Midwinter Meeting February 29, 2020 Whats Mine is Yours Mine: - - PowerPoint PPT Presentation

Midwinter Meeting February 29, 2020

What’s Mine is Yours Mine:

Controlled Substance Diversion in Health System Pharmacy

Megan Evans, PharmD, BCPS Director of Pharmacy

• St. Mark’s Hospital

Disclosure and Disclaimer

The presenter has no conflicts of interest and no off label uses of medications will be discussed. Details of nationally publicized healthcare worker diversion events as well as other de- identified events will be shared. The disease of substance abuse disorder is not taken lightly by the presenter and it is the intent to convey respect toward the persons named herein while discussing the dangerous reality this disorder may present when affecting healthcare workers.

Learning Objectives

At the conclusion of this activity, pharmacists should be able to successfully:

• 1. Appraise known indicators of substance abuse disorder in healthcare workers
• 2. Describe a strategy for identifying diversion in a health‐system pharmacy
• 3. Comply with state and federal requirements for timely reporting of confirmed controlled

substance diversion

• 4. Identify at least one program that offers anonymous assistance to healthcare workers with

substance abuse disorder

Learning Objectives

At the conclusion of this activity, pharmacy technicians should be able to successfully:

• 1. Analyze the role of pharmacy technicians in the timely reporting of confirmed controlled

substance diversion per state and federal requirements

• 2. Describe a strategy for identifying diversion in a health‐system pharmacy
• 3. Identify at least one program that offers anonymous assistance to healthcare workers with

substance abuse disorder

Prefrontal Cortex: Area of the brain uses these rewarding signals to drive decisions toward what is best for individual or group survival Nucleus Accumbens: Area of the brain that releases rewarding signals (e.g. dopamine) for making choices that are good for individual or group survival

Reward System Simplified: Go for a natural high!

“If you want to be happy… then you should keep doing those things”

Prefrontal Cortex: Interprets these signals as evidence that actions to create access to the addictive substance are the very most important things that can be done Nucleus Accumbens: Triggered by addictive substances to release rewarding signals (e.g. dopamine)

Reward System Simplified:

Go for an unnatural high – because can be even better!

“WHOA!!!! If you want to be happy… then you must do whatever it takes to be able to do THAT thing”

Survey 1: True or False

A healthcare worker with substance abuse disorder is motivated at work to…

• Ask lots of good questions – do things “right”
• Know the department policies and adhere to them
• Complete excellent documentation
• Volunteer for extra shifts
• Assist peers
• Anticipate the needs of patients
• Act charismatically
• Take actions that result in being well‐liked

You Cannot Tell Just By Looking At Them

Simplified Addicted Brain Checklist

Does this action give me immediate access to my drug of choice? Does this action ensure continued or future access to my drug of choice? If yes: Do it! x Does this action impede immediate access to my drug of choice? x Does this action restrict continued or future access to my drug of choice? If yes: Do not do it!

Progression of Addiction: Role of Preoccupation1

Preoccupation Euphoria Withdrawal

Preoccupation serves to create euphoria Preoccupation serves to stop the suffering caused by withdrawal

Signs of Addiction in Healthcare Workers2

Spends excessive time around storage location of controlled substances Appears to require more effort than required previously for similar task completion Excuses do not seem to be motivated by providing excellent patient care Leaving work location unexpectedly and frequently Inconsistent work effort Lacks attention or makes inferior decisions Attendance issues Seeks isolation Blames others for issues Appears at work when not scheduled nor expected Peers complain about changes in behavior Documentation is generally bad except for controlled substance documentation Wears long sleeves at inappropriate times Becomes angry when work assignments change Seeks to care for specific types of patients that increase access Unexplained, excessive waste Errors in documentation/records Diminished self‐care

Group Discussion

A problem in the United States? A problem in Utah? A problem in your organization? A problem in your department? A problem with your closest colleagues? Survey 2: Is substance abuse disorder in healthcare workers….

“Not-In-My-Backyard Effect”3

Respondent Type indicating “Yes” Substance Abuse disorder is a problem in: US Hospitals Respondent's Hospital Executive 89% 53% 17% Pharmacists 99% 59% 16% Nurses 97% 70% 13% Anesthesiologist 97% 48% 13% Respondent Type indicating “Yes” It is very or somewhat difficult to detect diversion7 Current tools at their

• rganization are very or

somewhat effective Executives 80% 92% Providers 60% 90%

“You have a personal responsibility to protect your practice from becoming an easy target for drug diversion. You must become aware of the potential situations where drug diversion can occur and safeguards that can be enacted to prevent this diversion.” Drug Enforcement Agency2

Healthcare Workers’ Responsibilities

Identifying Diversion: Health-System Pharmacy

This is an actual picture of me at work…

Stage of Medication System:

Procurement

Anthony D’Alessandro, Chief Hospital Pharmacist, stole 200,000 oxycodone tablets over ~ 5 years with a street value in New York of approximately $5.6 million by “selling” them to a falsified investigational study4 Strategies to Detect and Prevent:5,6

• Audit the leaders – consider using financial auditors or controllers
• Mandate separation of purchasing, receiving, and auditing duties
• Trace inventory access and final disposition of medications
• Reconcile inventory
• Log movement of drug into and out of pharmacy

Stage of Medication System:

Storage

Thirty vials of fentanyl, hydromorphone, and morphine were adulterated in 9 hours at a community hospital. This occurred shortly after the facility increased accountability and documentation for transfers of custody Strategies to Detect and Prevent:5,6

• Monitor for delays between dispense, administration and

return of controlled substances

• Track cancelled transactions
• Confirm inventory discrepancy resolutions
• Educate staff to detect and report signs of adulteration
• Increase individual surveillance after revealing new for‐

cause audit procedures

• Maximize security/surveillance footage of storage locations
• Limit manipulation of commercial packaging to point‐of‐use
• Reduce quantities of accessible inventory on clinical units

Stage of Medication System:

Prescribing

Lori Hoskins, Medical Assistant at a clinic in Utah, stole ~260 prescriptions for oxycodone used to receive ~56,000 tablets billed to insurance for herself, family members and friends by using the clinic physician’s computer password7 Strategies to Detect and Prevent:5,6

• Maintain confidentiality of passwords
• Review transactions at end of shift
• Secure prescription pads and track use
• Improve consistency of order interpretation
• Reduce use of range orders

Stage of Medication System:

Administration

University of Michigan Hospital fined $4.3 million for the

• verdose death of a nurse due to DEA findings of

incomplete/inaccurate documentation and failure to follow‐through with reporting of loss and theft8

Strategies to Detect and Prevent:5,6

• Complete internal audits to ensure compliance with legal

requirements

• Retain records after periodic audits for completion
• Audit use of controlled substance overrides with corresponding
• rders and documentation of need for emergency access
• Investigate use patterns that deviate from expected practice
• Enforce change of custody documentation
• Consider use of software for statistical outlier review
• Report incidents of loss and theft

Stage of Medication System:

Waste, Returns, and Expired Products

Community hospital surveyed over 100 nurses – the most prevalent answer for how they believe diversion

• ccurs is to swap waste ‐ stating “how do you know what

clear liquid is in my syringe? It will not hurt the patient.”

Strategies to Detect and Prevent:5,6

• Unannounced unused drug testing
• Encourage witnessed dispense transactions with immediate waste
• f remainder
• Review security footage to audit gaps in witness procedures
• Periodically inventory expired drugs prior to reverse distribution
• Audit and reconcile documentation to verify wastage

Stage of Medication System:

Peer-Identified Changes in Behavior

Two nurses died at hospital – 2 years apart – from use of controlled substances obtained from the hospital. One of the nurse’s brothers stated: “They knew she was a hard worker… and they covered for her.”9

Strategies to Detect and Prevent:

• Consider substance abuse disorder as a contributor when

investigating errors, patient falls, and patient code blue events

• Create a culture of open communication and awareness about

substance abuse disorder

• Respond immediately and completely to peer complaints –

recognize that voiced concerns are generally the tip of an iceberg

• Encourage self‐reporting and communicate resources for help

Confirmed Significant Loss or Theft

Reference Law Statement Utah Admin Code R156‐37‐602. Records. (2) (a)‐(b) 2) Any licensee who experiences any theft, including diversion, or significant loss of controlled substances shall immediately: a) file the appropriate forms with the Drug Enforcement Administration, with a copy to the Division directed to the attention of the Investigation Bureau; and b) report the incident to the local law enforcement agency.

Step 1: Notify Local Law Enforcement

Reference Recommendations UT Admin Code R156‐37‐602. Records. (2) (a)‐(b) Consider collecting the following before notifying law enforcement:

• Name, DOB, address, and phone number of suspected person (if known)
• Material/evidence with chain of custody documentation
• Written and signed witness statements
• Archived security footage
• Automated dispensing cabinet records
• Badge access records
• Timelines
• Photos

Step 2: Notify DEA Field Office

Reference Statement and Recommendations 21 C.F.R. §1301.76 (b) “Report significant loss or theft to DEA field office within one business day of discovery” Drug Enforcement Administration/Metro Task Force 348 East South Temple, Salt Lake City, UT 801‐524‐4156 Consider including the following:

• Name of DEA registrant
• Date/time of discovery
• What has been lost or stolen (include quantities)
• How you have come to this conclusion
• Reference this law as the reason for this communication
• State that local law enforcement has been notified and that a DEA Form 106 will

be filed if warranted

Step 3: Notify DOPL Investigations

Department of Occupational and Professional Licensing. File A Complaint. https://dopl.utah.gov/complaint/complaint_form.html. Updated: January 2020. Accessed: January 10, 2020.

Step 4: File DEA 106

Reference Statement 21 C.F.R. §1301.76 (b)

• Date of event
• Location of event
• Estimated value
• Specific NDC and quantity of product lost or stolen

Get Help, Anonymously

Organization Mission/Intent Employee Assistance Programs Contact Human Resources, as applicable Voluntary, work‐based program that offers free and confidential assessments, short‐term counseling, referrals, and follow‐up services to employees who have personal and/or work‐related problems Utah Recovery Assistance Program 801‐530‐6740 Assist chemically dependent individuals who hold professional licenses in Utah National Substance Abuse and Mental Health Helpline 1‐800‐662‐HELP Free, confidential, 24/7, 365‐day‐a‐year treatment referral and information service (in English and Spanish) for individuals and families facing mental and/or substance use disorders National Suicide Prevention Lifeline 1‐800‐273‐TALK 24/7, free and confidential support for people in distress, prevention and crisis resources for you or your loved ones, and best practices for professionals

Which of the following could be a sign substance abuse disorder in healthcare worker? A. Excellent documentation B. Seeks to care for specific types of patients

• C. New-onset attendance issues
• D. All of the above

Test Question 1

Healthcare workers have used vulnerabilities throughout the medication system to divert controlled substances? A. True B. False

Test Question 2

According to federal law, within what time period must the DEA Field Office be notified of discovery of theft of a controlled substance? A. One business day B. Within 72 hours

• C. Not required if the theft was not a significant amount
• D. This is not a requirement of federal law

Test Question 3

Which of the following is/are an organization that protects anonymity while providing help for substance abuse disorder in a healthcare worker? A. Human Resources at his/her place of employment B. DOPL Utah Recovery Assistance Program

• C. National Substance Abuse and Mental Health Helpline
• D. All of the above

E. B and C only

Test Question 4

References

1. Herman MA, Roberto M. The addicted brain: understanding the neurophysiological mechanism of addictive disorders. Front. Integr. Neurosci. 9(18):1‐4. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4365688/pdf/fnint‐09‐00018.pdf. [Accessed 27 Dec. 2019]. 2. Drug Enforcement Agency (2019). Drug Addiction in Health Care Professionals. [online] Deadiversion.usdoj.gov. Available at: https://www.deadiversion.usdoj.gov/pubs/brochures/drug_hc.htm [Accessed 11 Dec. 2019]. 3. BD (2019). Health care’s hidden epidemic. [online] go.bd.com. Available at: https://go.bd.com/BD‐Institute‐for‐Medication‐Management‐Excellence‐Drug‐Diversion.html#FormTitle [Accessed 27 Dec. 2019]. 4. Hartocollis A, Moynihan, C. Pharmacist is Accused of Stealing Oxycodone. New York Times. https://www.nytimes.com/2014/07/09/nyregion/pharmacist‐is‐accused‐of‐stealing‐

• xycodone.html Published July 8, 2014. Accessed December 27, 2019

5. American Society of Health System Pharmacists. ASHP Guidelines on Preventing Diversion of Controlled Substances. Available at: https://www.ashp.org/‐/media/assets/policy‐ guidelines/docs/guidelines/preventing‐diversion‐of‐controlled‐substances.ashx. [Accessed January 11, 2020]. 6. Fan M, Tscheng D, Hamilton M, et al. Diversion of Controlled Drugs in Hospitals: A Scoping Review of Contributors and Safeguards. J. Hosp. Med. 2019;14(7):419‐428. 7. Rivera A. Police: Roy woman stole $26K in painkillers with fake prescriptions. Standard‐Examiner. https://www.standard.net/police‐fire/police‐roy‐woman‐stole‐k‐in‐painkillers‐with‐fake‐ prescriptions/article_cecc1965‐3328‐5235‐97c9‐6a94aa2d556e.html. Published January 24, 2016. Accessed December 27, 2019 8. McNeal, B. Record settlement reached in University of Michigan hospital drug diversion civil penalty case. Drug Enforcement Agency Press Release. https://www.dea.gov/press‐ releases/2018/08/30/record‐settlement‐reached‐university‐michigan‐hospital‐drug‐diversion. Published August 30, 2018. Access January 11, 2020. 9. Ambrose S, Hacker H. Two nurses died of overdoses inside a Dallas hospital. What went wrong? The Dallas Morning News. https://www.dallasnews.com/news/investigations/2018/12/02/two‐nurses‐died‐of‐overdoses‐inside‐a‐dallas‐hospital‐what‐went‐wrong/ . Published December 2, 2018. [Accessed December 27, 2019]

Photo References

• Slides 6 and 7: https://publicdomainvectors.org/en/free‐clipart/Head‐cross‐section/53664.html. Accessed January 13, 2020.
• Slide 9 Left: Miller J. Former Utah nurse pleads guilty to stealing painkillers and infecting seven patients with hepatitis C. Salt Lake Tribune. https://www.sltrib.com/news/2019/09/25/former‐

utah‐nurse‐pleads/. Published September 25, 2019. Accessed January 11, 2019.

• Slide 9 Middle/Left:Kristen Parker Appeals for Lighter Sentence. 4 CBS Denver. https://denver.cbslocal.com/2011/01/18/kristen‐parker‐appeals‐for‐lighter‐sentence/. Published January 18,
• 2011. Accessed January 11, 2019.
• Slide 9 Middle/Right: Ramer, H. NH Hospital Tech Sentenced To 39 Years For Infecting Patients With Hepatitis C. CBS Boston. https://boston.cbslocal.com/2013/12/02/former‐exeter‐hospital‐

worker‐to‐be‐sentenced‐in‐hepatitis‐c‐infections/. Published December 2, 2013. Accessed January 11, 2019.

• Slide 9 Right: Presenter’s personal photo.
• Slide 15 Top: https://commons.wikimedia.org/wiki/File:Ostriches‐head‐in‐sand2.jpg. Accessed December 27, 2019.
• Slide 15 Bottom: https://pxhere.com/en/photo/1594923. Accessed December 27, 2019.
• Slide 17: Lamoureux, M. Why We’re Thinking About Conspiracy Theorists Wrong. Vice. https://www.vice.com/en_uk/article/9kgzee/why‐were‐thinking‐about‐conspiracy‐theorists‐wrong.

Published April 11, 2018. Accessed January 13, 2020.

• Slide 18: Hartocollis A, Moynihan, C. Pharmacist is Accused of Stealing Oxycodone. New York Times. https://www.nytimes.com/2014/07/09/nyregion/pharmacist‐is‐accused‐of‐stealing‐
• xycodone.html Published July 8, 2014. Accessed December 27, 2019.
• Slide 19 Right: Presenter’s personal photos.
• Slide 20: Rivera A. Police: Roy woman stole $26K in painkillers with fake prescriptions. Standard‐Examiner. https://www.standard.net/police‐fire/police‐roy‐woman‐stole‐k‐in‐painkillers‐with‐

fake‐prescriptions/article_cecc1965‐3328‐5235‐97c9‐6a94aa2d556e.html. Published January 24, 2016. Accessed December 27, 2019.

• Slide 21: https://www.uofmhealth.org/our‐locations/university‐hospital. Accessed December 27, 2019.
• Slide 22: https://www.pxfuel.com/en/free‐photo‐erjmh. Accessed January 13, 2020.
• Slide 23: Ambrose S, Hacker H. Two nurses died of overdoses inside a Dallas hospital. What went wrong? The Dallas Morning News.

https://www.dallasnews.com/news/investigations/2018/12/02/two‐nurses‐died‐of‐overdoses‐inside‐a‐dallas‐hospital‐what‐went‐wrong/ . Published December 2, 2018. Accessed December 27, 2019

• Slide 27 Left and Right: Department of Occupational and Professional Licensing. File A Complaint. https://dopl.utah.gov/complaint/complaint_form.html. Updated: January 2020. Accessed:

January 10, 2020.