DEA Compliance in Long-Term Care Pharmacy

ChangingChanging LivesLives
AANNUALNNUAL CCONFERENCE ANDONFERENCE AND TTRADERADE SSHOWHOW
August 25th, 26August 25th, 26thth
& 27& 27thth
, 2009, 2009

How Pharmacy ComplianceHow Pharmacy Compliance
with the DEAwith the DEA
Affects your Bottom LineAffects your Bottom Line
Session 15G
Wednesday, August 26, 2009
9:45 -11:15 a.m.

6175 Hi-Tek Court
Mason, Ohio 45040
www.skilledcare.com

Larry Galluzzo, RPh
Larry Galluzzo has been the President/Owner of Skilled Care Pharmacy
since 1980. He was the co-founder of Net-Rx, a purchasing group
comprised of owners of privately-held pharmacies, as well as the co-
founder of Excel CSO, a group service organization serving the Long Term
Care market. He is a member of the American Society of Consultant
Pharmacists and the Ohio Pharmacist Association, and an active participant
in the Ohio Health Care Association, The Ohio Academy of Nursing Homes,
Kentucky Association of Health Care Facilities, Association of Ohio
Philanthropic Homes and Housing for the Aging, The American College of
Nursing Home Administrators, and the Assisted Living Association of
America.

Tracy Overton
CII Compliance Supervisor
Tracy Overton has served as a pharmacy technician in the long-term care industry
for the past seven years assuming positions in both staff and supervisory roles. At
Skilled Care, Tracy is exclusively responsible for pharmacy and physician compliance
with the controlled substance (CII) prescription process per the Drug Enforcement
Agency regulatory expectations.
Recently, she participated in the successful realignment of the CII process within
the pharmacy for which she gained great knowledge and expertise in procedural
accountability and facility/physician buy-in.

Angela Sagraves, RPh
Senior Pharmacy Manager
Angela Sagraves has served in a pharmacist capacity for 15 years in the long-term
care industry. She has assumed positions in multiple settings as staff pharmacist
and consultant pharmacist as well as 10 years in institutional pharmacy
management. Her responsibilities at Skilled Care include oversight of the order
entry, controlled substances, dispensing, prescription verification, and intravenous
pharmacy processes encompassing over 100,000 prescriptions per month.
Most recently, in conjunction with her operational duties, she was actively involved
in the development and implementation of procedural changes relative to the
management of controlled substance prescription acquisition and medication
dispensing.

28601 Chagrin Boulevard
Eton Tower, Suite 500
Beachwood, Ohio 44122
Phone 216.831-0042 Fax 216.831.0542
www.meyersroman.com
Winner 2006 & 2007

Mary Louisa L’Hommedieu is experienced in a wide variety of
corporate health care, commercial, and employment matters. She has
litigated numerous cases in state and federal courts and before
administrative bodies. Mary Louisa devotes a substantial portion of her
practice to the resolution of business and regulatory disputes in the
health care, long-term care and pharmacy industries. She also handles a
broad range of other commercial litigation, and has authored and
presented seminars on health care, employment and real estate topics.
Prior to joining the firm, Mary Louisa’s practice was focused in
health care, commercial litigation and employment law . She also served
as a judicial attorney for the Honorable William B. Hoffman of the Fifth
District Court of Appeals, and as judicial attorney for the Honorable
Patricia A. Cosgrove of the Summit County Court of Common Pleas. She
graduated cum laude from the University of Akron School of Law in 1996,
where she was a member and an Associate Editor of the Akron Law
Review.
Mary Louisa is a member of the Cleveland and Ohio Bar
Associations, as well as a member of the American Health Lawyers
Association, OHCA (where she serves on the Facility Standards
Committee) , and AOPHA. She has served as an Executive Board
Member of the Youngstown Chapter of Habitat for Humanity, and is a
member of the Hudson Chamber of Commerce. Look for her article,
“Never Events and the Advent of Value Based Purchasing in Long Term
Care” in the September, 2009 edition of Health Lawyer’s News. She
lives in Hudson, Ohio with her husband and two children.
Mary Louisa
L’Hommedieu

Mark P. McGrievy focuses his practice on business services,
real estate, finance (representing both borrowers and lenders) and
health care transactions and regulatory issues. Mark is a partner in
the firm and serves as Chair of its Health Care Practice Group. He
counsels clients on organizational structure; mergers, acquisitions
and divestitures; financing; debtor/creditor workouts; licensure;
Medicare and Medicaid certification, compliance and regulatory
issues. Mr. McGrievy represents a number of health care
providers, including; Nursing Homes, Residential Care and Assisted
Living facilities, Physicians, Home Health Care and Senior Services
companies, Medical Billing companies, Device Manufactures,
Oxygen, Ambulance and Therapy companies and other Ancillary
Providers, as well as Real Estate companies, Lending Institutions
and closely held businesses in a variety of business sectors.
Mr. McGrievy graduated in 1988 from Cleveland-Marshall
College of Law and began his legal career as a law clerk to the
Honorable Thomas R. Rumana, JSC, Passaic County N.J. Superior
Court. He is admitted to practice in Ohio and New Jersey. Before
joining a downtown Cleveland law firm in 1995, he served as Chief
Financial Officer and General Counsel for a Nursing Home
Management company from 1990 to 1995.
Mark is a member of the Cleveland and Ohio Bar
Associations, as well as a member of the American Health Lawyers
Association, Ohio Health Care Association, and Ohio Academy of
Nursing Homes. He served as President of the Allied Healthcare
Professionals Association, and is involved in several Community
organizations; IPMC Treasurer (2002 to present), Fraternal Order of
Eagles, and March of Dimes.
Mark P. McGrievy
Chair, Healthcare
Group

AGENDA
Introduction & BackgroundIntroduction & Background

ChangingChanging LivLives
AGENDA
Introduction & Background
Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations

AGENDA
Controlled Substances Act & DEA Regulations
CII Dispensing RulesCII Dispensing Rules

AGENDA
CII Dispensing Rules
CIII through C-V DispensingCIII through C-V Dispensing

AGENDA
CIII through C-V Dispensing
““Agent” of the Practitioner IssuesAgent” of the Practitioner Issues

AGENDA
“Agent” of the Practitioner Issues
Is your Facility at Risk?Is your Facility at Risk?

AGENDA
Is your Facility at Risk?
Penalties, Fines and other RepercussionsPenalties, Fines and other Repercussions

AGENDA
Penalties, Fines and other Repercussions
Facility & Pharmacy challenges and how to work togetherFacility & Pharmacy challenges and how to work together

AGENDA
Facility & Pharmacy challenges and how to work together
Compliance challenges and Cost of Non-complianceCompliance challenges and Cost of Non-compliance

AGENDA
Compliance challenges and Cost of Non-compliance
Question & Answer SessionQuestion & Answer Session

AGENDA
Compliance challenges and Cost of Non-compliance
Question & Answer Session

WARNINGWARNING
DEA currently has ACTIVE investigations
in Ohio, Michigan, New York , Wisconsin,
West Virginia and Pennsylvania.

WARNINGWARNING
DEA currently has ACTIVE investigations
in Ohio, Michigan, New York , Wisconsin,
West Virginia and Pennsylvania.
Please do not discuss or raisePlease do not discuss or raise
questions regarding particularquestions regarding particular
Facility or Pharmacy issuesFacility or Pharmacy issues

In the last five years, prescription drug abuse hasprescription drug abuse has
risen more than two-thirds nationwiderisen more than two-thirds nationwide. It is the
DEA’s responsibility to work with our law enforcement
partners to monitor prescriptions and ensure that
legitimate pharmaceuticals are not diverted for illegitimate
abuse.
-Special Agent in Charge John P. Gilbride,
commenting on a recent case reported on
DEA website. 3/22/07

Nearly 7 million Americans are abusing prescription drugs7 million Americans are abusing prescription drugs*—more
than the number who are abusing Cocaine, Heroin, Hallucinogens,
Ecstasy, and Inhalants, combined. That 7 million was just 3.8 million in
2000, an 80 percent increase in just 6 years80 percent increase in just 6 years.

Methods of acquiring prescription drugs for abuseMethods of acquiring prescription drugs for abuse include “doctor-
shopping”, traditional drug-dealing, theft from pharmacies or homes,
illicitly acquiring prescription drugs via the Internet, and from friends
or relatives.

Misuse of painkillers represents three-fourths of the overallMisuse of painkillers represents three-fourths of the overall
problemproblem of prescription drug abuse; Hydrocodone is the most commonly
diverted and abused controlled pharmaceutical in the U.S.
From DEA Drug Fact Sheet, on DEA website:
http://www.usdoj.gov/dea/concern/prescription_drug_fact_sheet.html

Pharmacies investigated for common practices generally
are regulated by State Boards, but now DEA investigations
are on the rise.

Nursing Home, Residential Care and Assisted Living
facilities have experienced increased investigations and
should expect heightened scrutiny!
Pharmacies investigated for common practices generally
are regulated by State Boards, but now DEA investigations
are on the rise.

Controlled Substances Act
 Legal foundation of the Federal government’s authority over
controlled substances and listed chemicals.

 Consolidates more than 50 laws regulating controlled substances
and listed chemicals.

 Consolidates more than 50 laws regulating controlled substances
and listed chemicals.
 System of U.S. compliance with international treaties.
Implemented in DEA Regulations: Title 21 CFR 1300 to End

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 “Closed system” of distribution.

 Five “schedules” of controlled substances.
C-I through C-V

 Five “schedules” of controlled substances.
C-1 through C-V
 Created the Compliance Program (1971) to monitor
the legitimate manufacture and distribution of controlled
substances.

Closed System of Distribution:
 Registrants must maintain DEA registration

 Each registrant involved in a transaction must verify
the other registrant’s DEA registration

 Each registrant involved in a transaction must verify
the other registrant’s DEA registration
 Transfer by the end user to any other person is
illegal distribution

 DEA Registrants (Handlers of Controlled Substances)

 Importers, Manufacturers

 Distributors (Wholesalers), Exporters

 Pharmacies

 Pharmacies
 Narcotic Treatment Programs (NTPs)

 Pharmacies
 Practitioners (MD, DO, DDS, DVM)”

 Pharmacies
 Practitioners (MD, DO, DDS, DVM)
 Mid-Level Practitioners (PA, ARNP)

 Pharmacies
 Researchers, Analytical Labs

 Pharmacies
 Researchers, Analytical Labs
 “Reverse Distributors”

Disposition of Unwanted Controlled Substances:
 Return to supplier

 Send to “Reverse Distributor”

 Send to “Reverse Distributor”
 Receive permission from DEA to destroy

Long term care facilities such as nursing homes, assisted
living facilities, and other institutions providing extended health
care to resident patients are exempt from the Registration
requirement because they hold prescribed controlled
substances in a custodial capacity for their residents.

Some DEA offices have advised that flushing or pouring
down the drain are not acceptable methods of destruction.
Under current law long term care facilities who wish to dispose
or destroy controlled substances and do not want to just throw
them away or flush them down the drain, must submit a letter
to the local DEA office for authorization.

Schedule I – No current medical use in the United States,
with a Very High potential for abuse:
Heroin
MDMA (Ecstasy)
LSD
Marijuana
Scheduled Substances:
http://www.usdoj.gov/dea/pubs/scheduling.html

Schedule II - Legitimate medical use, but with High
potential for abuse:
 Methamphetamine
 Dilaudid
 Cocaine
 Morphine
 Ritalin
 Percocet
 Adderall
 Oxycontin

Schedule III - Legitimate medical use, but with lesser
potential for abuse including Narcotic (III), and Non-narcotic
(IIIN):
Examples:
 Vicodin, Lortab (Hydrocodone) (III)
 Tylenol with Codeine (III)
 Buprenorphine (Suboxone) (III)
 Butorphanol (Stadol) (III)
 Anabolic Steroids, Ketamine (IIIN)

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Schedule IV - Low potential for abuse:
 Valium
 Xanax
 Darvocet
 Diet Drugs

Schedule V - Lowest potential for abuse
 Cough syrups
 Lyrica
 Lomotil

DEA Regulations:
 The Controlled Substances Act of 1970 is the foundation for
the body of regulations that governs the production,
transfer,
and disposal of controlled substances.

DEA Regulations:
the body of regulations that governs the production, transfer,
 Current federal requirements can be found under 21 CFR
1300, et seq.

DEA Regulations:
the body of regulations that governs the production, transfer,
 Current federal requirements can be found under 21 CFR
1300, et seq.
 Controlled substances are also regulated at the state level
(usually under the State Department of Health)

Federal and State Regulations
 Healthcare professionals must comply with both federal and
state laws and regulations.

Federal and State Regulations
 Healthcare professionals must comply with both federal and
state laws and regulations.
 When federal laws or regulations differ from state laws or
regulations, the more stringent law applies.

http://www.usdoj.gov/dea/pubs/csa.html
DEA Website lists text of law, with links
to regulations:

DEA Diversion Web Site: www.deadiversion.usdoj.gov

 A prescription for a controlled substance (CII-CV) must be
issued for a legitimate medical purpose by an individual medical
practitioner “acting in the usual course of his or her professional
practice.”

practice.”
 Responsibility for the proper prescribing and dispensing of
controlled substances is upon the prescribing practitioner.

practice.”
 Responsibility for the proper prescribing and dispensing of
controlled substances is upon the prescribing practitioner.
 A “corresponding responsibility rests with the pharmacist
who fills the prescription.”
21 CFR 1306.04(a).
21 CFR 1306.03.

 All prescriptions for controlled substances must be:
 dated as of, and signed on the day issued,
.

 must bear the full name and address of the patient
.

 the drug name
.

 the drug name
 strength
.

 the drug name
 strength
 dosage form
.

 the drug name
 strength
 dosage form
 quantity prescribed
.

 the drug name
 strength
 dosage form
 directions for use and
.

 the drug name
 strength
 dosage form
 directions for use and
the name, address and registration number of the practitioner.
21 CFR 1306.05
.

 Prescriptions must be written with ink or indelible pencil
or typewriter
.

or typewriter
 Manually signed
.

or typewriter
 Manually signed
 Prepared by the secretary or agent
.

or typewriter
 Manually signed
 Prepared by the secretary or agent
 Pharmacy may not fill any prescription without all required
elements.
21 CFR 1306.05.

Proper Prescriptions for Schedule II Controlled Substances:
 Written prescription signed by the practitioner
 Original written, signed prescription must be presented to
the pharmacist for review prior to the actual dispensing
These general rules have specific, limited exceptions.
21 CFR 1306.11(a)
.

Proper Prescriptions for Schedule II Controlled Substances
Exception 1: Faxed CII prescriptions sufficient when:
 Long term care facility (“LTCF”) resident
 Hospice Patient
 Compounded for certain direct administration
In each of these cases, the facsimile serves as the original written
prescription.
21 CFR 1306.11.

Exception 2:
Oral authorization permitted in Emergency Situation:
(1) The quantity limited to the emergency period; (&)
.

Exception 2:
Oral authorization permitted in Emergency Situation:
(2) Immediate reduction to writing; (&)
.

Exception 2: Oral authorization permitted in Emergency
Situation (cont).
(3) Validation; (&)
.

Situation (cont).
(3) Validation; (&)
(4) Obtain written prescription within 7 days.

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Situation (cont).
Pharmacist must notify DEA of Doctor’s failure to deliver or
face loss of license.
21 CFR 1306
.

Exception 2: Emergency Situations (cont).
Oral authorization in Emergency Situations:
 Immediate administration is necessary
.

 No appropriate alternative treatment is available, including
administration of N-CII drug
.

 No appropriate alternative treatment is available, including
administration of N-CII drug
 Not reasonably possible for the physician to provide a written
prescription prior to the dispensing.
21 CFR 1306.11 and § 290.10.

Refilling and Multiple Prescriptions of CIIs:
Prohibited, except:
 Where pharmacist is unable to supply the full quantity
 Partial fills for LTC residents or terminally ill
21 CFR 1306.12
.

CIII, IV & V Dispensing RulesCIII, IV & V Dispensing Rules
SCHEDULE III, IV AND V SUBSTANCES
Prescriptions. Generally, a written prescription is required before
dispensing a Schedule III, IV or V controlled substance and may be
dispensed only with:
 a written prescription signed by a practitioner; or
 a facsimile of a written, signed prescription; or
 an oral prescription made by an individual practitioner and promptly
reduced to writing by the pharmacist containing all information required
in Sec. 1306.05, except for the signature of the practitioner.
21 CFR 1306.21

CIII, IV & V Dispensing RulesCIII, IV & V Dispensing Rules
SCHEDULE III, IV AND V SUBSTANCES
Refilling of prescriptions for controlled substances listed in Schedule
III and IV.
 No more than six months after the issue date.
 No more than five times.
21 CFR 1306.22 & 21

Dispensing RulesDispensing Rules
Robert J. Compliant, M.D.
123 Holly Lane Date: 5/01/09
Hudson, Ohio 44236 Reg. No.: ________
_________________________________________
Patient’s name: ___________________________
Address: ________________________________
Drug: ___________________________________
Disp: #______# (write out quantity)
Sig: __________________________
Signature of Individual Medical
Practitioner

Who is the “Agent,” and why is this causing
such a controversy?

Is your Facility at RiskIs your Facility at Risk??
 Just a Pharmacy issue?

 Patient Care

 Patient Care
 Nursing Home Resident’s Bill of Rights

 Patient Care
 Fraud & Abuse issues

 Patient Care
 False Claims Act

 Patient Care
 DEA Investigations, audits, fines

 Patient Care
 DEA Investigations, audits, fines
 Potential Criminal and Civil liability

WHAT SHOULD YOU BE DOING?
 Contact your Pharmacy to discuss issue

 Set protocols with your Pharmacy

 Assist Pharmacy in dealing with the Resident’s Physicians

 Assist Pharmacy in dealing with the Resident’s Physicians
 Audit medication requests for compliance

 Civil Fines and Criminal Penalties

 Litigation & Defense Costs

 Fraud & Abuse

 Fraud & Abuse
 Loss of Provider Agreements

 Fraud & Abuse
 Loss of Provider Agreements
 Five Star Ranking

 Recognize potential problems

 Appoint Liaison

 Appoint Liaison
 Recordkeeping

Compliance ChallengesCompliance Challenges
 Disruption to Facility

 Cost of Compliance

 Cost of Compliance
 Cooperation between all Parties involved

Question & Answer SessionQuestion & Answer Session
?
? Ask Away

DEA Compliance in Long-Term Care Pharmacy

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