News about drug diversion is grabbing national headlines across the country, and if you haven't been reading these headlines you need to start... NOW! Here is a quick primer to get you caught up... let's call it the Top 5 things you need to know NOW.
1. It's not a matter of "IF" but rather "WHEN". Do you know that after the Drug Enforcement Agency (DEA) went into Massachusetts General Hospital on a "for cause" investigation of two nurses stealing massive amounts of narcotics1, the DEA showed up at Tufts Medical Center the following week "without cause"? The rationale? ... If it's happening at this site it is probably happening over here too. There has been a progressive increase of investigative activity by the DEA over the past decade or so...the initial focus was on organized crime and international drug trafficking, then localized street gang activity. As law enforcement tightened their grip on this type of illicit activity the focus shifted towards other venues of diversion, namely the retail pharmacy sector. Several years ago the DEA came down on CVS and Walgreen's in the Florida market and other areas for lax oversight of opioid dispensing and purchasing activities. The net was cast wider when the DEA next visited and fined wholesalers such as Cardinal Health™ for not closely monitoring changes and patterns of increased opioid and narcotic ordering trends by pharmacies. With recent DEA activity in hospitals, it's probably safe to say the government is now focused on a new target, hospitals.
2. Fines are amounting in the $MILLIONS. Mass General fined $2.3 million1. Emory Midtown was recently fined $200,000 by the Georgia State Board of Pharmacy, and the hospital's pharmacy license placed on probation for 3 years2.... and the DEA hasn't even levied their fines yet but you can bet it will be big... perhaps even bigger than Mass General.
3. Loss of Reputation. You know this risk exists with patient safety events and other regulatory findings. The reputational risk from drug diversion is no different. Consider the case in Colorado where drug diversion led to potentially hundreds of patients being exposed to communicable diseases3. Or, recent news of 16 patients infected with hepatitis C virus at two hospitals outside Salt Lake City4. A nurse diverted narcotics for personal use apparently sharing the needle also used on her patients. I'll refer you back to point #1 above... do you really want to take this chance?
4. Consider the legal sequellae of patient harm. When patient harm occurs as a result of drug diversion and illicit use by healthcare workers, lawsuits will be filed such as the case against Swedish Medical Center in Colorado5. How big is your Risk budget? Do you have more dollars to put there? Why even take a chance... be proactive and get your wheels in motion.
5. You need a comprehensive strategy TODAY. Drug diversion is not just a Pharmacy issue. Consider all the disciplines that touch this topic... Pharmacy is of course a key player. What about Human Resources, Nursing, Regulatory Compliance and Risk, Facilities, Medical Staff, and Security? Does your organization have a plan in place with a centralized coordinating group? Does your management team know their roles, the communication plan and the progressive steps to guide proactive monitoring and subsequent investigations? Sadly, you are probably not alone if you said "no" to any of the above.
Drug diversion is a real issue and the cause for concern is building more and more each week. Over the last year there have been on average 2 to 3 organizations per month in the news regarding new drug diversion cases. Do you want to be next? Instead, be the next hospital to take action against drug diversion. Not sure where to start? Consider an external review of your organization to help identify risk points and recommend mitigation strategies. Don't have the internal resources to implement mitigation strategies? Consider using an external consultant with expertise and knowledge of the complex structures of hospitals and health systems to effectively map out a successful plan. To borrow a phrase from a classic movie (the original Wall Street), "This is your wake up call, pal... go to work!"
1. Settlement agreement [United States of America and Massachusetts General Hospital]. US Department of Justice website. http://www.justice.gov/usao-ma/file/778651/download. Published September 28, 2015.
2. 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
3. DOlinger and EHernandez, "Swedish Medical Center patients at risk of HIV, hepatitis", Denver Post, February 3, 2016. http://www.denverpost.com/news/ci_29470332/swedish-medical-center-patients-at-risk-hiv-hepatitis
4. MShenefelt, "Investigators: 16 hepatitis C cases identified at McKay-Dee and Davis Hospitals", Standard Examiner, April 4, 2016. http://www.standard.net/News/2016/04/04/State-announces-results-of-hepatitis-C-investigation.html
5. COsher, "Class action suit filed in drug theft case at Swedish hospital that put thousands at risk for hepatitis, HIV", Denver Post, March 8, 2016. http://www.denverpost.com/news/ci_29612427/class-action-lawsuit-filed-drug-theft-case-at-swedish-hospital
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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