claire brennan diversion program manager new england field ... presentations/2018/la… ·...

Claire BrennanDiversion Program ManagerNew England Field Division

I have no conflicts of interest

Drug Enforcement Administration

Diversion Control Division 2

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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


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

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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

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Title 21 Code of Federal Regulations

Food and Drugs

Part 1300 to End

• Requirements under Controlled Substances Act to

include:

–Registration

–Recordkeeping

– Inventories

– Security

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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

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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

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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

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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

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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

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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

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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)

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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

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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

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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

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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

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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



What to expect:

Presented, and asked to sign, Notice of Inspection

Provide most recent Biennial Inventory

Physical inventory of selected controlled substances

taken

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Provide Receiving Records

Provide Distribution Records

Review of Records



Records utilized to do audit

Review Security

Review of outcome of on-site investigation

Case closed or action taken

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More stringent rule applies…when there are both federal

and state regulations

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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)



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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)



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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



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

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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

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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…

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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

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Forged prescriptions = Diversion of controlled

substances

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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/

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CDC: Nearly 30,000 exposed to

Hep C over past decade by infected

employees using narcotics intended

for patients



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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

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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



http://www.emcdda.europa.eu/publications/drug-profiles/fentanyl

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Heroin seizure

Pharmaceutical oxycodone 30mg



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

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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

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Central Nervous System Stimulant

Brand Name: Adderall®


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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



High potency benzodiazepine

Brand Name: Xanax®




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Carisoprodol Alprazolam

Opiate

C-IV as of 1/11/2012

Muscle Relaxant

Benzodiazepene



• 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

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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

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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

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-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”

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• 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.



• 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



• 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)

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• 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)

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• The registrant has a modified registration authorizing the

collection of controlled substances from the “ultimate

user.”

100 Authorized Collectors (as of 10-15-18)



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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.



dea.gov

deadiversion.usdoj.gov

New England Field Division, Boston Office,

Diversion Unit 617-557-2220



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



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



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



What is the street name for one of the prescription

“cocktails”?

1) The Cross

2) The Trinity

3) The Bomb

4) The Trifecta



Who can be an authorized collector?

1) Retail Pharmacy

2) Town Library

3) Optometrist

4) Seven-Eleven



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