The relationship between hazardous drug (HD) exposure and the risk of adverse health effects is well established.^1-4 Peer reviewed studies verify that HD surface sampling is an effective way to identify and act upon surface contamination proactively.^1,5,6 USP <800> states that environmental wipe sampling for HD surface residue should be performed initially as a benchmark, and then conducted at least every 6 months, or more often as needed, to verify containment.⁷ From this practice, entities can use the detection of contamination as a marker to determine the effectiveness of safeguards and identify gaps in the HD use process.

While wipe sampling is an optional process per USP <800>’s current verbiage, the reality is with the persisting threat of HD exposure and the evolving NIOSH drug list, this recommendation has become increasingly critical for organizational success in compliance. Some entities have embraced the reality of HD wipe sampling as a requirement for their pharmacy processes. A Pharmacy Purchasing and Products survey in July of 2024 demonstrated that 45% of facilities are conducting wipe sampling, with just over half sampling on a semi-annual basis.⁸ Despite the rise in the number of facilities implementing HD wipe sampling, there is still hesitancy in navigating the unknown. This article seeks to provide clarity for the 55% of facilities that have yet to initiate HD wipe sampling and additional guidance for those who are still fine-tuning their processes. To bridge the gap between theory and practical application we explore how to tailor SOPs to the needs of different health systems with case studies using fictitious companies (see TABLE 1).

Recruit Stakeholders

The first step to introducing any initiative is to gather the appropriate stakeholders and create a forum for program development. USP <800> states that each entity must have a designated person who is tasked with developing, implementing, and overseeing the entity’s compliance with the chapter.⁷ Part of that oversight includes monitoring sampling, maintaining sampling reports, and acting on the results. Largely, pharmacy and nursing carry the onus for spearheading project initiation and execution of sample testing, however, the creation of a wipe sampling protocol should be a multidisciplinary effort in collaboration with other essential stakeholders from each step of the medication use process.

From the reception of the medication until the medication is administered to the patient, HDs touch many hands, thus the list of stakeholders should include all departments handling HDs and anyone responsible for cleaning those areas. Building a task force to develop processes for testing is critical. This HD wipe sampling committee (HDWSC) may include but is not limited to pharmacy, nursing, environmental services, and health and safety departments.

Developing Standard Operating Procedures

Once the program champions are engaged, begin developing policies and standard operating procedures (SOPs). USP <800>’s high-level recommendations for HD wipe sampling allow freedom to proactively plan and develop a program to meet the unique needs of each organization. When developing SOPs, outline the definition and purpose of HD wipe sampling as well as the sites accountable for adhering to the SOP. The SOP should also outline additional procedural objectives with guidance on how to execute each step (see TABLE 2).

Click here to view a larger version of this chart.

Selecting a Kit Vendor

Crucial to establishing an HD surface sampling program is evaluating and selecting an HD sampling vendor. The responsibility of reviewing vendors rests on the entity, as there is no agency tasked with certifying wipe sampling kit vendors. With a growing market of HD wipe sampling vendors, there are a variety of characteristics to consider when determining the best fit for your site or organization. For a high-level overview of factors to consider when evaluating an HD sampling vendor see the October 2023 Pharmacy Purchasing & Products supplement article “Review HD Wipe Sampling Vendors”. Take care to review the following factors as well:

• Cost: Kit costs can range from $100 to over $1,000. For a large organization with multiple sites, this can be a significant capital cost.
• Drugs tested: While USP <800> provides examples of marker drugs for testing, note that these are simply recommendations. Create a list of the commonly used HDs that best demonstrate a risk of contamination at each site and compare that with the drugs available through the vendor to determine a reasonable list of HDs to test for.
• Kit size: HD wipe sample kits vary in size or the number of samples that can be collected. When selecting sample locations, consider the number of samples available in each kit being evaluated. The number of samples may also change over time.
• Ease of use: Sampling kits include an instruction for use (IFU) detailing the preparation, specific sampling steps, storage, and shipping instructions. Evaluate the IFUs of various products to determine which will be a good fit operationally. If preparation is too cumbersome or if sampling steps are too intricate, this may result in frontline user dissatisfaction and thus increase the risk of error when sampling.
• Result timeline: Information on the turnaround time for samples is readily available through promotional materials or the IFU. For quantitative sample testing, turnaround times may range from days to weeks.

Case Study Assessments

Organizations of different sizes, resources, and operational workflows may prioritize different factors when selecting an HD wipe sampling vendor. The guidance provided in TABLE 2 establishes a strong foundation for SOP development, which should be followed by the implementation of site-specific details. Consider how the organizational differences in the following two scenarios (Hospitals A and B) can impact SOP development.

Hospital A is a large hospital with an inpatient oncology unit (one medication room), infusion center (10 bays), and high volume of HD utilization with multiple compounding spaces including a central pharmacy containing two HD compounding hoods, and an infusion center containing one HD compounding hood. Hospital A selected Vendor A (see TABLE 1) for the following reasons:

• The ability to customize the number of samples
• The medications available aligned with highest volume of use at Hospital A
• Most cost effective
• User friendly testing process

Conversely, Hospital B is a small rural hospital that does very little HD compounding. Most commonly, Hospital B may make the occasional methotrexate for ectopic pregnancy and only has one HD compounding hood. Hospital B selected Vendor D (see TABLE 1) for the following reasons:

• Small number of samples needed
• The medications available aligned with the highest volume of use at Hospital B
• Reasonable cost for the number of samples needed
• Quick result return time

The organizational differences between Hospital A and B are significant, see TABLE 3 for how these differences present in their SOPs.

Click here to view a larger version of this chart.

Conclusion

Investing in a robust HD wipe sampling program provides a critical layer of safety for effectively protecting healthcare staff that work with HDs. Since USP <800> allows organizations the freedom to tailor program components when establishing SOPs, the organizations should review the key areas where wipe sampling will be conducted, establish a clear remediation protocol, and assess how to use HD wipe sampling to drive quality improvements.

References

1. Risenburg S. Sequential Wipe Testing for Hazardous Drugs: A Quality Improvement Project. Clin J Oncol Nurs. 2023 Jun; 27(3): 267-273.
2. Hansen J, Olsen JH. Cancer morbidity among Danish female pharmacy technicians. Scand J Work Environ Health. 1994 Feb;20(1):22-6. doi 10.5271/sjweh.1433. PMID 8016595.
3. Valanis BG, Vollmer WM, Labuhn KT, Glass AG. Association of antineoplastic drug handling with acute adverse effects in pharmacy personnel. Am J Hosp Pharm. 1993 Mar;50(3):455-62. PMID 8442461.
4. Connor TH, DeBord DG, Pretty JR, et al. Evaluation of antineoplastic drug exposure of health care workers at three university-based US cancer centers. J Occup Environ Med. 2010 Oct;52(10):1019-27. doi 10.1097/JOM.0b013e3181f72b63. PMID 20881620.
5. Sessink PJ, Connor TH, Jorgenson JA, et al. Reduction in surface contamination with antineoplastic drugs in 22 hospital pharmacies in the US following implementation of a closed system drug transfer device. J Oncol Pharm Pract. 2011;17:39–48.
6. Sessink PJ, Trahan J, Coyne JW. Reduction in surface contamination with cyclophosphamide in 30 US hospital pharmacies following implementation of a closed-system drug transfer device. Hosp Pharm. 2013; 48: 204–212.
7. USP General Chapter <800>. Hazardous Drugs – Handling in Healthcare Settings. United States Pharmacopoeia Web Site. www.usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare. January 28, 2023.
8. Wipe Analysis. Pharm Purch Prod. 2024;21(7):S8. www.pppmag.com/article/3292

Alex Hayes-Porter, PharmD, MS, BCPS, is the associate director at Banner Thunderbird Medical Center in Glendale, Arizona. Alex completed her education at the Midwestern University College of Pharmacy–Glendale.

Blake Shay, PharmD, MS, BCPS, is the pharmacy manager at BayCare St. Joseph’s Women’s and Children’s Hospital in Tampa, Florida. Blake attended Mercer University College of Pharmacy and completed a HSPAL residency at The Ohio State University.