The tragedy of prescription drug addiction is apparent throughout the US. According to the CDC, nearly 15,000 Americans die annually by overdosing on prescription painkillers—more than from heroin, cocaine, and all other illegal drugs combined.1 Increasing prescription opioid abuse means that drug overdoses have become the largest cause of accidental death, surpassing traffic accidents.2
Although the serious addiction and health risks from prescription drug abuse are of prime concern, additional negative repercussions can be averted with effective diversion prevention programs. Reducing health care expenditures is a concern for health systems and payors, as well as state and federal governments. Prescription drug abuse costs medical insurers in the US approximately $72.5 billion annually.1 In addition, significant social costs accompany prescription drug addiction, including reduced productivity, loss of employment, and family and relationship breakups. Thus, considerable incentives exist for all stakeholders to improve oversight of prescription painkillers.
For pharmacists charged with the proper management of medications, these statistics are alarming and unacceptable. Health care workers are not immune to the dangers of prescription drug abuse, and their close proximity to these highly addictive medications requires the development and implementation of effective anti-diversion polices. Although some health care workers divert medications for personal use, others divert to sell drugs to others, supply a significant other or friend, or to ensure a party supply.
Fortunately, a great deal can be done throughout health systems to ensure medication security and prevent drug diversion by health care workers.
The common denominator in all cases of drug diversion is proximity and access to controlled substances. Restricting access to medications by utilizing ADCs and controlled substances vaults, as well as instituting robust tracking technology, are vital to ensuring medication security. Implementing systems that improve control over access to desirable drugs, as well as developing and reinforcing a culture that supports robust diversion management policies and procedures, will best prevent diversion incidence.
Create a Culture of Accountability
Begin by assessing the culture of your organization. Does the hospital reinforce a culture of accountability and personal responsibility? It is difficult to raise staff awareness of diversion when this is not a serious consideration that is regularly addressed in your institution. Oftentimes, when staff members have worked together for many years, the resulting familiarity may lead to a lackadaisical approach to diversion prevention; this can give rise to a culture that suggests diversion is not a major concern. In addition, remember that health care workers at all levels in the organizational structure are at risk; do not assume that individuals in positions of power are immune from the lure of diversion. And the fact that diversion has not occurred previously is not indicative of the future potential for diversion; approximately 10% to 15% of health care providers will misuse drugs and/or alcohol at some point in their careers.3 Moreover, it is probable that diversion has occurred but has simply gone undetected.
Pharmacy should take a leading role in raising awareness; however, diversion prevention must be a multidisciplinary effort that includes senior leadership. Policies and procedures (P&Ps) for all areas involved in storing and administering controlled substances should be carefully developed and implemented, and training should be provided to all staff emphasizing the expectation of adherence. Given this, P&Ps will only prove effective when used in conjunction with a nurturing safety culture. Pharmacy, nursing, human resources, risk management, and senior leadership must work collaboratively to affect and improve the safety culture of the facility.
Restrict Medication Access
Diverters often develop complex, skillful strategies to ensure successful diversion (see Table 1), and thus, effectively restricting access to controlled medications is the first step to preventing diversion. Pharmacy should work collaboratively with nursing, risk management, human resources, and senior leadership to create a plan that controls access. Improving control over medication access is imperative for all health systems, from small rural hospitals to large urban facilities.
Engineer a Transparent Ordering Process
Create a system of checks and balances to ensure that one individual does not have total control over the ordering process. Ideally, medication orders should be placed by one person, received and stocked by another, and the invoice processed by a third. Separation of duties ensures transparency in the ordering and handling of divertible drugs. However, this process should not be considered foolproof, as it is still possible to divert if employees work together to circumvent the system.
To prevent collusion, conduct periodic audits of controlled substance purchases and inventory receipts in ADCs or controlled substances vaults. Evaluate how often pairs of staff witness medication wastage together. In addition, ensure proper control of DEA 222 forms, and carefully evaluate the integrity of your delivery and receipt procedures. If feasible, consider implementing an electronic controlled substance ordering system (CSOS) to streamline the process and enhance security. The DEA’s CSOS is an example of a secure, electronic system for the transmission of Schedule I-V controlled substances without the paper 222 order form (go to http://www.deaecom.gov/about.html for more information). Adopting tamper-evident packaging also may prove beneficial.
Review Storage Concerns
Approximately 90% of hospitals utilize ADCs for medication storage and ideally, an automated controlled substance vault interfaced with the ADCs should be used as well. This will create a closed loop of controlled substance security and provide an audit trail for reconciliation of transactions to and from the vault. Automated controlled substance vaults are capable of generating transaction and discrepancy reports that can be used as a basis for auditing processes. Limit access to the controlled substances vault only to staff requiring access and periodically review ADC override lists to ensure included medications truly must be on the list.
If a manual system must be used, verify that each controlled substances transaction was received at the intended destination.
Incorporate Diversion-Detection Software
Consider implementing diversion-detection software to compliment P&Ps. This technology should be robust enough to ensure both hospital-wide and unit-specific transaction analysis, as well as transaction category analysis (eg, all fentanyl transactions). The chosen system also should have the capacity to evaluate transactions per shift, which is especially useful if your hospital employs part-time or floater nurses who work varying shifts. Look for software that provides waste transaction analyses specifying the number of wastes and the number of times the same two staff members witnessed waste disposal, override transaction analyses, discrepancy resolution analyses, and the ability to automatically flag alerts for hospital-specific thresholds. For example, a facility may choose to set up an alert for acetaminophen and hydrocodone removals in amounts greater than 25 at one time. Ideally, this data should be available in real time.
UV Light Technology
Ultraviolet (UV) light technology enables evaluation of returned narcotics to verify that they contain the indicated substance and amount of medication and have not been tampered with. It is interesting to note that prior to implementing the use of UV light technology to verify returned narcotics, most hospitals used a refractometry method. However, one of the most commonly diverted medications—fentanyl—reads the same as water via refractometry, while UV light technology is effective in verifying the drug and concentration.
Train Staff to Recognize Diversion
Educating staff to recognize the warning signs of possible coworker diversion is an effective method of reinforcing a hospital-wide culture of safety. Defining what constitutes suspicious activity in others and encouraging staff to report suspected diversion should be elements of every diversion-prevention program. Make it clear to staff that if they witness an instance of diversion, they are expected to report it. Diverters, as a group, typically display similar behavior. See Table 2 for information on how to identify an impaired coworker.
Ensure ADC Security
Perform a regular appraisal of how ADC passwords are issued and controlled. For example, upon review of valid ADC passwords, it is not uncommon to uncover several passwords for employees who no longer work at the hospital. So, periodically review and update ADC staff data to ensure that only current staff members appear. Likewise, limit the number of individuals permitted to add and delete staff from ADC technology to control the availability of that confidential information.
If your facility does not use ADCs with biometric fingerprint identification, consider implementing this tool in the future. While some earlier incarnations of this technology had reported design flaws that prevented robust utility, newer versions of biometric fingerprint identification software have improved significantly. Fingerprint identification improves medication security because access cannot be shared or stolen as with password-based systems.
Address Suspected or Confirmed Diversion
When discrepancies are uncovered in an audit, resolution should occur before the end of the shift to determine if the incident is a simple discrepancy or indicative of diversion. Too often these evaluations are put off and addressed long after the event. Confronting discrepancies quickly reinforces a proactive culture of safety and assures staff of management’s commitment to safe medication use.
Central to properly confronting diversion is the adoption of carefully developed, hospital-specific diversion P&Ps. Employees must be educated on correct P&Ps, as well as what steps will be taken if diversion is suspected. Clearly delineate your drug testing policy in P&Ps. Most hospitals perform a drug screen upon hire, and thereafter only when diversion is suspected; random drug screens are less common. However, random drug tests may be implemented in areas of high controlled substance usage, such as the OR. At a minimum, facilities should adopt a for-cause policy.
If a drug screen is negative but diversion is still suspected, additional tactics may be employed, such as installing cameras to record employees’ drug access in areas of suspected diversion. While polygraph testing may be considered, employers generally cannot require a polygraph test and cannot discharge, discipline, or discriminate against employees for refusing a test. Furthermore, the results of polygraph tests are not admissible in court. However, the option to use a polygraph is protected in the 1988 Employee Polygraph Protection Act under an exemption for drug security, drug theft, and drug diversion investigations. Thus, hospitals can legally require a polygraph for staff suspected of diversion provided: the suspected diversion incident is part of a specific ongoing investigation; a written statement has been provided to the employee demonstrating facts and reasonable suspicion (employee access alone is not sufficient); the employee receives 48-hour advanced written notice, including test date, time, and location; and a post-test interview of the employee is conducted, including a written action statement of what occurred, which is kept on file for three years. In circumstances meeting these requirements where diversion is strongly suspected but not confirmed, requiring a polygraph test may be a viable option.
P&Ps also should identify the steps to take if diversion is confirmed, including reporting to professional licensure boards, consideration of criminal prosecution, involvement of local law enforcement, when and how to notify the DEA of discrepancies (using Form 106), and whether the employee will be offered an employee assistance plan or state rehabilitation program. In addition, most facilities have policies specifying that the CEO should be notified in instances of significant diversion. Thus, your hospital’s definition of significant diversion should be outlined in these P&Ps. Most organizations tend to adopt a conservative definition, with anything over a few tablets, milliliters, or dosing units considered significant.
Developing a System-Wide Diversion Prevention Program
The emerging prevalence of mergers and acquisitions throughout hospital systems presents some unique challenges for diversion control, due to differences in information systems, nursing processes, and pharmacy dispensing processes. As noted, a systems approach always should start with a culture of accountability, no matter the particular systems being utilized. A standardized tracking and response process should be implemented to maximize diversion prevention efforts across facilities.
Diversion is a widespread concern in hospitals across the US. However, the development of automated systems and new medication transaction tracking capabilities, as well as increased awareness and education on the depth and breadth of diversion, have provided improved options for preventing it. Pharmacy working collaboratively with nursing, human resources, risk management, and senior leadership will best ensure the success of robust diversion-prevention P&Ps, grounded in a hospital culture of safety.
James A. Jorgenson, RPh, MS, FASHP, is the chief operating officer at Visante, Inc. He has served on the ASHP Commission on Credentialing and the Councils for Legal and Public Affairs and Administrative Affairs and in numerous state-affiliated chapter positions. Jim has authored more than 30 publications and has made more than 100 invited presentations, both nationally and internationally.