Mergers and acquisitions continue to scale smaller regional healthcare organizations into national systems with overnight growth, which can present challenges to even well established drug diversion programs. Because diversion programming is not a one-size-fits-all model, what works well in a single site or regional health system may not expand to multi-state health systems. While there are resources to guide the development of such a program, the foundation must be built with the facility’s organizational culture, policies and procedures, and goals in mind.

There are unique challenges for large health systems developing or scaling a diversion program, as these systems often contain complex, multi-level leadership structures which result in an added layer of complexity when assessing programs. Thoughtfully appointing multidisciplinary diversion program champions with dedicated roles can help navigate merger challenges and ensure a strong, appropriately scaled diversion program.

Navigate Merger Complexities

As organizations merge, their individualized, historic practices, policies, and procedures require reassessment. Standardizing medication handling workflows across various practices can be especially challenging, and the organization may not even be aware of varying medication handling practices until reviewing for drug diversion prevention opportunities.

Proactive diversion monitoring relies heavily on appropriate, standardized technology use. Legacy organizations are likely to source diversion software, automated dispensing cabinets (ADCs), and electronic health record systems from various vendors which can further complicate enterprise programming. Oftentimes, each facility has its own vendors for cameras, employee badge data, smart infusion pumps, repackaging software, human resource platforms, privacy monitoring programs, and investigation tracking software, all of which play a significant role in drug diversion investigations. Additionally, organizations that cross state lines face challenges with specific or differing state regulation and licensing board standards including external reporting requirements, controlled substance classifications, and the ability to practice with compact licenses. Navigating such challenges is impossible without dedicated drug diversion prevention resources.

Dedicated Resources

While smaller diversion programs may operate effectively with part-time resources, large, multi-state programs require dedicated assets to run smoothly. Inconsistencies in diversion prevention, education, and detection efforts across the enterprise position the organization for significant risk. Developing a team of committed resources helps establish repeatable, consistent procedures.

The Office of Inspector General (OIG) developed compliance program guidance documents to support the healthcare industry in its efforts to self-monitor compliance with applicable laws and program requirements.1 The seven elements of an effective compliance program speak to the importance of staff education, policies and procedures, employing dedicated compliance staff, and ensuring consistency within the program.

Appoint a Program Leader

First, the organization should appoint a diversion program leader. This individual (sometimes referred to as the diversion officer) should have extensive healthcare experience, a thorough understanding of healthcare operations and technology, the skills to lead complex investigation processes, and the ability to work with external agencies and internal partners, according to American Society of Health-System Pharmacists (ASHP) guidelines.2 The role of the diversion officer is not to develop a system-wide program single-handedly, but to channel various components from stakeholders and lead the program execution.

As the program is designed, this individual must devote significant time to marketing it internally and educating stakeholders across the enterprise. Despite the seemingly narrow focus of a diversion officer, the role requires broad expertise. Accountability for program oversight, data tracking and trending, and updating policies and procedures are among the many responsibilities this individual must oversee. They also serve as the lead investigator, which necessitates in-depth knowledge of surveillance and monitoring software and other analytic tools such as transactional data from ADCs. When investigations require escalation, the diversion officer facilitates the work of the diversion response team (DRT) and liaises between departments to ensure a thorough review. The program leader must also be a collaborator; it is essential that the diversion officer maintain good relationships with clinical and executive leaders to support and advise in drug diversion matters. They must be approachable to ensure leaders are comfortable reaching out under difficult circumstances. In large organizations, this individual will require the management skills to oversee a team of qualified drug diversion specialists.

Identify Support Staff

ASHP best practice guidelines on diversion recommend that the healthcare organization assign a diversion officer to the program while also allocating adequate support staff with dedicated time to conduct surveillance and monitoring. The drug diversion specialists team should represent diverse skillsets; consider including pharmacists, pharmacy technicians, nurses, auditors, data analysts, law enforcement, compliance officers, and other clinical staff to provide well-rounded experience that supports a best-in-class program. Recognizing that diversion is not solely a pharmacy problem, there is significant value in recruiting a diverse team that can bring varying experiences, opinions, and points of view to the table. Additionally, these teammates can provide unique perspective to support programming and investigations. The number of support staff allocated to the diversion program will vary by facility depending on organizational size and complexity of the medication use cycle.

A large component of the team’s workload encompasses data review to proactively identify diversion and complete proactive or reactive case investigations. Best practice is to assign a central team to conduct all investigations. By centralizing investigations to a dedicated team, investigations can be completed with efficiency and consistency. Key learnings from past cases across the organization can be applied to future scenarios, including any observed trends in operational or educational deficiencies. The dedicated team also maintains a specialized skillset which aids in interactions with external agencies.

Expanding organizations must make decisions around centralizing diversion resources versus establishing resources at every site, as well as how to utilize extension partners and the roles and responsibilities of operational staff versus the dedicated diversion staff.

Include Extension Partners

Effective drug diversion prevention and detection cannot be accomplished by the centralized drug diversion team alone. As the team structure is built, identify any missing skillsets and consider how to incorporate other individuals with those skills as extension partners. Do team members lack interview skills to conduct employee interviews? Consider partnering with the security department or human resources (HR). Does the team lack skillsets for building complex data visualization tools? Consider leveraging IT department resources and organizational data analysts to bring data visualization to life.

The team must have strong partnerships with pharmacy automation specialists to access and analyze data within automated dispensing cabinets or implement diversion monitoring software. A drug diversion program cannot exist without pharmacy leader relationships. These leaders are on the front lines of controlled substance accountability. Their operational insight, dedication to appropriate recordkeeping, and understanding of regulatory requirements are essential to the program. Ongoing facility-level monitoring of daily invoices, count discrepancies, and controlled-substance related safety events should continue at the facility and pharmacy leader level. Frontline nursing and physician leaders are also key extension partners. Even the best drug diversion teams fully supported with technology resources will miss diversion events if frontline partners are not identifying and escalating concerning teammate activities, as such behaviors often cannot be visualized through software measurements. Consider including extension partners as key members of the DRT.

Build an Oversight Committee

There are many decision points that require a multidisciplinary approach, and the most efficient way to present decision points, gain support and buy-in, and socialize the program is by assembling a diversion prevention oversight committee. As an organization expands, integrating multiple oversight committees may be daunting while individuals are still acclimating to their new positions within the combined organization. If it is necessary to maintain more than one committee in the interim, the content of the meetings should align to drive program standardization.

The committee should comprise organizational leaders who can make decisions and be led by the diversion officer. Disciplines to consider for membership include medical staff, anesthesia, pharmacy, nursing, security, human resources, compliance, risk management, administration, legal, communications, information technology, and employee health. Ad hoc members such as infection control, infectious diseases, or media/public relations may be added, depending on the circumstances of a given diversion event.

To begin, the committee should establish a charter that includes membership composition, roles and responsibilities, reporting structure, and meeting frequency. If combining committees, consider integrating the best parts from each charter to develop the new document. The committee should be proactive in its prevention efforts and actively address diversion prevention, detection, investigation processes, and reporting procedures.

It is important to document meeting activities. Ideally, meeting minutes document monitoring reports, quality improvement efforts and outcomes of those efforts, compliance with existing procedures, reviews of internal and external audits, and action plans. The functions of the oversight committee should integrate with existing compliance management programs, and the committee should ultimately report to organizational senior leadership. Appoint an executive sponsor to help facilitate buy-in and gain support from other executives who may be nay-sayers or lack awareness or understanding of diversion issues.

Assign DRT Members

Establish a DRT to respond immediately to any suspected or confirmed diversion events. The DRT should be multidisciplinary in nature and include representation from key stakeholders. Disciplines to consider for the DRT are pharmacy, nursing, compliance, security, HR/teammate relations (TMR), teammate/employee health, physician leadership, and risk management. Some members of the DRT may be ad hoc depending on the case. For instance, if the case involves a nurse, the DRT will have a nurse representative, but if the case involves a physician, then a physician leader may be beneficial. Ad hoc members such as infection prevention and media relations may benefit the team as well.

The DRT should remain small to help maintain confidentiality and protect the reputation of the implicated party. Additionally, it may be helpful to only include individuals on the DRT that are external to the area under investigation (ie, avoid including the individual’s direct manager) to ensure impartiality during the investigation. The DRT will provide consultation, direction, and oversight for suspected diversion events and should have reporting responsibilities to the diversion prevention oversight committee. In large healthcare systems, it is ideal to regionalize DRTs, if possible, with just a few members rotating based on the location. For example, compliance, HR/TMR, risk management, and security members may remain consistent with only pharmacy and nursing leaders changing based on location. This approach minimizes the effort required to educate core DRT members on current diversion trends and topics. Keep in mind that diversion program resources should be dedicated to onboarding DRT teammates and providing continuing education to ensure the team is up-to-date on relevant trends related to drug diversion.

An added benefit of centralizing the DRT is that historical knowledge of events will inform future decision making. This can be challenging for facilities that have yet to regionalize diversion team roles; this is a particularly common problem early in the integration process. However, all high-quality diversion programs consistently assess and reassess processes; as such, establishing regionalized teams can be an early goal to work toward as part of the organization’s alignment process.

Conclusion

While drug diversion management is markedly more complex at the large health system or enterprise level, multifaceted teams dedicated to scaling diversion efforts helps ensure program success. This process requires strong organizational skills, ongoing communications, and a willingness to fail and evolve. Be prepared to listen and adapt processes so stakeholders are comfortable with the components that make the program stronger. Identify program complexities and areas for improvement; each day is a new opportunity for gaining efficiency and effectiveness. While developing a foundational program or expanding an existing program can be daunting, the result is rewarding work that can instill pride in the organization.

References

1. U.S. Department of Health and Human Services. General Compliance Program Guidance. November 2023.Accessed April 15, 2024. https://oig.hhs.gov/documents/compliance-guidance/1135/HHS-OIG-GCPG-2023.pdf
2. Clark J, Fera T, Fortier C, et al. ASHP Guidelines on Preventing Diversion of Controlled Substances. AM J Health-Syst Pharm. 2022;79:2279-2306.

Leah Mitchell, PharmD, MBA, CHC, is the director, compliance-drug diversion for Advocate Health. She is a PharmD graduate of Campbell University College of Pharmacy and Health Sciences and MBA graduate of Capella University.

Danielle Neal, PharmD, MBA, BCPS, CHC, CPEL, is the associate vice president, compliance-pharmacy for Advocate Health. She is a graduate of Campbell University’s College of Pharmacy and Health Sciences and MBA graduate of Campbell University School of Business.