Back in 2017, the Centers for Medicare & Medicaid Services (CMS) implemented new guidelines about controlled substance management, storage, and distribution. Even though facilities have processes in place for the storage and destruction of controlled substances, it is important to take a fresh look at this issue and ensure you are using the latest technology and best practices to manage destruction and prevent diversion.
“These are high-risk medications. Any mistake or error can be critical in terms of adverse events or diversion,” said Adrienne Hearn, RPh, BCGP, manager of clinical operations at PharMerica. While it can be challenging to keep everyone up to date on appropriate processes, it is essential to make sure training and education about this issue are part of onboarding as well as regular programs and updates.
The Background and the Basics
First of all, it’s important to understand what constitutes controlled substances. The federal Controlled Substances Act identifies five categories. Schedule I includes illicit drugs (such as heroin) that have no medical use. Schedule II involves drugs that are used medically but also have a high potential for abuse (such as morphine and opioids). Schedule III through V drugs have less abuse potential (sedatives, codeine, etc.).
One challenge is that controlled substance use and destruction are overseen by multiple agencies. The U.S. Food and Drug Administration (FDA) regulations say: “A long term care facility may dispose of controlled substances in Schedules II, III, IV, and V on behalf of an ultimate user who resides, or has resided, at such long term care facility by transferring those controlled substances into an authorized, collection receptacle located at that long term care facility. When disposing of such controlled substances by transferring those substances into a collection receptable, such disposal shall occur immediately, but no longer than three business days after the discontinuation of use as directed by the prescriber, as a result of the resident’s transfer from the long term care facility, or as a result of death.”
CMS’s guidance, which involved an amendment to the State Operations Manual, called for facilities, among other things, to have a system to track the receipt and disposition of controlled substances. This must involve reconciliation, which facilities should do on a regular basis. Additionally, CMS requires records that document the name and strength of each medication, as well as the quantity and date it was received. The recipient’s name also must be documented. Additionally, facilities need careful records of personnel access, usage, and disposition of all controlled medications, as well as details regarding the disposal or destruction of medications.
Disposal Renders Drugs Unusable
Disposal must be done using a method that prevents diversion and accidental exposure and that renders the medication irretrievable. Specifically, this means that the drug’s physical and/or chemical condition is changed so that it is permanently unusable.
It is important to note that in addition to federal requirements, each state has its own rules for disposal of controlled substances. For example, some states require that a pharmacist be involved in the process, or they may have special forms for issues such as request for approval of disposal/destruction or controlled substance inventory. Check with your state Department of Health or Environmental Protection Agency office for details.
Most states require moving medications from the cart to a secured, double-locked location when they aren’t being used. This process must be carefully tracked, witnessed, documented, and verified. Drugs should only be moved from the secured storage area when the team is prepared for the actual destruction.
There are several ways to destroy these drugs, Hearn said. These include mixing them in a slurry with an undesirable substance, such as coffee grounds or kitty litter, and placing this in impermeable, nondescript containers, such as empty cans or sealable bags. There also are proprietary systems and commercially available products on the market, such as controlled substance wastage programs and chemical dissolution systems.
Ultimately, the destruction processes depend on the drug and the formulation. Whatever destruction processes you use, it is important to remember—and to make sure staff know—that you can’t throw unused controlled substances in the garbage, pour them down the drain, flush them, or return them to the pharmacy. They must be rendered beyond use and the destruction documented and witnessed.
When Drugs Should Be Destroyed
If a resident is deceased, or no longer needs or wants to take these medications (if someone refuses to take their controlled substance as prescribed, this must be documented in the records), they must be disposed of properly. If a patient is discharged, they must have an order from their physician to take the controlled medications with them. Additionally, there must be two witnesses to the handoff of the medications to the resident, and all three must sign a form documenting this transaction.
If family members take a loved one who is taking a controlled substance out of the facility for a holiday or visit, they can’t just take the drugs with them. With the physician’s sign off and the witnessing of two nurses, the resident can take only the doses they need, and family members may need to sign a release stating that they understand that the resident and just the resident can take these drugs. “It is important to talk to your risk or compliance team to ensure you have appropriate policies and procedures in place for this situation,” said Joe Marek, RPh, BCGP, FASCP, chief pharmacy officer at CommuniCare.
Get Everyone in the Know
Knowledge is power, and that is certainly true when it comes to controlled substances. Hearn said, “Know both the federal and state regulations because every state will be different. Know who is authorized to dispose of meds and who is allowed to witness the destruction. Everything must be carefully tracked and documented.”
This is an area where one little error could cause serious concerns. For instance, she said, there are some specific recommendations regarding disposal of the fentanyl patch, as it may have medication remaining on it even after use. It will be important to use gloves to handle the patches, and two people need to be present when they are changed on a patient. “If you forget to remove the patch and put on another, this could cause adverse events, and don’t think that just because a patch is used that it can’t be diverted.” You can’t just throw used patches in the garbage can or sharps container. They need to be folded in half and disposed of by flushing, if allowed by state/local law, or a chemical dissolution system like any other controlled substance.
When it comes to these drugs, one error could be deadly. For instance, Hearn observed that morphine sulphates come in two basic strengths for oral solutions: 100mg/5ml and 20mg/5ml. “This is a pretty significant difference, and if you get the strengths confused, there is a high potential for overdose.” It could cause respiratory depression in those not previously exposed to opioids, Hearn said, adding that it is important for patients and families to know what drugs in what dosages are being administered.
Tracking is a common error that can cause problems, Marek said, noting, “It can be a mundane process, and it’s more challenging when there are staffing shortages.” He observed, “The pandemic had an impact. Nurses worked longer hours and were overwhelmed and stressed out. This made it more likely that steps could be missed.”
This can be especially problematic during shift changes. Marek suggested, “Part of the process at shift changes is that controlled drugs are accounted for and what is on the accountability sheet actually is in the med cart.” Getting nurses from both shifts together at the med cart during the shift change or any time the keys are exchanged is critical in ensuring the accountability for the controlled substances, and it also prevents diversion. He stressed that having one or more witnesses to every action taken regarding controlled substances from the time they come into the facility is one key to preventing diversion.
Another common error involves the periodic reconciliation process, said Hearn. This needs to be done with acceptable standards of practice, making sure that tasks such as change of shift counts, documentation of dosages used, number of orders, and pharmacy invoices are reconciled regularly. Again, with staffing shortages and turnover, this is an easy area for mistakes or missed steps to happen.
Watch for signs of diversion. For instance, Hearn said, “When you are administering liquid controlled substances, your initial count should match what is dispensed on the label. As doses are administered and if the counts do not match, it will be important to determine if there was an over- or under-fill or diversion.”
The Diversion Dilemma
The U.S. Department of Health and Human Services defines drug diversion as “the illegal distribution or abuse of prescription drugs or their use for purposes not intended by the prescriber.” The agency further notes, “Prescription drug diversion may occur at any time as prescription drugs are distributed from the manufacturer to wholesale distributors, to pharmacies, or to the patient. Members of the medication profession may also be involved in diverting prescription drugs for recreational purposes, relief of addictions, monetary gain, self-medication for pain or sleep, or to alleviate withdrawal symptoms.”
Drug diversion can happen even in the best facilities. The most frequently diverted medications include opioids, such as hydromorphone, morphine, fentanyl, hydrocodone, oxycodone, and methadone. As Marek noted, “If these drugs aren’t disposed of properly or aren’t tracked properly, this can be considered potential diversion, even if no one moves or uses the medications or takes them out of the building.”
When there are missing drugs or some evidence of diversion, this must be reported promptly. Marek said, “Depending on your state, you have to report to numerous entities, including the police, board of pharmacy, board of nursing, and possibly even the state attorney general.” When a controlled substance or other medication goes missing, he said, this can be considered a potential misappropriation of a resident’s property. Particularly with opioids, which are used to control pain, it may be considered abuse or neglect if residents don’t get medications to manage their discomfort.
The good news about controlled substances destruction is that you don’t have to reinvent the wheel. Marek offered, “Work with your pharmacy and consultant pharmacist to ensure proper policies, procedures, and processes are in place. This should be part of their service offerings, and they should be able to support you and answer any questions you have.” At the same time, he suggested that facility leaders take the time to walk around and look at things—including the handling of controlled substances—on a regular basis.