Medication Management and Diversion Control Karla M Miller, Pharm D July 2017 January 18, 2017 NEWS Surgery Center Director Removed from Position after Alleged Drug Theft Director of the surgery center on the Luther campus on the Mayo Clinic Health System charged with 3 felonies and 3 misdemeanors for allegedly stealing drugs from the surgery center. The former Director admitted to taking and using narcotics one month before being caught and also confessed to stealing several hundred vials of Benadryl. The system believes that no patients were harmed during this process. 1
Scope of the Opioid Epidemic 13 of the highest prescribing states for painkillers have HCA facilities 249 million Rx In 2015 there were over 22,000 deaths involving prescription opioids, equivalent to about 62 deaths per day. Centers for Disease Control and Prevention (CDC). Injury prevention and control: Opioid overdose. 2016. 2
Substance Abuse: Healthcare Professionals It is estimated that 10% of healthcare workers are dependent on some type of drug. Healthcare Professionals versus General Population: o Unique patterns o Disproportionate misuse of prescription drugs by healthcare workers compared to street drugs o Tendencies occur based on the medications readily available Drug diversion in the healthcare setting is difficult to measure Substance Use Disorder: Anesthesiologist Anesthesiologists make up <4% of physicians, but make up 13% of physicians treated for chemical dependency 3x higher than other medical fields Inhalational anesthetics make up only 2% of substances abused by anesthesiologists Sevoflurane has been reported as the drug of choice among the inhalational agents Despite preventative actions, incidence is not decreasing Risk Factors Individual susceptibility Long monotonous working hours Fatigable work shifts Personal problems Easy accessibility to drugs Bajwa SJS. Kaur J. Risk and safety concerns in anesthesiology practice: The present perspective. Anesth Essays Res. 2012;6(1):14 20. Warner DO, Berge K, Sun H, Harman A, Hanson A, Schroeder DR. Substance Use Disorder Among Anesthesiology Residents, 1975 2009. JAMA. 2013;310(21):2289 2296. doi:10.1001/jama.2013.281954. Hines R. Substance abuse in anesthesia providers: An update. http://www.drroher.com/addiction. Accessed February 22, 2017. 3
A Patient and Employee Safety Threat Patient Safety Diversion and opioid tampering has emerged as the leading cause of provider to patient HCV transmission Patients not receiving adequate pain control Patients receiving care from an impaired practitioner Patients not receiving appropriate level of service Employee Safety Harm to another employee Harm to self Suicide Compromised Patient Safety Due to Diversion Six recent examples of Hepatitis C Virus (HCV) transmission associated with injectable opiates 2004 TX Hospital Nurse Anesthetist 16 surgery patients infected 2009 >8,000 Patients Notified, CO Hospital Surgical Technician 26 surgery patients infected 2010 >3,900 Patients Notified, FL Hospital Radiology Technician 5 surgery patients infected 2012 >11,000 Patients Notified (16 facilities, 8 states) Radiology Technician 45 hospital patients infected 2015 >7,000 Patients Notified (2 facilities, UT) Nurse 16 patient infected, 2 hospitals 2016 >4,000 Patients Notified (5 facilities, 4 states) Surgical Technician? hospital patients infected 4
Signs and Symptoms of Substance Abuse Signs and Symptoms Decline in emotional and physical health Weight gain or loss Picking up extra shifts Not taking vacation Frequent brief absence from work area Overly helpful with medication administration process Pain management discrepancies Behavioral Changes Mood changes Lack of concentration Insomnia/drowsiness Poor judgement Hyperactivity / hypoactivity Frequent lying Defensive if questioned Rideout Health 5
Federal Focus on Diversion May 11, 2017 Remarks of Attorney General Jeff Sessions Our country is losing the equivalent of a major league baseball stadium full of people every year to overdoses. That is simply unacceptable. Nearly two thirds of those deaths were from opioids that includes heroin as well as prescription drugs such as oxycodone, hydrocodone, codeine and morphine. Part of DEA s 360 Strategy is diversion control. A lot of drug abuse happens because legitimate controlled substances are diverted from their lawful purposes. We are also targeting and prosecuting dishonest medical providers who violate their oaths by diverting prescription drugs from legitimate uses. The Cost of Diversion 6
Federal Enforcement Against Hospitals Dignity Health (July 2014) Diversion of more than 20,000 hydrocodone from outpatient pharmacy Inventory problems and recordkeeping deficiencies $1.5 million penalty Massachusetts General Hospital (September 2015) Over a one year period, two nurses stole approximately 16,000 oxycodone from ADMs. Nurses failed to report suspicions and upon discovery of the theft, MGH failed to notify DEA. DEA audits identified 24,000 missing or extra pills from the inpatient and outpatient pharmacies Multiple recordkeeping violations $2.3 million penalty Northern Maine Medical Center (August 2016) Failure to maintain proper records of controlled substances wasting/disposal $125,000 penalty Rideout Health (October 2016) Expired DEA license Inadequate handling of controlled substances $2.4 million penalty Abington Memorial Hospital (January 2017) Pharmacist at inpatient pharmacy diverted 35,000 units of controlled substances by exploiting gap in pharmacy s monitoring software Recordkeeping violations $510,000 penalty THE GAZETTE DRUG DIVERSION BY HEALTHCARE WORKERS Ex-surgery center employee charged in drug theft March 8 2017 James Edwards, Wayne County District Attorney announced March 2 nd that Karen Feldner, age 56, of Honesdale was arrested and arraigned that day on charges of Theft of Fentanyl, a felony of the third degree and other charges. A large quantity of fentanyl vials were reported stolen from Mountain Laurel Surgery Center in October of 2016. - Since 1802 In the complaint it is alleged that Feldner stole Fentanyl from the surgical office as an employee, altered documents and forged signatures at the surgical center, obtained Fentanyl through misrepresentation and deception by claiming to have authority from her employer to obtain it when she did not and was in possession of fentanyl. There was a total of 98 vials of Fentanyl that was believed were tampered. Feldner was terminated as a result of her alleged actions. 7
Unattended Controlled Substances Managing A Potential Diversion 8
Where Do you Start? Implement process for managing a diversion prior to diversion occurring Assess the culture in center Do you have a culture of responsibility around controlled substances? Do you have a culture of reporting? Culture will win over strategy 1 7 Creating a Culture to Support Diversion Prevention Efforts Multidisciplinary approach Commitment to standard processes for monitoring and control Defined accountability and responsibility for monitoring in control Commitment to reporting suspicious behavior for both patient and employee safety reasons Make diversion prevention a priority of the entire facility 18 9
Understand Access in the Operating Rooms Evaluate the distribution system What does access look like during and after a case? How does documentation look? Are there orders for the medication Were the medications charted Manual systems much easier to game Evaluate the method for reconciling controlled substances Look for trends and Inconsistency 19 Develop the Diversion Prevention Program Structure Diversion Committee Diversion Response Team Diversion Risk Rounds (unannounced and at least quarterly) 20 10
Suspected Diversion Identify investigation lead (communication channel) Multidisciplinary approach Nurse Manager, Medical Director, Administrator VPO, Regional Medical Director, DQRM, Division Pharmacist Evaluate data Tools Video cameras Badge access data Reports Drug Testing Polygraph (?) Report 21 Would Someone Divert This? 11
Reporting Diversion Federal Law Federal regulations require that registrants notify the DEA Field Division Office in their area, in writing, of the theft or significant loss of any controlled substance within one business day of discovery of such loss or theft. The registrant shall also complete and submit to the Field Division Office in their area, DEA Form 106, "Report of Theft or Loss of Controlled Substances" regarding the theft or loss. (21 C.F.R. 1301.76(b)) 12
Theft All thefts, whether large or small, must be reported to the nearest DEA office upon discovery by utilizing DEA Form 106 Upon discovery is defined as immediately and without delay after realizing there has been a theft or significant loss The DEA views within one business day to be consistent with immediately Local law enforcement as well as state law enforcement should be notified as well as reporting to the state boards (and in some states other agencies) Determining Significant Loss The following factors should be considered when determining if a loss is significant or not: The actual quantity of controlled substances lost in relation to the type of business; The specific controlled substances lost; Whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substances; A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses; and, if known, Whether the specific controlled substances are likely candidates for diversion; and Local trends and other indicators of the diversion potential of the missing controlled substance US Pharm. 2015;40(12):43 45. 21 C.F.R. 1301.74(c) 13
Significant Loss Significant losses are required to be reported to the DEA DEA recognizes there is no single objective standard that can be applied to all registrants what constitutes a significant loss for one registrant may be construed as comparatively insignificant for another Any unexplained loss or discrepancy must be reviewed within the context of a registrant's business activity and environment Updated in a 2005 rulemaking discussion to provide guidance on how to determine if something is a loss vs a significant loss Suspicion of Diversion When there is a suspicion of diversion you should report it to MDT Suspicion of diversion can include but is not limited to: Heavy wastage of drugs Excessive amount of time spent near a drug supply Inconsistent or incorrect charting Behaviors consistent with substance use Frequent and unexplained disappearances during shift Obtains larger doses of narcotics when the ordered dose is unavailable and records the excess as waste Pharmacy Purchasing & Products. 2014;11(3):6 9. 14
DEA Form 106 Patient Case Nurse manager C receives a call from a local hospital and is informed that PRN Nurse D has been diverting medications and has been caught. PRN Nurse D calls Nurse manager C to let him know that she is entering a treatment program. PRN Nurse D tells Nurse manager C that she has never diverted medications from the surgery center. What should Nurse manager C do? a. Immediately notify leadership/mdt b. Review PRN Nurse D activities during monthly review to confirm report of not diverting c. Nothing, PRN Nurse D said they had not diverted any medications 15
Patient Case (Answer) Nurse manager C receives a call from a local hospital and is informed that PRN Nurse D has been diverting medications and has been caught. PRN Nurse D calls Nurse manager C to let him know that she is entering a treatment program. PRN Nurse D tells Nurse manager C that she has never diverted medications from this surgery center. What should Nurse manager C do? a. Immediately notify leadership/mdt b. Review PRN Nurse D activities during monthly review to confirm report of not diverting c. Nothing, PRN Nurse D said they had not diverted any medications Any time an employee has been found to be diverting at another facility, the MDT should be notified and conduct a thorough investigation of the case. 32 16
Unattended Unlabeled Controlled Substances If you are having surgery, do you want this syringe of fentayl that has been left unattended administered to you? 17
Summary Sub headline Pervasive social problem Healthcare professionals not immune Creates serious patient safety concern Exposes organizations to legal and regulatory sanctions Requires constant vigilance Multidisciplinary organizational commitment to a culture of responsibility THANK YOU! 18