Purpose: Antineoplastic preparation presents unique safety concerns and consumes significant pharmacy staff time and costs. Robotic antineoplastic and adjuvant medication compounding may provide incremental safety and efficiency advantages compared with standard pharmacy practices. Methods:We conducted a direct observation trial in an academic medical center pharmacy to compare the effects of usual/ manual antineoplastic and adjuvant drug preparation (baseline period) with robotic preparation (intervention period). The primary outcomes were serious medication errors and staff safety events with the potential for harm of patients and staff, respectively. Secondary outcomes included medication accuracy determined by gravimetric techniques, medication preparation time, and the costs of both ancillary materials used during drug preparation and personnel time.Results: Among 1,421 and 972 observed medication preparations, we found nine (0.7%) and seven (0.7%) serious medication errors (P ϭ .8) and 73 (5.1%) and 28 (2.9%) staff safety events (P ϭ .007) in the baseline and intervention periods, respectively. Drugs failed accuracy measurements in 12.5% (23 of 184) and 0.9% (one of 110) of preparations in the baseline and intervention periods, respectively (P Ͻ .001). Mean drug preparation time increased by 47% when using the robot (P ϭ .009). Labor costs were similar in both study periods, although the ancillary material costs decreased by 56% in the intervention period (P Ͻ .001). Conclusion:Although robotically prepared antineoplastic and adjuvant medications did not reduce serious medication errors, both staff safety and accuracy of medication preparation were improved significantly. Future studies are necessary to address the overall cost effectiveness of these robotic implementations.
Calcium gluconate is preferred over calcium chloride for intravenous (IV) repletion of calcium deficiencies in the inpatient setting. In the setting of a national shortage of IV calcium gluconate, our institution implemented a compounded calcium chloride admixture for IV administration. The objective of this analysis is to evaluate the peripheral infusion site safety of compounded IV calcium chloride admixtures in adult inpatients. A total of 222 patients, encompassing 224 inpatient admissions, from April to June 2011 were retrospectively reviewed. Sterile preparations of calcium chloride in 5% dextrose (600 mg/250 mL and 300 mg/100 mL) were used during the study time period. Adverse infusion site reactions were assessed using an institutional infiltration and phlebitis grading system. A total of 333 doses were administered peripherally. In all, 4 (1.8%) patients experienced a moderate to severe infusion site reaction, with 3 due to phlebitis and 1 due to infiltration. Naranjo Nomogram for Adverse Drug Reaction Assessment classified all 4 reactions to have a possible link to calcium chloride administration. Peripheral administration of compounded calcium chloride admixtures in 5% dextrose is associated with a low incidence of IV infusion site reactions and can be considered as an alternative in the event of a calcium gluconate shortage.
Purpose The purpose of this study was to evaluate the extended stability of extemporaneously prepared regular human insulin 100 units in 0.9% sodium chloride at a total volume of 100 mL under refrigeration. Methods Three admixtures of regular human insulin were prepared aseptically under a laminar flow hood at time zero. They were prepared by withdrawing 1 mL of regular human insulin with a concentration of 100 units/mL and adding it to a sufficient quantity of 0.9% sodium chloride for injection in a Polyvinylchloride (PVC) bag to yield a total volume of 100 mL. The 3 admixtures were stored refrigerated(2°C to 8°C [36°F to 46°F]) and three 1 mL samples of each admixture were withdrawn, transferred to a test tube, and frozen(–30°C to −15°C [–22°F to 5°F]) at hours 0, 6, 12, 36, 48, 72, 96, 120, 144, and 168. Insulin concentrations were measured by chemiluminescent immunoassay. The time points were considered stable if the mean concentration of the samples exceeded 90% of the equilibrium concentration at hour 6. Results The equilibrium concentration was 0.57 units/mL. Time points were considered stable if the mean concentration was at least 0.52 units/mL. All time points retained at least 90% of the equilibrium concentration with the exception of hour 120(0.46 ± 0.05 units/mL). At hour 168, the mean concentration was 0.63 ± 0.07 units/mL. Conclusion Regular human insulin 100 units added to 0.9% sodium chloride for injection in a PVC bag to yield a total volume of 100 mL is stable for 168 hours when stored at 2°C to 8°C(36°F to 46°F).
BackgroundRegular human insulin 100 units added to a sufficient quantity of 0.9% sodium chloride, to yield a total volume of 100 mL within a polyvinylchloride bag, is accepted to be stable for 24 hours due to physical denaturation and chemical modification. The objective of this study was to evaluate the extended stability of such extemporaneously prepared regular human insulin, stored under refrigeration, to the maximum beyond-use-date allowed by United States Pharmacopeia chapter 797.MethodsAt time “0” three admixtures of regular human insulin were prepared by withdrawing 1 mL of regular human insulin with a concentration of 100 units/mL and adding it to a sufficient quantity of 0.9% sodium chloride for injection in a polyvinylchloride bag to yield a total volume of 100 mL. The three admixtures were stored under refrigeration (2°C–8°C [36°F–46°F]), and one sample of each admixture was withdrawn and tested in duplicate at 0, 6, 24, 48, 72, 144, 168, 192, 216, 240, 312, and 336 hours. Utilizing high performance liquid chromatography, each sample underwent immediate testing. The time points were stable if the mean concentration of the samples exceeded 90% of the equilibrium concentration at 6 hours.ResultsThe equilibrium concentration was 0.89 units/mL. Time points were stable if the mean concentration was at least 0.80 units/mL. All time points retained at least 90% of the equilibrium concentration, with the exception of hour 168 (0.79 ± 0.03 units/mL). At 192 hours the mean concentration was 0.88 ± 0.03 units/mL. At 336 hours the mean concentration was 0.91 ± 0.02 units/mL.ConclusionBased on these results, regular human insulin 100 units added to 0.9% sodium chloride for injection in a polyvinylchloride bag to yield a total volume of 100 mL is stable for up to 336 hours when stored at 2°C–8°C (36°F–46°F).
Background: Executive Quality and Safety WalkRounds (EWRs) is a tool that engages department leadership in discussion with the front-line employees to solicit feedback to improve quality and safety. The purpose of this study was to evaluate the impact of the implementation of pharmacy department specific EWRs on quality and safety at a tertiary academic medical center. Method: This was a single-center, retrospective analysis conducted at Brigham and Women’s Hospital between November 2016 and November 2019. This study aimed to analyze the implementation of EWRs conducted every other month throughout various service areas and satellites of the pharmacy department. Data evaluated included the number of EWRs conducted, the specific areas visited, the total number of action items recommended by the staff, along with the total number of action items that were completed or remained in process. Results: During the study period, 17 visits were completed in 12 different BWH pharmacy sub-departments. A total of 98 operational, technological, and environmental action items were recommended by staff to improve quality and safety. Of the 98 action items documented, 95 (96.9%) were completed by time of our analysis. Conclusion: Pharmacy department EWRs are an important and systematic process of communication between the pharmacy leadership and frontline staff. Pharmacy department EWRs have resulted in safety and quality improvements at different levels in the pharmacy department. The EWRs program at the pharmacy department was effective in identifying and completing safety initiatives to improve the safety culture of the department.
Purpose Management of an acute shortage of parenteral opioid products at a large hospital through prescribing interventions and other guideline-recommended actions is described. Summary In early 2018, many hospitals were faced with a shortage of parenteral opioids that was predicted to last an entire year. The American Society of Health-System Pharmacists (ASHP) has published guidelines on managing drug product shortages. This article describes the application of these guidelines to manage the parenteral opioid shortage and the impact on opioid dispensing that occurred in 2018. Our approach paralleled that recommended in the ASHP guidelines. Daily dispensing reports generated from automated dispensing cabinets and from the electronic health record were used to capture dispenses of opioid medications. Opioid prescribing and utilization data were converted to morphine milligram equivalents (MME) to allow clinical leaders and hospital administrators to quickly evaluate opioid inventories and consumption. Action steps included utilization of substitute opioid therapies and conversion of opioid patient-controlled analgesia (PCA) and opioid infusions to intravenous bolus dose administration. Parenteral opioid supplies were successfully rationed so that surgical and elective procedures were not canceled or delayed. During the shortage, opioid dispensing decreased in the inpatient care areas from approximately 2.0 million MME to 1.4 million MME and in the operating rooms from 0.56 MME to 0.29 million MME. The combination of electronic health record alerts, increased utilization of intravenous acetaminophen and liposomal bupivacaine, and pharmacist interventions resulted in a 67% decline in PCA use and a 65% decline in opioid infusions. Conclusion A multidisciplinary response is necessary for effective management of drug shortages through implementation of strategies and practices for notifying clinicians of shortages and identifying optimal alternative therapies.
The role of a pharmacist is unique and can most effectively triage drug information and medication distribution, especially during times of high demand and high stress.
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