The nation is in the middle of an unprecedented opioid epidemic, with more than 130 people dying every day from opioid-related drug overdoses.1 In 2018, 32% of all opioid overdose deaths involved a prescription opioid.2 While the prevalence of drug diversion by health system employees is unknown, the risks posed to patients, health care workers, hospitals, and the public are significant. Drug diversion may cause unnecessary suffering to patients who receive inadequate analgesic relief, potentially unsafe care due to the health care worker’s impaired performance, and places patients at risk of infections from contaminated syringes. In addition to facing civil and criminal penalties, health care workers who divert are at risk of overdose and death.3 The hospital must pay the direct costs for the diverted drugs and subsequent investigations, and may also face regulatory fines for lack of safeguards.4 Moreover, diverted drugs impact the community by contributing to drug misuse.5
Drug diversion—the transfer of any prescribed drug from the individual for whom it was prescribed to another person for illicit use—includes any deviation that removes a prescription drug on its path from the manufacturer to the intended patient.6 Drug diversion plays a significant role in the substance abuse crisis occurring in America today with fentanyl being the most diverted drug and the leading cause of opioid overdose deaths.7 It is important to recognize that drug diversion happens in all clinical disciplines and at all levels of an organization, from frontline staff to chiefs.7
A leading cause of injury-related death is drug overdose and health care providers are not immune to this crisis.8 In fact, 10% to 15% of health care providers will misuse alcohol or drugs at some point in their careers, matching the rates of the general public.9 Impairment of a health care provider can have profound implications for their patients. In addition to untreated pain, infection risk, and harm from medical errors, patients cared for by impaired clinicians may lose trust in health care professionals.10 Thus, combating drug diversion is crucial.
Diversion in the Medication-Use Process
The medication-use process affords multiple opportunities for exploitation. Hospitals must assess each step in the process for potential vulnerabilities. This article discusses red flags that may indicate drug diversion at the various medication management stages, including procurement, storage, prescribing, preparation, dispensing, administration, as well as waste and destruction. FIGURE 1 illustrates potential failure points throughout the medication-use process.
Procurement and Storage
At the procurement stage, potential signs of drug diversion include compromised product containers as well as misplaced or altered packing slips. Excess drug may be ordered and then diverted by removing the packing slip to hide evidence of the diversion.11 Excess or unauthorized individual orders for controlled substances on DEA Form 222 are other key indicators.12
Unsupervised access to drug storage areas is a particular concern, as tampering may occur when there is a lack of oversight. IV medications are often targeted with the diverter removing drug from the container while ensuring the container appears intact and then substituting the diverted drug with saline to obscure evidence of tampering.13 Intentional miscounts can be used during medication restocking to cover up drug diversion schemes.14
Flexible ordering and unverified verbal orders in the ambulatory care setting are possible signs of diversion in the prescribing process. While legitimate reasons exist for flexible dose orders, such as dosing ranges or as-needed dosing, these approaches allow access to more drug than the patient may require. In addition, diverters may attempt to falsify verbal orders or forge prescriptions to support inappropriate controlled substance use.15
Preparation and Dispensing
In the preparation stage, drugs that require compounding and repackaging may be diverted. When unit doses are not purchased, tampering by substituting drug in solutions and diverting the overfill from the manufacturer’s container may occur.11 Sterile drugs are at risk for drug diversion through excessive withdrawals from multidose vials and diverted overfill from single use vials.4
On the units, the risk of diversion increases when the dosage of the stocked product exceeds the typically prescribed dosage. This provides an opportunity for clinical staff to divert the excess amount, rather than waste it. There is also increased risk of diversion among staff delivering medication to the units if there is poor verification of dispensing processes. In this situation, the delivery person can divert product by forging the signature of the second verifier.16 As inventory becomes increasingly less centralized overall, there can be a simultaneous reduction in awareness of drug use practices.17
During drug administration, a variety of scenarios can increase the risk of drug diversion. Unsecured prepared drugs are particularly vulnerable to drug diversion. A common scheme is to substitute the diverted drug with saline and then administer the adulterated (and possibly contaminated) product to the patient. Unsupervised access to drugs increases the risk of diversion. This may occur when health care workers forget to log out of automated dispensing cabinets (ADCs) or forget to secure locked boxes for infusions.18 Patient documentation may also be falsified. For example, a nurse may document complete administration of a drug after diverting a portion of the dose.11
Waste and Destruction
Red flags for drug diversion in the waste and returns processes include irregularities in the wasting process, falsification of witnessing, visual confirmation of wasting that does not detect drug content, unsecured waste receptacles, and a poorly controlled return process for expired products. When nurses use the buddy system, consistently wasting controlled substances with the same witness, this could be a sign both parties are actually diverting the medication. Health care workers signing off on waste verification without actually witnessing the process or using a coworker’s credentials without them being present is falsification of witnessing. When wasting is based solely on visual appearance, the drug content is not verifiable. This increases the risk that the drug may be diverted and the contents replaced with saline before a witness was requested. When waste receptacles are unsecured, drugs may be removed from sharps containers. This same risk also extends to unsecured bins designated for medication returns.11
Diversion Prevention Strategies
Identifying the signs of drug diversion is the first step to combating it. It is imperative that health care organizations develop preventative measures to address diversion and then monitor the effectiveness of these efforts. Incorporating prevention strategies and safeguards specific to each stage of the medication-use process is critical.
To decrease the risk of diversion during medication procurement, establish separate purchasing and receiving roles for personnel, and regularly rotate the positions of workers in those roles. Periodic auditing of controlled substances inventory can help manage discrepancies.16 Safeguards for medication storage include a commitment to drug security within the pharmacy, using tamper-evident packaging, and clearly tracing and documenting controlled drug inventory including the tracking of any staff who have accessed it. Security can be improved by minimizing unnecessary traffic and limiting access to inventory areas to the appropriate personnel. Regularly examine drugs with tamper-evident packaging and inspect inventory for signs of tampering, such as damaged medications, opened or damaged packaging, medication that is not sealed tightly or appears to have a missing seal, or lot and expiration dates that differ between the medication and the packaging. Audit trails for all controlled-drug access and cameras recording critical areas will help identify who has accessed inventory.16
Some of the risks for diversion during the prescribing process can be offset by monitoring for unusual or inappropriate prescribing. Identify unusual prescribing trends or patterns of health care workers compared to their peers.¹¹11 Creating policies against self-prescribing or prescribing for close friends and families is warranted. A large number of rejected verbal orders is a red flag and should be further investigated. An additional key strategy is restricting the use of dosing ranges when possible. Limiting the frequency of dosing ranges prevents health care workers from documenting higher ranges than were administered in order to then to divert the difference.19
Track all drugs entering and leaving the pharmacy for auditing purposes. Any discrepancies should be documented and resolved on a daily basis, preferably by a staff member who is not typically involved in handling drugs.16 Limiting access to controlled drugs on clinical units is a key strategy; set low par levels for controlled substances on the units and restock frequently. When the pharmacy is closed, limit the supply of controlled drugs available for urgent orders.¹11 In addition, purchase unit dose drugs whenever possible, rather than repackaging or compounding, to reduce opportunities for diversion.19
Key preventative measures during drug administration include monitoring clinical documentation for abnormal patterns, defining a specific interval at which drugs should be administered after retrieval, and minimizing credential sharing. Records should detail which health care workers are accessing what drugs at what time to ensure that the amount of drug ordered, administered, and wasted is appropriate. Resolve discrepancies as soon as possible, ideally within 24 to 72 hours.11 ADCs may help support this function by providing documentation, tracking usage, and generating alerts and reports for abnormal activity compared to peers. Opportunities for drug diversion between drug withdrawal and administration can be reduced through measures such as defining a specific interval within which drugs should be administered after retrieval and only permitting access to ADCs in the primary work area.19 Credentials such as passwords and identification badges should never be shared among employees.14
Ensuring secure containment for both wasted and expired drugs is key. In addition, waste audits should be conducted regularly, and the documentation reviewed to verify compliant practices are consistently followed. Waste containers should preclude the removal of drug by force. Further security may include physically securing the containers in place and utilizing cameras for surveillance.20 Drugs returning to the pharmacy for disposal should be closely tracked and all other waste should be witnessed and co-signed.11
Identifying vulnerabilities in the medication-use process is the first step to developing effective prevention strategies. Recognizing the signs of drug diversion and integrating targeted prevention strategies composes the necessary framework for a robust controlled substances diversion prevention program. With leadership and collaboration, organizations can create a culture of awareness and accountability, from the individual to the organization level, to support drug diversion prevention and response.
Blake T. Barta is a fourth year Doctor of Pharmacy Candidate at the UNC Eshelman School of Pharmacy in Chapel Hill, North Carolina, and a pharmacy technician at the University of North Carolina Medical Center in Chapel Hill, North Carolina. He graduated from the University of Florida with a Bachelor of Science in Biology. He is pursuing a Health-System Pharmacy Administration and Leadership residency. Blake’s professional interests include inpatient operations and automation, sterile compounding, data analytics, and infectious diseases.
Tyler A. Vest, PharmD, MS, BCPS, BCSCP, is a pharmacy manager of automation, medication distribution, and controlled substances at Duke University Hospital in Durham, North Carolina. He is also an assistant professor of clinical education at the UNC Eshelman School of Pharmacy. Tyler received his Doctor of Pharmacy degree from the University of Cincinnati James L. Winkle College of Pharmacy and his MS in Pharmaceutical Sciences with a specialization in Health-System Pharmacy Administration from the UNC Eshelman School of Pharmacy. Tyler’s professional interests include acute care operations, leadership development, oncology, pharmacy technician advancement, distribution models, productivity and monitoring, and the medication-use process.
Duke’s Spotlight on Drug Diversion Prevention
Duke University Hospital (DUH) is consistently rated as one of the top hospitals in the United States, recognized for outstanding care and groundbreaking research. With 980 inpatient beds, Duke offers comprehensive diagnostic and therapeutic facilities, including a regional emergency/trauma center, a major surgery suite comprising 51 operating rooms, an endo-surgery center, an ambulatory surgery center with nine operating rooms, and an extensive diagnostic and interventional radiology area.
Pharmacy uses a point-of-care distribution model supported by several satellite pharmacies and more than 250 ADCs. High-density storage carousels support a three-time daily cart-fill for medications that are not stocked in the cabinets. Dose tracking technology serves to monitor medication delivery and ensure that pharmacy technicians stock medications in the correct locations. The technology tracks all oral syringes and intravenous prepared medications, including controlled substances, allowing pharmacy to pinpoint where products are in the medication use process and identify who has handled them.
Throughout the medication use process, DUH has a robust controlled substances monitoring and drug diversion system in place. Inventory and discrepancy reports, including unit-specific reporting, are reviewed by pharmacy leadership on a daily basis to help maintain medication integrity. All areas throughout the institution that store controlled substances are regularly audited. One of the core responsibilities of the diversion-prevention program is to educate those who handle controlled substances. Ultimately, effective diversion management ensures our patients receive the appropriate doses of controlled substances, helping to ensure proper pain management.
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