New York Times: “The federal Medicare program and private health insurers waste nearly $3 billion every year buying cancer medicines that are thrown out because many drug makers distribute the drugs only in vials that hold too much for most patients, a group of cancer researchers has found. …Â “Drug companies are quietly making billions forcing little old ladies to buy enough medicine to treat football players, and regulators have completely missed it,” said Dr. Peter B. Bach… co-author of the study.”
I read this article with great interest. While itâ€™s true that â€œcancer drugsâ€, i.e. chemotherapy can be costly, the reasons are many and this article speaks about only a single issue that overly simplifies the problem and vilifies the manufacturers. Itâ€™s not that simple.
Before I discuss items not mentioned in the NYT article, let me give you a bit of background. As a practicing pharmacist for nearly twenty years, Iâ€™ve been involved with my fair share of sterile preparations, including chemotherapy. In the early years of my career pharmacies would frequently hold onto vials of medications that had only small amounts removed to make a patient dose. These vials with the remaining drug were affectionately called â€œpartialsâ€, and were often stored for later use in the refrigerator for periods of up to a week. Partials were then combined to make additional doses, thus minimizing waste. In addition, pharmacy as a whole would often utilize the â€œoverfillâ€ found in many medication vials to stretch inventory. As a specific example, I recall 50mcg/mL, 20mL vials of fentanyl routinely containing more than a full milliliter of overfill, i.e. more than 21mL of the solution. Sometimes, depending on the number of CSPs of a specific medication prepared, the overfill from several vials would be enough to generate another complete dose for a patient.
Itâ€™s important to understand that the two use cases described above were standard practices and were in no way meant to endanger patients or cheat anyone out of anything. At the time, they were considered strategies to minimize drug waste. Period.
Fast forward to today and neither partial vials nor overfill are routinely used. Why? Well, new regulatory requirements and standards of practice like USP <797> have made it increasingly difficult to hang onto partials secondary to beyond-use-dating, lack of stability and sterility data, and so on. In addition, insurance companies laid down the boom several years ago and mandated that pharmacies no longer use overfill because it was considered â€œfraudulent billingâ€. Iâ€™ve been in several pharmacies over the past several years where the complexity of regulatory compliance and insurance billing has made partials and overfill too risky and complex to deal with. Instead, any leftover drug is discarded, i.e. wasted. Wasting partials and overfill are now considered standard practice.
This is not to say that drug companies arenâ€™t trying to maximize their profits. Of course they are. Iâ€™m not completely oblivious to the fact. However, as a pharmacist, I think about what healthcare would look like without the billions of dollarsâ€™ drug companies spend on research and development. It would be a sad, desperate place. Several medications brought to market during the past decade have saved countless lives.
What does it all mean? It means we have some work to do. It means that we need to find a way to extend the shelf life of partial vials, especially chemotherapy. It also means that we need to find common ground with payers that allow pharmacies to utilize the entire contents of vials. Itâ€™s not rocket science, but itâ€™s certainly no walk in the park either.