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4 Efforts to Reduce Discarded Weight-Based Drugs
Pages 75-92

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From page 75...
... and the 116th Congress (2019–2020) that focused on discarded drug related to single-dose vials have proposed rebates from manufacturers to be directed to health care providers and payers for discarded drug amounts.
From page 76...
... 6142 -- Reducing Drug Waste Act of 2018: Both would require the U.S. Food and Drug Administra tion and the Centers for Medicare & Medicaid Services to develop a joint action plan to reduce drug waste and better manage costs with respect to drug vial sizes and other drug-delivery systems.
From page 77...
... have encouraged clinicians to adopt clinical practices such as dose rounding, dose capping, or dose banding (discussed later in this chapter)
From page 78...
... Many clinicians, for example, have embraced strategies that several Organisation for Economic Co-operation and Development (OECD) countries currently use, although these are not yet well established in the United States; these strategies include vial sharing, drug vial optimization, closed-system drug transfer devices (CSTDs)
From page 79...
... It should be noted that, generally speaking, a vial's contents are not given directly to a patient but rather are removed and compounded to generate the preparation that the patient ­receives, but that additional step does not affect the idea behind vial sharing. By contrast, with vial sharing, the remainder from each vial is retained and can be used for the next patient.
From page 80...
... Sharing a single vial can be complicated temporally, as consistently forecasting the amount of compounded product even over a few days is not simple, and the decision to puncture any individual vial will affect the usage pattern to follow. Vial sharing also demands additional attention and documentation by staff to prevent accidentally exposing multiple patients to a medication after its beyond-use date.1 Finally, vial sharing is generally unrealistic for small clinics and facilities that do not have enough patients to make it consistently feasible.
From page 81...
... . Drug Vial Optimization Certain difficulties associated with vial sharing can be ameliorated by a practice called drug vial optimization, which relies on extending the length of time that a drug remains sterile and stable up to as much as
From page 82...
... However, CSTDs make drug vial optimization possible by moving drugs from one place to another -- such as from a vial into a syringe -- without letting the drug or its vapor escape into the environment or introducing any contaminants into the vial or the syringe. As a result, CSTDs can ensure the stability and sterility of injectable drugs after vial puncture for much longer than the United States Pharmacopeia (USP)
From page 83...
... . By using CSTDs to extract partial contents from a single-dose drug vial, clini cians might be able to safely use the remaining contents for up to 7 days after the initial puncture, thus sharply decreasing the amount of discarded drugs -- and, potentially, saving a significant percentage of the cost of the drugs (Gilbar et al., 2019)
From page 84...
... . A few studies have shown that dose banding can reduce discarded drugs and medical errors and also preparation time (Chatelut et al., 2012; Fahey et al., 2020)
From page 85...
... Also, as with dose banding, dose rounding may be inappropriate for some patient populations, such as pediatric patients. However, clinicians provide pediatric information regarding a primary set of recommended rounding tolerances for commonly prescribed drugs for e-prescribing (Johnson et al., 2011)
From page 86...
... and strategies to improve patient care and health outcomes through the efficient and effective use of data. An example is the HHS partnership to facilitate the rapid deployment of prefilled syringes for quick response to widespread health emergencies.
From page 87...
... Integrated health care delivery systems may have direct incentives to decrease the amount of discarded drugs from single-dose vials. In these systems, health care providers may be motivated to "save costs" by applying vial-sharing mechanisms or some other clinical practices for patients to reduce discarded drugs through a cumbersome and expensive process that they still view as costeffective.
From page 88...
... CONCLUSIONS 1. Vial sharing and other clinical practices such as dose banding and dose rounding are possible mechanisms for reducing discarded drug.
From page 89...
... The Secretary of HHS should routinely review and evaluate the impact of such policies. Because the committee's assessment shows that there is limited economic value to discarded drugs from single-dose vials under the current system in which drugs are developed, administered or paid for, a rebate strategy seems unlikely to achieve the intended goals.
From page 90...
... 2019. Implementation of drug vial optimization to reduce drug waste.
From page 91...
... 2020. FDA says Pfizer vaccine vials hold extra doses, expanding supply.
From page 92...
... 2019. Current status of drug vial optimization use to prevent waste associated with injectable anticancer agents.


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