Pharmacy Track: Identifying and Remedying Internal Diversion IssuesTITLE

Pharmacy Track:
Identifying and Remedying
Internal Diversion Issues
Presenters:
• William J. Lynch, Jr., RPh, Clinical Staff Pharmacist,
Kennedy University Hospital-Cherry Hill Division,
and Task Force Manager, Camden County (NJ)
Addiction Awareness Task Force
• Jeanne Tuttle, RPh, National Pharmacist Program
Manager, Pharmacy Benefits Management Services,
Department of Veteran Affairs (VA)
Moderator: Tom Handy, Chair, Operation UNITE Board
of Directors

Disclosures
• William J. Lynch, Jr., RPh – Speaker’s bureau: Zogenix
• Jeanne A. Tuttle, RPh, has disclosed no relevant, real or
apparent personal or professional financial relationships with
proprietary entities that produce health care goods and
services.
• Tom Handy has disclosed no relevant, real or apparent
personal or professional financial relationships with
proprietary entities that produce health care goods and
services.

Disclosures
• All planners/managers hereby state that they or their
spouse/life partner do not have any financial
relationships or relationships to products or devices
with any commercial interest related to the content of
this activity of any amount during the past 12 months.
• The following planners/managers have the following to
disclose:
– Kelly Clark – Employment: Publicis Touchpoint Solutions;
Consultant: Grunenthal US
– Robert DuPont – Employment: Bensinger, DuPont &
Associates-Prescription Drug Research Center
– Carla Saunders – Speaker’s bureau: Abbott Nutrition

Learning Objectives
1. Identify internal diversion trends.
2. Outline internal diversion prevention
strategies.
3. Describe the VA’s controlled substance
inspection program.

William J. Lynch, Jr. BS-Pharm, RPh
Clinical Staff Pharmacist-Kennedy University Hospital
Core Teaching Affiliate of Rowan School of Osteopathic Medicine
Rutgers University, Ernest Mario School of Pharmacy Preceptor
Camden County New Jersey Addiction Awareness Task Force
State of New Jersey Police Training Commission Instructor
Camden County College Police Academy Instructor
Delaware Prevention Coalition Partner
National Prescription Drug Abuse Summit
April 8, 2015

Disclosure Statement
William J. Lynch, Jr. BS-Pharm, RPh wishes to
disclose he is a consultant with Zogenix, Inc.
He will present this content in a fair and
balanced manner

Learning Objectives
• Identify internal diversion trends
• Outline internal diversion prevention
strategies
• Describe the VA’s controlled substance
inspection program

A Wise Person Once Said…
It is important to learn from your mistakes
It is truly better to learn from someone else’s

A Wise Person
Once Said…
Few things are
more important
to someone than
their life or
livelihood

Reality Check
If you have ever
been apart of a
narcotic
investigation,
everyone is under
suspicion.
After living through
that experience, you
will never practice
the same way again.
EVER!

Diversion…
• “Diversion” means the transfer of a controlled
substance from a lawful to an unlawful
channel of distribution or use.
Uniform Controlled Substances Act (1994)1
• “Diversion” means any criminal act involving a
prescription drug.
National Association of Drug Diversion Investigators (NADDI)2
1 Berge, KH et al. Diversion of Drugs Within Health Care Facilities, a Multiple-Victim Crime: Patterns of
Diversion, Scope, Consequences, Detection, and Prevention. Mayo Clin Proc. July 2012;87(7):674-682.
2 What exactly is drug diversion?
http://www.naddi.org/aws/NADDI/pt/sd/news_article/43411/_self/layout_details/false
Accessed February 24, 2015

NIMBY *
If you are not finding any diversion…
You are not looking hard enough!
*NIMBY: Not in My Back Yard

Significant examples of high profile large-scale controlled substances
(CS) diversion in hospital, community, and mail-order pharmacy settings
• Maryland (2005): 7,900 oxycodone extended-release (ER)
tablets were unaccounted for. No arrests were made. The
university hospital agreed to a settlement with the US
Attorney’s office and paid a $250,000 fine.19
• Indiana (2007): A female pharmacy technician was
responsible for diverting more than 623,000 tablets of
hydrocodone-acetaminophen tablets from a hospital’s clinic
pharmacy. Her son (not an employee) was also implicated.
The not-for-profit hospital paid $2 million in fines.20
Martin, ES. et al. Preventing Large-Scale Controlled Substance Diversion From Within the Pharmacy.
Hosp Pharm May 2013; 48 (5):406-412

Significant examples of high profile large-scale controlled substances
(CS) diversion in hospital, community, and mail-order pharmacy settings
• Texas (2010): Five hospital pharmacy employees fired after
arrested for diverting >370,000 CS dosage forms (primarily
hydrocodone-apap tabs) from hospital clinic pharmacies. Some
technicians allegedly chose to train as technicians, hired on
with express intent of large-scale CS diversion with support of
outsiders. Two nonemployees also arrested. Public hospital
paid $100,000 in fines.21
• Pennsylvania (2012): Mail-order pharmacy chain paid $2.75
million in settlement with US Attorney’s office for allowing
employee diversion of undisclosed amount of prescription
controlled substances into ‘‘illicit channels’’ and for other
violations.22
Martin, ES. et al. Preventing Large-Scale Controlled Substance Diversion From Within the Pharmacy.
Hosp Pharm May 2013; 48 (5):406-412

Scope of the Problem
• Estimated 7%-24% of nurses practicing in US
experience chemical impairment
– ER nurses at particular risk due to stressful nature of
position/availability of substances1
• Nurses who divert drugs may not fit substance
abuser stereotype
– May be overachievers, very outgoing, signing up for all
hard shifts to fill, everyone’s friend, helpful with
assisting colleagues with medicine administration
– Most reviewers start investigation process in full
denial2
1 Emergency Nurses Association. Position Statement: Chemical impairment of emergency nurses.
December 12,2006. www.ena.org/about/position/PDFs/ChemicalImpairment.PDF
2 Journal of Emergency Nursing Narcotics Diversion: A Director’s Experience 2007:33:175-8

Scope of the Problem
• Specialty of nurse anesthesia has near 10% of
practitioners who face a chemical dependency1
• Between 1996-2006:
– 217,957 violations by 52,297 nurses reported to NURSYS
database
– 44/60 member boards of the National Council of State
Boards of Nursing
– 60,010 (27.53%) related to ETOH/drugs; 16,268 drug
diversion by nurse for own use2
– Underestimated (not just with only 16 not reporting)
1 A Nurses Responsibility: Report Possible Narcotic Diversion, http://allnurses.com, May 18, 2011
2 Burke, J. Nurse Diversion in Health Facilities Part I Pharmacy Times. August 1, 2010

Warning Signs of Chemical
Dependency: Job Performance
• Inconsistent work quality, alternate periods of high and
low efficiency
• Increased difficulty meeting deadlines
• Unrealistic excuses for lowered work quality
• Job shrinkage, doing minimum work necessary for job
• Sloppy/illogical charting
• Excessive number of mistakes/errors of judgment in
patient care
• Long breaks/lunch hours
2 Adapted from Hughes, TL, Smith, LL,. Is you Colleague Chemically Dependent? Am J Nurs 94(9):31-35, 1994,
and Catanzarite, A., Managing the Chemically Dependent Nurse, A guide to identification, intervention, and
retention, AHA Books, 1992.

Warning Signs of Chemical
Dependency: Job Performance
• Frequent/unexplained disappearances during shift
• Lateness for work and/or returning from lunch
• Volunteering to work overtime despite difficulty
showing for scheduled shifts
• Excessive use of sick time, especially following days off
• Absences without notice or last minute requests for
time off
• Repeated absences due to vaguely defined illnesses

Chemical Dependency Warning Signs: Behavior,
Attitude, Mood and Mental Status
• Wide mood swings from isolation to irritability
and outbursts
• Difficulty in concentration
• Marked nervousness on job
• Decrease in problem solving ability
• Diminished alertness, confusion, frequent
memory lapses
• Difficulty in determining or setting priorities

Chemical Dependency Warning Signs:
Behavior, Attitude, Mood and Mental Status
• Isolates from others, eats alone, avoids
informal staff get-togethers, requests transfer
to night shift
• Unwillingness to cooperate with co-workers or
inability to compromise
• Avoids contact with supervisor
• Over reaction to real or imagined criticism
• On unit when not on duty

Medication Centered Problems
• Consistently volunteering to be medication nurse
• Offering to hold narcotic keys during report
• Volunteering to work with patients who receive regular
or large amounts of pain medication
• Frequently found around medication room or cart
• Insists on administering drugs via IM when other
nurses give it PO to same patient
• Patient charting reflects excessive use of PRN pain
medication compared to shifts when other nurses are
assigned to same patient

• Patients complaining of little or no relief from pain
medications when nurse is assigned to patient
• Use of two smaller tablets of medication to give
prescribed dose (three 5 mg oxycodone tablets instead
of one 15 mg tablet)
• Use of larger than necessary dose, wasting the rest
(4 mg morphine when patient is to receive only 2 mg)
• Overzealous/always willing to sign for receipt of
controlled pain meds

• Missing drugs or unaccounted doses
• Frequently reporting spills, wastage or breakage of
medications
• Charting errors include medication errors
• Defensive when questioned about medication errors
• User names/passwords used by individuals when their
shift is over/off the clock/not working
• User names/passwords used by other individuals when
that nurse’s shift is over/off the clock/not working

Common Behaviors that Raise
Suspicions of Diversion
• Frequent tardiness
• Prolonged/frequent bathroom breaks
• Arrival at work when not scheduled
• Early arrival/late departure from work
• Regular requests for overtime/offers to
work overtime
• Frequent withdrawal of larger doses
than needed
• Wasting of entire doses
• Pattern of removal or wasting near the
end of a shift
• Poor judgment
• Inconsistent medical record entries
• Erratic work performance/implausible
excuses for poor performance
• Change in personality, appearance, or
demeanor
• Drugs or syringes in pockets
• Syringes inappropriately left out
• Patients complaining-unrelieved pain
• Missing medications or discrepancies
• Signs of medication tampering, holes
in packaging or glue around caps
• Missing prescription pads
• Evidence of tampering with sharps
containers
New, Kimberly. Preventing, Detecting, and Investigating Drug Diversion in Health Care Facilities. Missouri
State Board of Nursing . November, December 2014, January 2015. p. 12. Reprinted with Permission Journal
of Nursing Regulation Volume 5, Issue 1, April 2014 Publisher: National Council of State Boards of Nursing

Common Methods of Diversion
• Removal of medication when patient does not need it
• Removal of medication for a discharged patient
• Removal of a duplicate dose
• Removal of fentanyl patches
• Removal of medication without an order
• Removal under a colleague’s sign-on
• Substitution of a non-controlled substance for a controlled
substance
• Theft of patient medications brought from home
• Failure to waste when indicated
• Frequent wasting of entire doses

Diversion Causing Patient Harm
“Drug diversion harms patients,
staff members, the community,
institutions, and the diverters
themselves.”

• Patients can be harmed by:
– Receiving care from an impaired provider
– Being denied pain medication
– Receiving an unsafe substance instead of a
controlled substance
– Receiving injections from tainted needles,
syringes, or vials

In 2012, nurse pleaded guilty to theft of
hydromorphone in hospital. Nurse removed
hydromorphone from medication bags replaced it
with saline. Twenty-five patients infected with
Ochrobactrum anthropi, a blood-borne pathogen.
Six required treatment in intensive care setting;
three underwent surgical intervention because of
symptoms from unidentified source; one died.
Nurse sentenced to 2 years in prison
(Hanners, 2013).

In 2013, radiology technician who worked
extensively as a traveler pleaded guilty in federal
court to charges of drug theft and tampering after
he was found to have stolen fentanyl at several
institutions. He took syringes containing fentanyl,
injected himself, replaced fentanyl with saline, and
returned tainted syringes for patient use. More
than 45 patients contracted hepatitis C as a result
of his diversion. Technician was sentenced to
39 years in prison. (Marchocki, 2013).

Risks To Diverting Health Care Worker
• Loss of professional license
• Excluded from health care employment by federal government
under Office of Inspector General’s (OIG) exclusionary authority
– exclude individuals from work in health care if guilty of felony or
misdemeanor drug related offense
• Incarceration
– (42 U.S.C. § 1320a-7(a)(4), 1996; 21 U.S.C. §841 et. seq., 1980)
• Physical injury/death
• Infected with a blood-borne pathogen/die of an overdose
– (Berge, Dillon, Sikkink, Taylor, & Lanier, 2012)
• Many diverted opiates in fixed combination with acetaminophen
– diverter’s opiate need escalates, acetaminophen dose can reach lethal
levels

National Institute of Drug Abuse (2014). Gene Variants Reduce Opioid Risks Retrieved from
http://www.drugabuse.gov/news-events/nida-notes/2014/06/gene-variants-reduce-opioid-risks
on October 1, 2014

Detecting Diversion: Diversion Rounds
• Program to prevent diversion must operate with understanding that
any person with access to controlled substances may divert.
Frequently, detection of diversion is hampered by preconceived
notions of the characteristics of a diverting health care worker.
• Erroneously believe diverter will be unkempt, lazy, poor performer
• Often “last person” supervisor would suspect
• Hindered by close relationships between managers & staff
• Because of diverter’s desire to maximize opportunities to divert,
circumstances associated with higher risk of diversion include night-
shift work, assignment to critical care area or other unit with
increased autonomy, and agency or travel work
New, Kimberly. Preventing, Detecting, and Investigating Drug Diversion in Health Care Facilities. Missouri State
Board of Nursing . November, December 2014, January 2015. p11. Reprinted with Permission Journal of Nursing
Regulation Volume 5, Issue 1, April 2014 Publisher: National Council of State Boards of Nursing

It broke….
• Ampules fell off cart transporting them to the floor to put
in ADC
• All narcotics when transported are placed in a separate bag
for each drug and marked with “Controlled Substance”
• Carefully remove ampules, remove remaining liquid from
each ampule
• Tilt bag, insert syringe. Remove remaining fluid.
• Is total fluid present near equivalent that which should be
present in this closed system?
• Should be close, barring any leakage

It broke…
• Carpujects fell off cart while transporting to floor
• Carefully remove Carpujects, remove remaining liquid
from each Carpuject if possible
• Tilt bag, insert syringe. Remove remaining fluid.
• Is total fluid present near equivalent that which should
be present in this closed system?
• Should be close, barring any leakage
• Check rubber stopper end of Carpujects under a
microscope
• Has stopper been compromised? Punctured?

Preventing Diversion:
Pre-Employment Screening
• First line of defense is comprehensive pre-employment screening
• Clinical applicants who fail to provide a clinical reference should be
regarded with suspicion.
• During one investigation of a new employee who was diverting the
examiner found that no clinical references had been provided
during the hiring process. New nurse had worked in clinical settings
at other institutions over the years, but none of his references were
clinical personnel. Eventually, examiner learned that nurse had been
caught diverting but had been allowed to resign without being
reported to appropriate authorities.
Board of Nursing . November, December 2014, January 2015. p11. Reprinted with Permission Journal of
Nursing Regulation Volume 5, Issue 1, April 2014 Publisher: National Council of State Boards of Nursing

Preventing Diversion:
Employee Orientation
• Orientation of new employees should include education
about risks of diversion and institution’s policies regarding
diversion
• New employees should be made aware of resources
available to them if they find themselves at risk, such as
Employee and Professional Assistance programs.
• Self-reporting protocols should be detailed, if relevant. Any
policy of immunity from corrective action, such as allowing
individuals who comply with treatment and rehabilitation
to keep their jobs, should be fully explained

Preventing Diversion: Drug Security
• Most important feature of a diversion prevention program is drug
security
• Many diverting nurses prefer to divert from waste because they
believe such diversion does not harm the patient or institution.
• One nurse developed a practice of hanging a new bag of
hydromorphone for patient controlled analgesia at start of every
shift, regardless of whether or not existing bag contained sufficient
hydromorphone. She later admitted that this practice allowed her
to divert enough hydromorphone waste to meet her ever-
increasing needs without having to resort to a more easily
identifiable means of diversion.

Preventing Diversion: Drug Security
Detailed Policies & Procedures Should Ensure
• Storage areas are in locations that can be monitored to prevent
unauthorized access
• Traffic into storage areas is minimized
• Controlled substance handling, including removal, wasting, and
returning, is strictly managed
• Staff members who administer controlled substances know
requirements that must be met
• Amount of time drugs are out of secure storage is minimal
• Unused doses are returned, not wasted
• Controlled substances are withdrawn for one patient at a time
• Controlled substances are administered immediately after they are
removed from cabinet
• Controlled substances are not handed off from one provider to
another, or such handoffs are strictly limited

Drug Security: Wasting
• Because wasting a full or partial dose of a controlled
substance is an opportunity for diversion, waste should
be kept to a minimum
• Stock should consist of the smallest practical dosage
given the needs of the patients
• Facilities should require that all wasting be witnessed
by a second authorized person, that wasting be
documented, and that both persons sign off on waste
• Any pattern of wasting full doses or maximizing
opportunities to waste should be investigated promptly

Drug Security: Continuous Infusions
• Because of the large doses and accessibility, continuous infusions of
controlled substances warrant strict control measures
• Frequently, these infusions take place where direct supervision is
not feasible
• Institutions should use locking cases and port less tubing to reduce
the opportunity for diversion
• Policies for controlled substance infusions should require frequent
documentation of infusion rate and the amount infused; titration or
a bolus dose should be documented when it occurs. Totals should
be reconciled at the end of each shift.

Compliance With Selected Recommended Practices for
Diversion Detection and Preventiona for Pharmacy
Witness and documentation required for wasting of controlled substances
If an expired-returns company is used, DEA form 222 provided by company is reconciled against central
pharmacy vault inventory
Audit of controlled substance purchases against products added to pharmacy inventory performed at least
quarterly
Automated vault for storage of controlled substances used
If CSOS not used, log of DEA form 222 kept to ensure all are accounted forb
Individual who submits a controlled-substance purchase order not responsible for receiving the order
Use and waste of multi-dose vials of controlled substances audited
Discrepancies reviewed by individual not routinely involved in controlled-substance handling
Person-to-person transfers of controlled substances audited, including transfers to non-automated storage
areas
Cameras directed at controlled-substance storage areas (working, angles, sufficient view)
Cameras directed at storage areas for high-cost non-controlled medications
Purchases periodically reconciled against dispensings for high-cost non-controlled medications
Personal belongings banned from drug storage areas
Packaging of high-cost non-controlled medications defaced to inhibit diversion and resale
McClure, SR, et al. Compliance with Recommendations for Prevention and Detection of
Controlled Substance Diversions in Hospitals. Am J Health Syst Pharm 2011;68(8):689-694.

Compliance With Selected Recommended Practices for
Diversion Detection and Preventiona for Nursing
Decentralized ADMs used for controlled-substance distribution
ADM discrepancy resolution explanations investigated for validity
Use of system capable of electronically identifying discrepancies between central pharmacy vault
withdrawals and nursing unit-based ADM receipts
Use of "blind" count (ADM user forced to enter inventory count when accessing a pocket)
ADM discrepancies analyzed to identify individuals most frequently involved in discrepancies
ADM stock outages investigated for potential diversion
Biometric fingerprint scan used for ADM access
Locking cases used to secure non-PCA controlled-substance infusion containers while being administered
If diversion detection software used, flagged individuals are investigated for potential diversion
Diversion detection software flags users for controlled-substance ADM transaction counts significantly above
peer group mean (standard deviation 3-4 fold above average)
Alert (e-mail, voice mail, pager) sent to pharmacy leaders when a specified ADM per-transaction threshold
exceeded
a For fractional data, numerator denotes number reporting use; denominator denotes number answering survey item. DEA = Drug Enforcement
Administration, CSOS = controlled-substances ordering system, OR = operating room, ADM = automated dispensing machine, PCA = patient-controlled
analgesia. b Not applicable to 29 institutions that use electronic systems other than CSOS. cData limitations precluded statistical analysis
McClure, SR, et al. Compliance with Recommendations for Prevention and Detection of
Controlled Substance Diversions in Hospitals. Am J Health Syst Pharm 2011;68(8):689-694.

Significant Impact…
“If a large scale CS diversion occurs,
employee morale is impacted and the
aftermath can disrupt a pharmacy
department’s ability to provide optimal
services.”
Martin, ES. et al. Preventing Large-Scale Controlled Substance Diversion from within the Pharmacy.
Hosp Pharm. May 2013; 48 (5):406-412

Steps to Minimize the Risks for Large-Scale
Controlled Substances Diversions
Method of
Diversion
How it is done? How it is discovered &
prevented?
Fraudulent
transfer of drug
between facilities
or floors
Complete paperwork
for fictitious transfer
CIII CS to another
facility, diverts supply.
Request transfer of
class 3 CS from outside
facility and divert stock.
Same diversion risk present if CS transferred
between patient care areas. Limit number of
persons authorized to transfer CS. Secure
audit DEA 222 forms.Perform audit of
transferred CS, ensure receiving facility/floor
actually received drugs. Before paying
invoices for drugs transferred between
facilities, confirm inventory received into
stock. When transferring CS between ADC
units, return CS to secure narcotic vault prior
to reissue to another ADC.
Martin, ES. et al. Preventing Large-Scale Controlled Substance Diversion from within the Pharmacy.
Hosp Pharm. May 2013; 48 (5):406-412

Preventing Large-Scale Controlled Substance
Diversion Summary of Recommendations
• Screen & rescreen pharmacy employees:
– UDS, Criminal, Credit
• Divide Duties
– Separate CS ordering & receiving
– Cross train staff/rotate separate roles:perspective
• Limit CS Access
– Control # handle/order bulk CS
– Lock CIII-V like CII
• Optimize use of CS automation
– Record all hand-offs
– Simplify reporting/auditing
– Take advantage of all features
• Improve Surveillance
– Improve video camera surveillance
– Install “bird’s eye view” above CS receive/ dispense
areas
– Mandate transactions done there
• Guard the Door
– Door controls/e-badge; monitor non Rx personnel
– Restrict off duty access/no bags to work/escort
• Understand your Process
– Map out your process
– Examine CS handoffs/diversion risk points
• Audit In vs. Out
– How much of this CS is ordered/received?
– How does this compare w/previous months?
– How much is going out & being billed through normal
channels?
• Create Calendar for Success
– Delineate daily, monthly, annual CS security tasks
• Get Smart
– Learn CS ordering, distribution, dispensing,
administration, destruction, security best practices
• Foster Culture of Control
– Ask questions/Make suggestions
– Report Concerns
– Rigorous internal/external monitoring
Martin, ES. et al. Preventing Large-Scale Controlled Substance Diversion
From Within the Pharmacy. Hosp Pharm May 2013; 48 (5):406-412

What Would You Do?
“Helping the impaired nurse is
difficult, but not impossible. The
choices for action are varied.
The only choice that is clearly
wrong is to do nothing.” 1
1 National Council of State Boards of Nursing (2001). Chemical Dependency Handbook for Nurse
Managers-A Guide for Managing Chemically Dependent Employees. Chicago: NCSBN, p. IV.

Reporting Diversion Rationale
• Regardless of the reason, facilities that do not report diversion are
complicit in individual’s subsequent diversion activities at other
institutions
• Drug diversion is an emotionally charged issue, and having policies
and procedures can help ensure that cases are handled consistently
• Disposition of cases should not depend on employee’s job title,
seniority, or preference of employee’s supervisor. Imperative that
investigation and reviews be consistent; accusations of bias can
easily occur when investigative method is erratic or inconsistent
(O’Neal & Siegel, 2007).
• Institutions must have policies and procedures in place to prevent,
detect, and respond to diversion, and policies and procedures must
be followed consistently and without prejudice.

Checks and Balances Under Controlled
Substances Act (CSA)
“The responsibility for the proper prescribing
and dispensing of controlled substances is upon
the practitioner, but a corresponding
responsibility rests with the pharmacist who fills
the prescription.”
(21 CFR §1306.04(a))
US v. Hayes 595 F. 2d 258 (5th Cir 1979)
US v Leal 75 F. 3d 219 (6th Cir 1996)
US v Birbragher 603 F. 3d 478 (8th Cir 2010)
East Main Street Pharmacy 75 Fed. Reg. 66149 (Oct 27, 2010)
Pharmacists – The Last Line of Defense

Duty To Report…
“Pharmacists have a responsibility to protect
patients, as well as the public, from the abuse,
misuse and diversion of prescription drugs.”
American Association of Colleges of Pharmacy (AACP)
Annual Meeting Program Guide
July 26-30, 2014

Acknowledgements: Thank You!
• Rachel M. Lynch
– Doctor of Pharmacy Candidate 2016
– Rutgers University, Ernest Mario School of Pharmacy
• Brian V. Blazovic
– Doctor of Medicine Candidate 2018
– Jefferson Medical College, Thomas Jefferson University
• David Z. Yang
– Pharmacy Intern-Doctor of Pharmacy Candidate 2016
• Kurt D. Meakim
– Pharmacy Intern-Doctor of Pharmacy Candidate 2015

Jeanne A. Tuttle, R.Ph.
National Pharmacist Program Manager
Department of Veterans Affairs
Pharmacy Benefits Management Services

Disclosure Statement
Jeanne A. Tuttle, R.Ph., has disclosed no
relevant, real or apparent personal or
professional financial relationships with
proprietary entities that produce health care
goods and services.

Learning Objectives
• Identify internal diversion trends.
• Outline internal diversion prevention
strategies.
• Describe the VA’s controlled substance
inspection program.

Acronyms
• PBM = Pharmacy Benefits Management Services.
http://www.pbm.va.gov/
• BCMA = Bar Code Medication Administration, barcode
system designed to prevent errors and improve the
quality and safety of medication administration
• OIG-CAP = VA Office of Inspector General Combined
Assessment Program. http://www.va.gov/oig/
– Ensure that high quality health care is provided to our
Nation's veterans
– Provides collaborative assessments of VA medical facilities
on a cyclical basis
• ADR = Adverse Drug Reaction

• 8.92 M Total enrollees in
VA Health Care System
(FY13)
• 6.48 M Total unique
patients treated (FY13)
• 150 VA Hospitals
• 819 Community-Based
Outpatient Clinics (CBOC)
*http://www.va.gov/vetdata/docs/pocketcards/fy2015q
1.pdf

Importance
• When someone diverts drugs, public trust is damaged
and funds designated to care for Veterans are miss-
used.
• When the drugs are sold on the street, it has caused
catastrophic impact on the people who were caught
diverting and to those who end up taking the drugs.
• Pharmacists, physicians, and nurses have lost their
licenses to practice as a medical professional causing
devastating impact to their families, and in some cases,
costing them their freedom.
• Maintaining accountability of CS Inventory and use is
critical to preventing diversion

Background
• Inspection program in place over 40 years
• Initially focused on physical inventory of all CII
and CIII narcotics
• Slowly expanded based on thefts and
diversions
• Most requirements today are linked to
previous losses
– Adjust Inspection program limit vulnerability
• Types of diversion keep changing

Impetus for Major Change
• Around 2002, VA Supervisory pharmacist stole
235,000 dosage units of Schedule II and III
controlled substances
• Entered fake prescriptions which were filled
and diverted
• Transferred to her uncle and others for street
distribution
http://www.va.gov/oig/pubs/sars/VAOIG-SAR-
2003-2.pdf

Impetus for Major Change
• VA financial loss was $194,000, street value
much higher
• Pharmacist sentenced to 8 years confinement,
3 years probation and ordered to surrender
$500,000 as part of plea agreement
• Uncle sentenced to 5 years, 10 months
imprisonment and 3 years probation

Changes Made
• In response to this diversion, Office of Medical
Inspector partnered with PBM to conduct
unannounced inspections at 5 randomly selected VA
facilities to review controlled substance programs and
assess vulnerability to similar schemes
• Changed inspection program to focus more on use and
“hard copy” data such as prescriptions, provider
orders, BCMA, etc.
• Developed optional monitoring tools
• Inspection program requirements increased
significantly

VA Inspection Program Structure
• Programs falls under the Medical Center Director
• Composed of:
– Controlled Substance Coordinator (CSC)
• Overall program management, training, reporting, competency
assessment
• Duties included in position description
• May have alternate or “co” CSC
– Controlled Substance Inspectors (CSI)
• Collateral duty
• Perform the inspections
• No involvement in ordering, prescribing, dispensing,
administration
• Link to Policy:
http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2183

Program Requirements
• CSIs must complete web based course and local
training prior to serving
– Annual training focused on problematic areas, new
requirements, survey findings
• Inspect every area where controlled drugs are
stored monthly
• Inspections random and unannounced
– May not inspect same area 2 months in a row
• Monthly report of findings, includes patient self
reporting shortages/complaints
• Quarterly trend reports

Physical
Inventory &
RX pads
Invoice
Review
Rx
Verification
Drugs held
for
Destruction
Required
Inventories
Completed
Pharmacy
Inspection
Requirements

Unit/Clinic Inspection Requirements
• Physical Inventory
• Inventory transfer between units
• Verify meeting local policy requirements on
cycle counts
• Verify order and documentation of
administration for 5 randomly selected
dispensing activities
• Reconcile 1 day’s dispensing from the
pharmacy to EVERY automated device

“Wasting” of Partial Doses
• VA OIG October 2014 Monthly Highlight Report:
Former VA Contractor Arrested for Burglary and Possession of
Controlled Substance Paraphernalia
A former VA contractor was arrested for burglary and possession
of controlled substance paraphernalia. An OIG and VA Police
Service investigation revealed that the defendant stole sharps
containers that held used syringes and mostly empty narcotic vials
from the Palo Alto, CA, VAMC. The defendant used his position as
an exterminator to gain access to a biohazard-holding cage that
contained sharps containers ready for disposal. A search of the
defendant’s work vehicle revealed approximately 20 gallons of
used syringes and empty narcotic vials. During an interview, the
defendant admitted that he used syringes from the stolen sharps
containers to inject himself with morphine and dilaudid.

National Support
• Virtual learning calls for CSCs
– Self-identified learning needs
– Regulatory and VHA policy changes
– Sharing of strong practices
• National CSC SharePoint Community
• OIG – CAP
– External review process
– Medication Management component

Additional Safeguards
• Ordering, receiving and destruction
– Separation of duties within pharmacy
– Involvement of staff outside of pharmacy
• All losses greater than 5 doses reported for
further investigation to:
– VA Police
– VA Office of Inspector General
– DEA
– VA Central Office
• Utilization of ADDs reports and other vendor
software (e.g. Pandora)

Lessons Learned
• Include detailed instructions on inspection
worksheets
• Give inspectors flexibility in choosing the day they
inspect
• Teach inspectors to be “inquisitive”
– If they do not understand an answer regarding a
discrepancy they should report and discuss with CSC
– If they see drugs in boxes or shelves that they are not
included in the count – ask and report

Lessons Learned
• Create a facility wide culture that supports CS
Management and mitigates diversion
– Newsletter article highlighting importance of
program
– “Did you know” screen banners during patient
safety and/or quality week
– Educate front line staff on their responsibilities to
participate and support the program and support
their participation

Model for Change
Minimize
Diversion
Risks
Independent
Oversight
Data and
Metrics
Quality
Improvement
Approach

Independent Oversight
• “Inspection Program”
– Staff not involved in medication use process
– External survey
• Integrate into existing processes
– Environment of care rounds – look for BCMA wrist
bands laying around
– Ward inspections
• Educate all staff on what to look for
– Communicate clear expectations for reporting and
accountability
Independent
Oversight

Data and Metrics
• Examine the underlying data
• Always start with the validated source data
• Define what you want to look at and how often
– Changes in purchase activity
– Reports from automated dispensing devices
• Access
• Overrides
• Cancelled transactions
• Customizable report
• Track and trend
Data and
Metrics

Quality Improvement
Approach
• Integrate data and metrics into the overall PI/QA
plan for the organization
• Use an inter-professional approach
– Similar to med-error or ADR analysis
– Findings to a committee for review and action
• Focus on risk points versus just actual diversion
– Look at “near misses” and reported diversions outside
your organization
• Create a non-punitive culture of “see something,
say something”
Quality
Improvement
Approach

Final Thoughts….
Should the impetus for change
come after something bad
happens or from news media
headlines? OR, do we need a
national, non-punitive, open
system similar to med-error and
ADR reporting that makes data
available to everyone to
identity ways to improve and
mitigate the risk of diversion in
our organizations?
How many of you use
information found in the ISMP
or Joint Commission newsletter
or FDA Bulletins to drive
organizational change?
Wouldn’t it be nice to have
something similar for this topic?

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