Efficient Remdesivir Infusion Preparation with Vial2Bag Advanced® Admixture Device at Point-of-Care
Clinicians across the country are searching for effective distribution and preparation practices with remdesivir as the Omicron variant rages, leaving patients waiting to receive treatment at the exact moment that medication options, infusion supplies, and healthcare staff dwindle. Remdesivir or Veklury® was the first FDA-approved medication for the treatment of COVID-19 infection and its use varies by the institution with diverging recommendations on its place in COVID-19 therapy. With the January 24th FDA removal of authorizations for two monoclonal antibody treatments – bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab), based on limited activity against the highly circulating Omicron variant, many are turning to remdesivir infusion therapy for their patients. Remdesivir is given to outpatients who are at high risk for progression to severe disease or hospitalized patients with COVID-19 disease, but not yet requiring intubation, in line with NIH and IDSA recommendations. While it has been recommended for certain patients with severe or critical COVID-19 since 2019, a recent study investigated the use of remdesivir in outpatients with mild to moderate disease and found that a 3-day course of IV remdesivir in the outpatient setting resulted in an 87% lower risk of hospitalization or death from COVID-19 when compared to placebo.
The recommended remdesivir infusion dosage in adults and pediatric patients 12 years of age and older and weighing at least 40 kg, is a 200 mg IV loading dose followed by 100 mg IV daily for 5-10 days. The drug is delivered by IV infusion over 30-120 minutes and must be prepared and administered under the supervision of a healthcare provider. Preparation options include pharmacy compounding or point-of-care admixture using a universal point-of-care admixture device. Large influxes in patients, pharmacy and nursing staffing shortages, medication waste concerns, and pharmacy operational efficiency are compelling reasons for utilizing point-of-care admixture with remdesivir. The use of point-of-care medication preparation was evaluated in a 2019 study reviewing the cost, workflow, and safety of implementing Vial2Bag Advanced® Admixture Device
compared to local pharmacy compounding and purchase of ready-to-use infusions. In the study, a large tertiary academic medical center in Boston reported an estimated yearly cost avoidance of $2,295,261 and 41,082 yearly sterile product room units avoided by using Vial2Bag Advanced® Admixture Device
for point-of-care admixture.
Remdesivir Infusion and Supply Challenges
Point-of-care admixture with remdesivir requires considerations by the pharmacy. The first challenge with utilizing point-of-care medication preparation with remdesivir was the recommendation to use sterile water to reconstitute the drug. There are numerous medications that recommend reconstitution with sterile water in the package insert and it is common practice to use normal saline as the diluent, but with remdesivir, clinicians were faced with this challenge with limited experience or data to rely upon. Ultimately, with the sterile water vial shortage, Gilead has released data to pharmacists supporting the use of 0.9% sodium chloride (Normal Saline or NS) to reconstitute the drug, recommending that 250 ml NS is used as the final dilution volume based on osmolality increases greater than 400 mOsm/kg that can occur when using NS to reconstitute the 200 mg vial if diluted in 100 ml of NS. The data outlined indicates that NS can be used to reconstitute the 100 mg vial with final dilution in 100 ml of NS without concern for osmolality or tolerability. The support to use NS as the reconstitution diluent and the final container diluent, enables point-of-care preparation of the drug using an admixture device.
The vacuum on the remdesivir vial presents another challenge for drug preparation. Pharmacies report that attempts to use delayed-activation style admixture systems were unsuccessful unless air is added to the bag or vial, potentially compromising sterility. The unique design of Vial2Bag Advanced® Admixture Device allows for successful point-of-care preparation of remdesivir and the compatibility of the device with any IV bag brand, 50-250ml*, provides flexibility, now more critical than ever, as we continue to navigate cascading IV infusion supply shortages. With the Vial2Bag Advanced™ device, the adapter is attached to the drug vial first, releasing the vacuum before connecting to the IV bag, allowing for complete reconstitution and transfer of the vial contents.
Remdesivir Infusion and Point-of-Care Admixture
Point-of-care medication distribution with a universal admixture device can minimize the impact of supply disruptions, reduce drug waste, improve pharmacy operational efficiency, reduce cost, and eliminate delays in medication administration. As facilities face revolving supply, drug, and IV fluid shortages and are caring for more patients with fewer clinicians, optimizing efficiency is a priority. With more than 90 medications eligible for point-of-care medication preparation with Vial2Bag Advanced® Admixture Device, the operational, economic, and clinical advantages can grow exponentially.
For remdesivir infusion, point-of-care admixture with Vial2Bag Advanced® Admixture Device offers a unique IV infusion solution to clinicians. Using point-of-care medication preparation is not a new distribution practice and the benefits to healthcare organizations can be significant. We hope to see stabilization of IV infusion supplies, improvements in healthcare staffing and are desperate for the day when fewer COVID-19 patients present for care. In the meantime, embracing point-of-care medication practices enables flexibility in a dynamic and challenging environment.
*which contain an ISO standard port; ISO 8536-4 standard IV spike
Prescription Use Only.
The Vial2Bag Advanced® 20mm admixture device is 510(k) cleared by the United States Food and Drug Administration (FDA). The use of the Vial2Bag Advanced® 20mm admixture device should not be interpreted as modifying, extending, or superseding a drug manufacturer’s labeling recommendations for storage and expiration dating, unless otherwise limited by USP <797> compounding standards. Refer to drug manufacturer’s labeling and use instructions for recommendations, USP <797>, and applicable institution policy for shelf life and sterility information of reconstituted product and admixture device compatibility. The Vial2Bag Advanced® 20mm admixture device is not compatible for use with all drug products. Do not use the Vial2Bag Advanced® 20mm admixture device with lipids. Failure to follow the instructions provided may result in inadequate medication reconstitution, dilution, and/or transfer, possibly leading to overdose or underdose and/or delay in therapy. Products shown are for INFORMATION purposes only and may not be approved for marketing in specific regions. Important product and safety information and warnings at: https://www.westpharma.com/products/vial-adapter-systems/vial2bag-advanced