Despite longstanding guidelines on the hazards of antineoplastic drugs (ADs) used primarily in chemotherapy, public health officials are concerned that healthcare workers are still inadequately protected from these known or suspected carcinogens for which no safe exposure level exists.
“Chemotherapy drugs are wonder drugs, but they also pose a tremendous risk to healthcare workers,” says Jim Boiano, MS, CIH, an industrial hygienist at the NIOSH division of surveillance, hazard evaluations, and field studies. “They are highly toxic, they can cause cancer — they are just really nasty drugs that are used in healthcare.”
NIOSH studies1 are finding that despite existing guidance and recommendations on how to use the drugs safely, “for whatever reason, there is not a universal adherence to these guidelines,” he says.
Data from the studies have prompted discussions within NIOSH and OSHA about re-emphasizing the hazards of antineoplastic drugs, he says. In addition, the U.S. Pharmacopeial Convention (USP), a scientific nonprofit organization that sets various drug standards enforceable by the FDA, issued a new general chapter 800 “Hazardous Drugs — Handling in Healthcare Settings” in February of this year. To give healthcare facilities more time to comply, the standard does not become effective until July 1, 2018. (See related story in this issue.)
For its part, NIOSH is updating a 2004 AD alert that will re-emphasize that the exposures to the drugs can cause fertility problems in women and men.
“If healthcare workers and oncology nurses [administering ADs] are considering getting pregnant they need to take precautions and possibly have alternate work duties during that period of time,” Boiano says. “There are also some studies showing that the effects are aren’t just limited to females; there can be reproductive effects in males as well.”
The current OSHA guidance on ADs is in a chapter of a technical manual, but the agency appears to be moving to make the information more accessible, he notes.
“I was at a meeting last week and there was an OSHA representative there,” Boiano tells Hospital Employee Health. “They are currently going to be updating that guidance … so I believe it is going to be more visible.”
Little Training, Less Time?
The need for raised awareness on ADs is underscored by a recently published study1 by Boiano and fellow NIOSH investigators who looked at engineering controls, work practices, use of personal protective equipment, drug spills, and contamination. The data were from 1,094 hospital nurses who work with AD drugs and responded to the NIOSH 2011 Health and Safety Practices Survey of Healthcare Workers. In general, Boiano and colleagues found gaps and inconsistent use of safe methods in handling and administering ADs to patients. The following are among the findings:
- AD spills were reported by 9.5% of nurses during the week prior to the survey.
- Familiarity with safe handling guidelines and training in safe handling were associated with more reported PPE use.
- Nurse-perceived availability of PPE was associated with more reported PPE use and lower odds of reported spills.
- Use of closed system drug-transfer devices and luer-lock fittings also decreased the odds of self-reported AD spills, while more frequent AD administration increased the risk.
- AD administration frequency was also associated with performing more activities with gloves previously worn to administer ADs, and nurse perception of having adequate time for taking safety precautions with fewer such activities.
“The results suggest that training and familiarity with guidelines for safe handling of ADs, adequate time to adhere to guidelines, and availability of PPE and certain engineering controls are key to ensuring adherence to safe handling practices,” the authors concluded.
Previous studies have reported spills of ADs and skin contact with the drugs, resulting in contamination on hospital surfaces and presence in the urine of healthcare workers working with the ADs. In some cases, both training and resources were an issue as the researchers found safe handling guidelines were associated with consistent use of PPE, and availability of PPE was associated with fewer reported spills of ADs. For core PPE, including nonabsorbent gowns and chemotherapy gloves, institutional safe-handling procedures and employee familiarity with the procedures appeared to be key.
“We do think from other research that there are differences in [PPE] availability: Large hospitals have more resources than certainly ambulatory care facilities especially smaller ones,” says lead author Sharon Silver, MS, an epidemiologist in the NIOSH division of surveillance, hazard evaluations, and field studies. “There are different levels of training and some of it is how frequent the training is. Most of them have had some training, but they are supposed to have an annual refresher at the least and not everybody had that.”
Nurses who administered ADs more frequently reported more spills and performing more activities with potential for environmental contamination. The latter included touching bed controls, door knobs, and phones while still wearing gloves previously used to administer ADs. Given that the drugs are toxic and carcinogenic, HEH asked whether the environmental contamination of surfaces pose a risk to patients and other workers.
“That’s a good question, and yes, potentially,” Silver says. “There have been other studies that have looked at contamination in hospitals and found it on the floors, elevator buttons, at the reception desk. So visitors, patients, or other healthcare workers can be exposed. It is far less than what healthcare workers working directly with these materials are exposed to, but these are hazardous drugs.”
The findings call for a “commitment from all levels of healthcare organizations to protect workers from ADs,” they concluded.
“The perception of having enough time to take safety precautions was associated with fewer environmental contamination activities,” the authors noted. “Collectively, these results suggest that insufficient time to adhere to glove doffing and donning practices while performing core nursing functions in areas where ADs are administered may lead to greater potential for environmental contamination.”
The study is one of the largest to assess adherence to safe-handling guidelines for administration of ADs as reported by hospital nurses. Adherence to best practices for safe administration of antineoplastic drugs requires the efforts of employers through engineering controls, training, provision of PPE, and adequate time for adherence to safety measures. Healthcare workers should seek out training, consistently follow facility procedures, and report any safety concerns.
“While providing optimal equipment and adjusting workflows to ensure adequate time to take safety precautions may be difficult in the current health-economic climate, the results of this study suggest potential benefits in terms of both reduced exposures and reduced downstream healthcare costs for hospital personnel,” the NIOSH researchers concluded.
- Silver SR, Steege AL, Boiano JM. Predictors of adherence to safe handling practices for antineoplastic drugs: A survey of hospital nurses. J Occup Environ Hyg 2016;13(3):203-212.