Occupational exposure to hazardous drugs remains a serious risk to health care personnel, with potential exposure occurring at numerous points of hazardous drug handling from receiving the manufacturer’s vials at the loading dock through disposal of the corresponding waste.1-3 Formal wipe analysis has revealed that hazardous drug residue occurs throughout hospitals, including in areas outside of the pharmacy and oncology units.4 Given this risk, facilities handling hazardous drugs should consider establishing a formal wipe analysis plan to identify potential environmental residues and prevent health care worker exposure.
The National Institute for Occupational Safety and Health (NIOSH) Alert,Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings, recommends conducting environmental sampling and/or biological monitoring when exposure is suspected or symptoms have been noted.5 Preemptive environmental monitoring, however, can identify potential staff exposure risks prior to any concerns arising. At the time of publication of the NIOSH Alert (2004), there were few commercial options for hospitals to conduct environmental sampling. As a result, for some hospitals this monitoring did not become typical practice. Since the NIOSH publication, multiple environmental hygienist companies have introduced environmental sampling kits for hazardous drugs, making it straightforward for hospital pharmacies to adopt this practice (see Table 1).
It may be prudent for clinicians to partner with a vendor noted in the primary literature as having expertise and experience measuring hazardous drug residues in specific settings for sampling. While there are no standards defining which drugs to test for, the number of samples to collect, or the locations of sampling, there are many helpful investigative publications that can assist clinicians with making these decisions.6 Working closely with an experienced environmental sampling partner will help ensure health care workers are protected from the harmful effects of hazardous drug exposure, and developing a robust wipe analysis procedure will assist in identifying areas of potential contamination.
Establish Sampling Locations
Be sure to choose a vendor whose offerings match the needs of your practice. Once a vendor has been selected, the next step is to define the specific hazardous drug residues that will be tested for and determine the sampling locations. These are important considerations, as testing costs are determined by the number of drugs tested and the number of sampling locations specified. When evaluating which drugs to test for, consider the site’s compounding history, with the most frequently compounded drugs serving as representative agents. Sampling is not universally available for every hazardous drug, and each vendor tests for different drugs. To determine the number of sample locations, consider historical practice at the site, previous spills, and areas of high contact with hazardous drug products. It may be particularly advantageous to map out the hazardous product flow from receiving to disposal (see Figure 1). Sample locations should include areas noted to have the highest chance of residue as identified in the literature.6 These locations may include:
Testing Kit Contents
The vendor will provide a kit customized to their testing standards and available assays for drugs; the contents of these kits will vary (see wipe analysis step Photos). However, most of the kits are similar in nature and may include the following basic items:
Wipe Analysis Procedures
It is important to note that the process of collecting hazardous drug surface samples should be considered high risk, and every precaution recommended by NIOSH for compounding should be employed for sampling as well. Prior to beginning the sampling process, read the vendor’s instruction sheet, paying particular attention to the sections on the collection to shipping time, interim storage prior to shipping, and shipping requirements. Some vendors require samples to be shipped on dry ice. However, the vendor may not provide the dry ice or the dry ice shipping containers, in which case these items should be acquired prior to sampling. As a general rule, plan to use one pound of dry ice for every six samples. Because some vendors may not provide shipping containers, ensure the proper container is on site prior to collecting.
Although the process for collecting samples varies among the different vendors, the basic steps are similar.
Wipe Analysis Reports
Each vendor provides a basic report listing the collection locations and any residue of the sampled drug identified in a quantity of residue per quantity area (see Table 2). As previously noted, there is no standard reporting metric for quantifying hazardous drug residue, and result reports differ by vendor; however, each report identifies existing residue and its concentration. The goal of testing is to not find residue; however, there are many opportunities for residue to contaminate an area beyond the compounding and drug administration process.7
Some vendors provide a comparative analysis to similar facilities at an additional cost. Remember that these comparisons do not correlate to best practices; they only relate to the moment in time that each site conducted the sampling. These types of reports should not be used to measure the effectiveness of a site’s hazardous drug program against other facilities; rather, they are best used for internal benchmarking until national standards are established by a reputable, non-profit organization. The data from these reports provides valuable information to practitioners regarding hazardous drug residue. Unlike in the radiology department, where personal dosimeters and Geiger counters provide practitioners with immediate, continuous data on radiation exposure, hazardous drug sampling does not provide immediate results. In addition, because the reports only provide a snapshot in time within the hazardous drug flow process, they should not be construed as defining practices at a site. Information garnered from sampling should be used by sites to denote gaps and improve processes.
Given the serious consequences of occupational exposure to hazardous drugs, establishing a formal wipe analysis program for hazardous drug residue gives pharmacy leadership the opportunity to identify specific risks throughout their facilities, and in response, develop practices to continually avert these risks. Since numerous vendors now offer wipe analysis kits, establishing such a program can be simple; however, it is important to note that sampling for hazardous drug residue itself is a hazardous process, and the same precautions used for drug compounding and administration should be heeded during the sampling process. This approach will add an additional layer of safety to sterile compounding, thus allowing pharmacy to assert control over what has traditionally been a nebulous area to manage.
Firouzan “Fred” Massoomi, PharmD, FASHP, received his doctorate from the University of Kansas School of Pharmacy and is the pharmacy operations coordinator at the Nebraska Methodist Hospital in Omaha.
Kelly L. Knolla, PharmD, is a clinical pharmacist at Penrose Hospital in Colorado Springs, Colorado.
Enter our Sweepstakes now for your chance to win the following prizes:
Just answer the following quick question for your chance to win:
Entries are limited to one entry per person in any active sweepstakes.
Thank you for your entry.