days, respectively, when stored at 23 degrees C. Ceftazidime remained stable for only 1 day at 23 degrees C. CONCLUSION: Cefazolin sodium, ceftazidime, and ceftriaxone sodium exhibited physical and chemical stabilities consistent with those found in previous studies of these drugs. The AutoDose Infusion System bags did not adversely affect the physical and chemical stabilities of these three cephalosporin antibiotics.

Compatibility screening of precedex during simulated y-site administration with other drugs.

The physical compatibility of Precedex with 95 other drugs during simulated Y-site injection was evaluated by visual observation, turbidity measurement, and electronic particle content assessment (when appropriate). Five-milliliter samples of Precedex 4 micrograms/mL in 0.9% sodium chloride injection were combined with 5 mL of each of 95 other drugs. The other test drugs included anti-infectives, analgesics, antihistamines, diuretics, steroids, and other supportive-care drugs undiluted or diluted in 0.9% sodium chloride injection or 5% dextrose injection (for amphotericin B). Visual examinations were performed with the unaided eye in normal diffuse fluorescent light and with a Tyndall beam (a high-intensity monodirectional light beam) to enhance the visualization of small particles and low-level turbidity. The turbidity of each sample was measured as well, as was the particle content of samples with no visible incompatibility. Evaluation of the samples was performed initially and at 1 and 4 hours after preparation. Ninety-three of the 95 test drugs were compatible with the Precedex dilution during the 4-hour observation period; however, both amphotericin B and diazepam resulted in precipitation. Precedex, which is incompatible, with amphotericin B and diazepam, should not be administered simultaneously with those drugs.

Stability of Gentamicin Sulfate and Tobramycin Sulfate in AutoDose Infusion System Bags.

The objective of this study was to evaluate the physical and chemical stability of gentamicin sulfate 85mg/100mL and tobramycin sulfate 95mg/100mL, each of which was admixed in 0.9% sodium chloride injection and packaged in AutoDose Infusion System bags. Triplicate test samples were prepared by admixing the necessary amounts of the aminoglycoside antibiotics with a portion of 0.9% sodium chloride injection and bringing the admixture of each drug to a final volume of 100mL with additional 0.9% sodium chloride injection. The test solutions were packaged in ethylene vinyl acetate (EVA) plastic containers (AutoDose bags) designed for use in the AutoDose Infusion System. Samples were stored protected from light and were evaluated at appropriate intervals for up to 7 days at 23 deg C and up to 30 days at 4 deg C. Physical stability was assessed by means of a multistep evaluation procedure that included both turbidimetric and particulate measurement, as well as visual inspection. Chemical stability was assessed initially and at appropriate intervals during the study periods with stability-indicating high-performance liquid chromatographic (HPLC) analytical techniques based on the determination of drug concentrations. The aminoglycoside admixtures were clear and colorless when viewed in normal fluorescent room light and with a Tyndall beam. Measured turbidity and particulate content were low and exhibited little change. HPLC analysis indicated that both gentamicin sulfate and tobramycin sulfate remained stable for 30 days at 4 deg C and for 7 days at 23 deg C. Both gentamicin sulfate and tobramycin sulfate exhibited physical and chemical stability that were consistent with previous studies of those drugs. The AutoDose Infusion System bags did not adversely affect the physical and chemical stability of those aminoglycoside anitbiotics.