Upload
others
View
3
Download
0
Embed Size (px)
Citation preview
Claire BrennanDiversion Program ManagerNew England Field Division
I have no conflicts of interest
Drug Enforcement Administration
Diversion Control Division 2
3
LEARNING OBJECTIVES:
1. Recognize required recordkeeping regulations and
expectations for a DEA pharmacy audit
2. Recognize potential “red flags” as they relate to prescriptions
and/or customers
3. List common drugs of abuse and methods of diversion
4. Identify appropriate disposal options for controlled substances
Drug Enforcement Administration
Diversion Control Division
Mission
• Prevent, detect, and investigate the diversion of
controlled substances (pharmaceuticals, listed
chemicals) from legitimate channels.
• Ensure an adequate and uninterrupted supply of
controlled substances required for legitimate medical,
commercial, and scientific needs
4
Drug Enforcement Administration
Diversion Control Division
Title 21 Food And Drugs
CHAPTER 13 DRUG ABUSE PREVENTION
AND CONTROL
• 21 United States Code (U.S.C.) identifies the
scheduling of controlled substances
• Authorizes DEA to register individuals and companies
to handle controlled substances
• Specifies criminal, civil, and administrative sanctions
5
Drug Enforcement Administration
Diversion Control Division
Title 21 Code of Federal Regulations
Food and Drugs
Part 1300 to End
• Requirements under Controlled Substances Act to
include:
–Registration
–Recordkeeping
– Inventories
– Security
6
Drug Enforcement Administration
Diversion Control Division
Diversion Investigators – Regulatory, Complaint, and
Criminal Investigations
◦ Scheduled Regulatory Investigations (work plan)
◦ Pre-Registration Investigations/Registration Modifications
◦ Thefts and Losses
◦ Drug Complaints (e.g., prescription forgery; illegal
prescribing; hospital diversion) – usually with Tactical
Diversion Squad, local PD, other agencies
7
Drug Enforcement Administration
Diversion Control Division
Administrative Actions
◦ Letter of Admonition
◦ Memorandum of Agreement
◦ Voluntary Surrender
◦ Immediate Suspension Order
◦ Order To Show Cause
Civil Fines
◦ $14,502 or $62,500 PER VIOLATION
8
Drug Enforcement Administration
Diversion Control Division
9
Drug Enforcement Administration
Diversion Control Division
Initial and Biennial Inventories
When issued a DEA registration, a registrant must take an
initial inventory, which is an actual physical count of all
controlled substances in their possession
The registrant is required to take a biennial inventory (every 2
years) which requires the same information as the initial
inventory
10
Drug Enforcement Administration
Diversion Control Division
Inventory Requirements:
1. The date of the inventory
2. Taken at beginning or close of business
3. Name of each controlled substance inventoried
4. Finished form of each substance (e.g., 10 mg tablet)
5. Number of dosage units of each finished form in the
commercial container
11
Drug Enforcement Administration
Diversion Control Division
Inventory Requirements (Cont’d):
6. The number of commercial containers of each
finished form (e.g., four 100 tablet bottles)
7. A count of the substance – if Schedule II, an exact
count or measure, and Schedule III, IV, or V, an
estimated count or measure, unless the container
holds more than 1,000 tablets or capsules, then an
exact count is required
12
Drug Enforcement Administration
Diversion Control Division
Required Records:
1. Executed and unexecuted official order forms (DEA Form 222) or the electronic equivalent
2. Power of Attorney to sign order forms
3. Receipts and/or invoices for Schedules III, IV, and V controlled substances
4. All inventory records of controlled substances
13
Drug Enforcement Administration
Diversion Control Division
Required Records (Cont’d):
5. Records of controlled substances distributed
6. Records of controlled substances dispensed
7. Reports of Theft of Significant Loss (DEA Form 106)
8. Inventory of Drugs Surrendered for Disposal (DEA Form 41)
14
Drug Enforcement Administration
Diversion Control Division
Required Records (Cont’d.):
9. DEA registration certificate
10. Self-certification certificate and logbook (or
electronic equivalent) as required under the Combat
Methamphetamine Epidemic Act of 2005
15
Drug Enforcement Administration
Diversion Control Division
All required records for controlled substances must be maintained for a period of at least two years
Must be complete and accurate
Records for Schedule II controlled substances must be maintained separately
Records for Schedules III, IV, and V must be maintained separately or in a form that is readily retrievable from other records
16
Drug Enforcement Administration
Diversion Control Division
17
Drug Enforcement Administration
Diversion Control Division
Boxes overflowing with prescriptions
Prescriptions are not in any order
Prescriptions are mixed between legend and controls
Some prescriptions are missing a complete back tag label
18
Drug Enforcement Administration
Diversion Control Division
19
Drug Enforcement Administration
Diversion Control Division
End Result?
$600,000 Civil Fine through the US Attorney’s Office
based on violations of the Controlled Substances Act
and Code of Federal Regulations’ record keeping
requirements
20
Drug Enforcement Administration
Diversion Control Division
More civil violations…
2016 – a Boston hospital fined $100,000
2017 – MA pharmacy chain fined $20,000
2018 – MA pharmacy fined $30,000 to include CMEA
violations
Drug Enforcement Administration
Diversion Control Division 21
What to expect:
Presented, and asked to sign, Notice of Inspection
Provide most recent Biennial Inventory
Physical inventory of selected controlled substances
taken
22
Drug Enforcement Administration
Diversion Control Division
Drug Enforcement Administration
Diversion Control Division 23
Provide Receiving Records
Provide Distribution Records
Review of Records
Drug Enforcement Administration
Diversion Control Division 24
Records utilized to do audit
Review Security
Review of outcome of on-site investigation
Case closed or action taken
25
Drug Enforcement Administration
Diversion Control Division
More stringent rule applies…when there are both federal
and state regulations
26
Drug Enforcement Administration
Diversion Control Division
27
Drug Enforcement Administration
Diversion Control Division
28
Prescription
A prescription for a controlled substance
to be effective must be issued for a
legitimate medical purpose by an
individual practitioner acting in the usual
course of his professional practice.
21 CFR § 1306.04(a)United States v Moore 423 US 122 (1975)
Drug Enforcement Administration
Diversion Control Division
29
The responsibility for the proper prescribing
and dispensing of controlled substances is
upon the prescribing practitioner, but a
corresponding responsibility rests with the
pharmacist who fills the prescription.
21 CFR § 1306.04(a)
Drug Enforcement Administration
Diversion Control Division
30
Many customers receiving the
same combination of
prescriptions; cocktail
Many customers receiving the
same strength of controlled
substances; no individualized
dosing: multiple prescriptions for
the strongest dose
Drug Enforcement Administration
Diversion Control Division
Many customers paying cash for their prescriptions
Early refills
Many customers with the same diagnosis codes written
on their prescriptions
Individuals driving long distances to visit physicians
and/or to fill prescriptions
31
Drug Enforcement Administration
Diversion Control Division
Customers coming into the pharmacy in groups, each with the
same prescriptions issued by the same physician
Customers with prescriptions for controlled substances written by
physicians not associated with pain management (i.e.,
pediatricians, gynecologists, ophthalmologists, etc.).
Pharmacist did not reach out to other pharmacists to determine
why they were not filling a particular doctor’s prescription
Verification of legitimacy not satisfied by a call to the doctors
office
32
Drug Enforcement Administration
Diversion Control Division
Verification of a valid practitioner DEA number.
Invalid DEA number = Invalid RX!
Use of PMP
Knowledge and history with the patient
Circumstances of prescription presentation
Experience with the prescribing practitioner
It does not require a call to the practitioner for every
CS RX
This is not an all-inclusive list…
33
Drug Enforcement Administration
Diversion Control Division
Civil Penalties
Chain Pharmacy in MA found to have filled over 500
forged opioid prescriptions – failure to exercise
corresponding responsibility
Fined - $3,500,000.00
Another MA pharmacy failed to exercise corresponding
responsibility
Fined - $200,000.00
34
Drug Enforcement Administration
Diversion Control Division
Forged prescriptions = Diversion of controlled
substances
35
Drug Enforcement Administration
Diversion Control Division
Former GCMC nurse accused of stealing narcotic
painkiller from hospital – ScrantonTimesTribune
Nurse stole patient’s painkillers – Courier Mail
Support worker stole strong painkillers from
Furness General Hospital – NW Evening Mail
Source: heliometrics.net/2017/06/5/
36
Drug Enforcement Administration
Diversion Control Division
37
CDC: Nearly 30,000 exposed to
Hep C over past decade by infected
employees using narcotics intended
for patients
Drug Enforcement Administration
Diversion Control Division
38
Drug Enforcement Administration
Diversion Control Division
Schedule II synthetic opioid
• 25-40 times more potent than heroin
“Synthetic Heroin”
• Users are often unaware
Sources
• Mexico: Clandestine fentanyl
• China: Fentanyl and its analogs
• Pharmaceutical Diversion: Much smaller scale
39
Drug Enforcement Administration
Diversion Control Division
40
2 milligrams* of fentanyl
Source: *European Monitoring Centre of Drugs and Drug Addiction: http://www.emcdda.europa.eu/publications/drug-profiles/fentanyl
Accessed 01/20/2016
Drug Enforcement Administration
Diversion Control Division
41
Drug Enforcement Administration
Diversion Control Division
42
Heroin seizure
Pharmaceutical oxycodone 30mg
Drug Enforcement Administration
Diversion Control Division
Similarities:◦ Structurally related to codeine ◦ Equal to morphine in producing opiate-like effects
Brand Names: Vicodin®, Lortab®, Lorcet®
October 6, 2014 moved to SCHEDULE II
Street price: $7 to $20 depending on strength & location
43
Drug Enforcement Administration
Diversion Control Division
Similarities:◦ Structurally similar to morphine ◦ Equal to morphine in producing opiate-like effects
Brand Names: Percocet®, Roxicet®, Endocet®
Street price: Approximately $20 to $50 depending on strength & location
44
Drug Enforcement Administration
Diversion Control Division
Central Nervous System Stimulant
Brand Name: Adderall®
Street price: Approximately $20 to $50 depending on strength & location
45
Drug Enforcement Administration
Diversion Control Division
Used to treat opiate addiction
Brand Names: Suboxone®, Zubsolv®
Street Prices: Approximately $10 - $15 for 8mg strip
Approximately $20 for 12mg strip
Approximately $15 - $30 8mg pill
Drug Enforcement Administration
Diversion Control Division 46
High potency benzodiazepine
Brand Name: Xanax®
Street price: Approximately $2 to $25 depending on strength & location
Drug Enforcement Administration
Diversion Control Division 47
48
Carisoprodol Alprazolam
Opiate
C-IV as of 1/11/2012
Muscle Relaxant
Benzodiazepene
Drug Enforcement Administration
Diversion Control Division
• Synthetic designer drugs made to mimic THC
• Chemical compounds created in a laboratory
• Marketed as “herbal incense” and “potpourri”
• Abused most commonly by smoking but liquid
cannabinoids have been designed to be
vaporized
• Marketed to teens
49
Drug Enforcement Administration
Diversion Control Division
50
Drug Enforcement Administration
Diversion Control Division
Tramadol (Schedule IV) – Brand name, Ultram
Abusers can experience euphoria and possibly more if they
are opiate-naïve
Gabapentin (Prescription) – Brand name, Neurontin
Abusers can experience euphoria, improved sociability, a
marijuana like high, relaxation, and sense of calm (August 1,
2017, MA requires reporting to PDMP)
Many times these are combined with other drugs in an effort to potentiate
a high
51
Drug Enforcement Administration
Diversion Control Division
52
Drug Enforcement Administration
Diversion Control Division
Adderall ® - Football, Uppers, Speed
Fentanyl – China Girl, China White, Dragon’s Breath,Fent, Fire
Hydrocodone – Vics, Hydros, Watsons
Oxycodone – Buttons, Percs, Roxy
OxyContin ® - Greens (80mg), Hillbilly Heroin, OC
Xanax® - Bars (white pills), Hulk (green pills), School Bus (yellow pills), Z Bars, Benzos, Downers
53
Drug Enforcement Administration
Diversion Control Division
54
Drug Enforcement Administration
Diversion Control Division
-Authorized DEA to promulgate regulations that allow
ultimate users to transfer pharmaceutical controlled
substances to authorized entities for disposal
21 CFR Part 1317-Disposal
• Expanded options to safely and responsibly dispose
of unused/unwanted medications
• Established authorized “collectors”
55
Drug Enforcement Administration
Diversion Control Division
• The regulations continue to allow Federal, State, tribal,
and local law enforcement to maintain collection
receptacles at the law enforcement’s physical location;
• And either independently or in partnership with private
entities or community groups, to voluntarily hold take-
back events and administer mail-back programs.
Drug Enforcement Administration
Diversion Control Division 56
• Created an exception for Long Term Care Facilities
(LTCF) to dispose of controlled substances in
Schedules II-V on behalf of an ultimate user who
resides, or has resided, at the LTCF by disposing in an
authorized collection receptacle at the LTCF
• Only authorized retail pharmacies and hospital/clinics
with on-site pharmacy may install, manage, and
maintain collection receptacles at LTCFs
Drug Enforcement Administration
Diversion Control Division 57
• A person who has lawfully obtained, and who
possesses, a controlled substance for their own use, or
for the use of a member of their household, or for an
animal owned by them or a member of their
household.*
*21 USC § 802(27)
58
Drug Enforcement Administration
Diversion Control Division
• A registered manufacturer, distributor, reverse
distributor, narcotic treatment program, hospital/clinic
with an on site pharmacy, or retail pharmacy that is
authorized to receive a controlled substance for
destruction. *
*1300.01(b)
59
Drug Enforcement Administration
Diversion Control Division
• The registrant has a modified registration authorizing the
collection of controlled substances from the “ultimate
user.”
100 Authorized Collectors (as of 10-15-18)
Drug Enforcement Administration
Diversion Control Division 60
61
Drug Enforcement Administration
Diversion Control Division
62
Drug Enforcement Administration
Diversion Control Division
New England States
April 29, 2017
Connecticut – 8613.5 lbs.
Massachusetts – 27,694 lbs.
Maine – 27,140 lbs.
New Hampshire – 14,480 lbs.
Rhode Island – 3,435 lbs.
Vermont – 5,553 lbs.
Drug Enforcement Administration
Diversion Control Division 63
dea.gov
deadiversion.usdoj.gov
New England Field Division, Boston Office,
Diversion Unit 617-557-2220
Drug Enforcement Administration
Diversion Control Division 64
Under the Code of Federal Regulations, records for
controlled substances must be kept for how long?
a) Five years
b) One year
c) Two years
d) Ten years
Drug Enforcement Administration
Diversion Control Division 65
Under the Code of Federal Regulations, records for
controlled substances must be kept for how long?
a) Five years
b) One year
c) Two years
d) Ten years
Drug Enforcement Administration
Diversion Control Division 66
How often is a physical inventory required under the
Code of Federal Regulations?
1) Once every two weeks
2) Once every two years
3) Once a month
4) Once every year
Drug Enforcement Administration
Diversion Control Division 67
How often is a physical inventory required under the
Code of Federal Regulations?
1) Once every two weeks
2) Once every two years
3) Once a month
4) Once every year
Drug Enforcement Administration
Diversion Control Division 68
What is a potential red flag for a controlled substance
prescription?
1) Written on white paper
2) Written in cursive
3) Many customers paying cash
4) Many customers also buying off the shelf products
Drug Enforcement Administration
Diversion Control Division 69
What is a potential red flag for a controlled substance
prescription?
1) Written on white paper
2) Written in cursive
3) Many customers paying cash
4) Many customers also buying off the shelf products
Drug Enforcement Administration
Diversion Control Division 70
What is the street name for one of the prescription
“cocktails”?
1) The Cross
2) The Trinity
3) The Bomb
4) The Trifecta
Drug Enforcement Administration
Diversion Control Division 71
What is the street name for one of the prescription
“cocktails”?
1) The Cross
2) The Trinity
3) The Bomb
4) The Trifecta
Drug Enforcement Administration
Diversion Control Division 72
Who can be an authorized collector?
1) Retail Pharmacy
2) Town Library
3) Optometrist
4) Seven-Eleven
Drug Enforcement Administration
Diversion Control Division 73
Who can be an authorized collector?
1) Retail Pharmacy
2) Town Library
3) Optometrist
4) Seven-Eleven
Drug Enforcement Administration
Diversion Control Division 74