The Legal Ramifications of Diversion Prevention


July 2013 - Vol. 10 No. 7 - Page #6

Drug diversion represents a significant public health concern across the United States and estimates of prescription medication misuse suggest a problem of greater magnitude than illicit drugs. Nonmedical uses of opioid pain relievers alone are projected to cost insurance companies upwards of $73 billion annually in health care costs.1,2 Furthermore, in 2009, 1.2 million ED visits were related to misuse or abuse of pharmaceuticals.1 Hospitals present the greatest potential for diversion of prescription medications because medication inventories are abundant and are spread across numerous system access points, including medication rooms and automated dispensing cabinets (ADCs). Further complicating the problem is the higher rate of prescription drug abuse noted in health care workers when compared to the general public due to their increased access to these substances on a regular basis.3,4

Within a hospital, pharmacy holds a fundamental responsibility for managing all medications throughout the facility, and ensuring the safety and security of patients and staff when it comes to medication use. Furthermore, pharmacy bears responsibility for ongoing oversight of medication supplies to facilitate early detection of adulteration, abuse, or diversion. Numerous regulatory agencies mandate this responsibility, including the Drug Enforcement Agency, state boards of pharmacy, and accreditation bodies such as The Joint Commission. 

Design an Effective Diversion Prevention Program
Diversion routinely involves three basic medication types or classes: high-cost medications intended for resale, performance-enhancing medications, and controlled substances. Regardless of the class of medications involved, a multi-tiered and carefully designed surveillance system is essential to the early detection and resolution of diversion. The most successful programs employ multifocal strategies for surveillance, detection, and remediation and are based on the contributions of a multidisciplinary team. Likewise, program objectives, goals, as well as policies and procedures (P&Ps) must be clearly defined and well publicized in order to be effective.

Written P&Ps should provide clear direction and lines of authority for the reporting, investigation, and resolution of diversion episodes, as well as managing those individuals involved in diversion. The term diversion must be clearly defined and sufficiently broad to include future classes of medications. P&Ps must instruct all employees of their responsibility to report any suspected diversion or suspicious activities and also must define the chain of command for reporting and investigating such claims. It is equally important to outline the individual responsibilities of the chain’s hierarchy. Although the chain of command will vary according to the size and other characteristics of each institution, the following positions are commonly included:

Staff Member’s Direct Supervisor 
Oversees activities of those under his or her span of control, including monitoring for behavioral changes, signs and symptoms of diversion, anomalous changes in inventory levels, and detection of abnormal activity

Director of Pharmacy
Is accountable to senior administration, regulatory authorities, and licensing bodies for the activities of the pharmacy department as it relates to diversion, and its adherence to performance and conduct set forth in policies and regulations

Human Resources Representative
Develops and executes policies governing behavior within the institutionState/Federal Drug Control Authority Representative
Ensures that hospital pharmacies adhere to regulations set forth in statutes and investigates deviations from accepted standards of practice

Employee and Data Surveillance
Observational monitoring of staff by supervisors can lead to early detection of common physical and emotional signs and symptoms of substance abuse. Documentation of these observations over time creates a contemporaneous record of potential diversion, but this documentation must be objective, detailed, and whenever possible, corroborated by another supervisor. Suspicion should be raised when any of the following are noted: 

  • Erratic attendance, tardiness, and unanticipated absences
  • Increased confrontation with coworkers
  • Unpredictable mood swings
  • Secretive behavior such as leaving for unknown reasons without prior notice
  • Inappropriate clothing for the environment/time of year
  • Behavior suggestive of impairment such as tremors, slurred speech, or unsteady gait 
  • Unexpected changes in lifestyle or affluence

Effective diversion prevention also requires regular surveillance of medication inventory as well as ongoing review of ADC transaction reports for changes in patterns of use or dispensing. To assist these efforts, several effective computer applications are available that automatically monitor all controlled substance transactions. Monitoring discrepancy reports from ADCs and proof-of-use sheets, along with correlating drug destruction reports with dispensing activities, can provide early insight into potential diversion activities.

If Diversion Is Suspected
The central mission of hospitals is to protect and promote the safety and welfare of their patients and staff. As such, hospitals are expected to serve as patient advocates and have a moral and ethical (as well as legal) obligation to adhere to mandates set forth by statutes and regulatory agencies, including monitoring for illegal and unprofessional behavior. Keep in mind, individuals accused of diversion are entitled to the presumption of innocence until proven guilty. They also have the right to a notification of alleged charges, to view evidence presented against them, and to legal representation. The rights of the hospital in cases of diversion or suspected diversion are largely dictated through internal policies regarding theft and fitness for duty. Therefore, policies should be in place to address as many contingencies as possible without constraining the organization with cumbersome detail. Such policies should clearly define drug diversion within the context and scope of the organization’s operation, responsibilities for reporting of diversion, the manner of disposition of diversion allegations, the reporting cascade for diversion events, as well as the manner of involvement of external authorities.

The hospital’s policy, as well as state laws, should dictate the role of substance abuse testing. Hospitals that engage in substance abuse testing must have a comprehensive written policy that is uniformly applied to all employees. In states where reasonable suspicion testing (see SIDEBAR) is allowed, adherence to the criteria authorizing this manner of testing must be followed, and the institution’s policy must clearly delineate the consequences of refusal to test. A copy of this policy should be provided to all employees for review prior to commencement of duties.

When testing is permitted, the suspected diverted medication must be considered in order to select the best test methodology (eg, urine vs blood). In order to avoid challenges to test integrity, specimens must be collected under a strict chain of custody and a confirmatory test methodology equivalent in accuracy to gas chromatography or mass spectroscopy should be employed. Hair testing has limited utility due to its inability to detect the presence of a specific drug at a discrete point in time. 

Interviewing a Suspected Diverter
Interviews conducted for suspected episodes of diversion must be carefully prepared and structured. The accused should be escorted directly to the interview site by their direct supervisor without any stops en route, and the interview should take place in a private, quiet location away from the subject’s workplace. Interviews should be conducted as close in time to the alleged diversion as possible, but only after sufficient evidence has been collected and is ready for presentation. Evidence should be based on objective sources to the greatest extent possible, and all interviews should be disclosed and maintained as confidential proceedings. The accused should be informed of his or her rights including the right to legal counsel.

The interview is best conducted by individuals with whom the accused is not familiar, and may include a human resources representative and/or representatives from the state pharmacy regulatory body; the pharmacy director or a designee may also be present. The interview team should meet prior to the interview to designate a lead investigator, plan the interview strategy, and coordinate evidence for a seamless presentation. The interview team should include a trained interviewer, as the correlation of physical, verbal, and cognitive responses during the interview process can provide critical clues regarding guilt or innocence. Behavioral changes and changes in speech, body language, and posturing during the interview contribute to a global picture. Interviewers should watch for increases in rates of perspiration and respiration that do not resolve during the course of the interview, as well as listen for contradictions of previously submitted statements. It is important to understand that a determination of truthfulness relies not only on these observations, but also requires the extensive training and practice in their interpretation that a trained interviewer can provide.

An experienced interviewer is able to interpolate data and information from disparate sources into a global framework through which to assess the guilt or innocence of the alleged diverter. Data gained from statistical review of dispensing, administration, and inventory control records must be considered along with direct and indirect observations, and knowledge of the suspect’s personal life in order to create a comprehensive profile upon which to structure the interview questions and direction. Although considerable expertise may be developed through ongoing participation in this genre of interview, advanced techniques may be obtained and refined through participation in commercial interviewer training opportunities. 

Weighing the Evidence
Proceeding with only circumstantial evidence of diversion is difficult, and great care must be exercised if this course of action is chosen. It is inadvisable to proceed with interviews or disciplinary proceedings unless there is a factual, solid basis for the allegations. All collected diversion evidence, whether witness observations or data, should be meticulously verified. Whenever possible, obtain observations directly from the witness or supervisor, avoiding secondhand recounts of events. Obtaining supporting data from objective sources, such as ADC counts, lends credibility to the case and helps eliminate claims of subjectivity.

If a suspected diverter claims his or her innocence, what happens next depends upon the strength of the evidence. If the evidence is strong enough without a confession, the case should be pursued. If not, the evidence should be revisited for possible alternative explanations. Should the evidence continue to be compelling although insufficient for a solid case to be made, and the suspect continues to work, surveillance and monitoring for subsequent events should continue, and supervisors should consider assigning the employee to roles with less accessibility to high-risk substances.

Should the accused admit guilt, immediately suspend employment if permitted through HR policy. Hospital and patient security must be protected; therefore, it is crucial to immediately revoke this employee’s access to all secure locations and informational systems through inactivation of all passwords, and confiscation of all work-related identification cards, work materials, and keys. Ask the accused to provide written narrative documentation of all activities surrounding the incident. If available, offer him or her the option of assistance for drug abuse rehabilitation. Ultimately, there is no statutory obligation to provide rehabilitation services to an admitted diverter who seeks help. Nevertheless, it is good practice to provide assistance to individuals involved in diversion. Sudden unemployment with no source of income may cause the diverter to resort to further criminal activity to maintain their lifestyle. Without the option of rehabilitation, the problem is not resolved but merely displaced.

Concluding Steps
The state board of pharmacy should be notified as soon as a diversion episode has been positively identified. All proceedings involving diversion investigations and interviews should be treated as confidential information, with only authorized individuals notified of the outcome. This includes, at a minimum, the board of pharmacy, the human resources representative, the director of pharmacy, and the hospital CEO. Should a suspected but unproven diverter leave your facility and seek employment elsewhere, human resources policy should clearly define what information may be provided to outside employers on reference checks, keeping in mind that the presumption of innocence remains. Many hospitals have a policy to only verify any individual’s dates of employment. 

Whatever the outcome, a rigorous diversion prevention program, supported by clear and responsible P&Ps and diligent surveillance and enforcement will not only ensure your facility’s compliance with state and federal regulations, but will help protect your institution’s staff and patients from the risks of impaired practitioners.

References

  1. Paulozzi LJ, Jones CM, Mack KA, Rudd RA. Vital Signs: Overdoses of prescription opioid pain relievers- United States 1998-2008. MMWR. 2011;60(Nov 1):1-6.
  2. Sobel MG. A comprehensive guide to preventing controlled substance diversion. Pharm Purch Prod. 2005;2(6):16-18.
  3. Trinkoff AM, Storr CL, Wall MP. Prescription-type drug misuse and workplace access among nurses. J Addict Dis. 1999;18(1)9-17. 
  4. Hughes PH, Brandenburg N, Baldwin DC, et al. Prevalence of substance abuse among US physicians. JAMA. 1992;267(17):2333-2339.
  5. US Department of Labor. Employee Polygraph Protection Act. http://www.dol.gov/compliance/laws/comp-eppa.htm. Accessed May 11, 2013.

Ralph J. Frank, Jr, RPh, MPH, has served as the pharmacy manager at Hartford Hospital since 2005. He received his BS (1975) and his MPH (1990) from the University of Connecticut School of Pharmacy. Ralph maintains a professional interest in substance abuse trends as well as epidemiological trends of poisoning and overdose events. He is a past president of the Connecticut Society of Health System Pharmacists and also is active in the American Society of Health Systems Pharmacists.

Barbara T. Burke, JD, RN, MS, is a trial attorney who has represented a broad range of clients focusing her practice on personal injury, complex torts, professional negligence, and product liability. She has represented institutions and individuals in catastrophic personal injury cases, and has provided legal counsel and defense of hospitals and other clients in professional licensure actions. In addition to her legal experience, Barbara is a registered nurse with significant experience in critical care and extensive management expertise in multiple practice settings. She received her BSN from Syracuse University, her MS in nursing administration from the University of Connecticut, and her JD from Western New England University School of Law.

 

 

 

 

 

 

 

 

 


Reasonable Suspicion Testing
There are a variety of circumstances under which an organization may require a drug test and reasonable suspicion is among the most common:

Reasonable suspicion testing is similar to, and sometimes referred to as probable-cause or for-cause testing and is conducted when supervisors document observable signs and symptoms that lead them to suspect drug use or a drug-free workplace policy violation. It is extremely important to have clear, consistent definitions of what behavior justifies drug and alcohol testing and any suspicion should be corroborated by another supervisor or manager. Since this type of testing is at the discretion of management, it requires careful, comprehensive supervisor training. In addition, it is advised that employees who are suspected of drug use or a policy violation not return to work while awaiting the results of reasonable suspicion testing.
Courtesy of the US Department of Labor: http://www.dol.gov/elaws/asp/drugfree/drugs/dt.asp


Polygraph Testing 
The Employee Polygraph Protection Act of 1988 (EPPA) generally prevents most private employers from using lie detector tests, either for pre-employment screening or during the course of employment.5 Employers generally may not require or request any employee or job applicant to take a lie detector test, or discharge, discipline, or discriminate against an employee or job applicant for refusing to take a test or for exercising other rights under the EPPA. There are, however, certain exemptions when polygraph use is acceptable. The Act permits exemptions for polygraph testing of certain employees of private firms who are reasonably suspected of involvement in a workplace incident, such as theft, embezzlement, diversion, etc, that resulted in specific economic loss or injury to the employer. When polygraph examinations are allowed, they are subject to strict standards for the conduct of the test, including the pretest, testing, and post testing phases. Polygraph examiners must be licensed and bonded or have professional liability coverage. The Act also strictly limits the disclosure of information obtained during a polygraph test. Keep in mind, the admissibility of polygraph testing varies from jurisdiction to jurisdiction; some states allow results by stipulation while other states completely ban it.

 

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