As the opioid epidemic continues to rise and regulators clamp down on prescribing requirements, hospitals become bigger targets for diversion of controlled substances.
The CDC recently announced guidelines focusing on improved opioid prescribing practices to further reduce use and access to these medications. Little has been done to address the potential increase in diversion of prescription medications from hospitals. Drug diversion is a multifactorial and multidisciplinary issue, particularly involving pharmacy, nursing and medical staff. Organizations struggle with diversion prevention and often over-rely on automation to control access and detect diversion activity. Hospitals continually fail to recognize the importance of culture and access as two key factors contributing to drug diversion. The human component for a strong diversion prevention plan cannot be underestimated, and is intertwined with the overall culture of patient safety. In addition, pharmacies themselves are especially vulnerable because of the degree of access its employees have to inventory. An area of drug diversion that pharmacies tend to overlook is the segregation of the buyer and receiving duties.
Consider the facts! In a recent California court case (Sternberg v. California State Board of Pharmacy) a pharmacist-in-charge is being held liable by the state for drug theft by a technician due to their responsibility for record keeping and drug security. The technician had stolen at least 216,630 tablets of Norco® over the course of a few years by manipulating purchases, the receiving documents and records.1 In still another incident, at the Salt Lake City VA Hospital, a pharmacy supervisor is suspected of stealing more than 24,000 painkillers and 25 vials of testosterone over five years.2 If the two previous examples weren't enough to catch your attention, Emory University Hospital Midtown was just sanctioned with a $200,000 fine and had its pharmacy license placed on probation for 3 years by the Georgia Board of Pharmacy as part of a consent order. Two pharmacy technicians purportedly diverted more than 1 million doses of controlled substances from October 2008 until July 2013. According to The Augusta Chronicle.3 "The scheme was perpetuated through coordinated illicit activity, including misappropriating credentials from a pharmacy buyer; exploiting use of an electronic function in the hospital's system to conceal the unauthorized purchases, and bypassing the receiving/inventorying process." Many drug diversion programs focus on nursing personnel but these incidents highlight the need for increased scrutiny and segregation of duties with appropriate checks and balances in pharmacy. In one of the most publicized diversion events in 2014, the Director of Pharmacy at New York's Beth Israel Medical Center was charged with stealing approximately 200,000 oxycodone tablets with an approximate street value of $5.6 million. This case highlights both culture and access as the pharmacy director had unrestricted access and the culture tended to ignore warning signs that a person at that level would divert drugs. And finally, Massachusetts General Hospital has agreed to pay a record $2.3 million settlement to the federal government to resolve allegations that its control over the facility's drug supply was inadequate and allowed employees to steal significant amounts of pain medication. In this instance, two nurses diverted more than 15,000 doses of pain medications, primarily oxycodone.
Situational awareness in healthcare. When controlled drugs are used in an organization, all members of the organization should be educated about the internal and external risks associated with diversion, and their responsibilities for safe handling as appropriate to their roles and responsibilities. In healthcare it is not unusual for staff to become comfortable over time when drug diversion is not detected. Drug diversion not detected is not the same as drug diversion not occurring. Staff should receive regular and timely updates on expected behaviour for controlled drug handling so they are aware if something out of the norm is happening. For instance, pharmacy employees who order, receive, and store controlled drugs must be reminded that segregation of duties is a critical part of the checks and balances to prevent diversion and practices changed accordingly. Nursing staff should be well aware of the expectations for wasting controlled drugs and be able to notice when deviations occur. Staff must rely on checks and balances not trust to support a culture of safe handling of controlled drugs.
Empowerment to stop, question, and act. Everyone who works in a healthcare organization that handles controlled drugs must be expected and empowered to speak up when something seems out of the ordinary. This is not always easy to do when staff feels intimidated by those with more experience or authority. Leadership must look for opportunities to recognize and reward when any level of staff "call a situation into question." Staff should be encouraged to speak up and be given channels to safely bring up causes for concern. Typically we think of the staff that is most proximate to controlled drugs as having the greatest opportunity to notice when someone or something does not seem right. With drug diversion, all levels of staff should be encouraged to speak up including environmental service, food service, and maintenance. Empty drug vials in the wrong place or tampered waste containers may be evidence of diversion activities and should be brought to the attention of the department leadership. It is important for senior leadership to close the loop with staff who speak up to let them know the importance of their contributions to patient safety.
To combine or not combine. Oftentimes, pharmacies combine the roles of buyer and receiver to create one job title for a full-time employee. For some hospitals there isn't enough work to justify dedicating one person to either buyer or receiver and defending the reasoning for the difference in pay (if there is one) from the rest of the staff. Pharmacies fail to realize the consequence of having only one employee responsible for both tasks; failure to use a segregated process opens up the pharmacy to potential theft and fails to protect that employee from accusations. Many pharmacies utilize a pharmacist to receive and check scheduled drugs against the manifests and then place them in their designated secure location. An extra set of eyes on what is being ordered and received makes another person aware of what is coming into the pharmacy. Employers sometimes fail to realize how easy it is for a buyer to order something without their knowledge and then divert the product during the receiving process without appropriate check and balances.
What drugs are at risk? It is important to note that scheduled drugs are not the only products diverted. One example of this is Narcan®, now commonly in the news for reversing a heroin overdose. You can imagine what the street value of this product could be to a heroin addict that would like to have Narcan® on hand to avoid issues with law enforcement should an overdose occur. Another example is ephedrine and pseudoephedrine which may be used to manufacture methamphetamine. Most people do not even consider what these two products could be used for, making the ease of diverting these products even easier. Virtually any prescription product may be subject to diversion for personal use or financial gain. Expensive antibiotics, inhalers, anesthetic gases, high cost biotech drugs, and propofol are all possible targets. Another good reason to segregate these job roles relates to the heavy volume of products that are currently on manufacturer backorder. Backordered products have become such an ongoing issue that pharmacy employees have conditioned themselves not to expect a complete order. If only one person is doing both the buying and receiving it could go without question that an employee would miss the difference between a product being diverted and one who's ordered quantity was not completely filled due to a shortage. The question to ask is have you done a risk assessment and what mechanisms are in place to deter diversion. Separation of duties is an easy place to start.
Segregation of duties is an easy first step. Segregating the buyer and receiver duties does not have to be overly complicated, nor does it have to involve hiring extra staff. While a buyer's duties should be limited to very few employees, receiving duties do not need to be. Any employee should be able to match product to manifest. Employees can be rotated through and if you have more than one employee receiving, the faster it gets done. A buyer's duties can vary and be wide-ranging. Separating the receiving duties from them may actually give more time and opportunity to focus on other priorities.
Safety depends on teamwork. Every day in healthcare, teams are making decisions and taking actions that affect the lives of patients, staff, and the organization. This same team approach is critical to the success of diversion efforts. A robust diversion program depends on the collaboration and teamwork of a multidisciplinary group with oversight for managing controlled drugs and diversion events in the organization. Since diversion is an organizational problem, the committee should have members from pharmacy, nursing, anesthesia, security, accreditation, human resources, risk management, lab, environmental services, and human resources, as well as representatives from the medical staff, and senior leadership. The team would be responsible for policies, procedures, staff education and training, diversion monitoring, and management of diversion events. Ideally the team would be aligned with other patient safety efforts and report through similar channels to the Board.
Are you immune? Drug diversion can happen at all levels in the organization. News reports of diversion have implicated pharmacy directors, pharmacists and technicians as well as other health care providers. Implementing appropriate systems of checks and balances along with heightened awareness and sound business principles will aid diversion prevention efforts and protect the innocent.
Consider your options. Healthcare organizations would be well served to undertake a proactive risk assessment of their current drug diversion program, looking for the near misses or gaps in policies, procedures, and practices before a serious diversion event occurs. An internal review may be hindered by lack of time, resources, and perspective. The use of external experts to provide an unbiased "fresh look" at your controlled drug and diversion control processes can help reveal vulnerabilities that your staff is not seeing today.
1MRoss, "5 Court Cases Involving Pharmacists", Pharmacy Times, March 6, 2016. http://www.pharmacytimes.com/news/5-court-cases-involving-pharmacists
2DChen, "Federal authorities investigating large drug theft at VA Hospital", Salt Lake Tribune, March 9, 2016. http://www.ksl.com/?sid=38831444&nid=148&title=federal-authorities-investigating-large-drug-theft-at-va-hospital
3AMiller, "Emory Hospital reports large scale drug thefts", Augusta Chronical, March 8, 2016. http://chronicle.augusta.com/news/crime-courts/2016-03-08/emory-hospital-reports-large-scale-drug-thefts?v=1457457451
James Jorgenson, MS, RPh, FASHP
Chairman and Chief Executive Officer
Jim is Visante's CEO and Chairman of the Board. He is also very active with the overall strategy and project development for Visante's International Practice in the United Kingdom and Canada. His more than 30–year career has included pharmacy oversight of some very large health systems and their network associations as well as academic leadership in graduate pharmacy education. He is credited with more than 100 articles in the professional literature and is a sought after speaker, having given more than 190 presentations to groups in the US, Sweden, Australia, Japan, Spain, Canada, and the United Kingdom. Prior to working with Visante full time, Jim was Chief Pharmacy Officer, Vice President of Indiana University Health (IU Health), which is the largest and most comprehensive state-based healthcare system in Indiana. Before this, Jim was Administrative Director of Pharmacy Services for the University of Utah Health Care in Salt Lake City. In this position he was in charge of all pharmaceutical care for the University Health Care system. He was also appointed Interim Administrative Director for Solid Organ Transplant Services and directed pharmacy services for the 2002 Winter Olympic Games Athletes Village in Salt Lake City.
Gregory Burger, MS, RPh, FASHP – Vice President, Hospital and Health Systems. Greg has particular skills in the areas of hospital pharmacy operations management, drug diversion prevention, standards and compliance, patient safety, multiple facility redesigns and launches, outpatient prescription pharmacy administration, automation, and specialty pharmacy including the 340B Drug Discount program. He is a certified Six Sigma Green Belt in performance improvement methodology. Prior to joining Visante, Greg was Executive Director of Pharmacy Operations at Indiana University Health (IU Health) in Indianapolis, IN. He was responsible for all aspects of pharmacy operations at four hospitals, 6 outpatient infusion center pharmacies and 21 outpatient prescription pharmacies in the IU Health system. This involved overseeing an operating budget of $150 million in expenses and $800 million in revenue plus a staff of 585 full time employees. As Director of Pharmacy at UC Health–University Hospital in Cincinnati, he managed all aspects of pharmacy practice including annual pharmacy budget preparation, administering the hospital's residency program and overseeing 125 FTEs. Greg developed a "best in class" drug diversion program while in Cincinnati, working collaboratively with the DEA, local law enforcement and Board of Pharmacy investigators to detect and convict 73 drug diversion cases over 8 years. Before this, he was with the University of Iowa Hospitals and Clinics in Iowa City, Iowa, where he was Assistant Director of the Department of Pharmaceutical Care and Director of Pharmacy for the Ottumwa Regional Health Center.
Maureen Burger (MSN, RN, CPHQ, CPPS, FACHE) – Chief Nursing Officer, Visante. Maureen is a highly qualified nurse clinician and administrator. Her career covers more than 30 years and incorporates experience in many clinical and administrative aspects of hospital organizations ranging from tertiary referral facilities and academic medical centers to faith-based community networks and critical access hospitals. Prior to joining Visante, Maureen was Vice President Quality, Safety and Accreditation & Regulatory Compliance over the academic health center for the Indiana University Health System. In this position she was responsible for the strategic direction, design and operations of all quality, patient safety, risk management, infection control and accreditation/regulatory compliance programs for four acute care locations including the IU Simon Cancer Hospital as well as all outpatient oncology infusion programs. Prior to this, she was a Continuous Service Readiness Consultant with Joint Commission Resources. In this position she provided services as a highly experienced and objective observer giving counsel on performance improvements as well as accreditation and regulatory compliance issues. Maureen Burger received a Diploma in Nursing from Lutheran Medical Center in Cleveland, OH. Later, she received a Master's degree in Critical Care Nursing from the Frances Payne Bolton School of Nursing at Case Western Reserve University, also in Cleveland. She is a Certified Professional Healthcare Quality (CPHQ) and a Certified Professional in Patient Safety (CPPS). In addition, she has the benefit of Green Belt training in the Lean Six Sigma program. Maureen was recently recognized as a Fellow of the American College of Healthcare Executives.
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