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Implications of Discarded Weight-Based Drugs

Completed

Many prescription medications are dispensed in weight-based single-dose vials containing standard amounts of drugs that exceeds required dosages for the average patient, leading to billions of dollars in leftover single use medications that are destroyed. The National Academies with support from the Centers for Medicare & Medicaid Services through a congressional mandate initiated this study to examine federal health care costs, patient safety, and quality concerns associated with discarded drugs resulting from weight-based dosing of medicines contained in single-dose vials, and to produce a report which shall include recommendations to Congress to reduce waste in the biopharmaceutical supply chain.

Description

An ad hoc committee under the auspices of the National Academies of Sciences, Engineering, and Medicine will examine federal health care costs, safety, and quality concerns associated with discarded drugs resulting from weight-based dosing of medicines contained in single-dose vials. Based on that review, the committee will identify relevant drugs and examine:

• Current delivery practices, including manufacturing, storage, and transportation guidelines,

• Guidance from relevant federal agencies to biopharmaceutical manufacturers and distributors,

• Federal drug reimbursement and cost-sharing policies,

• Implications of current dosing practice to patients’ safety and quality of care, and

• Financial consequences of discarded drugs.

The committee will issue a report with findings and recommendations to consider in order to reduce waste in the biopharmaceutical supply chain.

Contributors

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Francis Amankwah

Staff Officer

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Conflict of Interest Disclosure

Disclosure of Conflict of Interest: Harold Paz

The conflict of interest policy of the National Academies of Sciences, Engineering, and Medicine (http://www.nationalacademies.org/coi) prohibits the appointment of an individual to a committee authoring a Consensus Study Report if the individual has a conflict of interest that is relevant to the task to be performed. An exception to this prohibition is permitted if the National Academies determines that the conflict is unavoidable and the conflict is publicly disclosed. A determination of a conflict of interest for an individual is not an assessment of that individual's actual behavior or character or ability to act objectively despite the conflicting interest.
Dr. Harold Paz has a conflict of interest in relation to his service on the Committee on Implications of Discarded Weight-Based Drugs because he currently owns shares of stock of Select Medical Corporation, United Surgical Partners International, and CVS Health. Dr. Paz receives financial remuneration from CVS Health through the end of May, 2020.
The National Academies has concluded that for this committee to accomplish the tasks for which it was established, its membership must include at least one person who has direct current experience in the health care system and direct recent experience with a major health insurance company. As described in his biographical summary, Dr. Paz recently served in leadership position in the health insurance industry, and brings experience and expertise crucial for this study that will need to consider the impact of discarded drugs on health systems and private insurers.
The National Academies has determined that the experience and expertise of Dr. Paz is needed for the committee to accomplish the task for which it has been established. The National Academies could not find another available individual with the equivalent experience and expertise who does not have a conflict of interest. Therefore, the National Academies has concluded that the conflict is unavoidable.
The National Academies believes that Dr. Paz can serve effectively as a member of the committee, and the committee can produce an objective report, taking into account the composition of the committee, the work to be performed, and the procedures to be followed in completing the study.

Disclosure of Conflict of Interest: Kenneth Silverman

The conflict of interest policy of the National Academies of Sciences, Engineering, and Medicine (http://www.nationalacademies.org/coi) prohibits the appointment of an individual to a committee authoring a Consensus Study Report if the individual has a conflict of interest that is relevant to the task to be performed. An exception to this prohibition is permitted if the National Academies determines that the conflict is unavoidable and the conflict is publicly disclosed. A determination of a conflict of interest for an individual is not an assessment of that individual's actual behavior or character or ability to act objectively despite the conflicting interest.
Mr. Kenneth Silverman has a conflict of interest in relation to his service on the Committee on Implications of Discarded Weight-Based Drugs because he is currently employed by a pharmaceutical manufacturer, AstraZeneca, as director of packaging technology, global technical operations. Also, Mr. Silverman is the single patent holder for a senior friendly single dose dispensing package (WO2009149267).
The National Academies has concluded that for this committee to accomplish the tasks for which it was established its membership must include at least one person who has current experience in drug packaging. As described in his biographical summary, Mr. Silverman has extensive current experience in biological packaging from late stage new molecular entities to commercialized products at AstraZeneca, as well as recent prior experience at major biopharmaceutical companies Merck and Bristol-Myers Squibb. Mr. Silverman has direct experience with both synthetic and biologic molecules, sterile manufacturing, primary containers and secondary packaging materials including formulation.
The National Academies has determined that the experience and expertise of Mr. Silverman is needed for the committee to accomplish the task for which it has been established. The National Academies could not find another available individual with the equivalent experience and expertise who does not have a conflict of interest. Therefore, the National Academies has concluded that the conflict is unavoidable.
The National Academies believes that Mr. Silverman can serve effectively as a member of the committee, and the committee can produce an objective report, taking into account the composition of the committee, the work to be performed, and the procedures to be followed in completing the study.

Committee Membership Roster Comments

Please note that the biosketches of committee members Anupam Jena and Gary Lyman were updated with additional disclosures. (12/22/2021)

Sponsors

Department of Health and Human Services

Staff

Francis Amankwah

Lead

Sharyl Nass

Tracy Lustig

Annalee Espinosa Gonzales

Alexandra Andrada

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