Medications in Single-Dose Vials Implications of Discarded Drugs (2021) / Chapter Skim
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6 Prescription for Reducing Discarded Drugs
6 Prescription for Reducing Discarded Drugs
Pages 109-122
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From page 109... ...
Understanding the ways in which drug waste is conceptualized is an important part of any approach to address the costs associated with discarded excess drugs contained in single-dose vials. As discussed in previous chapters, on the surface it can seem extremely wasteful that health care providers discard significant portions of the drug in single-dose vials that can cost thousands of dollars.
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From page 110... ...
While the committee asserts there is little recoverable value to discarded drugs, it does see several opportunities to reduce inefficiencies that could lead to cost savings and improve the quality of care for patients. Therefore, the committee's overarching recommendation1 is: RECOMMENDATION 5-1: Drug developers, health care providers, and payers should focus their efforts on reducing inefficiencies in drug development, delivery, and payment systems that lead to excess costs for both the health care system and for patients rather than on trying to recoup payments associated with the discarded drugs.
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From page 111... ...
Evidence from other dosing practices, such as dose banding and dose capping, suggests that alternatives to weight-based dosing might be just as safe and effective for many indications, but pivotal trials rarely com pare weight-based dosing with other methods. Empirical evidence supporting the use of weight-based dosing instead of fixed dosing for injectable or infused drugs is limited.
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From page 112... ...
The committee has identified significant conflicts among the safety concerns that motivate the regulatory guidance on the repackaging of single-dose drugs -- that is, dividing the content of a single-dose vial into multiple individual doses -- by pertinent federal agencies. For example, according to FDA, using multiple single-dose vials to treat a single patient can lead to medication errors and sharing a single vial among multiple patients can lead to contamination.
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From page 113... ...
Vial sharing and other clinical practices such as dose banding and dose rounding are possible mechanisms for reducing discarded drug. For small clinics and hospitals, vial sharing may be challenging to coordinate due to limited patient volume as well as the need to o btain special equipment to allow prolonged storage for safe drug use.
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From page 114... ...
Uncoupling the payments from the drug ASP, and focusing the payment for clinical administration on CMS's assessment of the time and complexity of treatment administration and safety monitoring would minimize incentives for clinicians' selection and administration of more expensive drugs when alternatives are available. Accordingly, the concern about discarded drugs is partly due to the particular approach to paying -- and reimbursing health care providers -- for these drugs.
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From page 115... ...
Some observers have argued that enforcing the requirement for using the JW modifier would lead to increased transparency regarding discarded drug payments. Others, however, argue that the JW modifier provides an economic incentive for discarding drugs and hinders efficient ways to distribute or administer drugs because it allows health care providers to be reimbursed regardless of whether all of the drug is actually used.
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From page 116... ...
Several versions of draft congressional legislation focused on discarded drugs from single-dose drug vials have proposed rebates from manufacturers to health care providers and payers for discarded drug amounts. However, most bills do not propose refunds directed to patients, who would continue to have cost-sharing responsibilities for the cost of discarded drugs that were not used in their care.
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From page 117... ...
Also, given the variety of ways that drugs are priced and reimbursed, a rebate system for clinician-administered drugs would likely be quite complex. 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.
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From page 118... ...
Thus if Recommendation 4-3 is adopted, and rebates from manufacturers for discarded drugs are directed to patients to cover their out-of-pocket expense, manufacturers may respond by increasing the price of individual vials so that the profit margins they realize from a particular drug remain approximately the same. Another potential unintended consequence is that the widespread use of multiple-dose vials envisioned in Recommendation 4-2 could give an advantage to larger medical centers, where there are more likely to be multiple patients who need the same drug at approximately the same time and thus can jointly receive the contents of a multi-dose vial.
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From page 119... ...
FIGURE 6-1 A representation of how two recommendations focus on different issues but are intended to have similar effects by 119 moving the system away from the current standard practice.
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From page 120... ...
Successful efforts may eventually trigger drug companies to raise the prices to derive constant or increased revenue for their products. Approaches to reduc ing discarded drugs from single-dose vials would need to leverage other strategies aimed at lowering drug prices, including allowing the Secretary of the U.S.
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From page 121... ...
This committee recognizes the importance of that proposal to reduce drug prices and to guard against unintended consequences in efforts to reduce discarded drugs and the associated costs, and it also recognizes that allowing the secretary to negotiate directly would require modifications to the Medicare Modernization Act of 2003 prohibiting the Medicare program from negotiating the price of drugs with manufacturers. In short, the set of recommendations offered in this report would yield significant results if they are leveraged with these other broader strategies aimed at lowering drug prices in the United States.
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From page 122... ...
Uncoupling physician payments for administration from drug price (Recommendation 2-3) will remove one incentive for physicians to use more expensive drugs.
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