WASHINGTON — Every year, significant amounts of drugs left over and unused from single-dose vials are discarded, but because of the way drugs are priced and paid for in the United States, the cost of the discarded amount cannot be recouped, says a new congressionally mandated report from the National Academies of Sciences, Engineering, and Medicine. Many of these drugs are among the most expensive drugs on the market, including those for treating cancer, macular degeneration, and rheumatoid arthritis. While the report asserts there is little recoverable economic value to discarded drugs from single-dose vials, it highlights several opportunities to reduce inefficiencies that could lead to a reduction in discarded drugs.

Many injectable or infused drugs are administered in doses that are based on a patient’s weight or body size. These medications typically come in single-dose vials intended for one-time use for a single patient — but often, the vial size is too large for a patient’s need, and medication is left over. Due to safety concerns and current regulatory guidance, clinicians are not able to save the remainder in the vial for the patient’s next visit or use it on another patient, so it has to be discarded.

Despite the widespread use of weight-based dosing, particularly in cancer treatment, there is only limited evidence to support this practice for some medications, says Medications in Single-Dose Vials: Implications of Discarded Drugs.

“It’s time to challenge the assumption that all of these drugs should be administered by weight,” said Edward Shortliffe, adjunct professor of biomedical informatics at Columbia University’s College of Physicians and Surgeons and chair of the committee that wrote the report. “There are several actions we can take to address this issue of discarded drugs, from rethinking the way proper dosing of medications is determined and subsequently tested in clinical trials, to finding ways to share vials safely among two or even more patients.”

Several weight-based drugs used today would likely work just as well with fixed doses, but pivotal trials rarely compare weight-based dosing with other dosing methods. The U.S. Food and Drug Administration (FDA) should require fixed dosing for pivotal trials or registration, unless safety and efficacy would be compromised, the report recommends. Trials that consider different dosing strategies (weight-based versus fixed-dose) early in the drug development process could help to determine which is most appropriate.

When patients are responsible for drug cost sharing, such as through a co-pay, their share is based on the cost of the full, often expensive vial, even if they received only a portion. While there may be a small number of patients affected by this, they may be among the most vulnerable and may face an overwhelming financial burden to get the care they need, the report says.

The current reimbursement system for weight-based drugs does not encourage the efficient use of infused or injectable drugs in single-dose vials, the report says. For example, health care providers who administer such medications receive payment for the full amount of drug in a single-dose vial — including the discarded portion — which offers little incentive to minimize the amount of discarded drugs. The Center for Medicare & Medicaid Innovation should design and evaluate new payment models that reimburse health care providers by treatment episode, rather than by the volume or cost of a drug vial, the report recommends.

Currently, Medicare and private payers reimburse health care providers for the drug administered based on its average sales price plus a percentage add-on for administering the drug. As a result, the dollar amount of the add-on is larger for drugs with higher prices. The secretary of the U.S. Department of Health and Human Services (HHS) should require the Centers for Medicare & Medicaid Services (CMS) to uncouple payments for clinician administration of infused or injected drugs under Medicare Part B from the drug’s average sales price. Instead, the payment for clinical administration should be based on CMS’s assessment of the time and complexity of treatment administration and safety monitoring, the report recommends.

The main reason for not using vials for multiple patients is concern about compromised sterility and cross-contamination or storage issues once the container seal has been broken. However, a number of countries have well-established clinical and operational approaches that allow administration of medication to multiple patients from a single vial. FDA, CMS, and the Centers for Disease Control and Prevention all have different guidelines on using the contents of single-dose vials for multiple patients. These federal agencies should review and harmonize existing regulatory guidance on the repackaging of single-dose drugs — that is, dividing the content of a single-dose vial into multiple individual doses.

There is a common assumption that one can assign an economic dollar value to a volume of drug discarded based on the price of the full vial and the total volume of that vial. However, the amount of money “wasted” on a discarded drug is not as simple as calculating the proportional value of the discarded portion, the report emphasizes. The price of a drug is not based on how much is used, but on the willingness to pay for its therapeutic benefit. Therefore, it is not feasible to recoup expenses to spend on other health care services, and the report notes that requiring rebates for discarded drug is unlikely to achieve the intended aim. In the event that Congress implements legislation to require manufacturer rebates for discarded drugs, the report recommends it should first redirect rebates to patients (who have cost-sharing responsibilities), and to health care providers and payers thereafter.

The report’s interdependent set of recommendations aims to achieve greater efficiencies in the system in which drugs are developed, administered, or paid for in the U.S. However, it is not possible to predict the amount of financial savings that might be associated with implementing those recommendations absent additional economic analyses. Approaches to reducing discarded drugs from single-dose vials should leverage other strategies aimed at lowering drug prices, for example, allowing the secretary of health and human services to negotiate directly with manufacturers regarding the price of drugs, as proposed by a 2018 National Academies report.

The study — undertaken by the Committee on Implications of Discarded Weight-Based Drugs — was sponsored by the U.S. Department of Health and Human Services. The National Academies are private, nonprofit institutions that provide independent, objective analysis and advice to the nation to solve complex problems and inform public policy decisions related to science, technology, and medicine. They operate under an 1863 congressional charter to the National Academy of Sciences, signed by President Lincoln.

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