Handling and disposing of oral cancer therapies can be hazardous, and certain protocols should be followed to reduce risks, according to Lisa Holle, PharmD, who spoke at the 11th annual Hematology/Oncology Pharmacy Association (HOPA) conference.
“Oral cancer therapies are very much like [intravenous] cancer therapies in that there is a risk of exposure; the type of exposure depends upon the qualities of the medication,” noted Holle, Assistant Clinical Professor, University of Connecticut School of Pharmacy, Storrs. “Most oral cancer therapies are cytotoxic agents, but there are many other ways that drugs can be hazardous,” she added.
Carcinogenicity, teratogenicity (or other developmental toxicity), reproductive toxicity, organ toxicity at low doses, and genotoxicity are other potentially hazardous drug properties. Drugs can also have structure and toxicity profiles that mimic existing hazardous properties, and can be toxic, ignitable, corrosive, or reactive.
In the United States, the National Institute for Occupational Safety and Health and the American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards provide the guidelines most often referred to for the handling of hazardous drugs, Holle noted.
Manufacturing and handling guidelines on package inserts can also serve as a guideline, but only some drug inserts provide guidance for how patients, family members, caregivers, or healthcare professionals should handle them. “With new drugs we should probably just assume they’re hazardous even if they’re not documented yet,” she said.
Handling Hazardous Drugs
Storage, preparation and handling, administration, and disposal of hazardous drugs can all result in exposure. Healthcare professionals should use personal protective equipment when cutting, crushing, manipulating, or administering tablets or capsules, as well as during the compounding or administration of oral liquids.
“We know that personal protective equipment is effective at reducing risk for healthcare providers, but we don’t really talk about the risk for family members who might be handling these medications on the outside,” Holle stated.
Patients should wash their hands after administration, use separate pillboxes when possible, swallow medications whole, and wash their hands after using the toilet or vomiting, she advised. Caregivers should always wash their hands and wear gloves when administering drugs, and pregnant or breastfeeding caregivers, along with children, should not handle drugs or waste.
Hazardous Drug Disposal
Improper disposal of hazardous drugs pollutes the water and ground, and is toxic to plants, animals, and humans. “The thing about oral cancer therapies is that under the Environmental Protection Agency [EPA], the guidance for how you handle any sort of waste depends on how the waste was generated,” Holle explained. “Once a medication is dispensed to a patient, it is actually considered a household waste and therefore falls under different regulations in terms of who manages the waste and how it can be disposed.”
Household waste management is governed by local and state environmental agencies, and is exempted under the Resource Conservation and Recovery Act (RCRA). RCRA is the principal federal law in the United States governing the disposal of solid and hazardous wastes, and classifies drugs according to their potentially hazardous natures. “There are a few oral cancer therapies, primarily those that are cytotoxic, that fall under RCRA, but those are exempt, too, because they’re considered household waste,” she noted.
Proper Disposal of Oral Cancer Therapies
Cancer.Net, an American Society of Clinical Oncology resource for patients and care providers, recommends conversations between healthcare providers and patients regarding proper disposal of oral cancer therapies, and advises returning any unused drugs and/or containers and other chemotherapy waste to providers for proper disposal, never flushing them down the toilet or disposing of them in the trash.
When hazardous waste is generated within a facility, different regulations apply. RCRA drugs must be disposed of very specifically because they can be potentially hazardous to the environment. Individual state departments of energy and environmental protection outline additional state-dependent designations. Within institutions, disposal of hazardous waste is regulated by the Occupational Safety and Health Administration and The Joint Commission, as well as by any additional institutional guidance, depending on how much hazardous waste is generated by an establishment.
“All of these guidelines are not necessarily complementary to the others,” Holle stated. “Sometimes they can be discordant, and then you have to figure out which guidance you’re going to follow and which you might deviate from, which can make things challenging.”
Oral Cancer Therapy Disposal at UConn Health
Holle and colleagues conducted a 12-month pilot program at the University of Connecticut Health Center’s (UConn Health) Carole and Ray Neag Comprehensive Cancer Center, from March 31, 2014, to March 31, 2015, where patients were instructed—via written and verbal communication—to bring their unused or expired oral cancer therapies, as well as their packaging and empty bottles, back to a licensed healthcare professional at the facility for proper disposal. “Educating patients on the importance of proper disposal in this program will hopefully lead to the development of state guidelines,” she said. Patients received recommendations for alternative collection sites for the disposal of all other medications.
Although Holle and colleagues could only accept drugs from patients of their clinic—because of guidance from EPA and the Division of Drug Control—she said, “I think we should open up to anybody who needs this service, since it is not available [widely].”
Holle and colleagues found the program to be beneficial to their patients, and because of their small patient population and lack of excessive waste, the program was not a cost burden to the facility. “I think one of the barriers that we run into is just trying to get other providers to see the value in educating [their] patients and making sure that they do have the opportunity to bring drugs back to [them] for proper disposal,” she added. “There should be a method for patients to be able to return their medications for proper disposal so that these drugs don’t end up within the environment affecting other people.”