NCHR Agrees with CDC Draft Recommendation to Remove Liraglutide and Pertuzumab from the National Institute for Occupational Safety and Health Hazardous Drugs in Healthcare Settings List

February 15th, 2024: NCHR supports the CDC recommendation to remove Liraglutide and Pertuzumab drugs from the NIOSH List of Hazardous Drugs in Healthcare Settings. We agree that due to the to the drugs' low bioavailability and limited risk of occupational exposures these drugs are unlikely to pose a harm to healthcare workers.

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February 16th, 2024

We appreciate the opportunity to comment on the Center for Disease Control’s proposed draft: “NIOSH Initial Recommendations to Change the Status of Liraglutide and Pertuzumab on the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings.”

The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

We support the proposed draft recommendation to remove Pertuzumab from the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings. Inhalation, dermal, and percutaneous occupational exposures to Pertuzumab are not likely to occur at high enough doses to reach a level of systemic distribution that would cause harm to healthcare workers.^1,2 This is because inhalation, dermal, and percutaneous exposures to Pertuzumab have very low systemic bioavailability and limits the drug’s ability to reach a level that would result in toxicity.^1,2Additionally, unintentional occupational exposures to Pertuzumab are rare among healthcare professionals, and even repeated exposures are unlikely to result in doses high enough to achieve a toxic dose.² Thus, we agree that Pertuzumab is highly unlikely to pose a hazard to healthcare workers and should be removed from the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings.

We also support the proposed draft recommendation to remove Liraglutide from the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings. Liraglutide is prescribed and distributed as a sealed, pre-filled, injectable pen that patients can self-administer. Thus, the risk of percutaneous, inhalation, or dermal occupational exposures among healthcare workers is very low. Further, an unintentional inhalation, dermal, or percutaneous occupational exposure to Liraglutide would likely be insufficient to achieve a toxic dose given the drug’s low bioavailability.^3,4 Repeated exposures are also highly unlikely to occur, considering the safety provided by the drug’s packaging and the ability for patients to self-administer the drug.^3,4 Therefore, we agree that Liraglutide is highly unlikely to pose a hazard to healthcare workers and should be removed from the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings.

In conclusion,  The minimal risk of harm to healthcare workers, coupled with the rare occurrence of unintentional exposures and the safety measures in place, make it clear that these drugs do not pose a significant hazard. Removing them from the list will not only alleviate unnecessary burdens on healthcare facilities but also ensure that the resources and attention can be focused on drugs that truly require heightened safety measures.

References:

1. Wang W, Wang EQ, Balthasar JP [2008]. Monoclonal antibody pharmacokinetics and pharmacodynamics. Clinical Pharmacology and Therapeutics 84(5):548–558.
2. Pfister T, Dolan D, Bercu J, Gould J, Wang B, Bechter R, Barle EL, Pfannkuch F, Flueckiger A [2014]. Bioavailability of therapeutic proteins by inhalation – worker safety aspects. Ann Occup Hyg 58(7):899–911.
3. Courtenay AJ, McCrudden MTC, McAvoy KJ, McCarthy HO, Donnelly RF [2018]. Microneedle-mediated transdermal delivery of bevacizumab. Mol Pharm 15(8):3545–56.
4. Sauter M, Uhl P, Majewsky M, Fresnais M, Haefeli WE, Burhenne J [2019]. An ultrasensitive UPLC–MS/MS assay for the quantification of the therapeutic peptide liraglutide in plasma to assess the oral and nasal bioavailability in beagle dogs. Bioanalysis, 11(9):887–9.

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