Stephen F. Eckel, PharmD, MHA, BCPS, FASHP, FAPhA
Many of you are familiar with Maxwell House’s slogan: “Good to the last drop.” It suggests, powerfully, that the coffee in your cup has such great taste that you should waste none of it. The FDA action on January 15, 2013, that created the new ONB code for closed system transfer devices (CSTDs) reminded me of this slogan, except that in this case, the idea is that one should not waste any of the precious medication contained in a given vial.1
I was first exposed to CSTDs through a 1999 article by Connor and colleagues in the American Journal of Health-System Pharmacy
entitled “Surface contamination with antineoplastic agents in six cancer treatment centers in Canada and the United States.”2
At the time, I was a manager at UNC Hospitals with operational responsibility for IV admixtures, including chemotherapy preparation. We prepared all of our inpatient chemotherapy in our IV room and were in the process of opening a new satellite. Reading this article gave me a new insight into the risk of exposure to chemotherapy my employees faced. I realized that in addition to ensuring the safety of the preparation process to minimize medication errors in patients, I also needed to create a safe work environment for my employees.
I immediately set to work with nursing to evaluate the various CSTDs that were on the market by reviewing the published peer-reviewed literature on their merits. We also authorized a wipe study to detect the amount of chemotherapy contamination in our preparation and administration areas. Even though I believed we were using excellent aseptic technique, I was appalled at how high the reported levels were. I shared the findings with hospital administration, and we worked as a team to budget for, select, and put into use a CSTD. Since we began to use CSTDs, our continued routine monitoring has recorded decreased levels of surface contamination.
A few years ago, I got involved in a discussion regarding the cost of drug waste remaining in vials. As organizations began implementing USP <797>, guidelines on appropriate beyond use dates (BUD) were recommended for drug vials. After the BUD passed, the remaining drug in the vial would be discarded. The safety of the patient was at the center of these guidelines. However, no one had quantified the quantity and value of the medication that was being discarded. We undertook a study at UNC Hospitals to evaluate this expense and determined that for 19 different chemotherapy medications in our organization, the aggregate cost of the waste was close to $750,000 per year.3
We also tested whether it would be safe to extend the BUD when a CSTD was in place. Early data at our organization demonstrate that CSTD use can allow for BUD extension that leads to a greater than 50% recovery of the cost of drug wastage, while maintaining the sterility of the medication.
The new FDA rule for ONB classification defines a CSTD as a device that demonstrates no escape of hazardous drug or vapor concentration, no transfer of environmental contaminants, and prevention of microbial ingress. These qualities remind me of why I evaluated and then adopted CSTDs in my health system. We should all be aware of the hazards of exposure to chemotherapy and the protection CSTDs can provide for our employees. We need to make sure our health care workers are ensured the same level of safety as our patients, and CSTDs are essential to doing so.
If you implement an ONB-approved CSTD and take advantage of the drug vial optimization opportunities it presents, your organization can ensure that its medications are also “Good to the last drop.”
Have your experiences demonstrated this principle to be true? I would appreciate hearing from you.
2. Connor TH, Anderson RW, Sessink PJ et al. Surface contamination with antineoplastic agents in six cancer treatment centers in Canada and the United States. Am J Health-Syst Pharm 1999; 56:1427-32.
3. Rowe EC, Savage SW, Rutala WA et al. Economic and Microbiologic Evaluation of Single-Dose Vial Extension for Hazardous Drugs. Journal of Oncology Practice. 2012;8:45e-49e.