Medications in Single-Dose Vials Implications of Discarded Drugs (2021) / Chapter Skim
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1 Introduction
1 Introduction
Pages 17-30
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From page 17... ...
2 Hereafter, the committee uses weight-based dosing to refer to drug dosing based on measures of "body size," including dosing based on either weight or BSA, which is closely correlated with body weight. Although these two approaches can be distinguished and justified clinically, for the purposes of this report, both are considered under the single phrase "weight-based." 17
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From page 18... ...
• Provide a comprehensive assessment of federal health care costs, to both the Medicare program and to Medicare beneficiaries, due to billing for wasted drugs and biologicals from single-dose vials. • Using available data sources, quantify the amount of waste asso ciated with single-dose injectable drugs and biologics in billing units and/or proportion of available vial sizes and calculate the associated dollar amounts.
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From page 19... ...
This report and its conclusions may be relevant to situations in which private health insurance payers use similar methods to reimburse providers for drug administration, but the charge limits the committee's purview to federal programs. COMMITTEE'S APPROACH The study committee contained individuals with various areas of expertise, including public health, health care access and affordability, health economics and finance, health care delivery, health care services research, pharmacy, federal health care payment policy, ethics and health care policy, drug manufacturing and packaging, oncology, U.S.
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From page 20... ...
Additionally, while the main focus of the report is on Medicare Part B, which involves primarily administered and injected drugs, not drugs for which the physician typically writes a "prescription" for a drug to be directly acquired by the patient, this report uses the term prescription drugs in a broader sense to indicate all drugs whose use is directed by a physician.
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From page 21... ...
described the steady rise in the cost of prescription drugs that has taken place in the United States over the past few decades and discussed the reasons for that rise. As of 2016, prescription drugs accounted for approximately 17 percent of the total cost of U.S.
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From page 22... ...
The populations these programs serve, the types of health care services they cover, and, specifically, their prescription drug coverage influence the trends in drug use and spending across these programs. Medicare Part A covers inpatient hospital costs, whereas Part B covers outpatient care and certain drugs -- primarily infusible and injectable drugs and biologics -- if they are administered in physician's offices and hospital outpatient departments and certain other drugs provided by pharmacies and suppliers.
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From page 23... ...
purchasers submitted to CMS in a calendar quarter divided by the number of units sold, minus all price concessions, such as volume discounts, cash discounts, and rebates. Under the budget sequestration cuts, payments to health care providers for most Part B drugs were changed from the ASP plus 6 percent to the ASP plus 4.3 percent (Werble, 2017)
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From page 24... ...
NOTES: Data include Part B–covered drugs furnished by several provider types including physicians, suppliers, and hospital outpatient departments, and e xclude those furnished by critical access hospitals, Maryland hospitals, and dialysis facilities. "Medicare spending" includes program payments and beneficiary cost sharing.
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From page 25... ...
QUESTION OF WASTE According to its Statement of Task, the committee was charged to offer findings and recommendations on how to reduce waste in the biopharmaceutical supply chain, and given that the committee's work was to focus specifically on the discarded portions of single-dose vials of weight-based drugs, it understood waste to be referring specifically to these discarded portions, which raised the question of how to understand the term. WHO uses the phrase waste pharmaceuticals to describe drugs that need to be disposed of for various reasons -- because they are past their expiration date, for instance, or labeled in a way that makes them unrecognizable (WHO, 1999)
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From page 26... ...
While a fuller discussion appears in Chapter 5, the committee ultimately decided that it is not appropriate to refer to the discarded portions as "waste" and that even if some inefficiency exists in the way these drugs are administered, the total economic value of discarded drug is nowhere near the amounts that have been suggested by simple calculations that multiply the nominal per-milliliter cost of the drugs by the total milliliters discarded each year. Nonetheless, there are important improvements that can be made to the system in which drugs are developed, administered, or paid for, and the committee does offer recommendations for such improvements in subsequent chapters.
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From page 27... ...
Weight-based dosing: Weight-based refers to the dosing strategy that adjusts dose for body weight. For the purposes of this report the committee uses weight based dosing to refer to drug dosing based on measures of "body size," includ ing based on body surface area, which is closely correlated with body weight.
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From page 28... ...
2018. Selection of the appropriate package type terms and recommendations for labeling injectable medical products packaged in multiple-dose, single dose, and single-patient-use containers for human use guidance for industry.
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From page 29... ...
2017. Paying for prescription drugs around the world: Why is the U.S.
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