For the first time, conjugated monoclonal antibodies have been added to a list of drugs that pose an occupational hazard. The new cancer treatment targets tumors with deadly toxins – but also can produce some residue that could put health care workers at risk, safety experts caution.
The drugs are among more than 150 on an updated list released by the National Institute for Occupational Safety and Health (NIOSH), which issues a roster of drugs that can cause cancer or reproductive effects. In 2014, 27 new drugs were added and 12 removed based on NIOSH criteria. The list will be updated again in 2016.
Health care employers need to constantly review new treatments to ensure that employees have the training and protection they need, says Thomas Connor, PhD, research biologist with the NIOSH’s Division of Applied Research and Technology and an expert on hazardous drugs and occupational safety.
For example, the conjugated monoclonal antibodies produce fewer side effects for cancer patients than older chemotherapy agents. But manufacturers warn that trace amounts of the toxin could be in a free state and could pose a risk for workers handling the drugs, he says.
"These are extremely toxic compounds bound to the monoclonal antibody (which targets the tumor)," Connor says.
Overall, administering oral chemotherapy is safer for workers than intravenous versions. But if the pills are not coated, they may leave a powder residue in the counting tray, which poses a risk of inhalation or dermal contact, Connor says.
Crushing pills to place them in apple sauce or liquid and make them easier to ingest also may expose health care workers, he says. Repeated, small exposures add up to a significant hazard, he says.
A 10-member expert panel reviews drugs and places them on the list based on six criteria: carcinogenicity, teratogenicity (causing birth defects), reproductive toxicity, organ toxicity at low doses, genotoxicity (causing mutations or other genetic damage), or new drugs that have a structure and toxicity that mimics existing drugs that have been deemed hazardous.
States move to reduce HCW drug exposures
NIOSH’s hazardous drug designation plays an important role as states develop new laws to protect health care workers from hazardous drugs.
In Washington state, employers must develop and implement a hazardous drug control program by January 1, 2015. They must complete employee training by July 1 and install "appropriate ventilated cabinets" to protect workers handling hazardous drugs by January 1, 2016.
Last year, the California legislature directed the Occupational Safety and Health Standards Board to develop a rule protecting health care workers from antineoplastic drugs. An advisory committee held its first meeting in June 2014.
And in July, North Carolina passed a law requiring new rules to protect health care workers from antineoplastic drugs, in line with NIOSH recommendations.
All hospitals will be subject to new standards when the U.S. Pharmacopeial Convention finalizes its proposed chapter on "Hazardous Drugs — Handling in Healthcare Settings" (USP 800). The USP standard provides specific guidance on personal protective equipment, handling and transport, cleaning and waste disposal, and medical surveillance of workers.
For example, compounding or other manipulation of drugs must occur using engineering controls in a negative pressure environment, with external venting, the USP chapter states. USP standards are enforced by state boards of pharmacy, Connor says.
With the proposed chapter, the USP would require facilities to use the NIOSH hazardous drug list and suggests that they may add other substances not on the NIOSH list. "The entity’s list shall be reviewed at least annually and whenever a new agent or dosage form is used," the proposed chapter says. "If the information provided is deemed insufficient to make an informed decision, the drug should be considered hazardous until more information is available."1
Make your own hazardous drug list
Ultimately, employers are responsible for determining which of their drugs pose occupational hazards, NIOSH says in its guidance.
"Not every institution is going to use every drug on this list. Go through the formulary. See which drugs match up with the hazardous drug list, then make a list for [your] employees," advises Connor.
Hospitals also should review new drugs and look at the properties of specialty and investigational drugs, he says.
NIOSH also reminds health care employers that:
- They must comply with the Hazard Communications Standard of the Occupational Safety and Health Administration (OSHA), which requires labeling of hazardous chemicals and annual training of employees. Training also must be provided when hospitals introduce new drugs or new ways of administering drugs.
- The tablet or capsule form of hazardous drugs should not be placed in automated counting machines.
- If toxicological data isn’t available on an investigational drug, but "the mechanism of action suggests there may be a concern," it should be treated as hazardous until there is enough information to show that the drug does not pose a risk.
[Editor’s note: The updated NIOSH list is available at www.cdc.gov/niosh/docs/2014-138/pdfs/2014-138.pdf.]
Reference
- U.S. Pharmacopeial Convention. General Chapter <800> Hazardous drugs—handling in healthcare settings. Available at www.usp.org/usp-nf/notices/compounding-notice.
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