NIOSH Medical Surveillance Recommendation On Hazardous Drugs May Prompt State Rule

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A Nov. 19 recommendation by the National Institute for Occupational Safety and Health on medical surveillance for workers exposed to hazardous drugs could lead to Washington becoming the first state to require such surveillance programs.

Washington had been waiting for an update from NIOSH before deciding whether to include surveillance in its hazardous drug rule.

Washington's Department of Labor & Industries established regulations, scheduled to begin taking effect in January 2014, to protect workers who handle chemotherapy drugs and other hazardous medications. Medical surveillance was addressed in the proposed rule, but the provision was removed from the final rule.

“This was done because NIOSH is currently updating medical surveillance guidelines,” L&I explained on its website. The state's Department of Occupational Safety and Health “will review the updated guidelines and determine at that time what requirements, if any, should be added to the rule regarding medical surveillance.”

NIOSH is recommending that employers conduct medical surveillance as part of a comprehensive safety program on hazardous drugs that also includes exposure prevention, good work practices, personal protective equipment, and training. The Nov. 19 document recommends baseline testing but does not call for routine laboratory tests.

Eight Million Exposed

NIOSH estimates that 8 million health care workers nationwide are potentially exposed to hazardous drugs. The Occupational Safety and Health Administration has rules for reporting exposure to hazardous medications (29 C.F.R. 1910.1020) and communicating the hazards of drugs and pharmaceuticals in the non-manufacturing sector (29 C.F.R. 1910.1200), but OSHA has no requirements for medical surveillance as it does for other substances, like benzene (29 C.F.R. 1910.1028 Appendix C) and inorganic arsenic (29 C.F.R. 1910.1018 Appendix C).

Washington's state legislature passed legislation(S.B. 5594) in 2011, directing L&I to set requirements to protect workers exposed to hazardous drugs. The bill called for rules consistent with NIOSH's 2004 alert on hazardous drugs in health care settings. The rule directs employers to develop and implement a written hazardous drug control program, train employees, and install ventilated cabinets for the drugs (41 OSHR 324, 4/14/11).

But it may be months before the state decides how to respond to NIOSH's medical surveillance recommendation, L&I spokeswoman Renee Guillierie told BNA Nov. 26.

NIOSH's 2004 alert was the first in a series of publications urging medical surveillance programs for health care workers exposed to hazardous drugs, Thomas H. Connor, a NIOSH research biologist, told BNA Nov. 26. Connor co-authored the 2004 alert, as well as publications in 2007 and 2012 recommending medical surveillance.

Aging Population, Increased Exposure

“Part of the reason we're doing all this work in general is the population is aging and more people are being treated with drugs, particularly anti-cancer drugs,” said Connor, who is also studying hazardous drugs as they relate to personal protective equipment and operating room personnel. “The potential for worker exposure is increasing proportionally to that aging population.”

Connor said the major change between NIOSH's 2007 and 2012 publications was dropping the recommendation of routine periodic laboratory testing on exposed workers, pointing to evidence that it is not very valuable. But NIOSH still advocates initial baseline evaluations that include laboratory testing, he added.

In addition to baseline clinical evaluations, NIOSH recommends that medical surveillance programs feature periodic reproductive and general health questionnaires, worker histories of drug handling, and follow-up plans for workers who show health changes suggesting toxicity or have had acute exposure to a hazardous drug.

Fighting a Misconception

Melissa McDiarmid, director of the University of Maryland Medical Center's Occupational/Environmental Medicine Program and a co-author of NIOSH's medical surveillance publications, said the institute put out its most recent publication partly in response to the misconception that medical surveillance is no longer necessary.

“A lot of people think we fixed this, but we didn't,” McDiarmid told BNA Nov. 26. She said the latest NIOSH publication cites research suggesting surveillance is still needed, such as a study finding that pregnant nurses exposed to anti-neoplasitc agents have a twofold risk of spontaneous abortions.

NIOSH does not keep statistics on the prevalence of medical surveillance programs for workers exposed to hazardous drugs, nor do groups such as the American Public Health Association, Public Safety Council, American Hospital Association, and American Medical Association.

But based on anecdotal evidence, the availability of medical surveillance was greater 15 years ago than it is now, said Martha Polovich, director of Duke Oncology Network's clinical practice and a NIOSH co-author. She estimated about three in 10 nurses involved in chemotherapy are in medical surveillance programs.

“Many [employers] that might have had programs in the past stopped because they weren't finding any health changes,” Polovich told BNA Nov. 26.

Primacy of Standards

David Marder, director of University Health Services at the University of Illinois, told BNA Nov. 26 that the university's Occupational Health Service Institute does medical surveillance for health care workers exposed to tuberculosis, but not hazardous drugs. He said the hospital community focused on TB because of OSHA's efforts to set standards, and the institute continued surveillance after the Bush administration withdrew a proposed rule in December 2003 (68 Fed. Reg. 75,767).

He said most of the medical surveillance for the Occupational Health Service Institute's corporate clients are for workers exposed to substances that have robust OSHA standards, like asbestos.

“It's all tied to standards,” Marder said. “If there's an OSHA standard, people do medical surveillance. If not, they don't.”

More State-Level Action?

In June, the American Nurse Association's House of Delegates approved a resolution to support nurses' access to medical surveillance programs modeled on NIOSH's recommendations and to advocate for legislation to protect health care workers who are exposed to hazardous drugs.

Following that resolution, the Maryland Nurses Association asked the Maryland Occupational Safety and Health to develop regulations--including medical surveillance--for health care workers who handle hazardous drugs, said Karin Russ, the chair of MNA's Environmental Health Committee. Russ told BNA Nov. 27 that MOSH is “in the midst” of drafting those regulations.

By Robert Iafolla  

NIOSH's Nov. 19 publication on medical surveillance is available at

NIOSH's 2012 list of hazardous chemicals in health care settings is available at

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