Lindsey Amerine, PharmD, MS, BCPS
Eight years ago, The University of North Carolina (UNC) North Carolina Cancer Hospital (NCCH) in Chapel Hill was under significant pressure to reduce drug costs. The hospital had already switched to cheaper medications and, where possible, renegotiated contracts, but it hadn’t tackled drug waste. “We were throwing away partially full drug vials. It was expensive,” said Lindsey Amerine, PharmD, MS, BCPS.
It is a problem that has frustrated many other clinicians. In 2012, 12 of the 13 new drugs approved for cancer indications each cost over $100,000 for a year of therapy.1
Clinicians routinely dispose of unused medication rather than attempt to preserve and use the remainder for an additional application. However, NCCH, which serves as the clinical home of the UNC Lineberger Comprehensive Cancer Center, realized that some drugs can be preserved for reuse. The hospital system managed to achieve substantial savings by developing a system for preserving unused infusion drugs, including high-cost immunotherapy drugs, once their packaging had been breached for initial use.
In its General Chapter <797> compounding standards, United States Pharmacopeia (USP) established that clinicians must dispose of some single-dose containers within hours of puncture or opening—generally 6 hours.2
However, NCCH realized that the standards allow the use of closed-system transfer devices (CSTDs) to preserve medication for repeat use, according to Amerine, the assistant director of pharmacy for the Oncology Service Line and Infusion Services at the University of North Carolina Medical Center in Chapel Hill.
NCCH had already implemented a CSTD program to protect employees from exposure to hazardous chemicals. Hospital officials knew also that CSTDs could prevent contamination of drug content. “If nothing comes out of the vial, nothing should go into it,” Amerine said.
Within a year of starting its drug-waste reduction study in 2010, NCCH became the first hospital in the country to implement a program systematically extending medications’ beyond use dates (BUDs) from several hours to upward of 7 days. The BUDs indicate how long a drug may be used from the time its packaging is opened for the initial use (not from the date of manufacture). For example, the BUD may specify that 6 hours after a drug vial is breached, that drug can no longer be used. By keeping the drug products sterile with CSTDs, NCCH discovered it could keep drugs uncontaminated and safe for use for much longer than the BUD guidelines specified. With the aid of a CSTD, the drug remaining inside a single vial, for example, can often be preserved and used later, either for the same patient or a different one.
Based on an assessment of 19 commonly used oncology drugs at NCCH, officials determined they reduced oncology waste by 94% in 2017, a level of efficiency they expect to be able to maintain. When extrapolating to their entire chemotherapy drug budget for almost 200 drugs, the hospital estimated that it saved $39 million and discarded only $49,000 in unused medication in 2017. This year, it’s on track to save $43.8 million. Because of this success, NCCH was recognized by the Association of Community Cancer Centers with its 2018 Innovator Award at its 35th National Oncology Conference in October.
Drug waste from unused medication is an industrywide problem. In 2016, BMJ reported that $3 billion in unused oncology agents are discarded each year because the medicine inside the drug packaging cannot be used after its BUD.3
For the report, Bach et al created a drug waste calculator for some of the most frequently used cancer medications. The investigators focused on the difference between drug vial sizes and average dosage. Because a dose is smaller than the amount of drug contained in the vial, the difference often ends up as medical waste. For example, Bach et al calculated that $76.7 million worth of nab-paclitaxel (Abraxane) is left over annually because, for a patient with breast cancer, five 100-mg vials must be opened to provide the average 442-mg dose needed (Table
How NCCH Developed its Program
Before instituting its drug vial optimization (DVO) program, NCCH had used CSTDs on chemotherapy drug vials to protect workers from the hazardous chemicals during mixing and transferring. The USP <797> standards establish a 6-hour BUD for drugs in vials, bags, bottles, and syringes that are administered inside an environmentally controlled environment. The goal is to protect against microbe growth inside containers after they are opened.
Table. Leftover Drug Adds up to Significant Waste3