Q&A with Neil A. Gilchrist, PharmD, MBA, BCPS, DPLA
Chief Pharmacy Officer
UMass Memorial Medical Center
Large Drug Enforcement Agency (DEA) fines have made national headlines over the past 5 years, cementing drug diversion as a top compliance priority recognized by executive leaders at hospitals and health systems nationwide. In response, many of these institutions now dedicate time and resources to programs focused on controlled substance diversion prevention. UMass Memorial Medical Center (UMMC) of UMass Memorial Health, an 1100-bed health system serving the Central Massachusetts region, is one such institution. UMMC has dedicated over a decade to the development and implementation of a strong controlled substance diversion and prevention program.
When creating a comprehensive program, the pharmacy department should play a key role in the development of the program’s goals, strategy, and outcome measures. In addition to providing education across the facility, pharmacy leadership has a responsibility to escalate concerns and mitigate the risks of drug diversion.
Q: What are some risk factors for diversion in the hospital setting?
Neil A. Gilchrist: The hospital setting has numerous risk factors for potential drug diversion. This can start as early in the medication management cycle as delivery of sealed totes from wholesalers and it continues through to the point of disposal of pharmaceutical waste. Risk factors may include a poorly organized surveillance system of automated dispensing cabinet (ADC) transactions, lack of oversight and appropriate controls within the central pharmacy and delivery to decentralized areas, unsecure storage of controlled substances in medication closets or refrigerators, and providing more medication for administration than is required.
Unfortunately, data alone cannot mitigate these risks. At many hospitals there are thousands of controlled substance transactions per month; this creates an overwhelming amount of data. Organizing, analyzing, and reporting transaction information can be challenging, making detection of diversion difficult.
Q: How can automation ease the burden of data analysis?
Gilchrist: With controlled substance management, there are thousands of data points from diverse sources, including ADCs, electronic medical records (EMRs), medication infusion pumps, electronic prescribing to retail pharmacies, employee payroll systems, and inventory software. One of the most efficient and optimal strategies to organize, analyze, and present this data in a usable format is to implement an automated software solution focused on controlled substance diversion prevention.
Moving from a manual to an automated system allows an organization to involve more stakeholders to review findings and conduct investigations due to the simplicity of the presented data. Older, manual systems rely on exports of Excel files that require intense scrutiny and an underlying understanding of the file data. An anomaly typically prompts further data collection from the electronic medication record and other systems to pull the investigation together. Conversely, contemporary diversion prevention software summarizes the overall finding in a simple statement such as delayed medication administration by nurse A or controlled substance removed from ADCs by certified pharmacy technician B not returned to pharmacy.
Q: What data should organizations utilize to detect anomalous behavior?
Gilchrist: There are many metrics that can be evaluated in the surveillance of controlled substance practices. Some key data points that should be part of the standard review include:
Q: What education and training is recommended for staff?
Gilchrist: All staff should undergo new employee and annual regulatory training focused on the concept of recognizing drug diversion, as well as its impact on patient care and our health care colleagues. It is important to educate as many staff members as possible because identification or recognition of a problem can come from any role. This could be a caregiver delivering a food tray to a patient complaining of pain, a housekeeper finding needles in an employee bathroom, or any caregiver observing impaired behavior by a health care worker. Incorporating risk rounds into your program by going to different patient care areas to observe controlled substance handling provides the opportunity to educate caregivers in real time on a monthly basis.
Q: How can pharmacy gain administration’s support for investing in prevention resources?
Gilchrist: Pharmacy leadership plays a key role in mitigating the risk of drug diversion in the hospital and health system. It is important to educate the hospital executive leadership team on gaps in the organization’s compliance program.
When presenting to hospital administration, share data, diversion cases from your organization, a survey of resources at other organizations, and national diversion cases from the media to emphasize that a strong program requires resources and tools. This information should be presented and shared with hospital administration, risk management, compliance, and general counsel to establish a baseline understanding of the topic and a recognition of the risks to the organization based on identified gaps. Pharmacy leaders may need to be creative, working closely with nursing and anesthesia to divide responsibilities for the compliance program based on the resources available.
Q: What other disciplines in your facility are involved in preventing diversion?
Gilchrist: Key stakeholders in the prevention of drug diversion span multiple disciplines including nursing, anesthesia, risk management, office of general council, employee assistance program, security, environmental health and safety, compliance, regulatory, information technology, and human resources. It is important to include different practice areas where applicable. Hospitals that have infusion pharmacies, retail pharmacies, and other care settings should ensure representation includes a member of each team. Nursing has many practice settings with different workflows and procedures that will be critical to represent as well.
Q: What elements should be included in a comprehensive program?
Gilchrist: A comprehensive drug diversion prevention program requires several elements for success. The base of an effective program is built on governance structure; start by instituting a multidisciplinary Controlled Substance Diversion Prevention Program Committee. Large health care systems may require local committees that report to a system level committee to ensure standardization and program compliance.
Once a structure of oversight and accountability is in place, the hospital or health system needs to ensure a strong surveillance program is developed, which may include automation or software tools. Sustained surveillance and accountability requires either dedicated resources or dividing the work among team members who then report back to the oversight committee.
Finally, develop a diversion response group that can assemble within a short period of time following the report or identification of a suspected diversion event. At a minimum, this response group should include pharmacy leadership, risk management, human resources, general counsel, and the respective leadership of the caregiver under review.
Q: How can pharmacists dispel the not in my backyard phenomenon?
Gilchrist: The most influential method for overcoming internal denial is to present data and cases from your organization over a period of time. It is often helpful to also pull cases of diversion that have made national news or local media reports of similar organizations in your state or region to demonstrate that this can occur in any health care facility. If hospital administration does not respond to internal information, an external consultant focused in the area of controlled substance diversion can build compelling arguments with facts and case examples from a variety of organizations. Ultimately, pharmacy leaders must maintain an ongoing dialogue and prioritize education if the hospital administration does not recognize the urgency of this issue.
Q: How can pharmacists help overcome the stigma of discussing diversion and addiction?
Gilchrist: Pharmacists can work with their organization to incorporate appropriate messaging and information in education for new and existing employees. Messaging should focus on protecting patients and colleagues and should include an offer of assistance for workers that may be affected by substance use and addiction.
Diversion investigations should also ensure that both the patient and the caregiver are safe. Include Employee Assistance Programs early in discussions, and have representatives on stand-by should the investigation result in discussion of the event(s) with a caregiver or if administrative leave, discipline, or termination occurs. Provide education on treatment options for substance abuse and addiction. Some health care workers confronted in a diversion investigation are relieved that they can move from diverting to a recovery program to get the help they need.
Q: What are some best practices for identifying and preventing diversion?
Gilchrist: As discussed, best practices start with education for all employees. This provides a baseline for staff to learn what drug diversion is and how to identify it, as well as makes them aware that a facility is actively monitoring for this type of event.
Similarly, a strong surveillance program with dedicated resources and standard procedures for review is key. Complementing the program are comprehensive organizational policies and procedures for handling controlled substances. These standards help create a system that lends itself to deterring diversion. For example, setting clear expectations for timing around removing medications prior to administration or for when waste of a controlled substance should be discarded helps to prevent opportunities for diversion.
During investigations, it is important to reference policies that employees should be familiar with, especially when discussing an instance when protocols were not followed.
Q: What policies and procedures have you implemented at your facility?
Gilchrist: To support the Controlled Substance Diversion Prevention Program, we have developed detailed policies and procedures:
Q: How do you identify and monitor drugs at high risk for diversion?
Gilchrist: Often, the highest use agents that caregivers are most familiar with are most at risk for diversion. The repetitive use of these drugs presents many opportunities for diversion, with the statistical risk for illicit use or transfer worsening over time.
Additionally, travel employees who move from one organization to another and permanent employees who have been let go from previous organizations due to a suspicion or finding of diversion pose particularly high risks. These individuals may move to another health care system and implement a diversion scheme immediately upon employment.
High-risk drugs that should be monitored include oxycodone tablets, fentanyl, propofol, midazolam and benzodiazepine tablets. In most organizations these drugs represent a significant number of transactions and are handled by a wide variety of health care workers. This requires a strong surveillance strategy that can easily identify early indicators of a possible diversion scheme, and then triggers the performance of an audit to confirm or refute suspicions. Those medications that have high use and present significant opportunity for diversion should be monitored closely via automated systems to pinpoint any anomalous transactions. Additional drugs at high risk for diversion include IV bags and patient controlled analgesia (PCA) syringes with high volumes of controlled substances.
Hospitals and health systems are responsible for ensuring the proper controls and management procedures are in place under both the Controlled Substances Act (CSA) and state regulations. While this article details some best practices for detecting and preventing diversion, it is important to keep the focus of every investigation on both the patient and the employee. The investigation team should ensure that there is no harm to the patient and provide further care if needed. Likewise, the safety of the employee is paramount; they must receive proper support to ensure they do not harm themselves or others. At the time of discovery, a health care worker who has been diverting controlled substances may be at one of the lowest and most challenging points in life. They may be facing extraordinary circumstances outside of work that the team is unaware of. Provide the investigation team with the right tools to manage such situations in a respectful manner. Whether an investigation yields findings of poor practice, a lack of documentation, or a true diversion event, the learnings from each investigation can be leveraged to strengthen the program moving forward.
Neil A. Gilchrist, PharmD, MBA, BCPS, DPLA is the chief pharmacy officer at UMass Memorial Medical Center (UMMC) in Worcester, Massachusetts. UMMC is part of UMass Memorial Health, an 1100 bed health system serving the Central Massachusetts region. Neil has worked on the development and implementation of a controlled substance diversion prevention for the past 10 years and serves as the UMass Memorial Health Co-Chair for the System Controlled Substance Diversion Prevention Program Committee.