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Suggested Citation:"Appendix A: Glossary." National Academies of Sciences, Engineering, and Medicine. 2021. Medications in Single-Dose Vials: Implications of Discarded Drugs. Washington, DC: The National Academies Press. doi: 10.17226/25911.
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Appendix A

Glossary

The definitions marked with an asterisk are from the glossary included in the 2018 National Academies of Sciences, Engineering, and Medicine report Making Medicines Affordable: A National Imperative.

Average sales price (ASP)*—The ASP is derived from the manufacturer’s unit sales of a drug to all U.S. purchasers in a calendar quarter divided by the number of units sold, after all discounts and rebates (except Medicaid rebates).

Beyond use date—Typically assigned to pharmacy compounded preparations to indicate the date after which a compounded preparation shall not be used, it is set based on the date on which the preparation was compounded.

Biological products (biologics)*—A category of products regulated by the U.S. Food and Drug Administration, including vaccines, blood and blood components, allergenic compounds, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.

Biosimilar—A biological drug that is very much like another biological drug (called the reference drug) that has already been approved by the U.S. Food and Drug Administration. Biosimilar drugs and reference drugs are made from living organisms, but they may be made in different ways and of slightly different substances.

Suggested Citation:"Appendix A: Glossary." National Academies of Sciences, Engineering, and Medicine. 2021. Medications in Single-Dose Vials: Implications of Discarded Drugs. Washington, DC: The National Academies Press. doi: 10.17226/25911.
×

Body surface area–based dosing—Drug dosing based on calculations made from height and weight together.

Clinical trial*—A formal study carried out according to a prospectively defined protocol that is intended to discover or verify the safety and the effectiveness of procedures or interventions in humans.

Clinician-administered drug—An outpatient drug other than a vaccine that is typically administered by infusion or injection by a health care provider in a physician’s office or other outpatient clinical setting.

Closed-system transfer devices—Systems that include multiple components that are used in various combinations when moving a drug from one container to another.

Coinsurance*—The percentage of costs of a covered health care service that a beneficiary will pay after a deductible has been met.

Copay*—A fixed amount that a beneficiary will pay for a covered health care service after the deductible has been met.

Cost-sharing*—The share of costs covered by a beneficiary’s insurance that he or she will pay out of pocket. This term generally includes deductibles, coinsurance, and copayments or similar charges, but it does not include premiums, balance billing amounts for non-network providers, or the cost of non-covered services.

Deductible*—The amount a beneficiary will pay for covered health care services before the insurance plan starts to pay.

Dose banding —A dosing method that standardizes injectable drugs into a defined set of dose ranges for patients.

Dose capping—A dosing method similar to dose rounding that is specifically designed to increase patient safety in obese populations.

Dose rounding—A dosing method that either increases or decreases a prescribed dose to the nearest whole vial strength available.

Drug repackaging—The act of dividing the content of a vial from the container in which it was distributed by the original manufacturer into multiple individual-dose containers without further manipulation of the drug. It also includes placing the contents of multiple containers of the same

Suggested Citation:"Appendix A: Glossary." National Academies of Sciences, Engineering, and Medicine. 2021. Medications in Single-Dose Vials: Implications of Discarded Drugs. Washington, DC: The National Academies Press. doi: 10.17226/25911.
×

finished drug product into one container, as long as the container does not include other ingredients.

Expiration date—The date before which a drug manufacturer will guarantee the potency and safety of the drug content when stored in the recommended conditions and in the original container.

Federally qualified health centers—Community-based health care providers that receive funds from the Health Resources and Services Administration Health Center Program to provide primary care services in underserved areas.

Fee-for-service system—A system of health insurance payment in which health care providers are reimbursed for each particular service rendered on the basis of the number of services they provide.

Fixed dosing—Also known as flat dosing, refers to dosing strategies that do not take into account body size or other pharmacological parameters.

Formulary*—An approved list of medications that may be prescribed for a particular hospital, health system, health insurance policy, or pharmacy benefit.

Integrated health care delivery system—A network of health care providers that coordinates a continuum of services to a defined population and is typically held clinically and fiscally accountable for the outcomes and health status of the population served.

List price*—The prices that purchasers display as those at which they are prepared to sell their products and/or the prices regulated by legislation.

Multiple-dose vial—A vial that is intended to contain more than one dose of a drug and is intended to be administered multiple times and for multiple patients.

Out-of-pocket costs*—The expenses for medical care that are not reimbursed by insurance and are the responsibility of the beneficiary to pay. Out-of-pocket costs include deductibles, coinsurance, and copayments for covered services plus all costs for services that are not covered.

Pivotal trial—Also referred to as pivotal study, it is a clinical trial or study that intends to provide the ultimate evidence and data that the U.S. Food

Suggested Citation:"Appendix A: Glossary." National Academies of Sciences, Engineering, and Medicine. 2021. Medications in Single-Dose Vials: Implications of Discarded Drugs. Washington, DC: The National Academies Press. doi: 10.17226/25911.
×

and Drug Administration uses to decide whether to approve a potential new medicine.

Rebate*—A payment made to a purchaser after the transaction has occurred.

Single-dose vial—A vial that is intended to contain one dose of a drug and to be used a single time for a single patient.

Specialty drugs—A general term for medications that have one or more of the following characteristics: are highly expensive, are molecularly complex (often derived from living cells), have limited availability or are available only through a specialized distribution network, have unique storage or shipment requirements, or are used for treating rare and complex disease indications.

Vial sharing—The practice of using residual drug from a vial to treat other patients within an acceptable time frame.

Waste—For efficiency in health care spending, waste refers to any spending that does not produce as much value as it could have if it were directed differently. This waste can appear in a variety of forms: administrative waste (e.g., excess overhead costs), operational waste (e.g., duplication of services), and clinical waste (e.g., practices that do not improve health outcomes or are detrimental to the patient). For the purposes of this report, the committee understood waste to generally refer to the discarded portions of weight-based drugs contained in single-dose vials.

Weight-based dosing—Drug dosing based on measures of “body size,” including both dosing based on weight and dosing based on body surface area, which is based on calculations made from weight and height together.

Wholesalers*—Drug distribution companies that purchase drugs from the manufacturers and then sell them to pharmacies at negotiated prices.

Suggested Citation:"Appendix A: Glossary." National Academies of Sciences, Engineering, and Medicine. 2021. Medications in Single-Dose Vials: Implications of Discarded Drugs. Washington, DC: The National Academies Press. doi: 10.17226/25911.
×
Page 123
Suggested Citation:"Appendix A: Glossary." National Academies of Sciences, Engineering, and Medicine. 2021. Medications in Single-Dose Vials: Implications of Discarded Drugs. Washington, DC: The National Academies Press. doi: 10.17226/25911.
×
Page 124
Suggested Citation:"Appendix A: Glossary." National Academies of Sciences, Engineering, and Medicine. 2021. Medications in Single-Dose Vials: Implications of Discarded Drugs. Washington, DC: The National Academies Press. doi: 10.17226/25911.
×
Page 125
Suggested Citation:"Appendix A: Glossary." National Academies of Sciences, Engineering, and Medicine. 2021. Medications in Single-Dose Vials: Implications of Discarded Drugs. Washington, DC: The National Academies Press. doi: 10.17226/25911.
×
Page 126
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Every year, significant amounts of expensive drugs are discarded. This is due in part to the growing number of prescription drugs that are administered in variable doses (rather than fixed or flat doses) based on a patient's weight or body size. Strict regulations and guidance generally prohibit or severely restrict the acceptable time frame for sharing medication from single-dose vials among patients, and so the unused amount will typically be discarded. Due to the current system for producing, administering, and paying for drugs in the United States, significant - but indeterminate - amounts of expensive prescription drugs are discarded each year.

At the request of the Centers for Medicare & Medicaid Services, Medications in Single Dose Vials: Implications of Discarded Drugs explores the federal health care costs, safety, and quality concerns associated with discarded drugs that result from the weight-based dosing of medicines contained in single-dose vials.

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