addressing the challenges of controlled substances

Provided by ASHP Supported by an educational grant from Fresenius Kabi USA, LLC

Addressing the Challenges of Controlled Substances Diversion in the Health System

A Virtual Midday Symposium conducted at the 2020 ASHP Midyear Clinical Meeting and Exhibition Tuesday, December 8, 2020 1:00 – 2:30 pm ET

Home Study Available January 20, 2021 – May 12, 2022

FACULTY Christopher R. Fortier, Pharm.D., FASHP, Activity Chair Chief Pharmacy Officer Massachusetts General Hospital Department of Pharmacy Boston, Massachusetts

Ryan Haumschild, Pharm.D., MS, MBA Director of Pharmaceutical Services Emory University Hospital Midtown Winship Cancer Institute Atlanta, Georgia

View faculty bios at ashpadvantage.com/diversion/webinar1

ACCREDITATION The American Society of Health‐System Pharmacists is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

• ACPE #: 0204‐0000‐20‐440‐L04‐P & T0204‐0000‐20‐440‐H04‐P & T

• 1.5 hour, application‐based

CE PROCESSING Participants will process CE credit online at http://elearning.ashp.org/my‐activities. CE credit will be reported directly to CPE Monitor. Per ACPE, CE credit for live Midyear activities must be claimed by February 1, 2021. CE credit for this archived activity must be claimed no later than 60 days from the date of completion.

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A relevant financial relationship is defined as a financial relationship between an individual (or spouse/partner) in control of content and a commercial interest, in any amount, in the past 12 months, and products and/or services of the commercial interest (with which they have the financial relationship) are related to the continuing education activity.

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https://www.ashpadvantage.com/diversion/webinar1/

Provided by ASHP Supported by an educational grant from Fresenius Kabi USA, LLC

Addressing the Challenges of Controlled Substances

Diversion in the Health System

Christopher R. Fortier, Pharm.D., FASHP, Activity ChairChief Pharmacy Officer, Massachusetts General Hospital

Boston, MA

Ryan Haumschild, Pharm.D., MS, MBADirector of Pharmaceutical Services, Emory University

Atlanta, GA

All planners, presenters, reviewers, ASHP staff, and others with an opportunity to control content report no financial relationships relevant* to this activity.

*As defined by the ACCME definition of commercial entity.

Financial Relationship Disclosure

© 2020 American Society of Health-System Pharmacists, Inc. All rights reserved. 2

Addressing the Challenges of Controlled Substances Diversionin the Health System

Learning Objectives

• Explain the magnitude of drug diversion in health systems in the United States, including the impact of i.v. push waste.

• Apply institutional strategies to prevent, detect, and investigate theft, loss, or diversion of controlled substances that comply with state and Drug Enforcement Agency regulations.

• Analyze critical points in the medication‐use process with respect to diversion management and surveillance.

• Develop a plan to identify and mitigate areas of risk for drug diversion within an institution.

CURRENTSTATE



Diversion and Healthcare Workers

• More than 100,000 annually

• 1 in 10 will abuse

• Affects people of all demographics equally

Substance Abuse and Mental Health Services Administration (SAMHSA) National Survey on Drug Use and Health: National Findings.September 2008. https://www.dpft.org/resources/NSDUHresults2008.pdf

Substance Use Rates

Baldisseri MR. Crit Care Med. 2007; 35(2 Suppl):S106‐16.

Nurses

4.7% to 8.8%

Pharmacists

9%

Physicians

6% to 8%

Nurses

178 to 334

Pharmacists

18

Anesthesiologists

27 to 36



Increases in Opioid‐Related Overdoses

54% of behavioral health organizations have closed programs and 65% have

turned away, rescheduled, or canceled patients

Shaw G. COVID reignites substance use epidemic. Emergency Medicine News. September 2020; 42(9):26.National Council for Behaviorial Health Member Survey. COVID ‐19 continuing impact behavioral health organizations in need of relief. September 2020.

40+ states increase in opioid‐related

mortality

Opioid overdose increaseMarch 2020: 18%April 2020: 29%May 2020: 42%

Polling Question

Which of the following best describes the status of the drug diversion surveillance program at your organization?

a. We have a 100% comprehensive drug diversion surveillance program

b. We have most pieces of a program in place but there are some gaps

c. We are just starting to establish a program and have a long way to go

d. We don’t have any issues with drug diversion in our institution



Viewpoint from Healthcare Executives

• Surveyed hospitals that did NOT have a drug diversion program

– 2017: 39%– 2019: 41%

Porter Research Study 2020: A comprehensive look at drug diversion from the view of healthcare executives. http://porterresearch.com/wordpress/wp‐content/uploads/2020/05/Invistics_Diversion‐Report‐2020‐Porter_Research.pdf.

Mass General/Emory



Comprehensive Drug Diversion Surveillance Program

1. Drug diversion task force2. Staff education and

competencies3. Surveillance systems

4. Investigations5. Reporting

6. Auditing7. Use of automation8. Pharmacy controls9. Human resources10. Interprofessional

collaboration

STRATEGIES



The Catalyst for Change

https://www.ajc.com/news/crime‐‐law/how‐theft‐ring‐stole‐millions‐drugs‐from‐emory/0GRb0SrS2KCxX85lJMTbxI/(September 4, 2016)

Trust, but Verify“Doverey, No Proverey” – President Ronald Regan

• Patient care was often cited as one of the reasons why a workaround was needed

• There were few restrictions on buyer access to controlled substances in case they needed to go above and beyond by helping with receiving

• Procedural areas historically lacked automation, and “just in time” processes were seen as more “provider friendly”

• Checks and balances existed but meaningful accountability did not always back them up

• Failure to detect drug diversion problems could mean that a big problem is brewing



The Culture ShiftA comprehensive overhaul of controlled substance programmatic oversight and involvement

Engage hospital leadership and the C-

suite sponsors recognizing it takes more

than pharmacy for a comprehensive program

Perform a gap analysis utilizing

tools from leading best pratice

organizations

Develop action plan and

determine risk stratification

Identify the team to lead the initiative and

what additional or repurposed positions

are needed

Engagement of Health System Leadership

• Ensure a culture of continuous compliance is embraced– Not satisfied with steady state

• Investment in several detection strategies across roles• Accountability for drug diversion extends beyond pharmacy

– SMART goals identified on the hospital’s Annual Operating Plan

– Consistent executive summaries made available each month for hospital leadership

• Include supply chain and finance personnel on the controlled substance committee



Prevention through Education

Creating educational opportunities across job roles

• Required annual competency for direct and indirect pharmacy staff

• Controlled substance education incorporated into patient services orientation

– Nursing, etc.• System learning from individual hospital events• Incorporation of medication safety risks pertaining to

controlled substance use and abuse

Warning SignsSituations to be aware of that can be associated with diversion

Characteristics• Volunteering to witness or

administer controlled substances

• Excessive late/early administrations

• Use of large dosage forms requiring significant waste

Symptoms• Major life changes or injuries

• Frequent disappearances from the floor

• Periods of high and low productivity that are not consistent with colleagues

• Float or night shift staff



The Art of Perpetual InventoryLifecycle of controlled substances

• Account for every dosage form from order generation to administration

– Utilization of controlled substance management system within an integrated platform

– Controlled substance order generation based on specific hospital unit utilization or established par levels

– All par level adjustments can be tracked and documented in systems

Traceability of Controlled Substances

Controlled Substance Movement

• Most transactions occur through automated dispensing cabinets (ADC)

• Direct hand‐to‐hand delivery of non‐ADC stock with signature confirmation

• All issues and comments are documented in the ADC

Controlled Substance Reconciliation

• Documentation of waste within the electronic system– Mechanism of witness also

within system

• Controlled substance administration record linked to patient electronic medical record (EMR) for documentation

• Returns can also be linked to healthcare employee and patient

Teitelman J, Detweiler K. AAHA Guide to Safeguarding Controlled Substances. 2020.



Segregation of Duties

• One of the most important strategies utilized for internal control

• Duties are considered incompatible if someone can carry out and conceal an activity based on their daily responsibilities

• Limiting access to the Controlled Substance Ordering System• No one is immune from oversight and separation• Periodic reviews of responsibility are important and

warranted• This is an important principle to implement regardless of size

of the health system

Segregation of Duties

Reduce opportunity for diversion and concealment

Automation helps propose the order on

validated pars

Pharmacy buyer reviews

order andaccumulation

Pharmacy leader reviews and submits

the final order

Pharmacist receives order and compares

with initial order submission

Automation reconciles order

for what is received in vault



Oversight within the Pharmacy

• Create receiving practices that do not involve receiving dock• De‐identify controlled substance shipments but have them

delivered directly to pharmacy

• Limit individuals who can receive controlled substances• Establish robust camera surveillance with multiple angles

covered

Brummond PW et al. Am J Health‐Syst Pharm. 2017; 74:325‐48.

Oversight within the Pharmacy

• Create an electronic and physical matching system– Order generation should match order submission with exception well documented, packing slip should match invoice, and invoice should be reconciled directly into automation

• Limit access to controlled substance vault




Safe Handling of Controlled SubstancesBest practices for administration of medications

• Utilizing the smallest dosage form possible to reduce waste or medication error

• Using prefilled, ready‐to‐administer syringes to reduce the need for compounding and product manipulation after dispensing

• Consistently utilizing same NDC and dosage form to create consistent practices across hospital areas

• Avoiding bulk dosage forms and sending up all doses in patient‐specific forms

Teitelman J, Detweiler K. AAHA Guide to Safeguarding Controlled Substances. 2020. NDC: national drug code

Waste Impacts on Safety/Cost Effectiveness• Understand how controlled substance waste impacts your organization

– Increased waste creates additional opportunities for diversion– Impacts staffing and labor costs– Higher waste also requires additional oversight and monitoring

Hertig et al. Hosp Pharm. Published online ahead of print. 2020 May



• Leftover controlled substance waste can be a pathway for diversion• Reduce opportunities for healthcare workers to divert• Focus on using strategies, such as prefilled syringes in the lowest dosage

form, to decrease leftover waste in disposal and sharps containers

Dangers of Partially Filled Vials/Syringes

Polling Question

Which of the following strategies can be used to minimize controlled substance IV waste?

a. Use of commercially available prefilled syringesb. Purchase of vials and syringes in the smallest dosage

formc. Both use of prefilled syringes and purchase of vials and

syringes in the smallest dosage form availabled. We do not have any strategies in place



Proactive Process Review and MonitoringBecoming more proactive rather than reactive• Selecting a third‐party software program to establish an

ongoing review of automated dispensing cabinet data– Selection has migrated from third party auditing software to new artificial intelligence that has learning capabilities

• Running reports with relevant frequency and creating robust follow up

– Being intentional with the data and requiring real‐time review and feedback

• Establishing benchmarks for all areas of the hospital

SURVEILLANCE



Diversion DashboardSep‐19 Oct‐19 Nov‐19 Dec‐19 Jan‐20 Feb‐20 Mar‐20 Apr‐20 May‐20 Jun‐20 Jul‐20 Aug‐20

Nursing Measures

Anomolous User and User

Activity Checks.

Activity and User Checks (S‐

S‐H).

Pharmacy / Anesthesia

Measures

PCR % MGH Main

PCR % Danvers

PCR % Waltham

Pharmacy Measures

Annual Inventory.

DEA 106 Filings

DPH Filings

Discrepancy Checks (Daily)

Dispense >5 Report.

Destock Transactions

(Monthly)

Destock‐Null Daily

Transaction Review

Omnicell User Adds

Omnicell User Deleted

Override Report.

Site Visits:

Suspicious Order

Monitoring

Discrepancies and Overrides



Discrepancies by Unit

Post Case Reconciliation



Reporting

Next Generation Surveillance



What current electronic diversion surveillance system are you utilizing?

a. First generation: Pandora, OC Analytics, RxAuditorb. Second generation product: Bluesight, Protenus, Invistics,

Heliometrics, BD HealthSight

c. Internally developed systemd. Not currently using any system

Polling Question

Machine Learning Algorithms

• Missing drug alerts• Gaps in documentation• Full waste transactions• Delays in administration• Delays in documentation• Dispense off clock• Pain scales• Monitor in eScribe data



Advanced Algorithms

Major Types of Machine Learning

• Supervised Learning: Learning on labelled data. Typical goal is to predict the label or value.– Example: Given a set of emails labeled as “legitimate” or “spam”, learn the patterns in the text indicating

whether an email is spam, and predict labels for incoming messages.

• Unsupervised Learning: Learning on unlabeled data. Typical goals include finding patterns in the data and identifying data points outside the normal range/pattern.– Example: Given a set of credit card transaction data, identify patterns of typical transaction behavior by

amount, geographic location, and purchase category, and “flag” transactions that are anomalous and may indicate fraud.



What is Machine Learning?• Supervised

– Must be exact or won’t progress forward

– Testing with different datasets often ends with poor results

– Will be too specific across hospitals with limited datasets

– Would need millions of rows

– If behaviors change, not able to adapt quickly

• Unsupervised

– Changes as behavior changes. What is identified as being risky changes based on the data being given and over time

– Looks for trends

– Don’t need to “train the machine”

Vendor Assessment

• Request for information

• Vendor demonstrations– Utilize drug diversion task force/interprofessional reps

• Vendor criteria and scorecard • Reference checks• Information technology (IT) requirements –interoperability and interfaces



Vendor AssessmentEVALUATION CRITERIA VENDOR #1 VENDOR #2 VENDOR #3

Ease of use

Visualization and dashboards

Alert methodology/algorithm

Type of alerts/behaviors evaluated (pain scores, shift analysis)

Machine learning capabilities

System documentation capabilities

Director/manager notification/email

Discrepancy compliance reporting

Pharmacy controls (narcotic vault reconciliation)

Non‐profile cabinet capabilities

Health system level analytics

Standardized and custom reporting capabilities (provider, medication, location, time)

Cloud capabilities

Closed loop functionality (ADC, AWS, EMR, wholesaler, ADT)

Real‐time data

Archived data (2 years readily available)

Interface/IT requirements

Staff training (nursing, pharmacy, anesthesia)

Implementation process and timelines

Equipment/software purchases

Fees, contract terms

Future roadmap

Overall ranking

GAPANALYSIS



Utilizing a Gap Analysis

Tool

• An assessment of current controlled substance performance compared with what it should or can be

• Used to identify what is preventing us from reaching that goal and how to get there

WHERE ARE WE NOW?

WHERE DO WE HOPE TO BE?

WHAT IS MISSING?

HOW CAN WE GET THERE?

SELF AUDIT / MONITORING

Gap Analysis Resources

Brummond PW et al. Am J Health‐Syst Pharm. 2017; 74:325‐48.Minnesota Hospital Association. Road Map to Controlled Substance Diversion Prevention 2.0, 2015.

Teitelman J, Detweiler K. AAHA Guide to Safeguarding Controlled Substances. 2020.



Gap Analysis Focus Areas


• Delivery of medications to the pharmacy

• Reconciliation of purchases or order generationProcurement

• Multiple‐dose vial overfill• Prepared syringe contents diluted or replaced with waterDispensing

• Prescription pads diverted or used inappropriately• Verbal orders for controlled substances created but not verifiedPrescribing

• Controlled substances pulled on discharged patient• Medication documented as given but not administered Administration

• Waste is not adequately witnessed by observation• Expired controlled substance taken from holding areaWaste

In which of the following steps in the medication‐use process does your organization have the greatest gaps in the handling of controlled substances?

a. Procurementb. Dispensingc. Prescribingd. Administratione. Waste disposal

Polling Question



Controlled Substance (CS) Gap Analysis Tool

SECTION ITEM Priority COMMENT TIMELINE

1.1

All CS are procured from the pharmacy. If other departments or individuals are authorized to procure CS, there are checks and balances established to ensure the same policies and procedures are consistently followed throughout the organization. Complete

1.1Separation of duties exists between the ordering and receipt of CS: Complete

1.11

Two authorized individuals count and sign (two signatures) for CS upon receipt (packing slip), and confirm that what is received matches what was ordered and invoiced (purchase order and invoice). < 1 year

1.13Automated vault technology is utilized in the central pharmacy main storage location. 3+ years

Evaluate the Gap ‐ Procurement

Order methodology

Ordering CS rights and privileges

Location of order received

Receiving the order

Order content verification



Measures of Success

Teitelman J, Detweiler K. AAHA Guide to Safeguarding Controlled Substances, 2020.

• % orders submitted unchanged

Order Methodology

• % compliance with segregation of duties

Ordering Privileges

• % orders received and reconciled same day

Order Receiving

• If specific measures of success are not met, targeted audits should be performed

– Audit of wholesaler segregation of duty settings• Targeted audits should be completed for short defined time

period– Workflow updates should be made based on identified areas of improvement

• Audit example: review daily report of users submitting orders

Targeted Self‐Audits



Key Performance Indicators

Minnesota Hospital Association. Road Map to Controlled Substance Diversion Prevention 2.0. 2015.

Indicator Description Importance

Time to Detection Time between event and detection

Validating tools and measures are appropriate

Time to Resolution Time elapsed between event and resolution

Reduces gaps in processes in a timely manner

False Positive Rate % investigations wheresuspects are cleared

Measures effectiveness of methods

• Membership includes:

– Executive leadership, anesthesia, pharmacy, nursing, security, human resources, compliance, risk management, legal, IT, and employee health

• Monthly standard meetings to create routine reporting

• Scorecard should include measures of success, targeted audits, and key performance measures

• Gaps and needs should be communicated transparently under privileged discussion


Diversion Prevention Committee



IMPACT OF COVID

COVID‐Related Considerations• Expansion of ICU units • Redeployed nurses and physicians

– More discrepancies, overrides– Travelers– Areas closed that store controlled substances

• High volume of controlled substance purchases and useRemote storage location security and surveillance

• Practice changes – limited access to patient rooms– Wasting and witnessing

• Lax federal and state requirements• Field hospitals



COVID‐Related Considerations

• Mental health impact on healthcare providers and opportunities for diversion and abuse

• Maintain daily surveillance and evaluate trending reports

• Recovery– Debrief– Consider accountability audit– Password and access cleanup

COVID Lessons Learned

• Confirmed strong surveillance framework in place

• Dedicated resources• Practice change gaps• Limited data and manual review and investigation



The New Normal

• Tipping point for staff• Attention from all players

• Practice changes• Future surges

©2020 ISMP | www.ismp.org | 60

KEYTAKEAWAYS



Key Takeaways• Goal to establish comprehensive drug diversion program

• Conduct gap analysis• Ensure diversion committee structure

• Make sure your own house is in shape

• Keep executive sponsors updated• Manual process with limited resources

• Strategies to reduce the risk• Product selection• Surveillance system• Real‐time dashboards

• Little direction from Drug Enforcement Administration

• Interprofessional collaboration

How will you change your practice?• Identify practices that support medication safety and eliminate risks for drug

diversion. • Discuss with key stakeholders interventions to minimize diversion of

controlled substances. • Engage key stakeholders in my health system to develop a drug diversion

stewardship program.• Collaborate with other healthcare providers and hospital staff to reduce the

opportunity for controlled substance diversion.• Develop a plan to ensure controlled substance medications are supplied in the

smallest ready to use dosage forms as possible.• Educate staff on identifying and preventing controlled substance diversion.

Take a moment to reflect on changes you would make based on what you learned today.



• Substance Abuse and Mental Health Services Administration. National Survey on Drug Use and Health: National Findings. September 2008. p83

• Baldisseri MR. The impaired healthcare professional. Crit Care Med. 2007; 35(2 Suppl):S106‐16.

• Shaw G. COVID reignites substance use epidemic. Emergency Medicine News. September 2020; 42(9):26.

• Porter Research Study 2020: A comprehensive look at drug diversion from the view of healthcare executives. https://porterresearch.com/porter‐research‐study‐2020‐a‐comprehensive‐look‐at‐drug‐diversion‐from‐the‐view‐of‐healthcare‐executives/ (accessed 2020 Nov 6).

• National Council for Behavioral Health Member Survey. COVID ‐19 continuing impact behavioral health organizations in need of relief. September 2020.

• Brummond PW, Chen DF, Churchill WW et al. ASHP Guidelines on Preventing Diversion of Controlled Substances. Am J Health‐Syst Pharm. 2017; 74:325‐48. doi:10.2146/ajhp160919

• Minnesota Hospital Association. Road Map to Controlled Substance Diversion Prevention 2.0, 2015. https://www.mnhospitals.org/Portals/0/Documents/ptsafety/diversion/Road%20Map%20to%20Controlled%20Substance%20Diversion%20Prevention%202.0.pdf.

• Teitelman J, Detweiler K. AAHA Guide to Safeguarding Controlled Substances. Lakewood, CO: AAHA Press; 2020.

References

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