Stability of dexmedetomidine 4 µg/mL in polypropylene syringes.

PURPOSE: The results of a study to determine the long-term (up to 14 days) stability of diluted dexmedetomidine kept in polypropylene syringes under typical pharmacy storage conditions are presented. METHODS: Four samples of dexmedetomidine injection diluted to 4 µg/mL in 0.9% sodium chloride were prepared and divided into 25-mL portions for storage in syringes at ambient room temperature (20-25 °C) with light exposure or under refrigeration (5 °C) in darkness. At 24 and 48 hours, the percentage of the initial dexmedetomidine concentration remaining in all samples was assessed via high-performance liquid chromatography with diode-array detection; further stability testing of the refrigerated samples was performed on days 7 and 14. At each time point, the test samples were visually inspected for color, clarity, and signs of formation of particulate matter. RESULTS: As determined by chromatographic analyses, the samples of diluted dexmedetomidine stored in syringes at room temperature exhibited a loss of drug concentration of <10% over 48 hours; the refrigerated samples exhibited a loss of drug concentration of <5% over 14 days. All of the syringe-stored samples remained clear and colorless on visual inspection for the duration of the study. CONCLUSION: Dexmedetomidine diluted to 4 µg/mL in 0.9% sodium chloride injection was stable for at least 48 hours at 20-25 °C and 14 days at 5 °C when stored in polypropylene syringes.

Improving Pediatric Outcomes through Intravenous and Oral Medication Standardization.

BACKGROUND: Standardization is an invaluable tool to promote safety, improve care, and decrease costs, which ultimately improves outcomes. However, a pediatric setting presents unique challenges with its wide variety of weights, medications, and needs that are distinctly different. Our goal was to develop and implement standards in complex high risk areas that show improved outcomes and safety. PROGRAM DESCRIPTION: A computerized prescriber order entry program with decision support for pediatrics was developed for parenteral nutrition prescribing. The program included dosing, calculations, calcium phosphate compatibility checks, automated IV compounder interface, osmolarity route calculation, end product testing verification, aluminum exposure and many other quality improvements. This same electronic order program, interface to sterile compounders, and end product testing was used to standardize and make common non-manufactured intravenous solutions. The drip compounding process was reengineered to include standard concentrations, label changes, and beta-testing of a smart syringe pump with dosing ranges for pediatrics. Common standard oral doses were developed along with standard oral formulations. CONCLUSIONS: Total parenteral nutrition (TPN) error rates decreased from 7% to less than 1% and compatibility issues decreased from 36 to 1 per year. Neonatal osteopenia rates decreased from 15% to 2%. Results from end product testing of TPN solutions were within USP standards showing statistical correlation (p<0.001). Intravenous standardization decreased error rates by 15% and compounding time decreased by 12 minutes (64%). Drip standardization allowed for drug concentration and smart pump standardization and decreased drip errors by 73% from 3.1 to 0.8 per 1000 doses. Compounding errors decreased from 0.66 to 0.16 per 1000 doses and ten-fold errors decreased from 0.41 to 0.08 per 1000 doses. Eleven oral liquids, including 329 different doses, were standardized, decreasing the number of doses to 59 (83% change). This decreased workload 15%, wastage 90%, improved turnaround time 32%, and saved $15,000/year. One hundred evidence-based standard oral formulations were developed and used in 22 different hospitals.