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February 25, 2021

Medications in Single-Dose Vials and Implications of Discarded Injectable Drugs: A National Academies Report

Author Affiliations
  • 1Department of Biomedical Informatics, Vagelos College of Physicians and Surgeons, Columbia University in the City of New York
  • 2Public Health Sciences and Clinical Research Divisions, Fred Hutchinson Cancer Research Center, Seattle, Washington
  • 3Healthcare Quality and Policy, Hutchinson Institute for Cancer Outcomes Research, Seattle, Washington
  • 4Health and Medicine Division, National Academies of Sciences, Engineering, and Medicine, Washington, DC
JAMA. Published online February 25, 2021. doi:10.1001/jama.2021.2414

Every year, significant amounts of expensive injectable or infused drugs, distributed in single-dose vials, are discarded in the United States. This is due in part to the increasing number of drugs that are administered in variable doses based on a patient’s weight or body surface area. Sharing medication from single-dose vials among patients is generally prohibited or severely restricted; accordingly, the unused drug amount will typically be discarded. Many of the weight-based drugs in single-dose vials are expensive and are paid for by federal health care programs (particularly Medicare Part B), private health plans, and patients who have cost-sharing obligations.

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    1 Comment for this article
    Single Use Drug Waste
    James Jorgenson, RPh, MS | Visante
    As pharmacists we agree that the potentially billions of dollars of chemically viable drug product wasted in the US annually as noted in this Viewpoint presents a real opportunity. This becomes even more critical as many of these medications are in “shortage” situations and every drop is needed.

    The United States Pharmacopeia (USP) standard mandates a 6-hour expiration for single use vials if the vial is entered and maintained in ISO 5 air conditions. Drug Vial Optimization (DVO) using specially designed devices for compounding drugs, closed-system drug transfer devices (CSTDs), to maintain sterility beyond the
    6-hour time currently specified by USP presents another option. CSTDs create a closed environment that prevents the escape of hazardous medications like cytotoxics. However, at the same time they prevent egress of hazardous medications they also prevent ingress of contaminants into the vial.

    There is a growing body of evidence to support DVO. Studies by University of North Carolina, Indiana University Health, MD Anderson, and The James Cancer Center at The Ohio State University have all demonstrated the ability to use CSTDs to maintain sterility of single use vials beyond the 6-hour rule from point of entry. There is also growing international acceptance of DVO with Japan and parts of the European Union now allowing the use of CSTDs for DVO programs.

    The FDA currently validates the performance of CSTDs under their ONB code designation. CSTDs gaining the ONB code must demonstrate that they prevent microbial ingress.

    Formalizing the use of ONB labeled CSTDs to support DVO is a viable option to safely reduce waste of single use products. Currently the major impediment to DVO use is lack of support by FDA and accreditation bodies. FDA and USP should review existing research and develop standards and best practices for the use of CSTDs for drug vial optimization for a safe program that minimizes the waste of medications.