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The Philosophy of Drug Diversion Programs: Fueling the Next Great Debate
by Adam Beeler, PharmD, MS, Director of Pharmacy Services at Protenus on March 28, 2024
The emergence of artificial intelligence (AI) driven software has created an array of possibilities for monitoring and investigating drug diversion related events. Time previously dedicated to performing manual audits can now be used to develop and execute program strategies to meet organizational goals. As a result, there has been a divergence in how organizations approach the complex problem of drug diversion.
Incident Management & Case-Based Investigations
Some programs are focused on each transaction in which the entirety of the controlled substance cannot be accounted for in documentation. In this approach, programs identify all scenarios in which any amount of controlled substance is not documented and immediately follow-up with the individual to identify where the medication is. As a result, end users such as nurses and CRNAs are notified of the event and typically will edit documentation within the electronic medical record (EMR) or automated dispensing cabinet (ADC) to account for the undocumented medication. For brevity sake, we will refer to this approach as incident management.
Another style has emerged in which the focus of the drug diversion program is investigating individuals who have patterns of suspicious activity that could be related to drug diversion. In this scenario, the diversion program reviews the employee’s activity and escalates any concerns of poor practice or drug diversion. We’ll refer to this approach as case-based investigations.
Although both strategies aim to address drug diversion, they each come with their own risks and rewards. The purpose of this blog post is to highlight the advantages and disadvantages of incident management and case-based investigations.
Strategy #1: Incident Management
Incident management takes a compliance-first approach, leaving no room for interpretation as to whether the entirety of the medication is accounted for in documentation. However, incident management is no simple feat. Hospitals can generate thousands of transactions per day, creating hundreds of controlled substance transactions that cannot be accounted for over the course of a month. Even with the assistance of a diversion surveillance software, this time-consuming task requires dedicated personnel to review and reconcile controlled substance transactions. Some systems alert end users of these transactions by pushing notifications of such events to them so they can take the appropriate actions to account for the medication. Most often, this means that the end user edits the administration records or documents a waste transaction well after the actual transaction occurred. Regardless of whether the diversion program is managing these incidents or alerts are sent to end-users, major concerns exist with this strategy.
Pitfalls
Aside from incident management being an arduous, time-consuming task, end user notification for each incident can train diverters to be smarter about covering their tracks. For those end-users who are diverting drug waste, a notification is seen as a signal to change course and divert via other means. To avoid detection, diverters who have reached this point may opt for more subtle (and dangerous) diversion tactics such as falsifying documentation and swapping medications. In a sense, notifying end users each time they have unreconciled drugs removes all accountability from the end user and provides a safety net for those who fail to document properly.
The incident management approach aims to maintain compliance and detect drug diversion. However, incident management still poses a threat to compliance. Recent research conducted by Protenus suggests that organizations are less likely to detect diversion utilizing this approach (more details on this to come). In my previous role as System Manager of Controlled Substance Compliance, I have experienced situations in which the nursing leadership team is directly alerted of the incident and take it upon themselves to resolve the matter. Aside from adding more work for the nursing leadership team, there are two incredibly concerning scenarios that can result.
- Delayed or absent reporting of diversion as a result of nursing leadership not notifying pharmacy of the events and associated outcomes. At the end of the day, pharmacy leadership is responsible for the DEA license. Failing to report diversion has been a central theme for prompting DEA investigations and can have a devastating impact on the Pharmacist-in-Charge (PIC) and the organization.
- The threat of diversion is inappropriately dismissed because the emphasis is on ‘reconciling’ the dispensed medication (viewed as a burdensome administration task), rather than investigating the incident as a potential drug diversion event. In which case, the employee responsible for the unreconciled drug is off the hook and able to scheme up more nefarious ways to divert if that was their initial motive.
Case Study Outcome: Incident Management
An organization deployed an incident management approach for their diversion program and initially found that routine follow-up on unreconciled controlled substances transactions decreased the overall number of unreconciled drugs throughout the health system. However, when this organization lost their FTE dedicated to triaging these events, the number of unreconciled drug incidents quickly skyrocketed to the initial volume. This indicates that incident management is not self-sustaining. By triaging each event, employees became reliant upon the diversion program to address their documentation errors instead of changing their practice.
This is not to say that an incident management approach will never detect drug diversion. But one must consider the amount of time and effort allocated to incident management compared to the results and additional risks of non-compliance.
Strategy #2: Case-Based Investigations
The alternative school of thought for diversion programs is the case-based approach, in which healthcare workers with the most suspicious activity are identified and escalated by AI-driven software for a more comprehensive investigation. This approach is simple in theory. Identify employees who have the most concerning practice patterns and conduct an in-depth investigation into their activity in an attempt to detect drug diversion or poor practice. The case-based approach places a priority on detecting as many diverters as possible. It focuses on learned and sustained patterns of activity that deviate from their peers rather than singular events. When compared to a single event (as seen with incident management), a pattern of activity creates a compelling case that the healthcare worker is purposefully (or unknowingly) practicing in a way that deviates from standard practice. We are all prone to making mistakes and healthcare workers are no exception to this rule. The case-based approach gives healthcare workers the charitable assumption by not assuming that a single event is drug diversion. By focusing on patterns of concerning activity, the case-based approach removes any doubt as to whether the activity was accidental.
Pitfalls
The disadvantage to this approach is that reconciliation of each and every controlled substance transaction is not prioritized over investigating cases of suspicious end-users. Some organizations may consider controlled substance reconciliation to be a bigger compliance risk than undetected diversion events.
Case Study Outcome: Case-Based Investigations
An organization deployed the case-based approach as their primary method of detecting diversion. For each case, the concerning employee was investigated by the diversion program and appropriately escalated to nursing and anesthesia leaders to take the appropriate action, everything from re-education/retraining to termination, and everything in between. What this organization discovered as a result is two-fold.
- The case-based approach sustainably decreased the number of singular events over time (i.e. unreconciled controlled substances). A simple explanation to this correlation is that case escalation places accountability on the end user. By making the employee aware of a repeated pattern of concern, it forces them to comply with the practice standards or face the consequences of additional corrective action. After all, it’s hard to refute that a sustained pattern of activity was accidental opposed to a one-off event seen with incident-management.
- The case-based approach enabled the organization to identify legitimate diversion events. Instead of spending a majority of their time and resources managing incidents, this program used that time to investigate more diversion cases and still had time for additional controlled substance compliance activities, such as real-time invoice reconciliation audits.
Our team at Protenus studied customer outcomes related to these two approaches and found that organizations that deploy the case-based approach are nearly 4 times as likely to detect diversion than those who focus their efforts on incident management. Not only did the case-based approach help detect more diversion, but it also decreased the total number of incidents created by holding end-users accountable for their actions.
Final Thoughts
Regardless of the strategy adopted by the healthcare organization, it’s critical that the approach aligns with the goals of the organization’s drug diversion program. Incident management expedites the resolution of controlled substance variances for compliance sake, whereas case-based investigations emphasize end-user accountability and detecting as much diversion as possible.
Both philosophies require engagement from key stakeholders such as nursing, anesthesia, security, human resources, risk, and legal. How and when these stakeholders get involved in drug diversion will be determined by the strategy adopted by the organization. Furthermore, both strategies require policies & procedures that support the diversion monitoring efforts, as well as dedicated personnel to effectively deploy the drug diversion program.
In an ideal world, drug diversion programs would be able to implement both strategies simultaneously, but the truth is that it’s not feasible for most organizations. Misalignment between state and federal regulatory agencies, professional organizations, and internal policies makes it practically impossible for a diversion program to meet all standards. However, it is possible for organizations to find a practical balance between the two strategies to minimize risks associated with diversion and maintain compliance. Stay tuned for future blog posts that will discuss finding the balance that is right for your organization.
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