As technology improves the ability to secure and account for medication inventory, drug diverters have relied upon drug waste disposal (among other methods) to steal their drug of choice. To reduce the opportunity of diversion and remain compliant with Drug Enforcement Administration (DEA) and Environmental Protection Agency (EPA) regulations, healthcare institutions should have policies and procedures in place to address drug waste disposal. 

To help reduce diversion risk, healthcare organizations should consider developing a controlled substance waste disposal policy with the following elements:

Who: 

Consider who is responsible for the disposal of the drug waste, as this may vary depending on where the drug is dispensed from. The policy may call attention to specific scenarios in which there is a change in custody of the controlled substance. For example, controlled substances dispensed from the central pharmacy, or those dispensed during a long procedural case. In any scenario, drug waste disposal should be witnessed by another licensed health care employee to ensure the drug and quantity disposed of corresponds with the documentation.

What: 

The controlled substance waste disposal policy should define what drug waste is. The DEA has strict record keeping regulations regarding drug disposal. Keep in mind that expired or recalled inventory must be disposed of differently than drug waste. Although all unusable/unwanted drug is often deemed drug waste, the DEA has more specific classifications. The most common use of the term drug waste refers to controlled substances dispensed by a practitioner for immediate administration at the practitioner's registered location, when the 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 further utilized). Per the DEA, this type of drug waste does not require a DEA Form 41 but still does require record keeping (21 CFR 1304.21(e)). The policy should clearly define what needs to be documented and any corresponding exceptions to the rule. To avoid any record keeping confusion, consider including verbiage so that each medication dispense has a corresponding waste transaction. In other words, waste from multiple dispenses should not be combined and wasted as a single transaction. 

 

Where: 

To comply with DEA and EPA standards, controlled substance waste must be disposed of into a waste container that renders the drug ‘non-retrievable’. To also limit the possibility of drug diversion, these containers should be strategically placed in areas with surveillance camera coverage. Since the drug waste should be disposed of at the time of dispense (more on that to come), the ideal location for controlled substance waste containers is in medication rooms or near the automated dispensing machines. The policy should also speak to other unique areas such as procedural areas, operating rooms, and pharmacies. Unless conducting random drug waste assays, controlled substance drug waste should never be returned to the pharmacy for the pharmacy team to dispose of. Not only does this create a massive burden for the pharmacy team, it also creates unnecessary safety and diversion related risks.

When:

To reduce the risk of drug diversion, controlled substance waste disposal should occur at the time of dispense, or as close to the time of dispense as possible. In a perfect world, the dose needed would be known before dispensing the drug and any unneeded portion could be disposed of at that time. However, this is not always the case in healthcare. If the waste cannot be disposed of immediately, the policy should set a time threshold for when to dispose of waste, given the situation. For example, in procedural areas, the policy may indicate that the waste must be disposed of before the end of the procedure (or before starting the next procedure). 

A well thought out policy allows the diversion investigation team to hold employees accountable for their actions and serves as the first line of defense against poor practice behaviors and potential diversion. If all personnel adhere to the policy, it is easier to identify those who deviate from the standard practice. Even if an employee does not intend to divert, improper handling of controlled substance waste creates opportunities for employee and patient safety risks as well as non-compliance. 

The next installment of this blog series will discuss methods to prevent and monitor for drug waste related diversion.

As technology improves the ability to secure and account for medication inventory, drug diverters have relied upon drug waste disposal (among other methods) to steal their drug of choice. To reduce the opportunity of diversion and remain compliant with Drug Enforcement Administration (DEA) and Environmental Protection Agency (EPA) regulations, health care institutions should have policies and procedures in place to address drug waste disposal.

Consider developing a controlled substance waste disposal policy with the following key elements.

Who:

Consider who is responsible for the disposal of the drug waste, as this may vary depending on where the drug is dispensed from. The policy may call attention to specific scenarios in which there is a change in custody of the controlled substance. For example, controlled substances dispensed from the central pharmacy, or those dispensed during a long procedural case. In any scenario, drug waste disposal should be witnessed by another licensed health care employee to ensure the drug and quantity disposed of corresponds with the documentation.

What:

The controlled substance waste disposal policy should define what drug waste is. The DEA has strict record keeping regulations regarding drug disposal. Keep in mind, that expired or recalled inventory must be disposed of differently than drug waste. Although all unusable/unwanted drug is often deemed drug waste, the DEA has more specific classifications. The most common use of the term drug waste refers to controlled substances dispensed by a practitioner for immediate administration at the practitioner's registered location, when the 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 further utilized). Per the DEA, this type of drug waste does not require a DEA Form 41 but still does require record keeping (21 CFR 1304.21(e)). The policy should clearly define what needs to be documented and any corresponding exceptions to the rule. To avoid any record keeping confusion, consider including verbiage so that each medication dispense has a corresponding waste transaction. In other words, waste from multiple dispenses should not be combined and wasted as a single transaction.

Side note: consider creating a separate policy for medication destruction and the management of recalled, expired, and unwanted (unused) controlled substance, including those from ultimate users (i.e. prescriptions left behind by patients).

Where:

To comply with DEA and EPA standards, controlled substance waste must be disposed of into a waste container that renders the drug ‘non-retrievable’. To also limit the possibility of drug diversion, these containers should be strategically placed in areas with surveillance camera coverage. Since the drug waste should be disposed of at the time of dispense (more on that to come), the ideal location for controlled substance waste containers is in medication rooms or near the automated dispensing machines. The policy should also speak to other unique areas such as procedural areas, operating rooms, and pharmacies. Unless conducting random drug waste assays, controlled substance drug waste should never be returned to the pharmacy for the pharmacy team to dispose of. Not only does this create a massive burden for the pharmacy team, it also creates unnecessary safety and diversion related risks.

When:

To reduce the risk of drug diversion, controlled substance waste disposal should occur at the time of dispense, or as close to the time of dispense as possible. In a perfect world, the dose needed would be known before dispensing the drug and any unneeded portion could be disposed of at that time. However, this is not always the case in healthcare. If the waste cannot be disposed of immediately, the policy should set a time threshold for when to dispose of waste, given the situation. For example, in procedural areas, the policy may indicate that the waste must be disposed of before the end of the procedure (or before starting the next procedure).

A well-thought-out policy allows the diversion investigation team to hold employees accountable for their actions and serves as the first line of defense against poor practice behaviors and potentially diversion. If everyone adheres to the policy, it will be easy to identify those who deviate from the standard practice. Even if an employee does not intend to divert, improper handling of controlled substance waste creates opportunities for employee and patient safety risks as well as non-compliance.

The next installment of this blog series will discuss methods to prevent and monitor for drug waste related diversion.

Nursing strikes continue to make headlines, exacerbating staffing shortages at hospitals and health systems. But they can also wreak havoc on your drug diversion prevention efforts — here's how.

These strikes not only create more potential for clinical drug diversion, but also make it more difficult to detect. Augmenting RN staff with travel or contract nurses poses a risk as they're less familiar with your organization's workflows, procedures, and policies. Naturally, they're going to make more mistakes. However, detection of actual diversion becomes more difficult as these mistakes lead to an increase in false positives for activity that may look like diversion but is strictly a result of not knowing protocols.

Aside from that, nursing strikes mean departments are working short-staffed, which inevitably leads to more errors, which then lead to more false positives. Due to the increased workload, RNs may change their workflows in an effort to maintain the level of patient care being provided. Changes in workflows may make it easier for the RN team, but also may amplify the risk of diversion.

Consider this example seen during COVID: one RN would dispense meds for patients assigned to all RNs on the unit so they didn't have to leave the bedside, resulting in:

• Increased suspicion as the RN dispensing looked like an outlier for dispenses compared to peers
• Increased number of false positive incidents (change in custody, delays in administration, delays in waste, backcharted administrations, etc.)
• Increased opportunity to divert as the RN has more times in the dispensing cabinet

If your health system or hospital experiences nursing strikes or frequent short-staffing, or relies on travel nurses to fill the gaps, it pays to be aware of the increased risk of drug diversion and the detection difficulties that may arise.

• What should the employee’s status be after they are caught diverting?
  • Are all drug diversion cases subject to termination?
  • Are there alternatives to termination? If so, who is eligible for different course of corrective action?
• How are employees supported if they admit to a substance use disorder?
• How are employees with SUDs re-introduced into the workplace?
  • Where will they work?
  • Do they require additional monitoring?
  • What ongoing support is offered?

The literature suggests that substance use disorder is considered a mental illness, which infers that the person suffering is not functioning within their normal capacity. The word illness also infers the possibility of successful treatment. In fact, there are thousands of people who have fully recovered from a substance use disorder. However, those who have successfully recovered often keep quiet in fear of being labeled an addict and the stigma attached to it. The drug diversion prevention program should consider the risks and benefits of rehabilitating and reintroducing those employees who suffer from SUDs that were caught diverting drugs.

When I started in a medication diversion prevention position, I remember hearing that any drug with a street name has the risk of being diverted. Although there are no street names listed on the DEA website, the short-acting, non-barbiturate sedative propofol (and its rapid, powerful high) is widely known to both healthcare workers and the public. Because it’s not classified as a controlled substance, despite the high potential for abuse and associated risk to workforce health and patient care, propofol’s dangerously easy accessibility makes it a prime target for diversion.

And propofol does, in fact, have street names — based on the milky white coloration of the medication it’s referred to as “Milk” or “Milk of Amnesia”, and also known as “Jackson Juice” following the pop star’s highly publicized 2009 overdose death. In 2007, prior to the increased street knowledge of the drug, it was reported that propofol abuse had risen fivefold over the 10 years prior based on email surveys sent to the 126 academic anesthesiology training programs in the United States. 

In the author’s opinion, classifying propofol as a controlled substance would help healthcare organizations greatly reduce risk to their workforces, patients, and communities at large.

Propofol’s Abuse Potential

To understand why propofol is so dangerous, it’s important to know its abuse potential. Users are drawn to the easy access and hard-hitting, quick high. "It's like three drugs rolled into one. It's like marijuana, Valium and the club drug Ketamine. It creates a unique high like no other drug,” says Paul Wischmeyer, MD, Anesthesiologist.

Propofol produces rapid loss of consciousness within 40 seconds of an IV injection, with a short duration of action lasting 3-5 minutes following a single bolus dose. In low (subanesthetic doses), propofol has been shown to increase dopamine concentrations and produce feelings of euphoria, "being high", light-headed, and spaced out. Studies investigating the recovery profile of propofol have reported patients wake up elated, euphoric, and talkative. Cravings do occur with repeated use.

Heavy abusers may inject up to 50-100 times a day to maintain their high, and unfortunately one of the first symptoms of propofol abuse or addiction is death. 40% of anesthesia residents who reportedly abused propofol died as a result. Overuse and abuse of propofol can lead to propofol toxicity which in turn can lead to metabolic acidosis. Although metabolic acidosis can occur, the leading cause of death is respiratory depression followed by hypoxia that leads to cardiac arrest.

Rethinking the FDA’s 2010 Ruling 

So knowing all of this, why isn’t propofol classified as a controlled substance? In October of 2010 the DEA proposed that the FDA include propofol as a schedule IV medication, which was supported by the American Society of Anesthesiologists (ASA) and the American Association of Nurse Anesthesiology (AANA). The proposal was ultimately rejected by the FDA. Commonly cited rationale for the rejection includes:

• Pain on injection and rapid onset: The pain on injection may be a deterrent for some, but inversely the pain followed by a rapid high may be a driving force for some abusers. The pain tells them the high is coming.
• Not enough evidence of drug dependence: Propofol is not associated with physical dependency.  Yet, treatment centers have reported propofol withdrawal symptoms similar to withdrawal from benzodiazepines; including irregular or fast heartbeat, tremors, hallucinations, confusion, agitation, and fever.
• Low risk to the public: It is true that the vast majority of reported propofol abuse has been among medical professionals, although reports indicate that the risk to the general population is increasing. Potentially, this is because controlled substances are under more harsh restrictions and propofol is not regulated under the same rules — it’s more easily accessible and poorly controlled in most healthcare facilities.

Yet the #1 reason I hear as to why propofol should not be scheduled is that making it a controlled substance is impossible and would negatively impact patient care and workflow. As someone who has worked as a registered nurse for the last 17 years and has firsthand experience conducting a propofol diversion investigation, I understand workflows and processes — I also understand when something isn’t right. I know the change won’t be easy but it’s far from impossible. At the state level, Alabama, Georgia, and North Dakota have already set the gold standard in requiring propofol to be treated as a controlled substance. 

Proactive Protection

For anyone working in a healthcare setting, I feel it is imperative that we, at a minimum, define expectations around wasting practices and a way to account for propofol within our organizations. 

In some organizations, propofol is treated as an antibiotic, with no true oversight around its dispense, waste, and administration. Defining expectations around the disposal of propofol (for example, prohibit in waste receptacles or garbage cans), working to limit access, and performing random audits around dispense compared to usage are all actions healthcare organizations can undertake proactively. 

Additionally, organizations can revamp the access to anesthesia carts to eliminate policy violations, like the wide use of common codes. Implementing automated dispensing carts in all procedural areas also has a huge impact. 

The risk to those in healthcare abusing propofol is grave. And after the extensive reading I have done on the topic, I also believe the risk to the public regarding propofol abuse does exist — whether it be through the risk of receiving care from an impaired provider or experimenting personally with the readily available drug.

Christy Rand, BSN, RN, is an independent Diversion Prevention Professional with 17 years experience as a registered nurse.

Interested in more drug diversion content? Read this short blog post to learn how and why an Academic Medical Center (AMC) switched to a proactive approach to drug diversion prevention.

As with all other healthcare-related departments, clinical drug diversion monitoring is facing challenges in filling open positions. However, due to recent regulatory sanctions there’s a renewed focus on dedicating resources to bring diversion monitoring programs up to parity with industry best practices. Here are four trends I’m seeing:

1. Different backgrounds are being requested — some organizations want pharmaceutical experience, but more are open to nurses with clinical backgrounds who understand medication movement.
   
   
2. Organizations who are creating positions that do not have qualified internal candidates are finding it harder to fill these specialist jobs when looking outside the organization. This is in part due to the lack of foundational education or certifications for diversion — it doesn’t allow for large-scale growth of these positions. Some industry associations like American Society of Health System Pharmacists (ASHP) and International Health Facility Diversion Association (IHFDA) are creating educational series to centralize some of that knowledge, but there is currently no formal training.
   
   
3. Thought leaders who do have full time employees in place have measurable outcomes in terms of productivity and effectiveness and are requesting more FTEs for further specialization and program expansion. An optimal diversion monitoring department encompasses three personas: an analyst using diversion tools daily and requesting follow up investigations; an operations manager overseeing the program and measuring outcomes; and a compliance specialist who is not just diversion monitoring but is responsible for patient and medication safety — they’re an additional check to ensure processes are being followed and sit outside the day-to-day operations of a compliance team, acting more as an auditor.
   
   
4. Community engagement in the form of requests to connect with other organizations — healthcare organizations and their stakeholders are all striving to improve their knowledge. Healthcare organizations and their stakeholders don’t have diversion prevention or monitoring totally figured out, so we’re all striving to improve our knowledge. There’s a desire to network and share best practices with peers through groups like IHFDA, National Association of Drug Diversion Investigators (NADDI), and PANDAS.

For more, read key takeaways from Protenus’ Special Report: State of Drug Diversion in America.

When you’re building a clinical drug diversion prevention program at your organization, or are ready to elevate your existing program, it can be overwhelming to know where to start. As outlined in this Controlled Substance Diversion Monitoring Playbook, these key elements of an optimal program can provide a solid foundation.

1. Executive buy-in: This is critical to get the necessary resources to execute your program. Because pharmacy is not a revenue generating department, executives want to reduce expenses to as little as possible.
   
   
2. Resource allocation: Technology identifies areas of risk much more efficiently than humans, but it isn’t the silver bullet. Build a good team, add in technology, and leverage your people, processes, and technology to scale.
   
   
3. Education: One of the most important components of a diversion prevention program. Frontline staff need to be informed about policies and procedures on engagement with controlled substances and how they’re held responsible. Education should go beyond clinical staff to all staff, even if they’re not handling controlled substances to cover questions like:

• What is diversion and why is it important?
• What are the federal and state regulations?
• If you have a substance use disorder, how do you engage with employee assistance to get help so you have a better chance of recovering and keeping your license?
•  What are the pathways and mechanisms to report suspicious behavior?

4. Policies and procedures: Having these in place gives organizations a baseline to hold people accountable and enhances security around controlled substances.
   
   
5. Measuring effectiveness: This is important to make sure your program is constantly improving in identifying gaps and keeping pace with regulations. Reporting on ROI helps prove the worth of your program to upper management in terms of how your team is reducing risk for the organization.

Read 9 critical steps for building or leveling up a robust, proactive diversion monitoring program.