Is your organization prepared for the growing risk drug diversion poses? Find out how to tackle the issue head-on.
Drug diversion is an unfortunate reality for healthcare provider organizations of all sizes. Most organizations have drug diversion controls in place, and many have created full-time drug diversion specialist positions to tackle this problem. Yet drug diversion is still occurring at healthcare provider organizations and often goes unnoticed for a substantial period of time before an internal diversion investigation is started.
Organizations need their drug diversion efforts to operate more effectively and make smarter use of constrained human and financial resources. But where should they begin?
Do this first: Focus on high-risk areas
Drug diversions can occur in many complex areas that exist within the drug cycle, from purchasing and receiving to patient administration and wasting. Identifying a facility’s highest-risk area can help an organization allocate precious resources and create a more effective drug diversion program.
High-risk areas will look different for each facility and are dependent on factors such as staffing levels and processes that might be unique to a facility (for example, manual versus automated processes). To determine high-risk areas, organizations should look where automated data is limited. This might include areas not found in drug diversion software, such as providers that document administration and waste on a noninterfacing system or even on paper records. The ability to produce automated reconciliation reports from disparate systems or paper sources is strenuous, often resulting in manual audits of these documents.
Once high-risk areas have been identified, an organization should consider developing its drug diversion audit program based on risk and should monitor lower-risk areas via preventive controls, such as spot audits. For example, if ambulance replenishment is not a typical high-risk area for a facility due to low volume, that facility could conduct spot audits of a predetermined number of ambulance replenishments per month. Just knowing an area is regularly monitored often can be a deterrent for potential diverters.
Higher-risk areas warrant complete reconciliation reviews. For example, an organization that has identified diversions within its sterile compounding processes might decide that reconciling 100% of drugs removed for compounding to what is compounded would be a good area of focus.
Next up: Define your audit approach
It is essential for organizations to define their drug diversion monitoring program, including all areas to be reviewed and a step-by-step process to facilitate a sustainable program. Processes that are not documented or defined could get lost over time, particularly if staff turnover occurs. Some suggested steps for defining the drug diversion monitoring program include:
- Document the entire drug diversion program. Again, it’s important to clearly define all steps in the process so any staff member can take over the process if needed.
- Define minimum expectations for areas of review (for example, “the organization will review five ambulance replenishments per month as a spot check”) and define the audit steps involved. Also include expectations for any drug diversion software the organization might use. For example, define the recommended processes and frequency for generating diversion reports from the software, what criteria to use, and how many instances will be reviewed daily, weekly, or monthly.
- Define how to track and trend potential diversions. Often, organizations will discover a potential diversion but conduct no follow-up. It is critical, therefore, that organizations track potential diversion instances. Even a simple tracking spreadsheet – including the employee’s name, the drug diversion issue, the date, how the potential diversion was uncovered, and what action was taken as a result of the finding (for example, the employee was given a warning, or an investigation took place) – will go a long way.
- Define key players. Drug diversion staff should work closely with human resources (HR) staff to define key drug diversion parameters such as how many documentation discrepancies would need to occur before an investigation is conducted. Successful drug diversion programs also have oversight committees. As part of defining their drug diversion audit approach, organizations should outline the method for and frequency of the committee’s status meetings and reporting.
Define investigation procedures
As part of the process for gathering results from drug diversion programs, staff should follow up with a diversion investigation if needed, including an interview with the suspected drug diverter if deemed necessary. Just as it should outline its drug diversion audit program, an organization should have formal investigation procedures in place. Effective procedures share the following characteristics:
- Standard format. The investigation process should have standard steps, though each investigation might be slightly different, depending on the diverter or circumstances. The investigation process should include procedures that define appropriate communications and give instructions for how to complete required regulatory reporting. Effective investigation procedures recognize that rapid response time is critical to protect data such as video footage from being erased and to maintain the safety of patients and staff.
- Multidisciplinary approach. Tackling drug diversion requires the expertise and contributions of many roles and departments across the healthcare provider organization, such as the pharmacy director or other pharmacy leaders, the drug diversion specialist (if the organization has one), patient care, compliance, risk management, HR leadership, and other members of the executive leadership team.
- Data analytics. Staff should conduct reporting and monitoring on an ongoing basis. Examples of continuous monitoring in nursing include drug waste transactions and comparison of patient pain scales to drug administrations. Examples of monitoring in pharmacy include comparisons of purchase to stock and of drugs removed for compounding to what was compounded.
- Strong interviews. A well-thought-out process for interviewing suspected diverters can help the drug diversion team assess whether a drug diversion took place. Typically, interviews with the suspected diverter’s co-workers and supervisors occur first, followed by the interview with the suspected diverter. Developing a standard list of interview questions can be helpful as a starting point, but interviewers should be aware that successful interviews flow freely and vary for each person. Open-ended questions allow the interviewee to share more information. The overall goal is to find the root cause of the drug diversion and provide help, such as a substance abuse treatment program, for the suspected diverter.
- An organized reporting approach. Reporting should be outlined in the organization’s drug diversion policies and procedures. Stakeholders should be notified about drug diversion instances using a tiered approach based on the stage of the investigation and findings. For example, hospital senior leadership and risk management staff should be involved with reporting to the U.S. Drug Enforcement Administration, state boards of pharmacy, state boards of nursing, or state boards of medicine. The risks of reporting (for example, lawsuits, fines, or negative publicity) should never outweigh the importance of preventing the risks that could occur if the diverter’s behavior is allowed to continue (patient harm and overdose or death of the diverter).
A growing risk
Drug diversion is a growing risk within healthcare provider organizations – one that can have negative consequences for patients, employees, organizations, and their communities. As diverters become savvier, today’s facilities need strong controls in place to stay ahead of the threat and manage risk. In addition to implementing ideas such as these to strengthen their drug diversion processes, organizations should consider seeking assistance from controlled substance and drug diversion specialists to make the most of their resources and develop more robust and tailored drug diversion programs.