Reproductive dangers linked to HCW exposure to antineoplastics
Researcher calls for better HCW protections
Female nurses and pharmacists who handle antineoplastic agents may risk infertility if they fail to protect themselves from exposure, according to new research.1
The finding fills a gap in medical research concerning occupational exposure to antineoplastic drugs, which has focused on two reproductive risks: spontaneous abortion and congenital malformation. Antineoplastics, which are used in cancer therapy, have been identified as a cause of infertility in patients, but the association with infertility among health care workers who are occupationally exposed had not been explored.
Data for the case-control study were gathered by questionnaires from 4,082 pharmacists, pharmacy technicians, nurses, and nurses' aides at more than 200 health care facilities. Infertility was assessed by answers to the following question: "Has there ever been a time when you tried for at least two years to have children and were unable to do so?" Of the total respondents, 405 answered yes and were considered as case subjects. Another 2,814 answering no served as control subjects. The remainder indicated they had never tried to have children and were excluded. Case subjects were matched with controls by sex and age.
Results for the total sample and for women showed a significantly elevated odds ratio for self-reported infertility associated with occupational handling of antineoplastic drugs prior to onset of infertility. For men, the odds ratio was not statistically significant.
In 1995, the U.S. Occupational Safety and Health Administration issued guidelines for controlling exposure to hazardous drugs, including antineoplastic agents.2 (See Hospital Employee Health, June 1995, pp. 76-79.) OSHA guidelines call for health care facilities to develop antineoplastic drug-handling policies for employees who are pregnant or trying to become pregnant. However, OSHA does not prescribe what those policies should be, nor does the agency require hospitals to prevent those workers from handling antineoplastics.
Angela Presson, MD, MPH, medical officer in OSHA's office of occupational medicine, says the hazards of handling antineoplastics "need to be discussed" with susceptible employees, but that the agency maintains only that a policy should be developed and followed. (See HEH, April 1994, pp. 41-44.)
However, "as an occupational medicine physician, I would say that if at all possible, I would certainly want to see a pregnant worker or someone trying to become pregnant avoid handling these agents," Presson tells HEH. "Institutions need to consider all the data regarding adverse outcomes in pregnancy and develop an appropriate policy based on available information."
Presson says it is "not surprising" that infertility has been linked to antineoplastic drug-handling. Some of the drugs have antifolate activity, "and it is now recommended that pregnant women take folates, so it only makes sense that antifolates might not be good for pregnant women."
In addition, many times the same substances that cause spontaneous abortion also cause infertility. "It just happens at another stage," she says.
But study researchers hope evidence of a connection between occupational exposure to antineoplastics and infertility might prompt OSHA to make a stronger statement about the need for susceptible employees to avoid handling those drugs.
"OSHA has not been able to make the guidelines mandatory or insist that it be hospital policy because there has not been enough research yet to convince them to do it," says researcher Karen Labuhn, PhD, RN, associate professor at Wayne State University College of Nursing in Detroit. "We hope that with the evidence we're publishing now, they'll be able to take a stronger stand, or that institutions will at least be willing to take a stronger stand. That's our thesis: It would seem to be most reasonable for it to be a hospital policy for pregnant women or women considering pregnancy to avoid handling these drugs. We want to warn people that this could be a problem."
Merely discussing the issues with employees individually is not enough, Labuhn says.
"We know that some hospitals are a lot more rigorous than others in terms of providing educational programs for nurses and doing good monitoring of compliance. This is a case where they really need to adhere to standards," she adds.
Hospitals must establish strong protective policies for HCWs who handle antineoplastic drugs and let employees know they will be monitored for compliance, she says.
In general, hospital pharmacists who mix the drugs are more knowledgeable about and compliant with OSHA guidelines for safe handling of antineoplastics than nurses, she says.
"The level of awareness and understanding of their own personal risks and being willing to go along with guidelines is probably less for nurses," Labuhn says, "even though they're more at risk in the sense that some of them both mix and administer, so they have multiple exposures."
Pharmacists follow guidelines for mixing antineoplastics under a biosafety cabinet, while nurses who mix the drugs on patient floors might not have access to that equipment. Also, nurses who administer the drugs can be exposed during that process if intravenous tubing comes loose, as well as through patients' sweat and other excreta.
While nurses probably would wear gloves during the process, they often fail to don other recommended personal protection such as masks or gowns, Labuhn observes.
Nurses show aversion to masks, gowns
"A lot of the nurses in our study were reluctant to do that," she says. "They tend to use gloves and think they're not going to be there very long. [Putting on personal protective wear] takes time, and nurses are always under time pressure. They also say they're concerned that patients would feel awkward if nurses were all bundled up in isolation-type garments."
Nurses are not concerned "nearly enough" and are not knowledgeable enough about the amount of exposure they get with skin contact, Labuhn adds. "Even those who are aware they're getting skin contamination do not have a high enough level of awareness about the implications of that. They must be willing to do what they need to do to protect themselves. Knowledge alone is not enough."
Linda Worrall, RN, director of the education/ cancer care issues team for the Pittsburgh-based Oncology Nursing Society, agrees that nurses must protect themselves properly when mixing or administering antineoplastic drugs.
While pharmacists usually mix the drugs, in some hospitals nurses perform the task, as well.
"When you mix antineoplastics, you should be doing so in a hood," says Worrall. "If you're wearing the proper safety equipment when administering the drugs - that is, gloves, gowns, and sometimes a mask - there really is not a problem. For nurses who don't wear, or are unaware of the need to wear, safety equipment, exposure hazards are an issue. We recommend that any nurses who are going to administer chemotherapy learn the safety related to administering that medication, and that would include safe handling and safety related to mixing that medication."
Worrall says pharmacists began to take over mixing tasks from nurses in many institutions in the last decade because it was easier to have safety cabinets in the hospital pharmacy instead of on every unit where chemotherapy was administered. For that reason, the American Society of Health System Pharmacists (ASHP) in Bethesda, MD, established recommendations for handling antineoplastics in 1990,3 a document that nurses also can use for guidance.
ASHP spokeswoman Julie Webb, RPh, says the organization created "stringent" guidelines to protect pharmacists from occupational exposure. (See HEH, April 1994, pp. 44-46.)
"Certainly the safe handling of [antineoplastic] drugs by health care personnel is pretty important. The effect of all of these products on health care workers is still pretty unclear, but this set of guidelines helps decrease the risk."
References
1. Valanis B, Vollmer W, Labuhn K, et al. Occupational exposure to antineoplastic agents and self-reported infertility among nurses and pharmacists. J Occ Environ Med 1997; 39:574-580.
2. U.S. Department of Labor, Occupational Safety and Health Administration. Controlling occupational exposure to hazardous drugs. OSHA Technical Manual (Section V, Chapter 3). Washington, DC: OSHA; 1995.
3. American Society of Hospital Pharmacists. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm 1990; 47:1,033-1,049.
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