SAFEGUARD YOUR CONTROLLED SUBSTANCES

SAFEGUARDING YOUR CONTROLLED SUBSTANCES
October 29, 2018

Presenters
Jack Teitelman
Special Agent (ret)
CEO
Andy Eiseman
Special Agent (ret)
VP Operations
TITAN
GROUP
Safeguarding Your Controlled Substances

With more than three decades of
law enforcement, security and
private-industry experience, the
TITAN team of experts help
veterinary practices stay
compliant, avoid penalties and
deter criminal activities.
TITAN GROUP DISCLAIMERS - We Do Not Represent DEA - We Do Not Speak on Behalf of DEA - We Suggest You Read the
Mentioned Federal Laws and Regulations www.deadiversion.usdoj.gov
Founded by a retired DEA Supervisory Special
Agent, TITAN Group is a full-service regulatory
compliance, drug security and anti-diversion
solutions provider.
We Know The DEA
Because We’ve Been The
DEA
TITAN
GROUP

What we do.
DEA compliance rules and regulations are more
complicated than ever, and unannounced visits to
healthcare providers by both federal and state
agencies are increasing.
TITAN’s full suite of DEA compliance and drug diversion-prevention services help
assess your risk, provide remedial solutions and let you focus on what you do best: care
for animals.
DEA Risk
Assessmen
t
Onsite assessment of
your end-to-end control
environment, with a
scorecard that evaluates
compliance and identifies
risks.
Mock-DEA
Inspection
s
One-day announced or
unannounced mock-DEA
investigations approximate
the intensity of a real
inspection and identify
gaps in your team’s
performance.
Regulatory
Compliance
Audit
In-depth review of your
controlled-substance
policy and procedures, to
ensure accreditation and/
or regulatory compliance.
Remediation
Work directly with you to
develop a remediation
plan Standard Operating
Procedure (SOP)
manual that guides the
maintenance of an in-
control business
operation.
Employmen
t Security
Review employee hiring
and screening practices,
drug-testing systems
and background-check
processes to lower the risk
of hiring at-risk individuals.
Training
&
Educatio
n
Post-remediation training
courses keep your
entire staff updated on
procedural changes,
current trends and
proactive anti-diversion
measures.
TITAN
GROUP

Drug
Diversion
• Requirements and
proactive
measures for
preventing
diversion and
maintaining
ongoing
compliance
Doctor
Shopping Compliance
• Based on the Code of
Federal Regulations
including inventory,
tracking, record-keeping
and reconciliation from
acquisition to disposal
DEA
Inspection
• Surviving a DEA
Inspection: main areas
of focus, pre-
inspection preparation,
and protocols for
personnel
Best Practices
• Tips and
suggestions for
maintaining long-
term compliance
and anti-diversion
success
Objectives
TITAN
GROUP Safeguarding Your Controlled Substances
• What it is, how to
recognize it and
preventative
measures for
protecting against it

Drug Diversion
TITAN
GROUP

DEA surge leads to 28 arrests and 147 revoked
registrations in just 45 days.
Driven by the current opioid crisis, DEA and state agencies have dramatically stepped up regulatory inspections on
healthcare providers who use, dispense or prescribe controlled substances.
Source: DEA press release 4/2/18
36.4%of people who misused pain
relievers got them through
prescription(s) or stole them
from a health provider.
53.7%bought them, took them
from or were given them
by a friend or relative.
Source: 2015 National Survey on Drugs use and Health Source: 2015 National Survey on Drugs use and Health
TITAN
GROUP
The threat is real.

Veterinary practitioners often think,
“It can’t happen to me.” Probably not the best
risk-mitigation strategy.
Many veterinary practices would fail a federal or state
controlled-substance regulatory audit or security
inspection if it were held today. Are you willing to take
that risk?
Vets treating large
animals or working
at horse tracks can
be prime targets for
individuals who
abuse anabolic
steroids.
Source: Pharmacy Times, 7/31/17
V E T E R I N A R I A N P R A C T I C
E S
TITAN
GROUP

Theft/Loss
Improper Disposal
Inaccurate Logging systems
Lack of Proper Power of Attorney (“POA”)
Out of date video Surveillance Systems
No Standardized Operating Procedures
Lack of Employment Security/Background Checks
Inadequate storing and locking facilities
Diversion Risks
TITAN
GROUP
Whether it’s a trusted
employee, long-time
client or even a
relative, veterinary
practices are at risk
for drug diversion.

Even for your best employees,
vulnerability and access can lead to a
higher rate of drug diversion.
If you run a veterinary practice, your daily commitment is to the health and well-being of your
patients. But sadly, there may be people in your office who are committed to something a little
less noble. And when the DEA shows up, “I had no idea!” probably isn’t your best defense
strategy.
100,00
0 U.S. doctors, nurses, technicians
and other health professionals struggle
with drug abuse or addiction.
Medscape: Drug diversion in healthcare settings
Safeguarding Your Controlled SubstancesTITAN
GROUP

Controlled Substance
Security
Some of the factors considered when evaluating a
practitioner's controlled substances security include:
 The number of employees, customers and/or
patients who have access to the controlled
substances.
 The location of the registrant (high or low crime area).
 Use of an effective alarm system.
 Quantity of controlled substances to be kept on hand.
 Prior history of theft or diversion.
TITAN
GROUP

Internal Theft
TITAN
GROUP
A video example of how
quickly drug diversion can
happen at a facility

Possible Signs of
Diversion
TITAN
GROUP
 Missing pages from the controlled substance manifest
 Missing prescription pads
 An employee frequently claims a drug bottle was “lost,” “destroyed” or
“thrown away by mistake”.
 An employee insists they always logs certain pharmaceutical
deliveries outside of their assigned responsibilities.
 Management refuses to upgrade and/or initiate a controlled
substance log.
 Associates or partners hold veterinary distributor accounts with
delivery addresses other than the practice location.

DEA registrants are responsible
for secure storage of controlled
substances in their facilities.
TITAN
 Must be stored in a secured container.
 The storage box must be bolted or
otherwise secured to an immovable object.
 The holder of the license should have
possession of the keys to the storage box.
 Do not label the cabinet on the outside
(making it easier for would be thieves to
locate the dugs).
Requirements

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GROUP
What to do When you
Discover a Loss?
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GROUP
 Any shortages that cannot be reconciled and have been
determined to be an actual loss, must be reported to the police
and DEA’s office of Diversion Control immediately.
 Federal regulations require that registrants notify the DEA Field
Division Office in their area, in writing, of the theft or significant
loss of any controlled substance within one business day of
discovery of such loss or theft .
 The registrant shall also complete and submit to the Field Division
Office in their area, DEA Form 106, "Report of Theft or Loss of
Controlled Substances" regarding the theft or loss.
(21 C.F.R. § 1301.76(b)) .
 Remember to account for HUB loss due to withdraw.

Diversion
Prevention Tips
 Know your employees
 Train your employees
 Review your systems
 Have a plan
TITAN

Doctor-Shopping
TITAN
GROUP

Source: 2015 National Survey on Drugs use and Health
TITAN
GROUP
Veterinary “Doctor Shopping”
“Doctor shopping” – a type of drug diversion - is
the practice of visiting multiple physicians to
obtain multiple prescriptions for otherwise illegal
drugs, or the medical opinion that one wants to
hear.

TITAN
GROUP
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GROUP
Patients may engage in doctor shopping for
various reasons ranging from mental health
conditions (substance abuse or addiction) to
the persistence of symptoms or a
dissatisfaction with a prior doctor. However,
there appears to be an increased rate of
doctor shopping among clients who have
higher rates of mental illness.
What’s Behind Doctor
Shopping?

TITAN
TITAN
GROUP
The opioid problem
nationwide only serves to
reinforce our role in ensuring
that opioids don’t enter
inappropriately into the
community.”
-Dr. John Kuehn,
Nebraska state senator & large
animal veterinarian
Commonly Targeted &
Diverted Drugs:
 Codeine
 Fentanyl
 Hydromorphone
 Buprenorphine
 Morphine
 Oxycodone
 Tramadol
 Ketamine
 Hydrocodone combinations
(Vicodin, Lortab and Lorcet)
 Methadone

TITAN
Laws Against Doctor
Shopping
Specific laws in each state vary slightly, but the Uniform Narcotic
Drug act of 1932 and the Uniform Controlled Substances Act of
1970 cover doctor shopping thoroughly.
It is illegal for anyone to obtain, or
attempt to obtain, a narcotic drug by
deceit, misrepresentation, fraud, or
concealment of facts.

TITAN
GROUP
Traits & Behavior

Texas Health and Safety Code Ann. Section 481.129 states that an individual may be
charged with prescription drugs fraud if he or she knowingly and intentionally 1) uses a
suspended, fictitious, or revoked registration manufacturer, distributor, or prescription number to
prescribe controlled substances, 2) issues prescriptions for drugs using a fictitious or forged
signature, 3) uses another person’s prescriber number to issue a Schedule II drug prescription,
Prescription Drug Fraud
TITAN
GROUP
What constitutes prescription drug fraud in the
State of Texas?
4) attempts to possess or possesses one or more controlled
substances (an a larger amount of controlled substances by
electronic or oral deception, misrepresentation, forgery, or
fraud, 5) produces or falsifies applications, reports or
documents to prescribe or obtain controlled drugs and
substances, and/or 6) delivers a prescription form or
prescription for a purpose other than for valid medical
purposes.

Multiple patients visit practitioner as a group on the same day
requesting controlled substance prescriptions.
Patient Refuses:
 To present identification
 To be examined
 To provide access to past medical records
 To provide other primary physician details
 To undergo diagnostic tests
Initial Visit Indicators
TITAN
GROUP
Patient Exhibits:
 Intoxicated, sedated, confused or withdrawal
behaviors
 Exaggeration of pain or indications of faking
 Physical signs of drug abuse
Additional Factors:
 Patient travels a long distance
 Patient insists on paying out-of-pocket
 Patient has specific medication requests or uses street names

 Unexplained dose escalations
 Claims of lost/stolen prescriptions
 Non-adherence to treatment plan/early refills
 Route of administration is other than prescribed
 Seeks medication from numerous treatment sites: ER,
walk-in clinic, urgent care, etc.
 Intentional/unintentional overdose
 Presents with high quantity and/or numerous
prescriptions
 Therapeutic duplications or highly-abused combinations
Medication Record
Indicators
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GROUP

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GROUP
Behavior & Subsequent Treatment
Indicators
 Resists change even when adverse effects are present
 Refuses to sign/comply with an opioid pain care agreement
 Evidence of multiple practitioners providing same prescription
 Previous discharge from another practice(s)
 Practitioner/staff/pharmacist is pressured or
threatened.

 Patient alters, forges or rewrites
prescription
 Prescriber informed of selling of or
borrowing medication
 Patient requests prescription in
another person’s name
 Known issues with the prescribers
DEA license
Illegal Activity
Indicators
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GROUP

TITAN
GROUP
Prevention - PDMPs
 PDMPs are state-driven databases designed to
reduce doctor shopping.
 PDMPs require doctors and pharmacists to record
each prescription filled in a government database,
allowing health care professionals to identify
individuals who are engaging in doctor shopping
behaviors.
 As of May 2016, every state except Missouri had an
operational PDMP in place. The District of Columbia
has enacted legislation to create a PDMP but does
not have an operational program.
Numerous studies cited by
the U.S. National Library of
Medicine found that PDMPs
are effective for deterring
doctor-shopping behavior
and decreasing the
prevalence of doctor
shopping.
Prescription Drug Monitoring Programs
(PDMPs)

 By watching for fake prescriptions, altered prescriptions and
patients with several prescriptions from multiple physicians,
pharmacists have the ability to recognize individuals who may
be doctor shoppers.
Prevention - Pharmacists
TITAN
GROUP
Research conducted
and published in PLOS
ONE estimated that
one in 143 patients
who received a
prescription for a
painkiller in 2008
seemed to be a doctor
shopper.
TITAN
GROUP
 Additionally, many pharmacies have hotlines to alert
other pharmacies in the area when a fraudulent
prescription has been detected.

TITAN
Doctor Shopping
Resources
Contact for questions regarding the Texas Prescription Monitoring
Program:
E-Mail – texaspmp@pharmacy.texas.gov
Phone – (512) 305-8050
For law enforcement assistance, contact the Texas Department of Public
Safety.
E-Mail – rsdcriminal@dps.texas.gov

TITAN
Compliance

TITAN
GROUP
The codification of the general and permanent rules published in
the Federal Register by the executive departments and agencies of
the Federal Government.
TITAN
GROUP
Code of Federal
Regulations (“CFR”)
 TITLE 21 is the portion of the CFR
that governs food and drugs within
the USA for the FDA, DEA and
National Drug Control Policy
(“ONDCP”).

TITAN
GROUP
GROUP
Sa
Maintain a DEA regulatory
inspection “ready and retrievable”
file that contains all required DEA
documentation (i.e., power of
attorney for ordering drugs, state
medical licenses, DEA registration
certificate, and copy of initial
inventory, biennial inventory)
DEA Readily Retrievable
File

Reconciliation
The minimum standards for veterinary
facilities should be weekly audits for most
companion animal facilities.
Best practice is for all facilities to routinely
conduct audits of their control drug at the
end of each shift
Unexpected circumstances such as a fire
or break in at your facility would drive the
need for additional audits
When To Reconcile
GROUP

TITAN
GROUP
Record Keeping Discrepancy
Questions
Do employees have open invoices that include product that have
not yet been adjusted by the practice owner?
Was any product returned to the manufacturer that hasn’t been
deleted from the inventory?
 Was product used for any other reason and not deleted from the
inventory?
 Is product stored in another location and wasn’t counted?
 Does the staff have any other ideas as to why the discrepancies
exist?
Have any purchase invoices not been entered into the inventory?
Was any product used administratively that hasn’t been recorded in the inventory? (e.g., through a
temporary patient account?)
Are there open invoices that include product pulled off the shelf and waiting for client pick-up?

Closed Loop
Distribution
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GROUP
Record-Keeping
Requirements
Reporting
Requirements
Established
Quotas
Registration
Established
SchedulesScheduled
Inspections/Audits
Security
Requirements

DEA Inspection
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GROUP

When Will I Be
Inspected?
Source: West Islip Patch, July 7, 2018
2. Random selection
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GROUP
1. Facilities dispensing a high volume of
Schedule II drugs and/or Schedule III
narcotics.
 Determined from ARCOS (Automation of
Reports and Consolidated Orders
System )

I N D E P E
N D E N T P
H A R M A
C I E S
Scheduled Investigations &
Audits
TITAN
GROUP
Title 21 United States Code, Section 880 authorizes
administrative inspections of DEA registrants for the purpose
of creating a physical inventory of all controlled substances
and listed chemicals at a premises, including:
• Inspecting, copying and verifying the correctness
of records, reports or other documents required to
be kept or made.
• Inspecting within reasonable limits and to a
reasonable manner all finished and unfinished
controlled substances and listed chemicals and
labeling.

Exclusions From
Inspection
 Financial data
 Sales data other than shipping data
 Pricing data
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GROUP
Unless the owner, operator or agent in charge of the
controlled premises so consents in writing, no inspection
authorized shall extend to:

Preparing For A
DEA Audit
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GROUP

Drug Audit - Steps
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GROUP
STEP ONE: Determine your expected inventory, this is the quantity of a drug you expect
to have on hand based on the information contained in the control drug log and other
records such as DEA-222s and invoices
STEP TWO: determine the actual inventory by examining and in some cases physically
counting stock. The actual inventory includes the quantity and unopened bottles and the
amount and open bottles
STEP THREE: compare the actual inventory to the expected inventory. These numbers
should be identical or very close. If you find a discrepancy between the actual and
expected inventory during an audit, begin by double checking the math and ensuring drug
entries are up-to-date

 Know how to provide a running total
of dosage units dispensed for any
given NDC for any given period of
time
 DEA does not want a perpetual inventory
 DO NOT attempt to figure out software if
DEA is in your facility
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GROUP
Dosage Units
Dispensed

DEA-222 &
Invoices
 Form DEA-222 will be checked that date and
quantity received/shipped is annotated.
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GROUP
 Schedule III-V invoices will be
checked that date and
quantity received/shipped is
annotated.

DEA Written Notices
Types Of Written Notices Used By DEA To Inspect
Controlled Premises:
 Notice of Inspection
 Administrative
Inspection Warrant
 Search Warrant
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GROUP

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GROUP
Tips & Suggestions
Compare invoices to the drug receiving history in the
computer– your accountant/book-keeper may also alert you to
unusual purchases for which invoices do not match or exist;
and,
Whenever possible have two people count inventory and
rotate the staff who count
Reconcile your inventory four times per year
Double count medications at the time of dispensing
Keep careful track of medication ‘shorts’ or ‘owes
Print a monthly narcotic report of all narcotic, controlled, benzodiazepine and targeted
drugs
Check the PMP failed transaction report for unusual prescriptions and ‘out of province’
patients
Review the drug inventory history report regularly for manual adjustments

Best Practices
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GROUP

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Assess Your Risk
TITAN
GROUP
It’s not a matter of if drug diversion will
take place, but a matter of when.
Having the right plan and the right partner can mean the difference between quiet
resolution and public indictment. To assess the risk in your business:
Take The Quiz!
BEGIN

TITAN
GROUP
Review employee hiring and
screening practices, drug-testing
systems and background-check
processes to lower the risk of hiring
at-risk individuals.
Preventing drug
diversion begins
with the hiring
process
Know Your Employees

What’s “SOP”?
TITAN
GROUP
Implement standard operating procedures (“SOPs”)
for every aspect of your controlled substance policy.
Following a written protocol for audits reduces errors
and inaccuracies.
Rotating roles within the facility is recommended so
that the roll of auditor is shared and other staff can
perform audits.
It is ultimately the DEA registrant/veterinarian’s
responsibility to ensure the security of controlled
substances. As part of the audit protocol the registrant
should regularly review control drug logs and audits

Training & Education
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GROUP
Employee Education: Implement an employee educational
program designed to keep your staff updated on standard
operating procedures and industry trends/issues.
Compliance Training: Preventing diversion begins with
internal training. Implement training to keep staff updated on
DEA compliance and state regulatory compliance
Diversion Training: Train all staff on
proactive measures to detect and prevent
controlled substance diversion.

 Improve physical security
 Increase awareness of security requirements
 Develop written security procedures
 Train your employees
 Invite local law enforcement to conduct a security assessment
 Check out the DEA Diversion Control website http://www.deadiversion.usdoj.gov/index.html
TITAN
GROUP
ACTION ITEMS

DEA Texas Office
Divisions
Houston
 Tel: (713) 693-3000
 Website: https://www.dea.gov/domestic-divisions/houston
Dallas
 Tel: (214) 366-6900
 Website: https://www.dea.gov/dallas-contacts
El Paso
 Tel: (915) 832-6000
 Website: https://www.dea.gov/domestic-divisions/el-paso
TITAN
GROUP

Contact Us
PHONE: 973 433 3400
EMAIL:
info@TITANgroupDEA.com
WEBSITE: titangroupdea.com

SAFEGUARD YOUR CONTROLLED SUBSTANCES

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