1. MANAGING YOUR
CONTROLLED SUBSTANCES
Steve Wunsch – City of Middleton EMS
Kep Anderson – City of Sun Prairie EMS

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3. What is Diversion Control?
When must people think of controlled substances
they think Heroin, Marijuana, Cocaine, LSD, etc.
They often don’t think of pharmaceutical drugs as
being a major part of the “drug problem” in the
United States
Unfortunately we do have a major problem of licit
chemicals and pharmaceutical drugs being
diverted to the illicit market
This presentation will familiarize you with the Drug
Enforcement Administration’s Diversion Control
Program
You will obtain a basic understanding of controlled
substance scheduling, record keeping
requirements, and basic law as it relates to
management of pharmaceutical controlled
substances used in the EMS industry

4. Why is Diversion Control
Necessary?
To prevent and detect the diversion of stolen
controlled substances
To protect the provider’s DEA Registration
To protect the honest employees with a system
of checks, balances and witnessed activities
To protect the public’s health and safety. The
practitioners treating the public should not be
impaired by illegally diverted drugs and the
medications the public receives should not be
diluted
In very simple terms, these records and
security measures should be maintained
because it’s the law

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Code of Federal
Regulations - Title 21
This is where you find all of the
regulations that were written to
implement the Controlled Substance
Act of 1970
Parts 1300 – 1321 apply to EMS (as
well as all other Practitioners)
Also contains the must recent lists
(Schedules I to V) of Controlled
Substances
Amended and published annually

6. Index of Parts 1300 - 1319
1300 Definitions
1301 Registration of manufacturers, distributors, and dispensers of
controlled substances
1302 Labeling and packaging requirements for controlled substances
1303 Quotas
1304 Records and reports of registrants
1305 Orders for Schedule I and II controlled substances
1306 Prescriptions
1307 Miscellaneous
1308 Schedules of controlled substances
1309 Registration of manufacturers, distributors, importers and
exporters of list I chemicals
1310 Records and reports of listed chemicals and certain machines
1311 Requirements for electronic orders and prescriptions (Eff. 6-1-10)
1312 Importation and exportation of controlled substances
1313 Importation and exportation of list I and list II chemicals
1314 Retail sale of scheduled listed chemical products
1315 Importation and production quotas for ephedrine,
pseudoephedrine, and phenylpropanolamine
1316 Administrative functions, practices, and procedures
1321 DEA Mailing addresses

7. REGISTRATION
Anyone who handles or intends to handle controlled
substances must register with the DEA
For EMS agencies this is typically the Medical Director
The physician must hold a state license and agree to
be ultimately responsible for accountability of the
controlled substances
Hospital owned EMS agencies may choose to use
whoever is the registered agent of the hospital
pharmacy
Some states require a separate state registration
before applying for a DEA number (Wisconsin does
not)

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Registration Classifications
Importer/Exporter
Manufacturer
Distributor
Narcotic Treatment Programs
Hospital
Pharmacy
Practitioner (this is where EMS falls)
Analytical Laboratory, Researcher,
Teaching Institution, Canine Handlers

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Number of DEA Registrants
Physician/Practitioners 1,021,865
Pharmacies 65,001
Hospitals/Clinics 16,249
Researchers, Labs, etc 7,924
Pharmaceutical Distributors 823
Pharmaceutical Manufacturers 515
Importers/Exporters 362

10. DEA REGISTRATION
CERTIFICATE
Application may be done online
Units of local or state government are
exempt from fees
A unique number is assigned to each
legitimate handler of controlled substances
(DEA number)
At the time that the application is approved,
a supply of 222 Forms will be issued
All orders from suppliers must be shipped
to the address listed on the DEA certificate

11. DEA REGISTRATION CERTIFICATE

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CSA = CLOSED SYSTEM
FOR DISTRIBUTION

14. Closed System Routing
Everything is tracked as product moves
through the system
Starts with import of raw materials into the
country
Then moves to manufacturers . . .
Then to distributors and suppliers . . .
Then to pharmacies, practitioners, and other
health care providers and facilities . . .
And finally to the patient to whom the
controlled substance is dispensed
This requires detailed records to be kept

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Types of Required Records
Inventories:
Initial
Biennial
Purchasing and Receiving Records
Order Forms, Invoices & DEA 222 Forms
Dispensing Records
Distribution Records
Theft and Loss Reports - DEA Form 106
Destruction Records - DEA Form 41

16. Common Schedule II Drugs
Form 222 is required to order these
from a Pharmacy or Supplier
Morphine Sulfate
Fentanyl Citrate (Sublimaze)
Hydromorphone (Dilaudid)
Meperidine (Demerol)

17. Filling out the 222 Form
Make sure it is filled out completely
No strike-outs or corrections are
permitted
Submit only the first two copies to the
supplier or distributor (including a
hospital or retail pharmacy)
Keep the third copy - when the order is
received at your facility record on that
copy the date, time & quantity received

18. Filling out the 222 Form
NEVER DESTROY OR DISCARD OLD
OR UNUSED 222 FORMS!
Void the form and maintain it on file
If a form is lost report it to the DEA
immediately

19. Schedule III Drugs
(Uncommon for EMS)
Ketamine is the only one used by
EMS that is included here (it is
classed as a CNS Depressant and
often used as an animal tranquilizer)
Make sure your DEA Certificate
includes the authorization to order
Schedule III controlled substances

20. Common Schedule IV Drugs
Form 222 is NOT required to order these
Diazepam (Valium)
Lorazepam (Ativan)
Midazolam (Versed)
Invoices and packing slips are your
only means to track these drugs

23. How Often Must An
Inventory Be Conducted?
An initial inventory must be conducted when
the practitioner is first registered with the
DEA
Thereafter, complete physical inventories
must be conducted at least once each year
However, the DEA strongly recommends
that EMS agencies conduct a count at every
shift change with two individuals, who then
record the physical inventory in some type
of log book (bound if possible)

24. What Information Must Be
Included in the Inventory
Record?
Date that the inventory was conducted
Exact time it was conducted (to provide a
reference point for any orders received or
doses administered on that same day)
Names of the controlled substances
Do not mix Schedule II drugs and Schedule
III – V drugs on the same inventory sheet
The finished form of the item (e.g. – 100 mcg
Carpuject vial)

25. What Information Must Be
Included in the Inventory
Record?
The number of dosage units of each finished
form in a package or container (e.g. – box of
10, 3 single Carpujects, etc.)
Include everything – even expired drugs or
drugs that are set aside for destruction

26. What Information Must Be
Included in the Inventory
Record?
Exact location where the controlled
substances are stored (e.g. – Medic 34
jumpkit, Medical Supply Room locking
cabinet, etc.)
If the inventory is being used as the annual
DEA Physical Inventory the record must
explicitly state that on the documents
All inventory records must be retained for a
minimum of two years

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Purchasing Recordkeeping
Schedule II records (222 Forms) must be
maintained separate from all other records
Likewise, Schedule III and IV records must
also be maintained separate from all other
records
Schedule III and IV records (invoices and
packing slips) must be “readily retrievable”
upon request of the DEA (highlight line items)
All records must be maintained and be
available for inspection for a minimum of 2
years following the transaction

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Dispensing Records
Patient name and address
Date the controlled substance was
dispensed/administered
Name and strength of the controlled substance
Quantity or amount dispensed
Names/initials of the individual(s) who
dispensed or administered the controlled
substance

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Dispensing Records
There must also be a corresponding
documentation of the same information
in the patient care report

30. A physician cannot simply write a
prescription to replenish
ambulance stock!
Prescriptions can only be written by
a physician in order to dispense a
specific drug dose to a single
patient

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Disposal of Partial Doses
Only drugs that were opened and
contaminated by patient contact may be
wasted
The drug that is being wasted must be
“destroyed beyond reclamation”
In other words, don’t squirt it in an
empty soda can and throw it in the
garbage – rather flush it down the sink
and rinse it down with copious amounts
of water

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Disposal of Partial Doses
Two responsible individuals must always be
present to witness the destruction of the
leftover controlled substance after
administering a partial dose to a patient
The waste must also be documented
Record the amount of any waste along with
the names / initials of the individual(s) who
witnessed the waste of the controlled
substance (huge area for potential diversion)
Many times it is most convenient to have the
Waste Record on the same form as the
Dispensing Record

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Disposal of Expired Drugs
A practitioner may dispose of out-of-date or
otherwise unused or unwanted controlled
substances by transferring them to a
registrant who is authorized to receive such
materials
These registrants are referred to as “Reverse
Distributors” – contact DEA for a current list
$$$$ This can be VERY costly $$$$
Essentially you become the supplier and must
obtain 222 forms from, and issue invoices to
the Reverse Distributor who accepts the drugs

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Disposal of Expired Drugs
An easier method is to request
permission to conduct a destruction
that is carried out by two responsible
individuals on an annual basis
First contact the Milwaukee District
Office and request a DEA “Destruction
Kit” to be sent out
Create a detailed inventory of the
controlled substances that you wish to
dispose of by destruction

35. Disposal of Expired Drugs
Determine the exact date, time and location
where you will conduct the destruction
Include all of these details in DEA Form 106
and submit it to the Milwaukee DEA office
DEA Form 106 can be submitted online at:
http://www.deadiversion.usdoj.gov
Wait for approval – once you are approved,
you may perform the disposal as planned
A DEA Official MAY appear at the location to
verify that proper disposal has occurred

36. What if a DEA Official Suddenly
Shows Up at My Door?
When the DEA arrives to conduct a
“controlled substance accountability”, you
can expect the following:
A Notice of Inspection or an Administrative
Inspection Warrant will be presented
The Diversion Investigator will conduct a
Closing Inventory of all controlled
substances in your possession

37. What if a DEA Official Suddenly
Shows Up at My Door?
Records for all purchases and deliveries
will be reviewed
Copies of all 222 order forms for Schedule
II’s along with delivery receipts
Invoice copies for all Schedule III’s and
IV’s along with packing slips, etc
Administration and Waste records will be
reviewed
Any Transfer Records will be reviewed

38. What if a DEA Official Suddenly
Shows Up at My Door?
Hopefully, after doing all of these
reviews, the Diversion Investigator will
discover that the Closing Inventory
matches all of the transactions that have
occurred since your last Annual
Inventory was documented
If not, an official investigation will be
undertaken to determine the source of
the potential diversion

39. How Is Secure Storage
Achieved?
Controlled substances are required to be
secured in a “substantially locked
cabinet” – but no clear definition exists
This can be a challenge, especially for
drugs carried in a “jump kit”
Tamper proof sequentially numbered
“break-away” seals can be useful
Best option is a storage box that requires
a code to entered with an audit trail

40. Knox Box Med Vault

41. Recommended Best
Practices for EMS Agencies
Always keep the stock carried on the
ambulance to a minimum
Back stock should be kept locked up with
limited access using some type of individual
ID coding system
Don’t keep keys to secured storage areas on
the ambulance in plain sight (in essence
creating a situation where there is no limited
access)

42. Recommended Best
Practices for EMS Agencies
Routinely review controlled substance laws
and regulations so you are familiar with
what is required
Contact authorities when you have
questions or concerns
Implement a written policy and procedure of
how and by whom controlled substances
are to be handled in your agency and what
steps are required

43. Recommended Best
Practices for EMS Agencies
Conduct periodic training meetings to
ensure that your staff knows what is
required and how to comply with laws and
policies
Conduct periodic reviews and self-
inspections of your own service to ensure
that you and your employees are
consistently complying with policies and
laws

44. Recommended Best
Practices for EMS Agencies
Periodically audit and reconcile your drug
counts against the record keeping to ensure
that all drugs are accounted for, drugs are
not missing, and there are no record
keeping errors
Most ambulance services have the drugs on
the ambulances counted with each shift
change, by one employee going off duty and
one employee who is coming on duty
When possible, have all controlled drug
activities performed by two people

45. Recommended Best
Practices for EMS Agencies
The person who orders and purchases the
drugs should be a different person than the
person who receives, checks them in and
adds them to inventory. These should
ideally not be the same people who also pay
the bills. Separate the duties of ordering,
receiving and paying so there are checks
and balances
Set up a calendar or reminder system so
you know when it is time for an annual
inventory or renewal of DEA registration

46. Recommended Best
Practices for EMS Agencies
Review your invoices from drug companies
to make sure you authorized the drugs
purchased
The person who receives controlled
substance shipments and checks them in
should have a second person verify what
was received and that the drugs are
accurately being added to the perpetual
inventory logs

47. Recommended Best
Practices for EMS Agencies
Although not required, perpetual inventory
logs are encouraged to provide an ongoing
record of what you have administered and
what you have remaining
Do not allow patients and visitors access to
drug supplies. This means if drugs are
missing, it is an employee who is
responsible. Although you trust your
employees, it is often the staff in a service
that divert drugs because they are ones who
have access and can falsify records

48. Recommended Best
Practices for EMS Agencies
All employees should be comfortable with
policies and procedures that require
oversight and witnesses because if there is
a discrepancy in the drug count, consistent
compliance with policies can protect them
from false accusations
Restrict the number of people who have
access to your drugs to the fewest people
possible

49. Recommended Best
Practices for EMS Agencies
Have a policy requiring random drug testing.
Even if you do not want to conduct random
drug testing on a regular basis, you should
be able to demand a drug test during the
course of an internal investigation if drugs
are found to be missing
Periodically review your administration and
dispensing logs to make sure that an
employee has not removed drugs and made
up a name of a fictitious patient you don’t
have a record of treating

50. Product Inspection
Examples of Intact Seals
Inventory requires more than just counting –
integrity of seals must also be verified.
Employees should be trained to check for
tampering, torn packaging, or holes in
packaging.
There should be no disruption in the
adhesive label seal
Look carefully at the small curved “slices”
in the label
All cut lines should line up with no gaps or
bumps noted
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53. Reporting Employee
Diversion
Federal Code of Regulations Title 21, Part
1301.91 states that an employee who has
knowledge of drug diversion from his
employer, by another fellow employee, has
an obligation to report such information
The employer is required to treat the
reporting employee’s report confidentiality
while the employer conducts an internal
investigation and notifies the proper
authorities.

54. Evidence of Tampered
Seals
The most common method of theft in
an ambulance service is to steal the
drugs and replace the drugs with
water so the containers appear full
If a theft or a loss (including evidence
of tampering) is discovered you have
one (1) business day to notify the
local DEA office of the incident
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55. Evidence of Tampered
Seals
Any evidence of tampering MUST be
reported to the DEA on Form 106 (this
can also be submitted online at:
http://www.deadiversion.usdoj.gov
Local law enforcement should also be
notified for a possible investigation
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Special Thanks to:
Kathy L. Federico
Diversion Investigator
(414)-336-7380
Milwaukee District Office
4725 W. Electric Avenue
West Milwaukee, WI 53219

69. Questions?

70. Recordkeeping Using Image
Trend Software
On to Kep . . .