Waste Not Want Not...Role of Clinical Pathways In Rx Waste Management

J Clin Pathways. 2021;7(10):26. doi: 10.25270/jcp.2021.12.3

With the high price of medications, assuring medicines are used in the most appropriate manner has made clinical pathway use a top priority of stakeholders focused on value-based care delivery. Historically clinical pathways have done this through identification of the right patient. But given increasing concerns of waste there is a place for clinical pathways to assist in reducing waste as well. “Pharmaceutical waste” relates to both unused medications often because of dispensed volumes as well as unused expired pharmaceuticals. Because of increasing volumes of waste, budget constraints and environment concerns, pharmaceutical waste management is emerging as a new major public and environmental health concern.

Quantify the Problem

Because of the concern of pharmaceutical waste, the Office of the Inspector General (OIG) is tracking waste.¹ The Medicare Claims Processing Manual, Pub. 100-04, Ch. 17, § 40 provides policy on the use of the “JW” modifier for discarded Part B drugs and biologicals to track the amount of reimbursed waste in single-use vials. The OIG has been determining the amount of waste for the 20 single-use-vial drugs with the highest amount paid for waste as identified by the JW modifier.

These calculations can also be done for medications both physician administered as well as patient managed through determination of dispensed amounts against used quantities, the difference being waste. This magnitude can play a role in clinical pathway recommendations for a specific treatment as well as dosing recommendations. But the starting point as is often the case is understanding the magnitude of the issue.

Identify the Reason

Since the US Food and Drug Administration (FDA) approves vial sizes for single use submitted by manufacturers but does not control the vial sizes submitted for approval, the decision of vial size is left in the hands of the manufacturer. Many pharmaceuticals, such as drugs used for cancer treatment, are only available in standard quantities, for example in 100-mg packages. One benefit of this standardization is the reduction of potential dosing errors as pharmacists, nurses, and physicians are most accustomed to the 100-mg vial size. This standard approach also allows for a more efficient production process.

Mitigate & Manage

Since pharmaceuticals often are administered based on patient characteristics such as weight or body surface area, an amount of product will be unused and must be disposed of as waste. One study developed a method for the analysis of optimum fill volumes of pharmaceuticals to minimize wastage across a patient population, using publicly available data.² The frequency fo wastage for patients at each “step” in the structure of the population is estimated using the method of moments, with wastage then estimated for each “step” multiplied by its prevalence. This same process can be incorporated into clinical pathways to assure the most efficient use of medications through reduction of waste.

Waste also will occur in the face of individualized patient use. In these situations, clinical pathways can assist in calling out the process for waste management. The Environmental Protection Agency has been working to prevent pharmaceutical waste from simply be disposed via the drain or toilet as this can result in the drugs seeping into groundwater, negatively impacting fish, animal, and human populations through the aquatic ecosystems. To avoid this many, pharmaceutical products include specific disposal instructions on their prescription drug labeling. When not available, general waste management steps can be followed, such as drug take-back programs in the community, or disposal in household trash provided a number of steps are followed.

Through thoughtful inclusion of waste management within clinical pathways, beginning by quantifying the magnitude of the issue, then providing mitigation and finally management direction, pharmaceutical waste can produce minimum negative economic and social impact.

References

1. US Department of Health and Human Services Office of the Inspector General. Drug waste of single-use vial drugs. Accessed December 1, 2021. https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000146.asp

2. Hatswell AJ, Porter JK. Reducing drug wastage in pharmaceuticals dosed by weight or body surface areas by optimising vial sizes. Appl Health Econ Health Policy. 2019;17(3):391-397. doi:10.1007/s40258-018-0444-0

Author Information

Author: Richard G. Stefanacci, DO, MGH, MBA, AGSF, CMD

Affiliation: EVERSANA™, Berkeley Heights, NJ

Disclosures: Dr Stefanacci is the chief medical director for the managed markets agency of EVERSANA™.