A common belief among health care workers is that diversion “could not happen at this facility” because the staff knows and trusts one another. The same reason is often given for signing off as a witness to waste that was not actually witnessed: “I trust her; she would never divert.” On occasion, a pharmacist will state that their institution is one of the lucky ones, where diversion is not a problem. Facilities that have identified minimal diversion in the past may develop a false sense of security, and thus have negligible ongoing surveillance. Likewise, in states where surveillance requirements for health care facilities are outlined in state regulations, organizations may conclude that if they simply meet the baseline requirements, they are doing enough.
In reality, every facility that manages controlled substances is at risk and will have diversion. If diversion is not being discovered, it is almost certainly due to insufficient attention or ineffective surveillance, not because diversion is absent. Diversion occurs at small critical access hospitals, prestigious academic medical centers, children’s hospitals, physicians’ offices, surgery centers, nursing homes, and other types of facilities. Rather than simply react to diversion after it occurs, it is important to identify anomalous drug usage early and take swift, preventive action.
One of the most effective methods facilities can use to detect possible drug diversion is through surveillance or auditing of automated dispensing cabinet (ADC) transactions. Many facilities use a combination of ADC data and diversion-detection software to help focus their auditing efforts; these reports facilitate identification of suspicious trends long before a staff member may exhibit recognizable behaviors of impairment. Identifying potential diversion as early as possible is the first step in a comprehensive diversion-prevention program, as behavioral manifestations are a late sign of diversion.
The tools available to help organizations detect drug diversion have improved significantly in recent years. Analytics programs have evolved and become more focused on current trends in diversion, and ADC vendors are increasingly focusing on integrating electronic health record (EHR) data into their reports. Even with this progress in technology, many organizations still find their controlled substance auditing to be inadequate and struggle to make their diversion-surveillance process sufficiently robust.
The importance of diversion surveillance and investigation of possible diversion should not be underestimated. If a facility does not review and act on the content of generated reports, it is still accountable for the contents therein. Furthermore, experience has proven that diverters will test the system to identify weaknesses that allow them to divert undetected. If diverters determine that diversion monitoring is not a priority and no one is watching, they will take full advantage of the situation. The result for patients, staff, and the institution is potentially disastrous.
Ensuring Comprehensive Auditing
Comprehensive diversion surveillance is critical to an effective diversion-prevention program. Identify every area in the institution where controlled substances exist (including areas with manual storage), define who has oversight for each of these areas, and evaluate what diversion auditing, if any, is being conducted. Specific areas that may be at risk for inadequate surveillance include anesthesia, emergency transport services, outpatient clinics and care centers, and even pharmacy.
Once the scope of controlled substance usage is determined, the organization should develop a policy and procedure (P&P) that clearly describes its expectations for surveillance in all areas. Those responsible for diversion surveillance need to know what data or reports will be generated, how often the data must be reviewed, expected time frames for completing audits, thresholds that necessitate further review, what that additional review should entail, how the review will be documented, and to whom they can go for support and guidance.
Maximizing a Diversion-Surveillance Program
Health care institutions should review their diversion-surveillance and auditing P&Ps at least annually to ensure they are comprehensive and accurately reflect real practice. Consider whether the organization has been successful in identifying diversion, and if diversion has been identified, how it occurred. Strive to identify diversion through surveillance of ADC data, as opposed to waiting to do so through behavioral clues.
The Role of Pharmacy and Nursing
Pharmacy staff and nursing leadership commonly assume responsibility for the majority of diversion surveillance. Unless the process is well defined, there may be inconsistencies in what data is reviewed, which can result in duplicative efforts and gaps in the surveillance program. Pharmacy staff and clinical leaders typically serve in multiple roles, with diversion surveillance one of many responsibilities. It is not uncommon for pharmacy staff to limit their surveillance to a cursory review of the reports prior to sending the information on to clinical leadership. There is value in involving clinical leaders in diversion surveillance, as they are often in the best position to understand workflows, patient acuity, and staff assignments. Their supervisory role, however, is conducive to bias that may impair their ability to view data objectively. For these reasons, diversion surveillance should not be in the purview of pharmacy staff and clinical leaders alone.
The Role of the Diversion Specialist
There is considerable value in establishing a diversion specialist or diversion program manager to oversee diversion auditing and operations. The diversion specialist provides value as they are inherently unbiased by a close relationship with clinical staff, and can accumulate significant diversion expertise by performing surveillance frequently. The specialist can conduct audits of specific controlled substance handling practices, such as patient-controlled anesthesia (PCA) and controlled substance infusions, and use the results to help the institution change practice and mitigate risk. Even if there is a limited likelihood of developing a full-time diversion specialist position, many organizations that start with a part-time position see the value of the role within the first 6 months, and the role then evolves into a full-time position.
If a facility does not have the resources to hire a full- or part-time diversion specialist, it is extremely important that an individual within the organization assume responsibility for the operations of the diversion program. Without clear-cut ownership, it is likely that the program will be fragmented and reactive.
Streamlining ADC Data
Automated drug dispensing systems and diversion analytics programs are capable of producing daunting amounts of information. Facilities may struggle to determine which reports are valuable and where to focus their surveillance efforts.
Organizations that attempt to review all or most of the reports they are capable of generating often experience report fatigue, which manifests in ineffective reviews and backlogs. We have yet to encounter a facility with the resources to review every report available, and even if such a situation exists, the usefulness of doing so is dubious. A list of primary and secondary reports facilities can use as a guide to determine which reports they will review regularly is available in TABLE 1 on page 16. Secondary reports are typically used to provide additional information when the primary reports fail to clarify the situation. Other reports may provide limited value and should not be generated for review under most circumstances. Identifying which reports are most critical for regular review helps streamline data to a manageable level while effectively identifying possible diversion.
Facilities should take advantage of ADC data to highlight poor controlled substance handling practices. Once a staff member has been counseled, the ADC data also can be used to monitor future performance. Transaction data may reveal workarounds or risky practices, such as pulling medication too far in advance of administration, pulling too much medication (over-pulling) and returning complete doses frequently, pulling excessively large doses, delayed wasting, and frequent wasting of complete doses. Transaction data can reveal when staff is carrying controlled medications in their pockets; inevitably, they will take medications home accidentally, and the first transaction of their next shift will be a telltale waste transaction even though no medication has been pulled. If poor drug handling practices are present at an institution, surveillance reports will include significant noise, ie, red flags that represent careless practice rather than diversion. Facilities should work to reduce the noise so that surveillance is more effective. Correcting poor practice reduces the risk of diversion and also makes diversion more apparent when it occurs.
Diversion program stakeholders should work with Human Resources to develop a process for counseling staff and implementing progressive discipline when poor practices are found. Ongoing education can also improve poor drug handling practices and elevate awareness about the danger of diversion.
Scope of Surveillance
To identify diversion, it is vital to include all controlled substances in ongoing surveillance; organizations should also consider monitoring transactions for noncontrolled substances that are known to be diversion risks, such as propofol. Some facilities limit their auditing to only a few drugs they feel are most likely to be diverted. However, experience has shown that there are few controlled substances that are not diverted. Another common pitfall is limiting the transaction review to only those drugs for which a staff member’s transactions are outliers. In order to pinpoint diversion, the auditor needs to review how the staff member handles all drugs and use those transactions as a comparison point. Does the individual frequently waste complete doses of one opioid, but not others? Does the staff member delay administration of one opioid, but promptly administer doses of all others? Focusing on only a few drugs removes an important reference point and may cause auditors to miss signs of diversion.
Because PCAs are a common target of diverters, PCA keys should be managed as a controlled substance and stored alone in a limited quantity in a secure pocket or bin in the ADC. Access to the keys should occur under the appropriate patient name, and staff should verify the number of keys with each transaction. PCA key surveillance should be ongoing, and the legitimacy of transactions should be verified in the same manner auditors confirm that controlled substance transactions are appropriate.
Once there is suspicion of diversion, auditors may find that monitoring transactions for commonly diverted noncontrolled drugs is useful to help clarify the situation. For example, we commonly see diversion of ondansetron, presumably to treat symptoms of nausea associated with opioid abuse, in conjunction with opioid diversion schemes. Moreover, injectable promethazine and diphenhydramine may be diverted to use as a substitute for an opioid. Acetaminophen is frequently diverted to use as a substitute for a diverted oral opioid. In advanced opioid diversion schemes, naloxone also may be diverted.
Barriers to Effective Surveillance
There are several issues that can limit the effectiveness of a diversion-surveillance program, including poorly defined roles, confusion over which drugs should be reviewed and how, report fatigue, a false sense of security, and a lack of resources dedicated to data review. Many facilities have not allocated resources exclusively to diversion detection. Even with advances in technology, diversion surveillance remains labor intensive. For that reason, resources must be allocated appropriately.
Gaining administration’s buy-in to the critical nature of diversion prevention is the first step in obtaining buy-in for additional resources. Executive leadership must be educated about the scope of the problem and gaps that are present in existing processes. Presenting an outline of the time commitment required using current auditing methods is helpful as well. Above all, emphasize the risks of diversion to patients, staff, and the institution. Highlighting information about recent DEA investigations and financial settlements can help convey the risks of inadequate attention.
Where there are drugs, there will always be attempts at diversion. Identifying and addressing anomalous usage through the review of ADC data and analytics reports is essential to diversion management.
The risks associated with diversion warrant that organizations devote appropriate resources to diversion surveillance. Done correctly, surveillance can help facilities detect diversion in a timely manner and respond accordingly, reducing the significant risks to patients, health care workers, and the community.
Kimberly New, JD, BSN, RN, is the founder of Diversion Specialists, LLC, a consulting service providing solutions for all aspects of institutional drug diversion. She is a specialist in controlled substance security and DEA regulatory compliance, working with health systems across the country to establish and expand drug diversion programs, with the overriding goal of improving patient safety. Kim is also the cofounder and executive director of the International Health Facility Diversion Association.
Lucas Overmire, BA, a partner at Diversion Specialists, LLC, has previously worked as an educator for a major manufacturer of automated dispensing cabinets. He is a specialist in pharmacy automation and analytics and is currently the creative director for the International Health Facility Diversion Association.
Part 1 of a 2-Part Series: Elements of a USP <800> Compliant Cleaning Program
Conduct a Drug Diversion Investigation
Special PP&P Buyer's Guide: Temperature Monitoring
Develop a Pneumococcal Vaccination Program
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