Ed Holmes (ed.holmes@fairwarning.com) is chief executive officer at FairWarning in Clearwater, FL.
In the healthcare industry, 10%–15% of healthcare workers will misuse medication during their career.[1] Unfortunately, the real number is likely even higher because it is extremely difficult to quantify exactly how many incidents there truly are in a hospital setting. Double-digit diversion numbers coupled with incidents that fall through the cracks show that drug diversion is an enormous issue and a risk to patient safety, delivery of care, and compliance. Noncompliance with drug diversion regulations can lead to heavy fines and reputational damage. During the COVID-19 pandemic, this is a recipe for disaster, with hospitals in the US losing an estimated $200 billion by the end of June 2020.[2] The first line of defense in stopping drug diversion is to set up a drug diversion monitoring program.
Traditionally, drug diversion monitoring is a time-consuming and manual process, but today, with access to technology, it’s easier to tackle. As regulations continue to evolve in support of better patient care and medication controls, hospitals need diversion monitoring programs to comply with state and federal laws and guidelines. When adopting such a program, compliance professionals should ensure it includes proper controls for compliance while reducing the risks to patients, staff, and hospital operations. By also selecting technology that supports tracking the flow of medications, healthcare systems can proactively work toward monitoring 100% of transactions.
The correlation between hospital settings and drug diversion
Drug diversion cases can appear anywhere in the US, particularly in areas that have been harder hit by the opioid epidemic. These regions tend to be rural areas with less access to treatment.[3] Diverters can also be more common in institutions that don’t have as many controls—think nursing homes or home caregivers. However, what’s at the forefront of headlines and on the minds of the broader healthcare industry is how the pandemic has changed hospital operations and what this means for drug diversion. With more medical staff jumping from hospital to hospital to care for patients where needed, diversions have a greater chance of flying under the radar.
Hospitals that don’t have a drug diversion program will find it’s a lot harder to track diversion cases without the proper tools and policies. Tracking drug diversions isn’t just about stopping it from happening. It’s also about ensuring compliance with regulations set out by the Controlled Substances Act; Drug Enforcement Administration guidelines; The Joint Commission standards; and, for those that take Medicare programs, Centers for Medicare & Medicaid Services guidelines. The Controlled Substances Act of 1970[4] is one of the earliest sets of rules surrounding drug diversion, and it stipulates guidelines such as appropriate and timely wasting of unused drugs and daily reconciliation of drug transactions. Generally, most new pieces of regulation can be mapped back to this law.
Documentation is where one of the biggest gaps in compliance can happen in a hospital setting. A common scenario involving improper wasting is when a nurse disposes of unused medication at the time of administration, without a witness present, as is required by regulation, but has a second person act as the witness when the waste is documented in the record. Or, a nurse documents administering a full dose of medication to a patient but actually only administers part of the dose. Then, the nurse diverts the unused portion for personal use. Both of these scenarios can cause issues with the auditing process because if the paperwork isn’t correct, it can be deemed fraudulent billing, particularly for Medicaid and Medicare.
Another area where hospitals have a gap in compliance is internal policies surrounding drug diversion and proper medication handling. Discrepancies can happen when the supervising nurse doesn’t properly go through reports on a weekly basis to reconcile medication transactions. The Controlled Substances Act says that hospitals should be reconciling transactions daily,[5] but that doesn’t always happen. When it comes to a suspected case of diversion, there can also be a level of hesitancy by staff to act on it, whether it’s because they don’t feel comfortable “snitching” on a colleague or that they simply don’t believe that the suspect could divert (without clear proof to tell them otherwise).[6]
The breakdown of compliance increases risk
Compliance issues go hand-in-hand with the risks associated with patient care and damage to a hospital’s reputation. The most significant risk at the forefront of drug diversion comes in the form of patient safety and, for those who need it, the denial of pain relief. If a needle was tampered with, it is then no longer sterile and can encourage blood-borne pathogens or an outbreak of Hepatitis C, for example. For patients who require drugs for pain, when a staff member diverts part of their medication, they’re denied appropriate pain relief. Recently, a Veterans Affairs nurse in Boston was caught diverting morphine from patients in the hospice unit at a local medical center.[7]
Adjacent to patients not receiving medication is the risk of fraudulent billing by the hospital. If medications that are being diverted are then billed to the insurer, there are significant consequences and fines, especially for hospitals that bill Medicare and Medicaid. The healthcare organization could lose their Drug Enforcement Administration license or ability to bill the Centers for Medicare & Medicaid Services. When this happens, not only is the bottom line affected, but it can also result in damage to the organization’s reputation if patients can’t trust in its quality of care. The University of Michigan Health System paid a record $4.3 million settlement in 2018 for violating the Controlled Substances Act through its handling of controlled substances.[8]
Mitigating risk through drug diversion monitoring programs
To reduce the risks of drug diversion and to start the journey toward consistent compliance, organizations should begin with decision makers at the top by cultivating executive buy-in on a formal drug diversion program. It can be a challenge to get managers to believe that drug diversion is a problem, so approval from these decision makers can help a hospital move into the next phase of building a drug diversion monitoring program. Once the decision is made to begin a drug diversion program, organizations should set up a committee with members from critical areas such as nursing, pharmacy, compliance and risk management, and legal who can weigh in on policies and continuously improve the program.
Department managers and staff should also be trained to spot common red flags of diversion. For instance, diverters often want to work with pain patients so they can split the medication between the patient and themselves. When a staff member is suspected of diverting medications, oftentimes their colleague doesn’t feel comfortable reporting it because they don’t want to get them in legal trouble. However, staff members need to understand that diverters are typically offered rehabilitation first, rather than punished in a punitive manner. As a solution, staff should also be provided with the ability to report a suspected diversion incident anonymously.
Once internal policies and committees are in order, an organization is ready to begin proactively monitoring drug transactions. The only way to spot diversion is to be looking for it. Documentation should be checked at least weekly—if not daily—because when a nurse is tasked with checking monthly reports, these reports are too large to accurately reconcile. If a hospital has the resources, a drug diversion monitoring program can be supplemented with technology, which can proactively track 100% of daily transactions. At the end of the day, humans are only so fast, whereas technology can scan thousands of transactions in a matter of seconds, rather than days. When diversions are spotted faster, then a hospital can close the loop on cases more quickly and with less risk. Technology can also easily help with reporting—both for internal purposes and compliance reasons. With more medical staff moving from hospital to hospital today, precise reporting can help prevent diverters from continuing to do so at different hospitals.
Several key tips for drug diversion compliance are:
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Be proactive about drug diversion monitoring rather than reactive.
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Form a committee of staff from different departments to continuously evaluate current processes and whether any gaps occur.
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Educate your staff on best practices for handling medications and how to spot potential diversions—the more you educate your staff, the harder it is for diverters to operate in a culture of compliance.
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Empower a diversion investigator who devotes their time to conducting investigations into diversion cases.
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Look for technology that can work in the background to monitor all medication transactions and proactively flag potential diversion cases.
Drug diversion may be a pervasive issue in the healthcare industry, but it’s also preventable (or at least can be minimized) given the right resources and tools. Through a monitoring program, a healthcare organization can create a culture of compliance so that employees feel empowered to report an incident. Having a monitoring program in place also has implications for reducing the risk of noncompliance in the future. As diverters get smarter, regulations and technology are adapting, so hospitals should too, starting with identifying gaps in compliance and building a drug diversion monitoring program.
Takeaways
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Drug diversion is an enormous healthcare issue because it’s a risk to patient safety and compliance.
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Hospitals that don’t have a drug diversion compliance program have a harder time tracking diversion cases and complying with regulations set out by the Controlled Substances Act, Drug Enforcement Administration guidelines, The Joint Commission standards, and the Centers for Medicare & Medicaid Services guidelines.
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Getting started with a drug diversion compliance program is a combination of policy, regular transaction reconciliation and reporting, investigation, and resolution.
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Educate staff on best practices for handling medication and how to spot common red flags of diversion in order to close the gaps between internal policies and adherence to the rules.
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Compliance programs that include the support of technology have better adaptability to new changes in regulations and higher efficacy to catch new cases, and sooner.
