A recent study has found that the size of vials used for cancer drugs directly results in waste, and a significant portion of the high – and steadily increasing – cost of cancer drugs. With most cancer medications available in only one or two sizes, usually designed to provide an amount of medication for the largest patients, many times medication is left over in each vial.
The researchers estimate that about $2.8 billion is spent by Medicare and other insurers reimbursing for medication that is discarded.
This cost – paying for medication that is literally thrown out in most cases – can be considered an impact to the property goal. As the cost increases for drugs, it’s not only Medicare and other insurers that are impacted, but patients, many of whom pay a fixed percentage of their drug costs. This impacts the patient services goal. The disposal of these drugs has a potential environmental impact, impacting the environmental goal. The impacts to the goals as a result of an issue, as well as the what, when and where of that issue, are captured in a problem outline, which is the first step of the Cause Mapping process, which develops a visual diagram of the cause-and-effect relationships (a type of root cause analysis).
The second step of the process is to begin with an impacted goal and develop the cause-and-effect relationships. This can be done by asking “why” questions and ensuring that all the causes necessary to result in an effect are included. In some cases, more than one cause is required to produce an effect. In these cases, the causes are both connected to the effect and joined with an “AND”.
In this case, beginning with the property goal, we can ask “Why do Medicare and other insurers have increased costs?” This is due to the increased cost of cancer drugs, which results from significant amount of medications being thrown away. We can add evidence to the causes to support their inclusion in the Cause Map or provide additional information. For example, the study found that the earnings on disposed medication made up 30% of the overall sales for one cancer medication.
A significant amount of medication is being thrown away because there is medication left over in each vial used to deliver the medication, and the leftover medication in the vials is thrown away. Both these causes are required to result in the medication waste. Leftover medication is thrown away because it can only be used in rare circumstances (within six hours at a specialized pharmacy). There is leftover medication in the vials because the vials hold too much medication for many patients. (Most medication is administered based on patient weight.) The vials hold too much medication because many medications are provided in only one or two vial sizes. This is true of 18 of the top 20 cancer drugs. Providing alternate vial size is not required by regulators, whose concern is limited to patient safety or potential medical errors. Specifically, Congress has not authorized the US Food and Drug Administration (FDA) to consider cost. Drug manufacturers select vial size based on “marketing concerns” or, effectively, profit. The study found that providing more vial sizes for one medication would reduce waste by 84% but would also reduce sales by $261 million a year.
Several of the vials for cancer medications are sized based on a larger (6’6″, 250 lb.) patient. According to one drug manufacturer, this is done by design, resulting from working with the FDA for a vial that would provide enough medication “for a patient of almost any size.” At least one drug manufacturer has suggested that the full vial be administered regardless of patient size, but one of the study’s co-authors says that extra medication does nothing to help patients, so it would still be wasted.
Instead, the researchers propose that the government either mandate the drugs be distributed in multiple vial sizes that would minimize waste, or that the government is refunded for wasted quantities. They point out that alternate vial sizes are provided in Europe, “where regulators are clearly paying attention to this issue”, says Dr. Leonard Saltz, a co-author of the study.
To view the initial outline, Cause Map and proposed solutions, please click on “Download PDF” above. Click here to view the study and drug waste calculator.