An abundance of studies have been published over the last 40 years providing clear evidence of the harm caused by occupational exposure to hazardous medications, raising concerns over employee safety (see SIDEBAR). In response, national organizations have released guidelines and standards for safe hazardous drug (HD) handling,1-6 and many of these standards have been adopted by enforcement agencies across the country. Given the unequivocal danger of HD exposure, hospitals where HDs are used must establish a robust strategy to safely handle HDs from the moment they enter the facility until they are wasted. However, with the breadth of new regulatory requirements, many organizations have yet to finalize a comprehensive plan to reduce the dangers of HD handling. Nonetheless, it is critical that organizations implement programs to ensure their hazardous handling initiatives are preventing exposure as intended.
HD wipe sampling, which is used to detect workplace contamination in health care settings where antineoplastic and other HDs are prepared and administered, helps quantify the effects of improved work practices and identify the need for effective engineering controls and personal protective equipment (PPE). Although wipe sampling is the most appropriate methodology available to evaluate workers’ potential exposure to HDs,3,7-11 many organizations have yet to implement wipe sampling into their quality assurance (QA) programs.
HD Handling Requirements and Recommendations
United States Pharmacopeial Convention (USP) General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings states that a comprehensive HD management program must include an HD list, facility and engineering controls, competent personnel, safe work practices, proper use of PPE, and policies for HD waste segregation and disposal.6 While these elements are essential, a robust HD management program should be supported by another critical component: a method to validate that these practices are preventing HD contamination and occupational exposure.
The American Society of Health-System Pharmacist (ASHP) Guidelines on Handling Hazardous Drugs state that the HD handling process should be validated by surface wipe sampling.3 The guidelines also state that surface wipe sampling is currently the method of choice to determine surface contamination of HDs in the workplace.3 Although USP <800> does not require wipe sampling, the chapter states that it should be routinely performed at least every 6 months.6 This suggested frequency is unchanged from previous USP <797> recommendations.12
If wipe sampling detects contamination, the organization’s designated HD person should identify, document, and contain the cause of contamination. This process may involve reevaluating work practices; providing additional training and education to staff; thoroughly deactivating, decontaminating, and cleaning; and improving engineering controls. Thereafter, repeat wipe sampling to validate that these efforts have proven successful.6
Dermal absorption is the most prevalent route of occupational HD exposure.7 OSHA states that this route of exposure is more critical than inhalation, especially for non-volatile hazardous chemicals, which remain on work surfaces for long periods and may not be noticed by employees.13
Work surface contamination is often attributed to procedure failures relating to work practices, equipment handling, engineering controls, cleaning methods, and drug disposal.13 Surface sampling helps illuminate the efficacy of a facility’s cleaning program. Although not a direct measurement of exposure, hazardous wipe sampling can provide critical information regarding unnoticed contamination of work surfaces that may lead to dermal uptake.
Facilities that have been slow to adopt wipe sampling into their QA programs historically cited the following as reasons for their lack of implementation: the absence of regulatory requirements, the cost of sampling, and the limited number of available marker agents to assess various surface contaminants.
Prior to 2015, a facility could only test for a limited number of marker chemotherapy agents. This challenged those facilities with a low compounding volume that did not compound the HDs most commonly available for wipe sampling analysis. Once the less commonly available markers became available, the cost of testing could be significant, due to the limited number of sites capable of evaluating the samples. Finally, pharmacies may have limited in-house expertise to interpret the results.
To overcome these challenges, a facility must first commit to enhancing its QA program beyond what is required by USP <800>. Protecting staff from HD exposure is a critical element of a comprehensive HD safety program, and as such, should not be ignored. Once administration has a clear understanding of the importance of HD wipe sampling, gaining financial resources can be justified. If financial considerations play a significant role in the decision, a facility can limit sampling by rotating remnant assays, rather than evaluating a large amount with each analysis.
Integrating wipe sampling provides quantitative measurements to reduce occupational exposure to HDs. In addition, wipe sampling results can help support the need to reevaluate practice, incorporate new devices or products, and help gain buy-in from administration to implement these changes. Although USP <800> recommends but does not require wipe sampling, organizations would do well to implement this critical safety measure as part of their commitment to valuing a culture of safety.
To read about Sentara Healthcare’s efforts implementing HD wipe sampling, see the CASE STUDY below.
Jamin Engel, PharmD, MBA, is the pharmacy manager at Sentara RMH Medical Center in Harrisonburg, Virginia. He received a Doctor of Pharmacy degree from VCU School of Pharmacy in 2008, and an MBA from James Madison University in 2013. Jamin serves as a system expert for sterile compounding within Sentara, and has experience serving on regulatory committees focused on sterile compounding. He has additional experience in evaluating CSTDs, inspecting 503B facilities, and implementing measures for USP compliance.
The Dangers of HD Exposure
Employee exposure to HD residue has been documented since 1979, when the Lancet published the first evidence of occupational exposure to hazardous medications.1 That article identified chemotherapy in the urine of nurses administering HDs. HD residue has been found on work surfaces inside pharmacies and in medication administration areas, including on the vials used for admixing.2,3 In particular, one study in six large cancer centers found that there was up to a 75% contamination rate on surfaces sampled.4
Although HD handling practices and guidelines have evolved over time, recent studies illustrate that health care worker exposure to
hazardous medications continues to occur. More than 30 years after the initial Lancet publication, another study identified detectable levels of cyclophosphamide in the urine of health care workers.5
Occupational exposure to hazardous medications causes dangerous
health effects and potentially impacts a significant number of people.
According to the CDC, approximately 8 million US health care workers may be exposed to HDs, including pharmacists, technicians, nurses, physicians, operating room personnel, environmental services workers, workers in research laboratories, veterinary care workers, and shipping and receiving personnel.6 Exposure to HDs can cause acute and chronic health effects, such as skin rashes, adverse reproductive outcomes (including infertility, spontaneous abortions, and congenital malformations), and possibly leukemia and other cancers.6
By Jamin C. Engel, PharmD, MBA
Sentara Healthcare’s HD Wipe Sampling Program
Sentara Healthcare is an integrated health system comprising 12 hospitals and over 300 sites of care throughout Virginia and North Carolina. The pharmacy at Sentara RMH Medical Center, a 238-bed community hospital and regional cancer center in Harrisonburg, Virginia, has been conducting biannual hazardous wipe sampling analysis since 2014. The purpose of implementing hazardous wipe sampling was to determine the efficacy of our HD handling practices.
Focusing on the recent updates to the NIOSH Alert: Preventing
Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings,1 we conducted a gap analysis of our hazardous handling program, which spanned processes, equipment, and PPE. The gap analysis identified several opportunities for improvement, including ensuring that staff handling HDs who are not involved in the compounding process wear appropriate PPE. Best practices for reducing opportunities for hazardous contamination within engineering controls were identified, including establishing maximum fill volumes on syringes and implementing needless-access devices. Finally, we analyzed material handling to ensure appropriate HD decontamination and disposal.
Hazardous wipe sampling is a logical starting point from which to understand the opportunities for improvement identified in the gap analysis. Just as pharmacy leverages viable air and surface sampling to reduce the risk of contamination within sterile compounding areas, it is important to recognize that wipe sampling serves an equally critical role in the pharmacy. We rely on viable surface sampling to evaluate the effectiveness of our cleaning processes, and hazardous wipe sampling also serves to evaluate both proper dwell time as well as the sequence of deactivation and decontamination. When contamination is found, identifying the specific location of the positive sample and involving compounding personnel in this process are essential to determine the root cause of the contamination. The benefit of a wipe sampling program is that it flips often-unrecognized surface contamination into a known and measurable entity, thus enabling staff to invest in changing processes to reduce contamination.
The initial design for the wipe sampling program was based on USP <797> recommendations for testing frequency, sampling locations, and interpretation of results. The chapter states that sampling should be conducted initially as a benchmark, and at least every 6 months thereafter to verify containment.2 Thus, we employed the services of a sterile compounding certification company, which conducts sampling at Sentara RMH Medical Center every 6 months.
The recommended locations for testing were identified as the work area within the primary engineering control (PEC), the countertops adjacent to the PEC, and the floor below the work area. The chapter also indicates that the treatment area should be sampled, but since USP <797> does not provide standards through drug administration, that area is not included in our wipe sampling program. However, the wipe sampling language in USP <800> is similar to the language in <797>, and provides standards to implement throughout drug administration3; therefore, we are considering future sampling of the drug administration areas.
USP <797> names common marker HDs that can be assayed: cyclophosphamide, ifosfamide, methotrexate, and fluorouracil.2 Our initial testing included only these four HDs, as they are common medications admixed in the infusion center. As the availability of assays for hazardous medications has increased over time, the wipe sampling program has evolved. Assays are rotated every 6 months based on which high-usage HDs are admixed, to ensure we are assessing commonly used medications and expanding the scope of our sampling program.
According to USP standards, any measurable contamination identified should be considered an actionable level.2,3 Often, depending on the laboratory conducting the analysis, a detectable limit is placed on the sample being assayed. The sampling program is designed so that if a detectable limit is reached, it requires evaluation and response. Many organizations use this detectable limit as the definition of “actionable level,” as standards have yet to be developed. USP <797> recommendations for interpreting results are built into our QA program.
Our wipe sampling program has identified opportunities for process changes that have been validated as effective through subsequent wipe sampling:
Perhaps the most significant benefit of wipe sampling is that it provides transparency into the success of an organization’s HD cleaning processes and facilitates improvements. In our experience, the costs associated with sampling have been offset by the quantitative measures we have taken in response to wipe results, which have proven to reduce occupational exposure. Looking to the future, the number of organizations within Sentara Healthcare conducting wipe sampling is expected to increase. Because the health system assigns significant value to continuous improvement, we plan to expand wipe testing into the medication administration areas. In addition, wipe sampling will expand to include all infusion centers throughout the health system.
Case Study References
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