For now, Karen Lewis is able to control her myelodysplastic syndrome with periodic transfusions. But even though transfusions have kept the disease in check so far, the 57-year-old Maryland-based pharmacist knows myelodysplastic syndrome is considered a premalignant condition and that in a subgroup of patients, it eventually progresses to acute myeloid leukemia.
Figure. Hospital pha...Image Tools
On the other side of the continent, Sue Crump, another pharmacist, succumbed to pancreatic cancer in September 2009. Crump, who was 55 when she died, had worked at Swedish Medical Center in Seattle—and had hoped to live long enough to see her daughter graduate from college. She didn't. (The two cases presented here are real and have been reported online in Investigate West, http://bit.ly/ar0eaI.)
What both of these pharmacists had in common was a long history of working with chemotherapeutic agents—and the belief that their long exposure to the drugs caused their respective illnesses.
Although many types of health care workers come into contact with chemotherapeutic agents, the two groups who spend the most time with them are undoubtedly pharmacists and oncology nurses, and much still needs to be done to protect them.
NO SHORTAGE OF GUIDELINES
The problem isn't that there's a paucity of recommendations and guidelines on the safe handling of hazardous drugs in the health care setting. The first set of recommendations was published in 1985 by the American Society of Hospital Pharmacists (now the American Society of Health-System Pharmacists) in the American Journal of Hospital Pharmacy. The following year, the Occupational Safety and Health Administration (OSHA) issued its first set of guidelines in the same journal, and others followed.
The most recent addition to the collection was a 2004 alert (http://bit.ly/9iqYrJ) published by the National Institute for Occupational Safety and Health (NIOSH) that makes perhaps the strongest case regarding the dangers associated with these drugs. At the beginning of the document, a prominent and ominous boxed warning states, "Working with or near hazardous drugs in health care settings may cause skin rashes, infertility, miscarriage, birth defects, and possibly leukemia or other cancers." The alert lists steps that health care workers "should take" to protect themselves against exposure, as well as steps for employers to take in order to protect their workers. It also notes that workers who "prepare or administer hazardous drugs or who work in areas where these drugs are used may be exposed to these agents in the air or on work surfaces, contaminated clothing, medical equipment, patient excreta, and other surfaces."
The alert also reaffirms what's already known, namely that for several decades, numerous studies "have associated workplace exposures to hazardous drugs with health effects such as skin rashes and adverse reproductive outcomes (including infertility, spontaneous abortions, and congenital malformations) and possibly leukemia and other cancers."
NIOSH estimates that the number of workers at risk for exposure, which includes not only nurses and pharmacists but physicians, operating room personnel, environmental services workers, employees in research laboratories, veterinarians, and shipping and receiving personnel, may exceed 5.5 million.
So if the data are there and the guidelines exist, what's the problem?
A TIGER WITH NO TEETH
Nurse researcher Marty Polovich, PhD, RN, associate director, Clinical Practice, Duke Oncology Network at Duke University, believes that one of the biggest problems is the lack of documentation requirements. Even though the carcinogenicity of several antineoplastic drugs was established in the 1970s, neither environmental monitoring nor exposure tracking is mandated for health care workers in the United States. For the most part, safety regulations remain voluntary.
"If surveillance isn't mandated," says Polovich, "how do you track exposure? Europe has a much better handle on it."
Some European countries are indeed more aggressive when it comes to requiring facilities to monitor employees working with hazardous drugs. In the Netherlands, for example, according to InvestigateWest (http://bit.ly/a0Bh9M), "workers can choose to be monitored for exposure, and work areas must be tested for contamination." Germany, Austria, and Belgium, according to the article, also have aggressive safety programs to regulate chemotherapy agents, and the United Kingdom and France strictly regulate veterinary practices that use these agents.
The second problem is that compliance with guidelines, if voluntary, will vary. A new study by the Centers for Disease Control and Prevention (CDC) has found that across three large university affiliated cancer centers, only half (56%) of workers exposed to chemotherapy wore gloves.
"I think that's shocking and upsetting," says Melissa A. McDiarmid, MD, MPH, a professor of medicine at the University of Maryland School of Medicine and a study coauthor. "And we're just talking about gloves, not even gowns and eye protection."
The CDC study, which hasn't yet been published, also found evidence of contamination on workplace surfaces. As compared with nursing stations on oncology units, pharmacies had a higher rate of contamination, and traces of a chemotherapeutic agent were found in urine samples of two pharmacists.
What's known as the climate of safety—how seriously employees perceive the issue is taken at their institution—varies across health systems, explains Polovich, who is a member of the NIOSH Hazardous Drug Working Group. In her own study, which was presented this year at the Oncology Nursing Society 35th Annual Congress, Polovich identified several predictors of greater use of precautions: fewer patients per day, fewer barriers to the use of precautions, and a better climate of safety at the institution.
The relationship between a higher number of patients per day and the lower use of precautions is particularly important in outpatient settings, she says, where the patient volume can be very high.
Some nurses in the study reported that gowns weren't available and that there wasn't support or encouragement in their workplace for using precautions. Polovich says that more than 90% of facilities have written policies, but they vary tremendously. "Some policies had requirements for how to mix chemotherapy or what was required for administration, but not all had strict policies on disposal. And only 20% had any provision for medical surveillance, which is part of the OSHA recommendation. And in many policies, gowns were optional."
Misconceptions despite improvements. "Things are definitely better than when I was in school 30 years ago," says McDiarmid. "The biggest change is that the use of biologic safety cabinets is now standard."
But although there have been improvements in safety, McDiarmid says that people believe the problem has been solved by a hood or because they usually wear gloves.
"There is a misconception among the public that if something is a guideline rather than a standard—if it's voluntary rather than the law—the science isn't good enough to make it a law, and that's just wrong," says McDiarmid. "These are acutely toxic drugs."
NURSES MUST MAKE THEMSELVES HEARD
Nurses can make a difference in mandating standards and surveillance, says McDiarmid. "I think nursing is in a good position to help us get some regulatory teeth into the guidelines," she says. "If nurses go knocking on their representatives' doors and ask OSHA for protection, they're more likely to effect change than any journal article is."
One group of nurses has already shown that advocacy can make a difference. In 1991 Sally Giles, RN, an ED nurse working in rural British Columbia, Canada, was diagnosed with cancer of the bile duct. Her job required mixing and administering cytotoxic chemotherapeutic agents, but there were no policies in place governing their use, and no training had been provided. (Read the whole story at http://bit.ly/coYVXB.) She died eight months after her diagnosis, and British Columbia's workers' compensation board, WorkSafeBC, denied her family's claim for compensation.
Her death, however, became the rallying cry of the British Columbia Nurses' Union, which demanded changes to regulations and increases in protection for nurses working with antineoplastic drugs. The union's efforts led to the establishment of extensive regulations governing the use of cytotoxic agents, including monthly inspections to ensure that guidelines are being followed and equipment is in proper working order.
"I think this should be on people's radar," says McDiarmid. "I can't think of another group of workers in the United States that handles human carcinogens with protections that are only voluntary. We need a voice clamoring for change, and that voice needs to come from the workers most affected. The nurses and the pharmacists need to ask for it."—Roxanne Nelson, BSN, RN
© 2010 Lippincott Williams & Wilkins, Inc.