Is there a new consensus about wearing personal protective equipment (PPE) for infusion of monoclonal antibodies (MABs), such as rituximab (Rituxan)? I have heard professional discussion about it not being necessary. As an oncology infusion nurse, I believe you can never err by wearing your PPE, regardless of whether the drug is an MAB. Our employee exposure to all of the agents we administer to patients is too great. Is there any evidence-based research to support not wearing PPE for these agents? —Name withheld on request
The National Institute for Occupational Safety and Health (NIOSH) has established universal standard recommendations in regard to handling, preparation, and administration of potentially hazardous agents. Classification of what is determined to be hazardous is based on three drug groups: antineoplastic drugs, non-antineoplastic drugs, and drugs that primarily pose a reproductive risk to men and women who are actively trying to conceive and women who are pregnant or breast feeding, because of the risk of excretion in breast milk.1 Furthermore, hazardous drugs must meet the criterium of being one of the following: carcinogenic; teratrogenic or have other developmental toxicities, reproductive toxicity, organ toxicity at low doses; and genotoxicity.
Whereas there have not been any new changes to the NIOSH guidelines for PPE use, agents such as rituximab were removed from the hazardous list, given that they do not meet the criteria for hazardous drugs. Rituximab is a genetically engineered medication used to produce humanized antibodies. However, these agents do not interact directly with the transcription of DNA or RNA and are not expected to be mutagenic or teratrogenic, and they do not mimic the traditional cytotoxic, antineoplastic cancer chemotherapy treatments that are considered to be hazardous. It was recommended that these medications could be handled with the same level of specialization as aseptic products.
Bioengineered drugs target specific sites in the body and do not directly superimpose a risk to the clinician administering the drug. Rituximab was removed from the hazardous drug listing, especially that it is administered in non-oncology settings. However, NIOSH does take the position that any safety handling procedures should be in correlation with institutional policies and any additional recommendations included in the manufacturer’s safety data sheets. —Jiajoyce R. Conway, DNP, CRNP, AOCNP
1. Connor TH, MacKenzie BA, DeBord DG, et al. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings. 2014. Cincinnati, OH: US Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health; 2014. DHHS (NIOSH) Publication No. 2014-138 (Supersedes 2012-150). http://www.cdc.gov/niosh/docs/2014-138/pdfs/2014-138.pdf. Accessed May 18, 2015.