Complying with USP <800>

June 2022 - Vol.19 No. 6 - Page #22
Category: USP Training Programs

Pharmacy Purchasing & Products recently held a webinar entitled:
Meet USP <800> Requirements for CSTD Utilization
presented by Fred Massoomi, PharmD, BCSCP, FASHP, and Seth Eisenberg, RN, OCN, BMTCN

The following questions were submitted by attendees.
The webinar slides and full presentation can be downloaded at pppmag.com/webinars.


Q: Are there standard criteria for comparing the different brands of closed system drug-transfer devices?

Massoomi: There was hope that the NIOSH closed system drug transfer device (CSTD) performance test protocols would serve in that role, but the protocols are still not official. I would recommend selecting the companies that you want to work with, then requesting they visit your facility and demo those products in front of both the pharmacy and nursing decision makers. This will allow you to determine which device will work best for you at your site. At this point, the official criteria to compare CSTDs is defined solely by whether or not the product has received FDA clearance and FDA ONB classification.

Q: Is it acceptable to prepare cidofovir and ganciclovir without CSTDs as they are not antineoplastics?

Massoomi: This is a frequently discussed issue. To answer this question, we must first consider the broader question of how to best develop a hazardous drug (HD) list. Currently, pharmacy relies upon the NIOSH 2016 list, which is considerably outdated. Ideally, every facility would develop an HD list that reflects the products in use at their facility and includes a review of each product’s package insert to determine any special handling needs.

For some historical context, prior to the existence of the NIOSH HD list, these products were typically prepared in a biological safety cabinet (BSC) using a CSTD because the package insert clearly states that the handling of this product needs to be done in a protective manner. My recommendation is to review the package insert for these products as part of your handling assessment. Consider developing a hazardous medication team that can bring the appropriate expertise to the table to address these complicated issues.

Eisenberg: On the administrative side, it is important to recognize that antivirals that are not considered chemotherapy are often widely administered throughout the hospital by staff that may not be trained in CSTD use. While this practice poses a logistical challenge, it does not negate the handling risks. The decision can be simplified by asking a clarifying question: If we are committed to protecting our oncology nurses by providing CSTDs for HDs, do we not owe that same protection to our med/surg nurses who are handling dangerous drugs? At my facility, we treat ganciclovir like any other HD based on the toxicities of the drug itself, not based on where it is administered or who is administering it.

Q: If the BSC in the negative pressure room is down and a STAT order is received for a fluorouracil bag, would it be safe to mix it in a regular vertical hood using a CSTD?

Massoomi: Under USP <800>, that approach is not permitted. The chapter outlines the layers of containment strategies that need to be in place for HD compounding, including primary, secondary, and supplemental controls. CSTDs are supplemental controls as they are designed to offer additional levels of protection. Under no circumstances should they be used as a substitute for a containment primary engineering control (C-PEC) when compounding. The safety of the staff must always be the primary consideration when handling HDs for patients.

Q: At what point on the IV line do you recommend connecting the CSTD?

Eisenberg: A CSTD should be placed at the point where you will be doing an intentional disconnect or intentional connection. In a typical secondary infusion piggyback setup, the CSTD is connected to the primary line at the distal end of the tubing, where it connects to the patient. There is a common misconception that flushing the line with saline mitigates the risk of potential contamination with disconnection. However, we know that HD residue exists even after the tubing is flushed, meaning there is a significant risk present at disconnection, thus the need for connecting at the distal end of the tubing. Secondary tubing should also have a CSTD at the distal end to prevent contamination prior to and after disconnection, particularly if the tubing comes with the drug from the pharmacy.

Q: Can you elaborate on the use of dry connection devices to eliminate the need for priming?

Eisenberg: When pharmacy sends the HD bag to the floor with a dry spike attached, this allows the nurse to use their normal PPE and swabbing processes, attach the tubing that contains the mating CSTD, connect it to their pump, and back-prime from the pump to remove any air from the tubing. This allows for a dry connection at the bedside while also eliminating the chance of an accidental spike into a bag of fluid. The benefits of this method are that it is quick, efficient, and safe.

Q: What are your thoughts on compounding and administering large molecule biologics using CSTDs?

Massoomi: The answer to this is not straightforward. There are currently eight monoclonal antibodies that are on the proposed NIOSH list, and in almost all those cases, it is the combination product that is hazardous. Thus, it is not recommended to automatically assume that all monoclonal antibodies used in oncology or immunotherapy are hazardous and require a CSTD. The physical structure of a drug as a monoclonal antibody does not alone define it as being hazardous, regardless of the pharmacological use. However, if the drug has the attributes of being hazardous per NIOSH with any of the listed hazards (carcinogenic, teratogenic/developmental toxicity; reproductive toxicity; organ toxicity at low doses; genotoxicity; and, manufacturer special handling instructions) then it should be handled in accordance with USP <800> standards. It is critical to note that sites must review any hazardous handling risks associated with new drugs as part of the formulary review process. This is particularly important as we know that NIOSH’s published HD lists are out of date. In fact, in the proposed draft of the 2020 NIOSH Hazardous Drug List, it clearly states that the list is not all-inclusive and employers should consider creating a facility-specific HD list.1 See the October 2019 Pharmacy Purchasing & Products article Develop an Entity-Specific HD List by the good folks at The University of North Carolina Health Care System for further guidance.2

Eisenberg: For conjugated monoclonals, the concern is focused on the HD that is attached to the molecule. As such, the conjugated monoclonal antibodies must be prepared and administered with a CSTD because we do not know how those linked drugs will behave outside the body.

While there are a few non-conjugated monoclonals that have been shown to be potentially dangerous for people who are pregnant or trying to get pregnant, these are less of a concern from an administration point of view. This is because, for example, if the drug spilled on someone’s bare hand, the molecules are too large to be absorbed. However, during compounding, it is important to consider the inhalation risk when withdrawing the needle from the vial.


Fred Massoomi, PharmD, BCSCP, FASHP, is a director of sterile compounding compliance for Option Care Health. He received his doctorate from the University of Kansas School of Pharmacy. Fred is a member of PP&P’s Editorial Board.

Seth Eisenberg, RN, OCN, BMTCN, professional practice coordinator for infusion services at the Fred Hutch Cancer Center (formerly Seattle Cancer Care Alliance) Ambulatory Clinic, has worked in the field of oncology since 1983 and has authored several publications on CSTDs and the nursing implications of USP <800>. His experience includes 36 years in hematopoietic stem cell transplantation.


References

  1. NIOSH [2020]. NIOSH list of hazardous drugs in healthcare settings 2020. By Connor TH, MacKenzie BA, DeBord DG, Trout DB, O’Callaghan JP, Ovesen JL, Whittaker C. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication Number 2020- (Supersedes 2016-161)
  2. King E, Eberwein SM. Develop an Entity-Specific HD List. Pharm Purch Prod. October 2019;16(10).

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