Sugammadex Vial Wastage: Implications for the Cost of Anesthesia Care in Children
Myron Yaster MD and Lynn Martin MD, MBA
When I (MY) started my anesthesia residency training in the 1970s, I was told that for every case, and I do mean for every case, I had to draw up 3 drugs, atropine, succinylcholine, and thiopental, have an opened, styletted endotracheal tube with a syringe attached to test and inflate the pilot balloon, a second smaller opened and tested endotracheal tube, an oral airway, tongue blade, appropriately sized black face masks, and working and tested laryngoscope handles and blades. Aside from the endotracheal tubes there was very little use of disposables. Indeed, as my good friend Dr. Susan Nicolson reminded me, we washed our circle tubing, anesthesia machine black bag, oral airways, esophageal stethoscopes, face masks, and of course our laryngoscope handles and blades. We had to buy our own manual blood pressure cuffs and devices (oscillotonometer) and I’m pretty sure we went through our entire residencies without washing them except when they got bloody! Further, because we drew up our own drugs, multi-dose vials were often used on multiple patients.
Ah, we live in a completely different world today. Virtually everything is single use and disposable. As discussed in several recent PAADs, many of us question the need for many single use items and would encourage reprocessing. Not so much though for the need to waste unused drugs. The risk of patient-to-patient cross infection is simply too great when done by one of us in the OR. And it did occur (think hepatitis and HIV) in the recent past! Thus, unused drug in these vials is and should be wasted. Since most drugs vials are designed for adults in which patients receive a unit dose (the complete vial) this isn’t usually an issue. However, it is in children because we use weight-based dosing and there is often a significant amount of unused drug left in each vial that will be wasted. A work around for expensive drugs like dexmedetomidine and IV acetaminophen is to have the hospital pharmacy make smaller pediatric unit sized dosing from the original vials. However, this too potentially increases institutional costs (pharmacy staff time and equipment) and shortens drug shelf life, leading many institutions to be hesitant to use this process or simply put limitations on what drugs can be used (i.e., formulary controls). Today’s original article by Mpody et al.1 looks at drug wastage for sugammadex and offer some suggested solutions. I’ve asked Dr. Lynn Martin who is also an MBA to help in today’s PAAD. Myron Yaster MD
Not mentioned at all in the letter by Mpody is that the U.S. is experiencing a rapidly increasing frequency of drug shortages, which has caused many difficulties for patients, clinicians, health care facilities, and federal regulators.4 These shortages have real consequences for patients, such as increased costs, drug errors, adverse events and even mortality.5 These problems have been further compounded by the recent world-wide pandemic. Under these circumstances, unnecessary drug wasting is a serious problem for everyone in health care and need to be addressed.
Original article
Mpody, C. , Beltran, R. , Hayes, S. , Nafiu, O. & Tobias, J. (2023). Sugammadex Vial Wastage: Implications for the Cost of Anesthesia Care in Children: Research Letter. Anesthesiology, 139 (1), 108-109. doi: 10.1097/ALN.0000000000004551.
Mpody et al. open their article by stating that “measures to control care-related expenditures is the issue of medication wastage that occurs when a medication vial is opened but not used. This waste represents a potential cost saving if the drug was not discarded, because unadministered drugs account for more than 25% of the anesthesia medication budget.”1, 2 Sugammadex is significantly more expensive than neostigmine and is supplied in single use vials (100 mg/mL) of either 2mL (200 mg/vial) or 5 mL (500 mg/vial). In pediatric practice much of each vial is typically wasted. Although not mentioned in today’s PAAD, this wastage is becoming increasingly common in adults as well, particularly when neuromuscular blockade is monitored with quantitative neuromuscular monitors. Using quantitative monitors as a guide to reversal results in many adult patients who require less than a full sugammadex vial for reversal and many may not need any antagonist at all!3
Mpody et al. retrospectively studied children 18 yr or younger across 49 children’s hospitals reporting to the Pediatric Health Information System who were anesthetized, paralyzed, and reversed with sugammadex between January 1, 2017, and September 31, 2022. “Drug wastage occurred in almost 3 of 5 administered doses (59.2%, n = 237,092). If sugammadex vial size of 100 mg/mL were available and it cost roughly half that of a 200-mg vial, or if vials were split, then an estimated $14,000,000 worth of drug would not have been discarded during the study period. By the third quarter of 2022, the quarterly average cost saving in the absence of medication wastage was $40,235.”
“Solutions include regulations to require manufacturers to identify vials that match doses commonly used in the pediatric population (e.g., 50-mg or 100-mg vials). Another solution would be the adoption of certified disposal and a virtual return system that would require manufacturers to refund the cost of leftover drugs. Finally, there is the option of not using sugammadex for neuromuscular blockade reversal” and to use the cheaper alternative neostigmine instead.
Formal guidelines from the Center for Disease Control and Prevention for vial repackaging are often used for expensive drugs with high wastage . As pointed out by Mpody, this repackaging must be “performed under USP Pharmaceutical Compounding Compendium, as well as the manufacturer’s recommendations about the safe storage of medications outside their original containers. Vial repackaging should be performed by a trained pharmacist or pharmacy technician under a sterile hood. The new vial or syringe must be labeled with pertinent information regarding the medication, including its name, medication concentration, total volume, and expiration date.”1 In Seattle we have followed these USP practices for dexmedetomidine and many other medications to reduce our drug wastage, costs, and address regional or national drug shortages. The business case for this practice can be easily made through collaborative efforts by pharmacy and anesthesiology leaders. The data typically shows that the small increase in pharmacy staff time and equipment use is typically easily covered by the reduced drug acquisition expenses, particularly when the drug is expensive or in short supply.
Mpody’s suggested solution (i.e., smaller drug vials) is not practical in our opinion. Governmental regulations have thus far been proven to be ineffective in altering ‘big pharma’ practices. Furthermore, the small market share for pediatrics has led to the vial size problems we experience daily. Perhaps drug companies would be more willing to consider ‘pediatric vial concentrations’ with some form of monetary motivation (i.e., extended patent duration and/or slightly higher profit margin for the pediatric vial size). Until the pharmaceutical industry is willing to address these pediatric issues, USP practices should be used more widely to reduce waste, costs, and drug shortages in children’s hospitals around the country.
What do you do in your practice? Do you use quantitative monitoring to guide reversal? Does your pharmacy fractionate doses and repackage to reduce waste? Send your thoughts to Myron who will post in a Friday Reader Response. And keep your eyes on the PAAD. We will be reviewing an article and editorial on quantitative monitoring and sugammadex in about 2 weeks.
References
1. Mpody C, Beltran R, Hayes S, Nafiu OO, Tobias JD. Sugammadex Vial Wastage: Implications for the Cost of Anesthesia Care in Children: Research Letter. Anesthesiology. Jul 1 2023;139(1):108-109. doi:10.1097/aln.0000000000004551
2. Weinger MB. Drug wastage contributes significantly to the cost of routine anesthesia care. Journal of clinical anesthesia. Nov 2001;13(7):491-7. doi:10.1016/s0952-8180(01)00317-8
3. Thilen SR, Weigel WA, Todd MM, et al. 2023 American Society of Anesthesiologists Practice Guidelines for Monitoring and Antagonism of Neuromuscular Blockade: A Report by the American Society of Anesthesiologists Task Force on Neuromuscular Blockade. Anesthesiology. Jan 1 2023;138(1):13-41. doi:10.1097/aln.0000000000004379
4. Ventola CL. The Drug Shortage Crisis in the United States. P T 2011;36(11):740-57. PMID: 22346307.
5. Phuong JM, Penm J, Chaar B, Oldfield LD, Moles R. The impacts of medication shortages on patient outcomes: A scoping review. PLoS ONE 2019;14(5): e0215837. doi:10.1371/journal.pone.0215837.