Controlled Substance Diversion and Monitoring in the Hospital

Controlled Substance Diversion and Monitoring in the Hospital Sharon Smith, Pharm. D. , Medication Safety Manager Jerry L. Burleson, RN, MBA, Manager, Employee Health and Clinic

Disclosure Slide • Sharon Smith and Jerry Burleson have no conflicts of interest or any relevant financial disclosures with any commercial companies related to this presentation. • There is no commercial support for this presentation. • There is no endorsement of products or off-label use in this presentation.

Objectives • Discuss the epidemiology, trends, and contributing factors of the prescription drug abuse epidemic • Discuss the risks of diversion to the hospital, co-workers, the individual diverting, and to the patient • List the classes of drugs that are most commonly abused and/or diverted • Discuss behaviors associated with drug abuse and diversion in the hospital • Describe the components of an effective diversion detection and prevention program • Describe what happens when an employee is suspected of diversion/impairment • Describe resources available to help those who may be at risk for diversion

INTRODUCTION • Abuse of prescription opioids and other contolled substances is on the rise across the country and within our community. • Healthcare professionals may be at greater risk for abuse and diversion because of frequent access to drugs in the workplace. • Estimated that 10 -15% of healthcare workers misuse alcohol or drugs at some point in their careers (similar to general public) Those who understand the risks and signs of drug abuse and diversion within the hospital will be better equipped to intervene with patients and colleagues who may be at risk.

Which Case Happened Here? 1. After co-workers complained about her erratic behavior, an ED nurse admitted to “being a heroin addict. ” 2. An ICU nurse was caught withdrawing fentanyl from his patients’ PCA cassettes and self-administering in the bathroom. 3. An ED nurse was arrested after it was discovered she had been stealing doses of hydromorphone, oxycodone, and morphine from Pyxis machines and selling them on the street. 4. A nurse traveler working nights in the emergency department admitted to stealing waste from his patients’ injections of fentanyl, Dilaudid, morphine, and Ativan injections and then taking them orally while working. 5. A nurse was arrested after it was found she had stolen 100 of the 180 oxycodone tablets she had removed from Pyxis over the previous 2 months. 6. A pharmacy technician working nights was found to have been unlocking the backs of Pyxis machines and removing Vicodin tablets to treat his addiction. 7. An ICU nurse asked his coworkers to witness waste of unit dose packages in which he had substituted Tylenol tablets in place of the Percocet. 8. A CRNA was found dead in a hospital restroom after overdosing on his patient supplies of fentanyl. All of them happened here.

Scope of the Problem • Diversion of hospital supplies of medications is not a new thing. But because of the recent rise in abuse of opioids and other controlled substances, we must be more vigilant and work harder to detect and prevent it.

Scope of the Problem The U. S. is in the midst of an epidemic of opioid overdoses. Source: “Drug Poisoning Mortality: United States, 2002– 2014” by Lauren M. Rossen, Brigham Bastian, Margaret Warner, Diba Khan and Yinong Chong, National Center for Health Statistics, CDC

Scope of the Problem Everyday, 46 people die as a result of overdose from Rx painkillers CDC, 2015, NSC, 2014

U. S. Drug Poisoning Deaths By County https: //blogs. cdc. gov/nchs-data-visualization/drug-poisoning-mortality/

Drug Poisoning Deaths – New Hanover County >43 deaths from drug poisonings in NHC in 2014 https: //blogs. cdc. gov/nchs-data-visualization/drug-poisoning-mortality

The Problem Hits Home • Wilmington Police Department reports: • 37 deaths in New Hanover County due to opioid OD in 2014 • 52 deaths in 2015 Mitch Cunningham, Deputy Police Chief, WPD WHQR, Feb 2017

The Problem Hits Home Wilmington leads the nation in opioid prescription abuser rates, according to a report from Castlight Health. Source: The Opioid Crisis in America’s Workforce, Castlight Health, 2016.

The Problem Hits Home Castlight Health Report – The Opioid Crisis • Castlight Health is a San Francisco-based healthcare information company. • In April 2016, they reported findings specific to workforce populations at large self-insured employers. • Greater than 11. 6% of individuals in Wilmington who received an opioid prescription met Castlight's definition of abuse. • Castlight's definition of abuse: – An individual without cancer and/or receiving palliative care, who received a greater than 90 day supply of opioids AND received an opioid prescription from 4 or more providers (from 2011 - 2015. ) This report has gotten out attention. Source: The Opioid Crisis in America’s Workforce, Castlight Health, 2016.

Contributing Factors CDC. gov

Scope of the Problem Drug overdose deaths nearly tripled during 1999 - 2014 CDC, 2015, NSC, 2014

Contributing Factors • Concerns about under-treatment led to more aggressive pain management practices being pushed in the 1990's. • Hospitals accredited by The Joint Commission were required to proactively treat acute and chronic pain, incorporating pain assessment and management tools. Remember "The 5 th Vital Sign? “ • More liberal prescribing practices have resulted in widespread availability of controlled substances for nonmedical use and diversion.

Contributing Factors CDC. gov

Contributing Factors North Carolina averages greater than 1 opioid prescription person.

Path to Addiction and Diversion Past misuse of prescription opioids is the strongest risk factor for initiation of heroin use & addiction Diversion is a symptom of the disease of addiction

A Common Path to Diversion Pain issue due to injury, surgery, ect. Legal Rx for opioids for pain tx Addiction occurs Doctor shopping Legal supply cut off Illegal supply • Diversion • Street supply • Heroin

Diversion from Hospital Supplies • Drugs are typically stolen from hospitals to support an addiction of – The healthcare worker – A friend or partner • Less commonly, drugs are stolen for sale or financial gain

Methods of Diversion from Hospitals • How are drugs being stolen? – Unopened vials – Syringes or vials that have been tampered with, resulting in substituted or diluted drug being administered to the patient – Residual drug left in syringes, vials, cassettes – Discarded syringes in sharps containers – Patches removed from patients’ bodies – Administering part of the dose removed from ADC to the patient, keeping the rest for self-administration

POTENTIAL HARM OF DIVERSION Harm to patient Risks to the individual Risks to co-workers Risks to Hospital

RISKS TO HOSPITAL Loss of revenue from diverted drugs & poor work quality or absenteeism Civil litigation if patient is harmed Negative publicity Civil liability for failure to prevent diversion Time and expense involved in monitoring and investigations

REPORTING TO AUTHORITIES • Any theft or significant loss of controlled substances must be reported to: – Drug Enforcement Administration – North Carolina Board Of Pharmacy – Law Enforcement – Appropriate Licensing Board - eg. , NC Board of Nursing DEA 106 Form used to report loss of CS

RISKS TO CO-WORKERS • Co-workers may unwittingly aid their addicted colleague by “witnessing” waste they did not actually see. This puts the coworker at risk of disciplinary action for not following defined procedures. • Shared patient care responsibilities may result in adverse patient outcomes due to the colleague’s impairment. All members of the healthcare team are at risk of medicolegal liability. • Co-workers may be exposed to bloodborne pathogens if they come upon contaminated needles left by impaired colleague. • Disappointment and mistrust when a colleague is found to be diverting

RISKS TO INDIVIDUAL • Employees who divert controlled substances risk losing their licenses, credentials, and employment. • Consequences may include litigation or imprisonment. – In 2013, a traveling medical technician working in New Hampshire, Maryland & Kansas infected 45 patients with Hepatitis C. He was convicted and sentenced to 30 years in prison. • They risk infecting themselves with bloodborne pathogens. • They risk death or anoxic brain injury due to overdose.

HARM TO PATIENTS • Abuse and diversion of controlled substances by healthcare workers puts patients at risk of: – Lack of appropriate pain relief In 2008, the Mayo Clinic discovered a cath lab nurse was stealing patients' fentanyl, using the syringe on herself, then replacing with saline for use on the patient. So the cath lab patients were getting no sedation for their procedures.

HARM TO PATIENTS Abuse and diversion of controlled substances by healthcare workers puts patients at risk of: • Falsification of records - Inappropriate documentation can lead to patient therapy being inappropriately adjusted. • Theft of patient's supply • Increased charge for patient's medications • Exposure to bloodborne pathogens – In 2010, Mayo Clinic discovered a radiology technician in its Jacksonville, FL location had infected 5 patients with hepatitis C. One patient died.

HARM TO PATIENTS

U. S. Outbreaks Associated with Drug Diversion by Healthcare Providers, 1983 -2013 Centers for Disease Control and Prevention, 2014

Most Commonly Abused/Diverted Medications • Opioids – Oxycodone - is the most frequently dispensed medication to NHRMC patients. Avg > 21, 000 doses per month – Hydromorphone – Fentanyl – Hydrocodone – Morphine • CNS Depressants – Benzodiazepines - alprazolam (Xanax), lorazepam (Ativan) – Hypnotics - zolpidem (Ambien) • Stimulants – Amphetamines - Adderal – Methylphenidate - Concert, Ritalin

How To Identify Someone Who May Be Abusing/Diverting Typical Drug Seeker? ?

How To Identify Someone Who May Be Abusing/Diverting • No typical appearance. Every form, race, age • Could involve any healthcare worker -- nurses, pharmacists, technicians, physicians, respiratory therapists, laboratory technologists, etc. • 10 to 15 percent of healthcare workers have substance abuse problems at some point in their careers.

Who May Be Abusing/Diverting – Nurses? • Nurses are the largest group of healthcare professionals found to be pilfering opioids from hospital supplies. – Nurses who work in high stress environments -- eg. , emergency medicine, critical care units, anesthesia -- may be particularly vulnerable. – Nurses who reported perception of easier availability – twice as likely to divert – Nurses employed by hospitals perceived to have poor workplace control of controlled substances were 1. 5 times more likely to use a controlled substance

Who May Be Abusing/Diverting – Pharmacists? According to the National Institute on Drug Abuse – A study showed that 46% of pharmacists and 62% of pharmacy students reported using a prescription drug without an authorized prescription – 20% of the pharmacists surveyed reported that they had used a prescription drug without an authorized prescription at least 5 or more times in their lifetime. – Predisposed by: stress associated with working conditions or the demands of working long shifts, personal issues, or the belief that their knowledge of medicines will somehow prevent them from becoming addicted

WARNING SIGNS FOR SUBSTANCE ABUSE/DIVERSION Change in shifts or job performance Absence from unit for extended periods Excessive number of mistakes, med errors Frequent trips to the bathroom Arriving late or leaving early Subtle changes in appearance which may escalate over time Increasing isolation from colleagues Inappropriate verbal or emotional responses Diminished alertness Confusion or memory loss NCBSN, 2014

BEHAVIORS ASSOCIATED WITH DRUG ABUSE & DIVERSION IN THE HOSPITAL • Frequent controlled substance discrepancies (undocumented waste, drug counts) • Frequent waste of the entire dose removed from ADC (Automated Dispensing Device) • Long delay in waste following removal from ADC • Failure to waste when partial dose to be given (Undocumented waste) • Numerous corrections of medication administration records • Frequent reports of ineffective pain relief from patients

BEHAVIORS ASSOCIATED WITH DRUG ABUSE & DIVERSION IN THE HOSPITAL • Offers to medicate co-workers' patients for pain • False or altered verbal or phone orders • Variations in controlled substance discrepancies among shifts or days of week • Obtaining med for patients who have been discharged • Overwillingness to work extra shifts • Waste buddies

How to evaluate a Pyxis activity report Compare Pyxis controlled substance activity with Epic charting. − Is there an order for each CS dose removed from Pyxis? − Are all CSs documented as administered? − Does timing of administration correspond to removal time? − Does dose administered match up with amount removed? − Do doses match up with order? Are they given more frequently than ordered? − If total amount removed from Pyxis was not administered, was there a waste documented on the Pyxis report? − Does waste documentation occur in a reasonable amount of time after dose removed from Pyxis? − Do patients report receiving the medications that were administered? − Do patients report their pain not being controlled when under this person’s care? − Does employee behavior seem unusual? If any of the above do not seem appropriate, contact Pharmacy manager to discuss further investigation.

HOW CAN WE DETECT DIVERSION IN THE HOSPITAL? Proactive Diversion Monitoring • Diversion Detection Software - eg. , • Monthly Hot User List • Routine review/audits of CS data • Routine random drug testing

Diversion Detection Software - Rx. Auditor Uses a 10 -Step process to facilitate identification of potential controlled substance diversion activity. Uses Automated Dispensing Cabinet (Pyxis) data

Diversion Detection Software - Rx. Auditor Pyxis activities are compared with other users at the same station or area, and also hospital wide. Statistical outliers are listed with a color-coded metric that helps identify risk level for diversion activity.

HOW CAN WE PREVENT DIVERSION IN THE HOSPITAL? Policies/procedures/ standard work which address: • Procurement • Handling and storage of controlled substances • Maintaining chain of custody • Documentation of administration • Witnessing of waste

HOW CAN WE PREVENT DIVERSION IN THE HOSPITAL? • Camera surveillance in high risk areas • Diversion Response Team - ready to launch to investigate potential cases. Collaboration of Pharmacy, Nursing, Human Resources, Legal Department, and Law Enforcement • Education about risks and responsibility for reporting • Random Drug Testing Program – Organization • Random Drug Testing Program – High Risk Areas

PREVENTION TIPS • • • Only remove medications for your assigned patients Only remove current dose of medication for your patient Administer dose immediately after removal from Pyxis Properly document medication administration and pain scores Waste or return unused medication immediately after administration with a witness Don’t be a “virtual witness” to medication wasting Report medication discrepancies promptly to charge nurse or pharmacy Report attempted inappropriate access to medications to pharmacy Report witnessed or suspected medication diversion to pharmacy

REPORTING SUSPICION OF DRUG ABUSE/DIVERSION • We all have a duty to protect our fellow employees from harming themselves and others. • We should encourage employees to seek help for dependency and addiction. • Once an employee suspects diversion or impairment, it is imperative that it is reported immediately (manager, director, nursing supervisor) to protect the patient. • Your personal observation is vital. It may be the only clue. • Early intervention may help save a co-worker’s career or life. • TRUST YOUR GUT…. . KEEP EACH OTHER HONEST

WHAT HAPPENS WHEN DIVERSION IS SUSPECTED • If impairment is suspected, employee is immediately removed from duty. • Diversion Response Team is put on alert. • Situation is reviewed and data analyzed, including ADC and EMR reports. • Employee is interviewed. • Urine drug screen may be performed if the investigation reveals a possible diversion. • Suspension pending conclusion of investigation.

Reasonable Suspicion Testing Reasonable suspicion is a belief that an employee is impaired and/or is under the influence of alcohol or drugs or diverting controlled substances that can be drawn from specified and particular and objective facts, documented and reasonably inferred from any of the following: − Impairment − Suspected Drug Diversion

Reasonable Suspicion Testing Impairment Observable phenomena, such as the direct observation of drug and alcohol use, drug possession or the physical symptoms of being under the influence of drugs or alcohol such as, slurred speech, unsteady gait and/or odor of an alcoholic beverage. – A pattern of consistent abnormal conduct or erratic behavior. – Conviction for a drug or alcohol-related offense. – Accident, unusually careless acts, incidents where safety precautions were violated.

Reasonable Suspicion Testing Suspected Drug Diversion Investigation During the investigation of situations involving the diversion of drugs and/or other controlled substances. Such investigation may be initiated when reasonable suspicion is presented, which includes − − − − − Medication dispensing system audit discrepancies Removal of patient medication from dispensing system when not needed Wasting discrepancies or non-standard wasting practices Patients complaining of pain despite documentation of medication administration Theft of hospital or patient medication Evidence of substitution or tampering Disappearance from work unit or extended bathroom visits Unusual or careless acts, incidents related to patient medications Any circumstance surrounding potential diversion −

Reasonable Suspicion Testing for Drug Diversion • Employee is explained their rights and responsibilities regarding the urine drug testing and given a copy. • Once samples are obtained the employee is informed that an an administrative suspension will begin effective immediately pending the results of the urine drug test. Testing may take up to 10 business days before results are received. • Once the urine drug test results are received, an analysis of the test results will be performed the Employee Health Medical Review Officer. The determination will either be positive or negative.

WHAT HAPPENS WHEN DIVERSION IS CONFIRMED • The employee suspected of drug diversion will be relieved from duty (if working) and requested to consent to reasonable suspicion testing. • If consent is given, the employee will be escorted to Employee Health for testing. • Employee Health will proceed with an evaluation based on the information provided and obtain written consent to proceed with testing. • Breath sampling for alcohol and urine sampling for drugs will be obtained. Urine sampling will be completed through a chain-ofcustody process.

Reasonable Suspicion Testing for Drug Diversion cont’ • If the urine drug test results are determined to be positive Employee Health will: – Inform the employee of the positive test results and gather information as necessary – Inform the employee that he/she will be contacted by the Manager regarding further steps/investigation processes – Inform the employee that appropriate licensing agencies will be notified (if applicable) – Inform the HR Business Partner and Manager of the test results

WHAT HAPPENS WHEN DIVERSION IS CONFIRMED • Employment disposition will be determined. • Theft/loss will be reported to law enforcement, and all state and federal drug enforcement and licensing agencies as required. • Patient billing implications will be determined and rebilled as appropriate. • Patients will be notified as appropriate.

Resources For the Employee With a Drug Problem

• Questions?