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Just about anyone can be mistaken or confused about the correct way to dispose of hazardous waste, hazardous drugs, and controlled substances. They might even be a little uncertain about the definitions of these terms.
“There is a lot of confusion around hazardous drugs vs. hazardous waste,” says Monica Livingston, senior implementation manager for PharmEcology Services at Waste Management Sustainability Services (WMSS) in Houston.
Soon, new guidelines from the United States Pharmacopeia (USP), in the USP 800, will be made official. They’ll outline how facilities handle hazardous drugs (). The USP 800 provides specifics on all aspects of hazardous drug handling. USP 800 is a section of standards that will be implemented on Dec. 1, 2019. The deadline had been June 2018, but it was extended, Livingston notes.
ASC administrators and staff should know the main definitions, regulations, and standards regarding hazardous waste, drugs, and controlled substances. Livingston provides some clarity:
“In a healthcare setting, hazardous drugs to an employee would mean, ‘I need to be protective of myself, me as a person, administering this drug,’” she says. “Chemotherapy is on this list. The National Institute for Occupational Safety and Health [NIOSH] produces a list of hazardous drugs every two years.” NIOSH provides six definitions of hazardous drugs, including carcinogenicity, organ toxicity, and reproductive toxicity, taking into consideration absorption through the skin, Livingston notes.
“Employees also could be at risk of inhaling it through their nose or getting it in their eyes,” she adds.
All employees who handle these hazardous drugs must follow NIOSH guidelines for wearing personal protective equipment (PPE), as well as deactivating, decontaminating, cleaning, spill control, and documenting the hazardous drug’s use and disposal.
On the other hand, hazardous waste takes into consideration what is hazardous to the environment, Livingston says. Hazardous pharmaceutical waste is defined by the Environmental Protection Agency’s Resource Conservation and Recovery Act (RCRA) laws and regulations. Not all hazardous drugs are also hazardous waste, but while only a few chemotherapy drugs are defined as hazardous waste, all are NIOSH hazardous drugs. Employees should follow safe handling and proper disposal.
Controlled substances are drugs that are listed by the Drug Enforcement Agency (DEA) as drugs that could be abused, and they’re treated differently — depending on whether they’re inventory vs. wastage.
“A couple of years ago, the DEA Drug Disposal Rule implied that all controlled substances not given to patients must be treated by incineration,” Livingston says. “It posed a humongous problem from an operational perspective.” The DEA published a clarification letter on Oct. 17, 2014, that distinguishes between inventory and wastage (). In healthcare organizations, a controlled substance is in the inventory of the licensed healthcare facility until the product is dispensed to a patient. Once it is taken out of inventory, then any leftover product is waste, which is no longer regulated by the DEA. It can’t be used for any other patient and must be rendered non-divertible, Livingston explains.
The DEA letter states that if a controlled substance “is not fully exhausted (e.g., some of the substance remains in a vial, tube, or syringe after administration but cannot or may not be used further), then the DEA registrant is obligated to destroy the remaining, unusable controlled substances, and record the destruction.”
The DEA also emphasizes that practitioners must record the destruction of pharmaceutical wastage.
“We were all surprised when the clarification letter came out because it leaves the onus of keeping all employees and the public safe from these drugs on the healthcare location,” Livingston says.
There is always the possibility of medication diversion. If a nurse retrieves a controlled substance from the inventory, then gives only part of the drug to the patient, there is the possibility the remaining waste product could be diverted. “Given that these items are highly abused and have street value, the industry must be aware of the risk, but the DEA says it’s out of their jurisdiction at that point,” Livingston says.
Plus, some staff might throw away leftover medications in a hazardous waste container or a red sharps container because they don’t know the correct disposal process, she notes.
“If it’s disposed of somewhere that’s open, then someone can get their hands on it, and the patient population is at risk,” Livingston warns.
Some new companies provide a technological solution to disposing of controlled substances. One strategy is a drug deactivation pouch or device in which leftover product can be placed for neutralization. It mixes the controlled substance with chemicals that make it no longer useful as a drug.
The end product does have to be disposed of as pharmaceutical waste, because it no longer poses a danger to the public and staff, Livingston explains.
In a surgery center, all staff handling a hazardous tablet must wear gloves. If the hazardous drug is liquid, then they need a gown and gloves, and perhaps goggles or a face mask, Livingston notes.
Most healthcare professionals know these rules apply to chemotherapy drugs. But there are medications on the hazardous drug list that they might not consider, such as steroids, she explains.
“Steroids would be bad for pregnant women to have come in contact with their skin,” she says. “There are more than 200 items they need to take into consideration for pregnant women or for staff that are immune-suppressed.”
The safest strategy is to review NIOSH’s list of drugs that are dangerous to employees (). “It can be complicated and overwhelming,” Livingston says, noting that experts can help ASCs develop a compliance plan.
Unfortunately, in addition to all federal requirements, some states have created even stricter rules, Livingston says.
“The state has the authority to be stricter, so the healthcare facility has the responsibility to follow the highest level of regulations,” she says. “If the EPA has the higher level of regulations, the state follows the EPA.”
Also, keep in mind that it will be state inspectors the surgery center will see most.
Another area of compliance involves accreditation. Centers that are accredited must follow their accreditation body’s hazardous drugs and waste rules, as well as all federal, state, and local laws.
Financial Disclosure: Editor Jonathan Springston, Editor Jill Drachenberg, Editorial Group Manager Terrey L. Hatcher, Author Melinda Young, Physician Editor Steven A. Gunderson, DO, FACA, DABA, CASC, Consulting Editor Mark Mayo, MS, and Nurse Planner Kay Ball, RN, PhD, CNOR, FAAN, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. Stephen W. Earnhart discloses that he is a stockholder and on the board for One Medical Passport.