San Antonio, TX—Oncology nurses may believe that personal exposure to hazardous drugs is a thing of the past, but they would be wrong, according to Seth Eisenberg, RN, ASN, OCN, BMTCN, Professional Practice Coordinator for Infusion Services, Seattle Cancer Care Alliance Ambulatory Clinic, and an expert on hazardous drugs and their safe handling, who discussed the topic at the 2016 Oncology Nursing Society Annual Congress.
“Some nurses think we don’t have problems anymore, that those occurred only in the ’80s and ’90s, but that’s not the case,” Mr Eisenberg said.
A turning point in drug safety occurred in 1986, when the Occupational Safety and Health Administration issued its first guidelines for the safe handling of antineoplastic agents. This was followed in 2004 with guidelines issued by the National Institute for Occupational Safety and Health (NIOSH).1 NIOSH is currently updating those guidelines; meanwhile, another organization, the US Pharmacopeial (USP) Convention,2 has set standards that will be more enforceable and therefore more “groundbreaking” than those of the Occupational Safety and Health Administration or NIOSH, Mr Eisenberg said.
The risks associated with some antineoplastic agents are well-known: adverse reproductive outcomes (spontaneous abortion and infertility), acute effects (nausea, vomiting, rash, diarrhea), and carcinogenicity (chromosomal changes).
Cyclophosphamide Exposure Still Common
Despite having guidelines for safe handling, 4 recent studies underscore the ongoing problem of exposure to hazardous drugs in oncology.3-7
Between 2013 and 2015, a team of researchers at the University of British Columbia studied cyclophosphamide contamination and made rather alarming findings. In their first study, the researchers wipe-tested 438 surfaces in the pharmacy and chemotherapy administration areas of 6 hospitals and found 36% of samples to be above the level of detection.3,4 Cyclophosphamide was found on carts, computer mice, pens, printers, and elevator buttons.
“If we looked at these drugs as bags of Ebola, we might think about how we should handle them [the drugs] differently,” Mr Eisenberg commented.
In 2014, the same researchers took 225 hand-wipe samples from 110 nurses, pharmacy workers, transport workers, oncologists, dietitians, ward aides, and volunteers at the same 6 hospitals and found 20% of the samples to be above the limit of detection for cyclophosphamide.5 The highest level of contamination was among those who are not nurses, particularly volunteers, oncologists, ward aides, and dietitians (who do not wear gloves or wash their hands often). For nurses, hand washing was not correlated with lower levels.
In their 2015 study of urine samples from 103 individuals, 55% tested above the limit of detection for cyclophosphamide.6 Again, the highest concentrations were found in unit clerks and other staff who were not preparing or administering the drug, and there was no correlation between cyclophosphamide levels and known contact with the drug.
Finally, another Canadian research team made a similar observation in a study of 584 wipe-tested samples, of which 50% were positive for cyclophosphamide, 21% for ifosfamide, and 9% for methotrexate.7 Contamination was found in pharmacy and patient care areas, including on the counters.
“How many times in our jobs are we not wearing gloves or personal protective equipment [PPE] because we are just at the computer? Indeed, we still have problems,” Mr Eisenberg emphasized.
Nurses can do more to protect themselves, he added. A survey by NIOSH of 1954 healthcare professionals (most classified as oncology nurses, hematology/oncology nurses, or infusion/intravenous [IV] therapy nurses) found that 61% touched IV pumps or bed controls while wearing chemotherapy gloves, and 20% touched doorknobs and cabinets; only 20% always double-gloved; only 58% always wore recommended gowns; and while 12% reported a spill within the past week, 9% reported not always cleaning up these spills.8
According to the “hierarchy of controls” against exposure, “elimination or substitution” of a hazardous drug is the most effective means of protection. The fact that methotrexate has remained in use since 1948 indicates that “this is not the answer,” Mr Eisenberg commented, adding that engineering and administrative controls also fail. “The current thinking is we need to prevent the drug from getting out of the bag or tubing.”
Audience Survey and Current Recommendations
Via an audience response system, session attendees described their own approaches to safe drug handling with their responses to the following questions:
- How often do you wear PPE when hanging IV chemotherapy? Every time (71%), most of the time (23%), never (5%)
- Why do you not wear PPE every time? Not conveniently located (40%), too uncomfortable (31%), not provided by employer (17%), wrong sizes of gloves and/or gowns (5%), do not believe it is needed (7%)
- For those who wear PPE, do you wear double gloves? Yes (50%), no (50%)
The current NIOSH recommendations are to double-glove with certified, chemotherapy-resistant gloves (not 2 pairs of regular exam gloves), to wear certified, chemotherapy-resistant gowns as single use, to use closed-system transfer devices for compounding and administration, to crush or cut oral hazardous drugs inside of a biologic safety cabinet, to spike IV bags with neutral solution, to have spill kits available, and to ensure all personnel are trained in hazardous drug handling.1
Unfortunately, NIOSH lacks the ability to enforce these guidelines, and the Occupational Safety and Health Administration lacks the resources to do so, Mr Eisenberg indicated.
The USP 800 Standard Is Good News
Enforcement of safe handling guidelines is expected to come from the USP, a pharmacy-based quality organization. The organization recently issued standards “that will change the lives of oncology nurses from here on out,” according to Mr Eisenberg.
The USP Chapter 800 (USP 800) sets standards for hazardous drug handling, from delivery to disposal.2 It is enforceable by each state’s Board of Pharmacy or designated agency, and will be tied to the Centers for Medicare & Medicaid Services and reimbursement.
“The implications of USP 800 are huge,” he noted. “For the first time in the history of nursing, we have a pharmacy-based organization dictating practice to us, and it is good news. They will make sure that nurses adhere to guidelines. It’s totally enforceable, and it’s groundbreaking.”
The USP 800 standard will require chemotherapy-tested double-gloves, chemotherapy-resistant gowns, spill training, appropriate respiratory protection for drugs that vaporize at room temperature (eg, etoposide, carmustine, cyclophosphamide, thiotepa, nitrogen mustard, fluorouracil, cisplatin, and ifosfamide), and use of closed-system transfer devices.
Safety Starts with You
AnnMarie Walton, PhD, MPH, RN, OCN, CHES, a postdoctoral fellow at the University of North Carolina at Chapel Hill School of Nursing, spoke about her journey to advocate for safe drug-handling laws in North Carolina. She learned, along the way, that awareness and acceptance is not a given, even among nurses themselves.
While spearheading an effort for safer drug handling within her hospital, she sometimes sensed resistance. Nurses would comment, “Why does this apply to me? I’m going to die of something,” or “I’m past my baby-making years,” or “I’ve been hanging chemo for 30 years and nothing’s happened yet.”
“To those folks you have to start talking about the culture of safety,” Dr Walton said. They need to hear, “You will touch a button and expose others. If you don’t think about yourself, think of your colleagues.”
A Lesson Learned the Hard Way
The lesson was a hard one learned by Rosaleen Bloom, MS, ACNS-B, AOCNS, a clinical nurse specialist in oncology in Milwaukee, WI, who stood up to share her personal story “so you will know how important safe handling is.”
“As a young nurse I gave a lot of chemo, and one day I spilled Cytoxan on my arm. I washed it off, didn’t report it, and didn’t think about it,” she said. “Eventually I became a clinical nurse specialist, and safe handling became a super priority for me. A few years later I was diagnosed with infertility.”
The underlying cause was never clear, but 2 assisted reproduction specialists agreed, telling her, “You’ve been a cancer nurse. That’s probably why.”
“I don’t doubt that even on days when I was safe-handling, I touched things all over that unit. It can happen,” Ms Bloom said.
Happily, she is now the mother of a young son, she added, “but I had to go through a lot that I shouldn’t have had to.”
1. National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, US Department of Health and Human Services. NIOSH alert: preventing occupational exposures to antineoplastic and other hazardous drugs in health care settings. September 2004. www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf. Accessed September 14, 2016.
2. US Pharmacopeial Convention. General chapter <800> hazardous drugs—handling in healthcare settings. Updated December 1, 2014. www.usp.org/sites/default/files/usp_pdf/EN/m7808_pre-post.pdf. Accessed September 14, 2016.
3. Hon CY, Chua PP, Danyluk Q, Astrakianakis G. Examining factors that influence the effectiveness of cleaning antineoplastic drugs from drug preparation surfaces: a pilot study. J Oncol Pharm Pract. 2014;20:210-216.
4. Hon CY, Teschke K, Chu W, et al. Antineoplastic drug contamination of surfaces throughout the hospital medication system in Canadian hospitals. J Occup Environ Hyg. 2013;10:374-383.
5. Hon CY, Teschke K, Demers PA, Venners S. Antineoplastic drug contamination on the hands of employees working throughout the hospital medication system. Ann Occup Hyg. 2014;58:761-770.
6. Hon CY, Teschke K, Shen H, et al. Antineoplastic drug contamination in the urine of Canadian healthcare workers. Int Arch Occup Environ Health. 2015;88:933-941.
7. Janes A, Tanguay C, Caron NJ, Bussières JF. Environmental contamination with cyclophosphamide, ifosfamide, and methotrexate: a study of 51 Canadian centres. Can J Hosp Pharm. 2015;68:279-289.
8. Boiano JM, Steege AL, Sweeney MH. Adherence to safe handling guidelines by health care workers who administer antineoplastic drugs. J Occup Environ Hyg. 2014;11:728-740.