TITAN Group's presentation on Safeguarding Your Controlled Substances during the VHMA 2018 Annual Conference. The presentation provides guidance on proper protocols concerning security, storage, record keeping, and hiring/training personnel to safeguard controlled substances from theft/diversion, as well as how to meet the DEA requirements. Jack Teitelman, a retired DEA Special Supervisory Agent, will provide real-life examples of the dos and don’ts of preventing your practice from being exposed to loss, theft or government fines.

1. Safeguarding Your Controlled Substances
Jack Teitelman
TITAN Group Founder & CEO

2. Presenters
Jack Teitelman
Special Agent (ret)
Founder & CEO
Andy Eiseman
Special Agent (ret)
VP Operations

3. 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.
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 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

4. 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
Assessment
Onsite assessment of your
end-to-end control
environment, with a
scorecard that evaluates
compliance and identifies
risks.
Mock-DEA
Inspections
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.
Employment
Security
Review employee hiring
and screening practices,
drug-testing systems and
background-check
processes to lower the risk of
hiring at-risk individuals.
Training &
Education
Post-remediation training
courses keep your
entire staff updated on
procedural changes,
current trends and
proactive anti-diversion
measures.

5. DEA
Diversion
Control
• An overview on
DEA Diversion
Control,
inclusions and
guidelines
Security
• Requirements
and proactive
measures for
preventing
diversion and
maintaining
ongoing
compliance
Storage
• Controlled
substance
inventory,
tracking and
reconciliation
from acquisition
to disposal
Record
Keeping
• Maintaining a
"readily
retrievable" file
and
recommended
SOPs
Inspection
• Surviving a DEA
Inspection: main
areas of focus,
pre-inspection
preparation, and
protocols for
personnel
Education
• Continued
learning and
training for
staff and key
personnel
Objectives

6. 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 TITAN Risk Assessment Quiz.
Take the quiz!
BEGIN

7. DEA Diversion Control

8. The DEA Office of Diversion Control’s mission is to
prevent, detect, and investigate the diversion of
controlled pharmaceuticals and listed chemicals from
legitimate sources while ensuring an adequate and
uninterrupted supply for legitimate medical, commercial,
and scientific needs.
DEA Office of
Diversion Control

9. Role Of The DEA
To familiarize participants with
the authority given to DEA when
enforcing the laws and
regulations pertaining to
controlled substances and
regulated chemicals.
TITAN
GROUP
Safeguarding Your Controlled Substances

10. What Are Controlled
Substances?
Production, possession, importation, and distribution of these drugs is
strictly regulated or outlawed, although many may be dispensed by
prescription only.
The basis for the regulation is to control the danger of addiction, abuse,
physical and mental harm, the trafficking by illegal means, and the dangers
from actions of those who have used these substances.
Accurate accounting of controlled drug transactions by inpatient hospital
pharmacies is a requirement in the United States under the Controlled
Substances Act.
Controlled
substances are
drugs regulated
by federal and
state law.Controlled substances are drugs regulated by federal
and state law.

11. A “CLOSED SYSTEM” established to track and
account for controlled substances from import and/or
manufacturer through wholesale distribution to the
ultimate end-user.
Control Substance Act of
1970

12. Commonly Diverted
Drugs:
 Codeine
 Fentanyl
 Hydromorphone
 Buprenorphine
 Morphine
 Oxycodone
 Tramadol
 Ketamine
 Hydrocodone combinations
(Vicodin, Lortab and Lorcet)
 Methadone

13. Controlled Substance
DEA Schedules
Controlled Substances
are segregated into DEA
Schedules I, II, III, IV, or
V based upon:
• Abuse potential,
• Medical value
• Danger of serious
physical effects to
the user

14. Security

15. 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.
The threat is real.
36.%of people who misused pain
relievers got them through
prescription(s) or stole them
from a health provider.
53.%
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

16. Veterinary Practitioners
“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

17. Source: 2015 National Survey on Drugs use and Health Source: 2015 National Survey on Drugs use and Health
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.
100,000
U.S. doctors, nurses,
technicians and other health
professionals struggle with
drug abuse or addiction.
Medscape: Drug diversion in healthcare settings

18. 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
Whether it’s a trusted
employee, long-time
client or even a
relative, veterinary
practices are at risk
for drug diversion.

19. Internal
Theft
A video example
of how quickly
drug diversion
can happen at a
facility

20. Security Factors
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.

21. What To Do When You
Discover A Loss?
 Remember to account for HUB loss due to withdraw
 Any shortages that cannot be reconciled and have been determined
to be an actual loss, must be reported to the police immediately and
to the DEA’s office of Diversion Control
 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))

22. FORM
DEA-106
Report of
controlled
substances
theft or loss
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23. DEA
Website
Online drug
theft/loss
reporting

24. Destruction/Form
DEA-41
The breakage or spillage of controlled
substances does not constitute a "loss"
of controlled substances.
When there is something other than
breakage, damage, or spillage or some
other form of destruction, it must be
documented on DEA Form 41.

25. OM APPROVANO 1117-0007 ExpiroiO OI 9/30/2017
U.,S DEPARTMENT OF JUSl l.CE- DRUG FORCEMENT AOMINISlltATION
REGISTRANT RECORD OF CONTROLLED SUBSTANCES DESTROYED
FORM OEA 1
A. REGISTRANT INFORMATION
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Destroyed

26. Storage

27. TITAN
GROUP
TITAN
GROUP
All DEA registrants are responsible for
secure storage of controlled
substances in their facilities.

28. Controlled Substances
Storage
 Must be stored in a double locked, 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).
Even though Federal
regulations do not
specifically define locked
cabinet construction, the
intent of the law is that
controlled substances must
be adequately safeguarded

29. Dosage Units Dispensed
Know you dispensing software
 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

30. REQUIREMENTS
DEA Registrants
Accountability
Audit time-scope (Biennial)
Records and Controls
Accountability Variance
Balancing Inventory
Negative Variance
Positive Variance
Regular Internal Audits

31. Record Keeping

32. Reconciling v. Inventory
Reconciliation. To check (a financial account) against another for
accuracy and to account for changes
Inventory. A complete count and list of items available in-stock that
have been both tracked and logged

33. The term “readily retrievable” means that certain
records are kept by automatic data processing
systems or other electronic or mechanized record-
keeping systems in such a manner that they can be
separated out from all other records
Readily Retrievable

34. Controlled Drug Log
 The control drug log acts as a system for recording the inventory of
controlled drugs including purchases sales and in facility dispensing
 A log book must be maintained for each drug. Each log book
contains:
 Authorized Users Signature Log
 Unopened container log
 Opened container log
 Reconciliation log book
 Ideally, the drug logs should be kept in the
drug cabinet. If this is not possible, they
should be kept in a secure location near
the controlled substances cabinet.

35. Log Book Samples
 Disposition Record
 Authorized
Signature Log
 Unopened
Container Log
 Opened Container
Log
 Biennial Report
 Inventory Audit
Form

36. Disposition Record

37. Authorized
Signature
Log
The signatures
and initials of the
DEA license
holder and all
authorized
personnel under
their direct
supervision

38. Back Stock Log

39. Opened
Container
Log

40. Biennial
Report

41. Inventory Audit Form

42. Recordkeeping
Spot Checks
During the course of the audit, or
after the audit, Investigators will
conduct spot checks on your
invoices, prescriptions, and other
records.

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

44. Prescriptions
 Dated as of, and signed on, the
day when issued
 Full Name and address of the
patient
 Drug name
 Strength
 Dosage form
 Quantity prescribed
 Directions for use
 Name, address and registration
number of the practitioner

45. Prescription Labels
 Date of filling
 Pharmacy Name andAddress
 Rx Number
 Name of Patient
 Name of Prescribing
Practitioner
 Directions for use and
cautionary statements
Prescription labels must show the
following:

46. Liquid Drug Inventories
 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 in the open
bottles

47. Extracting Drugs For An
Accurate Count
 Contamination
 Hub Loss
 Benefits of
Measuring
Volume
In the case of an open bottle of an injectable control drug it is not
recommended to consistently withdraw their liquid to determine
the volume.

48. Hub Loss
 There is an allowance made for loss
due to withdrawal from the bottle This
is typically referred to as “hub loss”
which is loss due to withdraw and is
normally between 0.1 and 0.2 mils for
withdraw.
 An example would be if 12
withdrawals were made from bottle a
total of up to 2.4 mil

49. Tracking Controlled
Substances By Weight
 Best practice is to gather
the initial weight of the
unopened bottle along with
the initial listed volume i.e.
50mg/ml and track the
weight through the usage
period until you zero out.
This will allow an accurate account of the last weight in
comparison to what will be next deducted.
This will identify any discrepancy with the current weight prior to
dispensing the next dose.

50. When to Reconcile?
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 drugs 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

51. Best Practices
Closed Loop Distribution
Record-Keeping
Requirements
Reporting
Requirements
Established
Quotas
Registration
Established
Schedules
Scheduled
Inspections/Audits
Security
Requirements

52. Discrepancy Questions
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?
Do employees have open invoices that include product that have not
yet been adjusted by the practice owner?

53. DEA Inspection

54. Preparing For A
DEA Audit

55. Drug Audit - Steps
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

56. Sample Computation Chart
Audit Period: January 1, 2014 to March 31, 2014
Opening Inventory Date: January 1,2014
Closing Inventory Date: March 31, 2014

57. Sample Computation Chart
Audit Period: January 1, 2014 to March 31, 2014

58. Who Will Be Inspected?
Facilities dispensing a high volume of
Schedule II drugs and/or Schedule III
narcotics.
 Determined from ARCOS (Automation of
Reports and Consolidated Orders System )

59. 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:
Scheduled Investigations &
Audits
• 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.

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

61. Controlled Premises
Types Of Written Notices
Used By DEA To Inspect
Controlled Premises:
• Notice of Inspection
• Administrative Inspection
Warrant
• Search Warrant

62. Notice Of
Inspection Of
Controlled
Premises
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NOTICE OF INSPEC TION
OF CONTROLLED PREMISES
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3 t, nyth rng of an Inc m na ng na!ur wh wh ay be ouoel ay De serLed a se,.dagalrst youm
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5 You may withdraw you consenl at any t.emedur rig Iha course o the 1npectlon
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63. Warrant For Inspection
UNJTED STATES DISTRICT COURT
F R THE CENTRAL DJSTRICT OF CALIFORNIA
WESTERN DJVISION
IN THE MATIER OF THE )
ADMINISTRATIVE INSPECTION OF )
A&MGROSS )
OBA: MICKEY FINE PHARMACY )
433 NORTH ROXBURY DRIVE )
BEVER1YHILLS;,CALIFORNIA90210 )
Magistrates Docket No.
WARRANTFORINSPECTION
TO: Diversion Investigator Spencer Shelton and any other duly authorizedinvestigator
or agent of the Drug Enforcement Administration of the nited States Department of J ustice.
Application having b,eenmade and probable cause as defined by 21 U.S.C. §880(d)(l)
having been shown bytheAffidavit For Administrative Inspection Warrant by Diversion
controlled premise of433 North Roxbury Drive, Beverl.y Hills, California 90210, and basedon
the lack of any pr.ior inspection pursuant to 21 CFR B 16.09(a)(4)(i) and physician self-

65. Under
Seal
Search
Warrant

66. 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

67. Education & Training

68. Today’s DEA rules and regulations are
so complex, business owners and
practitioners struggle to understand
what they should be doing.
Have A Plan.

69. What’s “SOP”?
Implement standard operating procedures
(“SOPs”) for every aspect of your controlled
substance policy.

70. Controlled Substance Policy
SOP’s
 Following a written protocol or SOP (Standard Operating
Procedure) for audits can help cut down on errors and
inaccuracies.
 Ideally it is good to rotate roles within the facility so 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 veterinarian should be regularly reviewing their
control drug logs and audits

71. 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

72. Diversion Training
Train all staff on proactive measures to detect and
prevent controlled substance diversion.

73. Compliance Training
Preventing
internal theft
begins with the
hiring process
Implement ongoing employee training
to keep staff updated on:
 DEA compliance
 State regulatory compliance
 Procedural changes
 Industry trends/issues

74. Ongoing Education
Implement an ongoing employee education
program optimized to work with your team to
facilitate long-term success.

75. Action Items
 Improve physical security
 Increase awareness of
security requirements
 Train your employees
 Develop written security
procedures
 Invite local law enforcement to
conduct a security
assessment
 Check out the DEA Diversion
Control website: http://www.deadiversion.usdoj.gov/index.html
Controlled substance diversion
protection program

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