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| Title: | The Opioid Epidemic and the Practice of Legitimate Medicine |
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| Body: | The Opioid Epidemic
and the
Practice of Medicine
Aziz Elkholy
Acting Chief Liaison Section
Diversion Control Division
Practitioner Diversion Awareness Conference
New Orleans, Louisiana
October 21-22, 2019
2
LEGAL DISCLAIMER
The following presentation was accompanied by an oral
presentation on October 21-22, 2019, and does not purport to
establish legal standards that are not contained in statutes,
regulations, or other competent law. Statements contained in this
presentation that are not embodied in the law are not binding on
DEA. Summaries of statutory and regulatory provisions that are
summarized in this presentation do not purport to state the full
extent of the statutory and regulatory requirements of the cited
statutes and regulations. I have no financial relationships to
disclose.
This presentation is for educational purposes only. This presentation may not be further
copied or used, with the embedded images and videos, without an independent analysis of the
application of the Fair Use doctrine.
Fair Use
Under section 107 of the Copyright Act of 1976, allowance is made for "Fair Use" for
purposes such as criticism, comment, news reporting, teaching, scholarship, education and
research.
Fair Use is a use permitted by the copyright statute that might otherwise be infringing. Any
potentially copyrighted material used in this presentation has been reviewed and found to be
used in a manner consistent with Fair Use. A completed Fair Use checklist is attached.
Fair Use Act Disclaimer
Objectives
To Introduce the DEA registered Practitioner with:
. Real Mission of the Diversion Control Division of the
DEA
. Extent of the Opioid Epidemic in the U.S.
. History and Complexity of Drug Abuse in the U.S.
. Trends in Prescribing and Dispensing Patterns
. Nationwide Efforts to Combat the Problem
Questions To Discuss
At the completion of this block of instruction you will be able to
answer the following questions:
1. What limits has Louisiana placed on controlled substance
prescriptions?
2. What are the top three most commonly prescribed controlled
substances in the U.S.?
Questions To Discuss
3. According to the CDC approximately how many people died
from drug overdoses in the year 2017?
4. Under Federal Law what is the primary responsibility of
practitioners when it comes to issuing prescriptions for
controlled substances?
5. According to IMS Data the total number of prescriptions being
filled for oxycodone for the last three years has declined?
There
Is
Pain
7
There
Is
Legitimate
Pain
8
There
Is
Dependence
9
There
Is
Addiction
10
There
is
Death
as a Result of
Addiction
11
Public Health Epidemic
In 2014, there were 47,055
drug overdose deaths
In 2015, there were 52,404
drug overdose deaths
In 2016, there were 63,632 drug overdose deaths
1. Rudd R, et al. MMWR Morb Mortal Wkly Rep. 2016 Jan 1;64:1378-82.
2. CDC. https://www.cdc.gov/drugoverdose/data/analysis.html. Feb 2017. Accessed May 2017.
Public Health Epidemic
In 2017, there were 70,237
drug overdose deaths,
...one death every 7.5 minutes,
...approximately 192 per day,
...Opioids, many synthetic opioids (other than
methadone) were involved in 47,600
overdose
deaths..
https://www.cdc.gov/drugoverdose/data/statedeaths.html
Soldier Field
Capacity: 61,500
15
17
Pills laced with deadly opioid infiltrating drug market,
DEA says
The Guardian
By Susan Zalkind
The illegal drugs look like known prescription painkillers and
contain high amounts of fentanyl as law enforcement says
problem is expected to escalate. Hundreds of thousands of
counterfeit prescription pills laced with a deadly synthetic
opioid have infiltrated the US drug market, according to the
(DEA)...
Heroin Seizure Pharmaceutical Oxycodone 30mg
U.S. Drug Enforcement Administration
19
U.S. Drug Enforcement Administration
2018: Ten Most Commonly Filled Controlled
Substances Prescriptions in the U.S.
. Hydrocodone
. Oxycodone
. Alprazolam
. Tramadol
. Dextroamphetamine
. Zolpidem
. Clonazepam
. Lorazepam
. Codeine
. Buprenorphine
20
IQVIA Data on file as of March 11, 2019
The Most Common Drugs Involved in
Prescription Opioid Overdose Deaths include:
Oxycodone
Methadone
Hydrocodone
https://www.cdc.gov/drugoverdose/data/prescribing.html
Unfortunately,
The United States
has a Long History
of
Drug Use
and
Abuse
22
1804
Morphine is Distilled from
Opium for the First Time
23
Sam Quinones, 2015, Dream Land: The Tale of America's Opiate
Epidemic
24
1839
The First Opium War Breaks
Out as Britain Forces China to
Sell Its India Grown Opium
Sam Quinones, 2015, Dream Land: The Tale of America's Opiate
Epidemic
25
1853
The Hypodermic Syringe is Invented
The Inventor's Wife is the First to Die of an
Injected Drug Overdose
Sam Quinones, 2015, Dream Land: The Tale of America's Opiate
Epidemic
U.S. Drug Enforcement Administration
Diversion Control Division
26
1861-1865
Morphine Addiction
The Civil War
The "Soldier's Disease"
27
1898
Bayer Chemist Invents
diacetylmorphine,
Names It Heroin
Sam Quinones, 2015, Dream Land: The Tale of America's Opiate
Epidemic
28
Advent of the 20th Century
Abuse Of Opium And Morphine A Significant
Problem In The US
But
There Was Widespread Distribution Of
Medicinal Products Containing The New
"Non-addictive" Alternative To Morphine -
Heroin.
29
30
31
32
33
34
35
36
37
38
February 9, 1909
Congress
Public Law 221
"An Act to Prohibit the Importation and Use of
Opium for Other Than Medicinal Purposes"
39
1914
U.S. Congress Passes Harrison
Tax Act
Sam Quinones, 2015, Dream Land: The Tale of America's Opiate
Epidemic
40
1928
Committee on the Problems of Drug
Dependence is Formed
To Organize Research in Pursuit of the Holy
Grail:
A Non-addictive Painkiller
Sam Quinones, 2015, Dream Land: The Tale of America's Opiate
Epidemic
41
1951
Arthur Sackler Revolutionizes
Drug Advertising
With Campaign for the
Antibiotic Terramycin
Sam Quinones, 2015, Dream Land: The Tale of America's Opiate
Epidemic
42
1960
Arthur Sackler's campaign for
Valium makes it the industry's
first $100 million drug
Sam Quinones, 2015, Dream Land: The Tale of America's Opiate
Epidemic
43
1980
The New England Journal of
Medicine
publishes a letter to
the editor that becomes known
as "Porter and Jick"
Sam Quinones, 2015, Dream Land: The Tale of America's Opiate
Epidemic
ADDICTION RARE IN PATIENTS
TREATED WITH NARCOTICS
44
Jane Porter
Hershel Jick, M.D.
Boston Drug Surveillance Program
Boston University Medical Center
New England Journal of Medicine.
January 1980
http://www.nejm.org/doi/pdf/10.1056/NEJM1980011030020221
ADDICTION RARE IN PATIENTS
TREATED WITH NARCOTICS
"We conclude that despite widespread use of
narcotic drugs in hospitals, the development of
addiction is rare in medical patients with no
history of addiction."
45
http://www.nejm.org/doi/pdf/10.1056/NEJM1980011030020221
46
1986
Drs. Kathleen Foley and Russell Portenoy
publish paper in the journal Pain, opening
a debate about use of opiate painkillers for
wider variety of pain
Sam Quinones, 2015, Dream Land: The Tale of America's Opiate
Epidemic
47
1990
Dr. Mitchell Max
President
American Pain Society
"therapeutic use of opiate analgesics
rarely results in addiction..."
The Joint Commission's Pain Standards: Origins and Evolution, David W. Baker, MD,MPH, May 5, 2017
48
1995
OxyContin
FDA approved labeling
"iatrogenic addiction was "very rare" and that
the delayed absorption of OxyContin reduced
the abuse liability of the drug"
The Joint Commission's Pain Standards: Origins and Evolution, David W. Baker, MD,MPH, May 5, 2017
49
"Iatrogenic"
"an illness that is caused by medical
examination or treatment."
https://en.oxforddictonaries.com/definition/iatrogenic
50
1996
Purdue releases OxyContin, timed-
released oxycodone, marketed largely for
chronic-pain patients
Sam Quinones, 2015, Dream Land: The Tale of America's Opiate
Epidemic
51
1996
Dr. David Procter's clinic in South Shore,
Kentucky, is presumed
the nation's first pill mill
Sam Quinones, 2015, Dream Land: The Tale of America's Opiate
Epidemic
52
1996
President of American Pain Society urges
doctors to treat pain as a vital sign
Sam Quinones, 2015, Dream Land: The Tale of America's Opiate
Epidemic
53
October 2000
Department of Veterans Affairs
Pain: The Fifth Vital Sign Toolkit
The Joint Commission's Pain Standards: Origins and Evolution, David W. Baker, MD,MPH, May 5, 2017
54
October 31, 2000
106th U.S. Congress
H.R. 3244
"Decade of Pain Control and Research."
55
2001
Dr. Dennis O'Leary, President
Joint Commission on Accreditation of Healthcare
Organizations (The Joint Commission)
. standards for health care organizations to
improve pain management.
. recommendation for systematic assessments
and use of quantitative measures of pain
The Joint Commission's Pain Standards: Origins and Evolution, David W. Baker, MD,MPH, May 5, 2017
56
2002
Dr. David Procter pleads guilty to drug
trafficking and conspiracy and serves
eleven years in federal prison
Sam Quinones, 2015, Dream Land: The Tale of America's Opiate
Epidemic
57
2007
Purdue and three executives plead guilty to
misdemeanor charges of false branding of
OxyContin; fined $634 million
Sam Quinones, 2015, Dream Land: The Tale of America's Opiate
Epidemic
58
2008
Drug overdoses, mostly from opiates,
surpass auto fatalities as leading cause of
accidental death in the United States
Sam Quinones, 2015, Dream Land: The Tale of America's Opiate
Epidemic
59
2011
Ohio passes House Bill 93,
regulating pain clinics
Sam Quinones, 2015, Dream Land: The Tale of America's Opiate
Epidemic
60
2013
The College on the Problems of Drug
Dependence turns seventy-five without
finding the Holy Grail of a non-addictive
painkiller
Sam Quinones, 2015, Dream Land: The Tale of America's Opiate
Epidemic
Intoxication: The Universal Drive for
Mind Altering Substances
"Dr. Ron Siegel has suggested that throughout our entire history
as a species, intoxication has functioned like the basic drives of
hunger, thirst, or sex, sometimes overshadowing all other
activities in life. Siegel further suggested "intoxication is the
fourth drive".
"Individual and group survival depends on the ability to
understand and control this basic motivation to seek out and use
intoxicants."
David V. Gauvin, Director, Department of Neurobehavioral Sciences, MPI Research: "A "Budding" Cannabis Cottage Industry Has
Set the Stage for an Impending Public Health Crisis", Pharmaceutical Regulatory Affairs: Open Access 2018, Volume 7, Issue 1
The
Problem
Affects
Everyone
62
No one
Is
Un-Affected
63
WA
OR
MT
ID
WY
ND
SD
MN
IA
NE
WI
MI
CO
KS
MO
IL
IN
UT
NV
CA
AZ
NM
OK
TX
AK
AR
LA
TN
KY
MS
AL
GA
SC
NC
OH
VA
PA
NY
ME
V
T
N
J
MD
RI
DC
DE
HI
V
W
FL
H
N
PR
DEA Registrants as of July 10, 2018: 1,817,663
Importers 272
Manufacturers 588
Narcotic Treatment Programs
1,737
Researchers
11,935
Distributors 863
70,884 1,698,002 18,272
Pharmacies Practitioners Hospitals
(394,256)
Patients (U.S. Population)
328,837,199
64
Exporters 259
DEA Registration Data
66
https://www.local10.com/news/florida/palm-beach-county/tamarac-dentist-arrested-after-cache-of-drugs-found-at-delray-beach-home
https://www.campussafetymagazine.com/hospital/nurse-arrested-stealing-drugs-hospital/
Katie Malafronte
December 10, 2018
https://www.dallasnews.com/news/investigations/2018/12/02/two-nurses-died-overdoses-inside-dallas-hospital-
went-wrong
Nearly 60 Doctors, Other Medical Workers Charged In Federal
Opioid Sting
April 17, 2019
CARRIE JOHNSON
Federal prosecutors are charging 60
doctors, pharmacists, medical
professionals and others
in connection with alleged opioid pushing and
health care fraud, the Justice Department said Wednesday.
The cases involve more than 350,000 prescriptions for controlled
substances
and more than 32 million pills - the equivalent of a dose of
opioids for "every man, woman and child," across Ohio, Kentucky,
Tennessee, Alabama and West Virginia, said Assistant Attorney General
Brian Benczkowski.
What's Trending ?
Some Good News ?
83
Opioid addiction is plateauing. But the crisis isn't over.
Vox
By Dylan Scott
New data from the Blue Cross Blue Shield Association suggests opioid
addiction rates are finally plateauing.
The big finding from the BCBSA data, which compiles medical claims
information from the various Blue Cross affiliates across the United States:
Diagnoses of opioid use disorder (addiction, in other words) declined from
2016 to 2017, from 6.2 per 1,000 patients to 5.9.
It was the first decline BCBSA had measured in eight years
U.S. Health Chief Says Overdose Deaths Are Starting to 'Plateau' But
'We Are So Far From the End'
. TIME Health
. (WASHINGTON) - The number of U.S. drug overdose deaths
has begun to level off after years of relentless increases driven
by the opioid epidemic, (HHS) health secretary Alex Azar said
Tuesday, cautioning it's too soon to declare victory.
. "We are so far from the end of the epidemic, but we are perhaps,
at the end of the beginning," Azar said in prepared remarks for a
health care event sponsored by the Milken Institute think tank.
By
RICARDO ALONSO-ZALDIVAR AND CARLA K. JOHNSON / AP,
October 23, 2018
84
85
Overdose Deaths Likely to Fall for First Time Since 1990
Health officials and scientists warn U.S. is far from defeating
drug epidemic
Wall Street Journal
June 26, 2019
For the first time in decades, drug-overdose deaths in the U.S. are on the precipice
of declining. Authorities are still counting fatalities around the U.S. from 2018,
but provisional data from the Centers for Disease Control and Prevention are
pointing lower. Those data predict there were nearly 69,100 drug deaths in the 12-
month period ending last November, down from almost 72,300 predicted deaths for
12 months ending November 2017.
86
0
20,000
40,000
60,000
80,000
100,000
120,000
140,000
160,000
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018
In
Thousands
of
Rx's
Total Prescriptions Dispensed: Hydrocodone 2009-2018
(x 1,000) Data On File
87
0
10,000
20,000
30,000
40,000
50,000
60,000
70,000
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018
Total Prescriptions Dispensed: Oxycodone 2009-2018
( x 1,000)
Data On File
88
0
500
1,000
1,500
2,000
2,500
3,000
3,500
4,000
4,500
5,000
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018
In
Thousands
of
Rx's
Total Prescriptions Dispensed: Methadone 2009-2018
( x 1,000)
Data On File
Total Controlled Substance RX's Filled 2009-2018
( x 1,000)
0
100,000
200,000
300,000
400,000
500,000
600,000
700,000
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018
Data On File
90
0
2,000
4,000
6,000
8,000
10,000
12,000
14,000
16,000
18,000
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
In
Thousands
of
Rx's
Total Prescriptions Dispensed Buprenorphine 2009-2018
(x 1,000)
Data On File
*As of July 10, 2019: DEA Registration
Data
Opioid Treatment Programs (OTPs)
1,375
1,418
1,509
1,595
1,737
0
200
400
600
800
1,000
1,200
1,400
1,600
1,800
2,000
2014
2015
2016
2017
2019
Opioid Treatment Program (OTP) Totals
4
24
170
84
28
88
4
20
4
72
16
DC
6
43
23
56
6
19
9
10
83
91
10
48
17
17
5
4
77
3
3
9
16
43
18
132
19
56
93
20
6
82
14
22
1
98
17
39
1
10
28
21
9
4
DEA Registered
Opioid Treatment Programs (OTP)
Drug Enforcement Administration, Diversion Control Division Updated July 10, 2019
Total: 1,737
22
93
*As of July 10, 2019
DEA Registered Qualifying Practitioners
14,778
27,719
63,462
0
10,000
20,000
30,000
40,000
50,000
60,000
70,000
2010
2015
2019
Data Waived Physician (DWP)/Qualifying Practitioner Totals
388
607
6451
1145
1457
300
235
229
1029
217
DC 277
1231
1390
1716
252
1048
242
624
2704
1980
863
1597
719
805
277
218
1668
106
129
620
727
1817
446
6144
549
3190
3436
1202
457
3962
917
739
106
1954
738
1068
418
2590
893
512
98
DEA Registered Qualifying Practitioners
Drug Enforcement Administration, Diversion Control Division Updated July 10, 2019
Guam:
4
4
510
Total: 62,655
Qualifying Practitioners (US)
. Practitioner DW-30 36,046
. Practitioner DW-100 9,045
. Practitioner DW-275 4,505
. Nurse Practitioner DW-30 9,166
. Physician Assistant DW-30 2,449
. Nurse Practitioner DW-100 1,793
. Physician Assistant DW-100 471
95
*As of July 10, 2019
Qualifying Practitioners (LA)
. Practitioner DW-30 283
. Practitioner DW-100 135
. Practitioner DW-275 109
. Nurse Practitioner DW-30 116
. Physician Assistant DW-30 09
. Nurse Practitioner DW-100 35
. Physician Assistant DW-100 02
96
*As of October 17, 2019
Nationwide Efforts
to
Combat
the Problem
98
States
Practitioners
Hospitals
Treatment Providers
Medical Schools
Pharmacies
State Limits: Opioid Prescribing
Alaska 7 Day Supply (initial prescription/adults)
7 Day Supply (minors)
Arizona 5 Day Supply (initial prescription)
California Currently no special restrictions on Schedule 2
Colorado 7 Day Supply (initial limit/Medicaid recipients
only)
Connecticut 7 Day Supply (initial prescription)
5 Day Supply (minors)
99
https://ballotpedia.org/Opioid_prescription_limits_and_policies_by_state
Delaware 7 Day Supply (initial prescription/adults)
7 Day Supply (minors)
District of Columbia 7 Day Supply (emergency situation)
Florida 3 Day Limit/Acute Pain
Hawaii 7 Day Supply (initial prescriptions)
Indiana 7 Day Supply (initial prescription)
7 Day Supply (minors)
100
https://ballotpedia.org/Opioid_prescription_limits_and_policies_by_state
101
Kentucky 3 Day Supply (initial limit)
Louisiana 7 Day Supply (initial prescription/adults)
7 Day Supply (minors)
Maine 30 Day Supply (chronic pain)
7 Day Supply (acute pain)
100 MME Per Day
Maryland Must prescribe lowest effective dose.
No set pill or day limit.
State Limits: Opioid Prescribing
https://ballotpedia.org/Opioid_prescription_limits_and_policies_by_state
102
Massachusetts 7 Day Supply (initial limit/adults)
7 Day Supply (minors)
Michigan 7 Day Limit (acute pain)
Minnesota 4 Day Limit (acute dental or ophthalmic pain)
Missouri 7 Day Supply (initial limit/Medicaid recipients)
Nebraska 150 Tablets per 30 days(Medicaid recipients
only)
State Limits: Opioid Prescribing
https://ballotpedia.org/Opioid_prescription_limits_and_policies_by_state
103
Nevada 14 Day Supply (initial limit/acute pain)
90 MME per day
New Hampshire 7 Day Supply
New Jersey 5 Day Supply (initial limit/acute pain)
New York 7 Day Supply (initial limit/acute pain)
North Carolina 5 Day Supply (initial limit/acute pain)
7 Day Supply (post-operative)
Ohio 7 Day Supply for Adults (initial limit)
5 Day Supply for Minors
State Limits: Opioid Prescribing
https://ballotpedia.org/Opioid_prescription_limits_and_policies_by_state
104
Oklahoma 7 Day Supply
Oregon No set pill or day limit. Lowest possible dose.
Pennsylvania 7 Day Supply (emergency rooms/urgent care
centers)
7 Day Supply (for minors/consent)
Rhode Island 30 MME/day
South Carolina 5 Day Supply or 90 MME daily
State Limits: Opioid Prescribing
https://ballotpedia.org/Opioid_prescription_limits_and_policies_by_state
105
Tennessee 3 Day Supply (initial limit/new patients)
Utah 7 Day Supply (initial limit/acute pain)
Vermont Limits vary between adults and minors
Must assess non-opioid and opioid treatments
before prescribing opioids.
Must discuss treatment decisions with patients.
Moderate pain (Adults): 24 MME per day
Severe pain (Adults): 32 MME per day
Moderate to Severe Pain (Minors): 24 MME per day
State Limits: Opioid Prescribing
https://ballotpedia.org/Opioid_prescription_limits_and_policies_by_state
106
Virginia 7 Day Supply (acute pain)
14 Day Supply (post-surgical pain)
(Some exceptions)
Washington Medicaid Program- 20 years and
younger (18 tablets)
Medicaid Program- 21 years and
older (42 tablets)
West Virginia 7 Day Supply (short-term pain)
4 Day Supply (ER prescriptions)
3 Day Supply Dentists/Optometrists
State Limits: Opioid Prescribing
107
. In March 2016, Massachusetts became the 1
st
state to enact legislation to
limit the supply of opioid painkillers prescribed by practitioners.
. 35 States Have Enacted Legislation with Some Type of Limit, Guidance, or
Requirement Related to Opioid Prescribing
. Seven Day Supply in the Most Common
. Most States Exempt Treatment for Cancer, Palliative Care, Medication
Assisted Treatment
. Exceptions for the Professional Judgement of the Provider/Documented
http://www.ncsl.org/research/health/prescribing-policies-states-confront-opioid-overdose-epidemic.aspx
State Limits: Opioid Prescribing
108
Utah and Washington Become Latest States to Require
Conversations between Prescribers and Patients
12 States Now Require Patient Notification of Opioid Risks
With the recent adoptions by Utah and Washington, 12 states have now
passed versions of the Patient Notification Law, requiring a conversation
between prescribers and patients and parents, when a minor is being
treated, before an opioid-painkiller is prescribed to warn about risks of
dependence and when appropriate to discuss the use of a non-opioid pain
relief alternative.
info@preventopioidabuse.org
109
Utah and Washington Become Latest States to Require
Conversations between Prescribers and Patients (continued)
Versions of this life-saving legislation have also passed in California,
Connecticut, Maryland, Michigan, New Jersey, Nevada, Oklahoma,
Ohio and Rhode Island and West Virginia Efforts to adopt this life-
saving legislation are currently underway in Alaska, Kansas, Missouri,
Maine, Pennsylvania and Texas.
In the states where this legislation is being implemented, it is driving
down the number of opioid pain reliever prescriptions written. In New
Jersey, for example, opioid prescriptions have declined by 25% in a little
over a year.
info@preventopioidabuse.org
CVS Pharmacy Policy: 2/01/18
. Acute Pain (Opioid Naïve Patients: No Opioid
Script within the Past Year)
. 7-Day Supply
. Opioid Prescriptions
. Requirement to Counsel Patients:
-Risks Of Addiction
-Secure Storage Of Medications In The Home
-Proper Disposal of Medications
110
111
Walmart giving away solution to dispose
of unused prescription pills
January 26, 2018
Gene Myers, Staff Writer, @myersgene
112
Narcan available at more than 8,000 Walgreens locations
nationwide
. CBS News, By Peter Martinez: October 27, 2017
. Walgreens (WBA) is now stocking Narcan at all of its more
than 8,000 locations nationwide, the company announced
Thursday. The nasal spray, which is an FDA-approved form of
naloxone, can reverse the effects of an opioid overdose.
. The drug store chain said the move was "part of its
comprehensive national plan to combat drug abuse" and help
the communities it serves.
113
Knowing the Risks of Opioid Prescription Pain Medications (Rite
Aid)
Opioid prescription pain medications are a type of medicine used to relieve pain.
Some of the common names include oxycodone and acetaminophen (Percocet®);
oxycodone, (OxyContin®); and hydrocodone and acetaminophen (Vicodin®).
These medications...
. Cause your brain to block the feeling of pain; they do not treat the underlying cause of pain.
. Are very addictive, especially if they are not used correctly.
. Increase your chances of accidental overdose, coma, and death if taken with
prescription medications, including anti-anxiety and sedating medications, and alcohol.
Effective non-opioid options are available for relieving short-term pain, including ibuprofen (Advil®, Motrin®),
acetaminophen (Tylenol®), physical therapy, chiropractic, acupuncture, and cognitive behavioral therapy. Talk with
your pharmacist or healthcare provider to learn more.
114
Protect yourself -
and your loved ones -
with Naloxone (Rite Aid)
What is Naloxone?
. Naloxone is a lifesaving, rescue medication that can be used in an emergency to reverse the effects of an
accidental opioid overdose.
Why should I get Naloxone?
. Any prescription opioid medication has the potential risk for unintended
consequences such as slowed breathing and accidental overdose.
. Guidelines recommend naloxone if you take high doses of opioids, certain interacting medications or have
medical condition(s) that increase your risk.
. Having naloxone at home can not only protect yourself, but loved ones that may ingest the opioid by accident - an
emergency can occur after just one dose.
. Similar to a fire extinguisher in your home, naloxone is important to have "just in case" of an emergency or
accident it is always better to take appropriate precautions and be safe!
Walmart Will Implement New Opioid
Prescription Limits By End Of Summer
115
Vanessa Romo, May 8, 2018
116
Walgreens Expands Safe Drug Disposal Program
Drugtopics.com
June 26, 2019
Walgreens launched a national effort to help consumers safely dispose of
unwanted or expired medications year-round in all of its pharmacies.
If the chain does not currently have a safe disposal kiosk, it will
offer DisposeRx packets to help consumers safely discard unwanted
medications, the company says in a prepared statement.
Walgreens says the company has delivered on the expansion of its safe
drug disposal program announced last fall, at no cost to customers.
117
"Tylenol, Motrin just as effective in treating
pain in ER patients as opioids"
November 7, 2017
Lindsey Tanner, November 7, 2017, The Denver Post,
https://www.denverpost.com/2017/11/07/tylenol-motrin-effective-treating-pain-er-
patients-as-opioids/
118
Reducing opioids not associated with lower patient
satisfaction scores, study finds
Science Daily
A Kaiser Permanente study of nearly 2,500 patients who used high doses of opioids for at least six months
showed that reducing their opioid use did not lower their satisfaction with care. The study, "Satisfaction
With Care After Reducing Opioids for Chronic Pain," was published today in The American Journal of
Managed Care.
"Physicians are often concerned they will receive lower satisfaction scores if they reduce opioids for patients
who are accustomed to high opioid doses to manage chronic pain," said the study's lead author, Adam L.
Sharp, MD, MS, of Kaiser Permanente Southern California Department of Research & Evaluation. "This study
showed that following current recommendations and reducing opioids for chronic pain did not result in lower
satisfaction scores."
119
Could DNA help doctors predict opioid addiction?
MDDI
By Kristopher Sturgis
New research out of Bentley University aims to explore the genetic links
between human DNA and opioid addiction. The new study could help
doctors identify patients susceptible to opioid dependence and choose
different treatment methods.
The research project aims to help better inform doctors on how likely a
patient is to become addicted to opioids before ever prescribing opioid
drugs. The new data could also be used to predict how patients addicted
to opioids will respond to certain treatments.
120
FDA approves the first non-opioid
treatment for management of opioid
withdrawal symptoms in adults
Encouraging more widespread innovation and
development of safe and effective treatments for
opioid use disorder remains top agency priority
121
Most doctors are ill-equipped to deal with the
opioid epidemic.
Few medical schools teach addiction.
Jan Hoffman, The New York Times
Comprehensive addiction training is rare in American
medical education. A report by the National Center on
Addiction and Substance Abuse at Columbia University called
out "the failure of the medical profession at every level - in
medical school, residency training, continuing education and
in practice" to adequately address addiction.
September 27, 2018
Guidelines for the Chronic
Use of Opioid Analgesics
Federation of State
Medical Boards
April 2017
123
CDC
. New project to estimate best practice opioid prescribing in
the United States.
. Using large health insurance claims data, CDC will
estimate current opioid prescribing rates in the US for
various conditions and procedures. Using clinical
guidelines and related research, CDC will estimate what
the prescribing rates would be for these conditions and
procedures if best practices were followed.
124
Study: Dental painkillers may put young people at risk of opioid
addiction
The Washington Post
By Ronnie Cohen
Dentists who prescribe opioid painkillers to teenagers and young adults after pulling their wisdom teeth may be
putting their patients at risk of addiction, a new study finds.
The study, published in JAMA Internal Medicine Monday, shines a light on the largely overlooked role dental
prescriptions play in an epidemic of addiction that has swept the United States, leading to a record 70,237 drug
overdose deaths in 2017.
"Given the gravity of the opioid epidemic, the degree of persistent use and abuse we observed in adolescents and
young adults, especially females, is alarming," said researcher Alan Schroeder, a pediatrician and professor at
Stanford University School of Medicine. "Our findings should trigger heightened scrutiny over the frequency of
prescribing dental opioids."
Adolescents and young adults often are introduced to highly addictive opioid painkillers when they have their third
molars pulled. Millions of Americans undergo the procedure every year, and dentists routinely prescribe opioids to
the vast majority. Only recently have dentists - the most frequent prescribers of opioids for youths between the
ages of 10 and 19 in 2009 - started to reconsider the use of narcotics in managing post-surgical pain.
DEA Initiatives
Diversion Control Division:
Outreach Activities FY 2015 - FY 2019(3
rd
Quarter)
*As of 3
rd
Quarter, FY 2019, July 10, 2019
191
784
1254
1913
2394
0
500
1000
1500
2000
2500
3000
2015
2016
2017
2018
2019
HQ and Field Outreach Totals FY2015-2018
EOY Total
127
Dear DEA-Registered Practitioner -
February 2018
CDC's Recommendations for the Prescribing of Opioid Pain Medications
Dear DEA-Registered Practitioner:
In March, 2016, the Centers for Disease Control and Prevention (CDC) published its "CDC Guideline for Prescribing Opioids for
Chronic Pain" to provide recommendations for the prescribing of opioid pain medication for patients 18 and older in primary care
settings. Recommendations focus on the use of opioids in treating chronic pain (pain lasting longer than 3 months or past the
time
of normal tissue healing) outside of active cancer treatment, palliative care, and end-of-life care.
CDC's Guideline is part of a comprehensive approach to addressing the opioid overdose epidemic and is one step toward a more
systematic approach to the prescribing of opioids, while ensuring that patients with chronic pain receive safer and effective
pain
management. According to the CDC, The Guideline's twelve recommendations, published in August 2017, are based on three key
principles:
1.
Non-opioid therapy is preferred for chronic pain outside of active cancer, palliative, and end-of-life care. Opioids should only
be used when their benefits are expected to outweigh their substantial risks.
2.
When opioids are used, the lowest possible effective dosage should be prescribed to reduce risks of opioid use disorder and
overdose. Clinicians should start low and go slow.
3.
Providers should always exercise caution when prescribing opioids and monitor all patients closely. Clinicians should minimize
risk to patients-whether checking the state prescription drug monitoring program, or having an 'off-ramp' plan to taper.
You are receiving this email as part of DEA's effort to improve its communication with its more than 1.7 million registrants while
simultaneously improving the dissemination of the CDC Guidelines to those authorized to prescribe opioids.
A copy of CDC's publication entitled, "Guideline for Prescribing Opioids for Chronic Pain: Recommendations" may be found at:
https://www.cdc.gov/drugoverdose/pdf/Guidelines_Factsheet-a.pdf.
Additionally, an Interactive Training Webinar for providers who prescribe opioids may be found at:
https://www.cdc.gov/drugoverdose/training/index.html.
Taken from CDC.gov - More than 11 million people abused prescription opioids in 2016.
128
Opioid Addiction Resources - March 16, 2018
Opioid Addiction Resources
Resources for DEA Registered
Practitioners for Patients Who May
Be Dependent and/or Addicted To
Opioids
According to the U.S. Centers for Disease
Control and Prevention (CDC) there were
63,632 drug overdose deaths in the United
States in 2016; 174 deaths per day; one death
every 8.28 minutes; 42,249 (66.4%) of those
deaths were due to opioids. More deaths than those as a result of firearms,
homicide, suicide, and motor vehicle crashes.
Practitioners are in a unique position to help combat the current opioid epidemic in
this country. Please take time to understand and recognize the signs of this disease
in your patients. If you or anyone in your office suspects that a patient may have a
problem with opioid dependence, please provide your patients with the below listed
information so they, or someone in their family, can get the help that they may
need.
Practitioners may also wish to talk with their patients who are currently taking opioids
for a legitimate medical issue about the benefits of naloxone (e.g. Narcan®, Evzio®)
in the case of an overdose situation which may involve themselves or anyone in the
ir
family. These types of products can rapidly reverse the effects of an opioid overdose
and are the standard treatment for these types of situations. Information on
naloxone products can be found at www.fda.gov.
The Substance Abuse and Mental Health Services Administration (SAMHSA) has a
National Helpline, 1-800-662-HELP (4357), for those with a possible opioid use
disorder. The Helpline is a confidential, free, 24-hour-a-day, 365-day-a-year,
information service, in English and Spanish, for individuals and family members facing
mental and/or substance use disorders. This service provides referrals to local
treatment facilities, support groups, and community-based organizations. Callers can
also order free publications and other information here.
To find an authorized Opioid Treatment Program dispensing methadone or
buprenorphine to treat opioid dependency in your state visit:
129
Use of Telemedicine While Providing MAT - May 15, 2018
The Use of Telemedicine While Providing Medication
Assisted Treatment (MAT)
Under the Ryan Haight Act of 2008, where controlled
substances are prescribed by means of the Internet, the
general requirement is that the prescribing Practitioner must
have conducted at least one in-person medical evaluation of
the patient. U.S.C. § 829(e). However, the Act provides an
exception to this requirement. 21 U.S.C. § 829
(e)(3)(A). Specifically, a DEA-registered Practitioner acting
within the United States, is exempt from the requirement of
an in-person medical evaluation as a prerequisite to
prescribing or otherwise dispensing controlled substances by
means of the Internet, if the Practitioner is engaged in the practice of telemedicine and is acting in
accordance with the requirements of 21 U.S.C. § 802(54).
Under 21 U.S.C. § 802(54)(A),(B), for most (DEA-registered) Practitioners in the United States,
including Qualifying Practitioners and Qualifying Other Practitioners ("Medication Assisted
Treatment Providers") who are using FDA approved Schedule III-V controlled substances to treat
opioid addiction, the term "practice of telemedicine" means the practice of medicine in accordance
with applicable Federal and State laws, by a practitioner (other than a pharmacist) who is at a
location remote from the patient, and is communicating with the patient, or health care professional
who is treating the patient, using a telecommunications system referred to in section 1395m(m) of
Title 42 (42 C.F.R. § 410.78(a)(3)), which practice is being conducted:
A. while the patient is being treated by, and physically located in, a DEA-registered
hospital or clinic registered under 21 U.S.C. § 823(f) of this title; and by a practitioner
-who is acting in the usual course of professional practice;
-who is acting in accordance with applicable State law; and
-is registered under 21 U.S.C. § 823(f) with the DEA in the State in which the patient is located.
OR
B. while the patient is being treated by, and in the physical presence of, a DEA-
registered practitioner
-who is acting in the usual course of professional practice;
-who is acting in accordance with applicable State law; and
-is registered under 21 U.S.C. § 823(f) with the DEA in the State in which the patient is located.
130
Use of Mobile Devices in the Issuance of EPCS - August 16, 2018
Use of Mobile Devices in the Issuance of EPCS
The DEA is issuing the following statement
regarding the use of mobile devices for issuing
electronic prescriptions for controlled
substances (EPCS) due to confusion
surrounding this issue.
At this time, the DEA does not preclude the use
of a mobile device, for the issuance of an
electronic prescription for a controlled
substance, if the encryption used on the device
meets security requirements set out in Federal Information Processing Standards
(FIPS 140-2). The DEA will allow the use of a mobile device as a hard token, that is
separate from the computer or device running the EPCS application, if that device
meets FIPS 140-2 Security Level 1 or higher. The device used to create the
prescription cannot be the same device that serves as the hard token in the two-
factor authentication.
A practitioner who uses a mobile or other electronic device for EPCS, and who does
not wish to carry a hard token on a separate device, must use biometrics, and a
password or a challenge question. See 21 C.F.R. §§ 1311.115 and 1311.116.
A practitioner may issue an electronic prescription for a Schedule II, III, IV, or V
controlled substance when all of the requirements under 21 C.F.R. Part 1311
(Subpart C) are met.
Please note that while this document reflects DEA's interpretation of the relevant
provisions of the Controlled Substances Act (CSA) and DEA regulations, to the extent
it goes beyond merely reiterating the text of law or regulations, it does not have the
force of law and is not legally binding on registrants.
For more information contact DEA Policy & Liaison Section at ODLP@usdoj.gov.
131
April 10, 2019
Continuing Education available through the FDA-approved
Opioid Analgesic Risk Evaluation and Mitigation Strategy
(REMS)
Opioid analgesics, such as hydrocodone, oxycodone, and morphine, are powerful
pain-reducing medications that have both benefits as well as potentially serious
risks. The FDA has determined that a Risk Evaluation and Mitigation Strategy
(REMS) is necessary for all opioid analgesics intended for outpatient use to ensure
that the benefits of these drugs continue to outweigh the risks. The Opioid
Analgesics REMS, approved on September 18, 2018, is one strategy among
multiple national and state efforts to reduce the adverse outcomes of addiction,
unintentional overdose, and death resulting from inappropriate prescribing, abuse,
and misuse of opioid analgesics.
The REMS program requires that training be made available to all health care
providers (HCPs) who are involved in the management of patients with pain,
including nurses and pharmacists. To meet this requirement, drug companies with
approved opioid analgesics are providing unrestricted grants to accredited
continuing education (CE) providers for the development of accredited CE
programs for HCPs based on the FDA's Opioid Analgesic REMS Education Blueprint
for Healthcare Providers Involved in the Treatment and Monitoring of Patients
with Pain.
Although training is not mandatory for HCPs to prescribe or dispense opioid
analgesics, the FDA believes that all HCPs involved in the management of patients
with pain should be educated about the fundamentals of acute and chronic pain
management and the risks and safe use of opioids so that when they write or
dispense a prescription for an opioid analgesic, or monitor patients receiving these
medications, they can help ensure the proper product is selected for the patient
and used with appropriate clinical oversight.
HCPs are strongly encouraged to use the Patient Counseling Guide to discuss the
safe use, serious risks, and proper storage and disposal of opioid analgesics with
patients and/or their caregivers every time these medicines are prescribed. HCPs
are also strongly encouraged to emphasize to patients and their caregivers the
importance of reading the Medication Guide every time it is provided by their
pharmacist, and to consider other tools to improve patient, household, and
community safety such as a patient-provider agreement.
Accredited CE programs available under the Opioid Analgesic REMS are offered for
free or for a nominal fee and can be found at the following website:
https://search.opioidanalgesicrems.com/Guest/GuestPageExternal.aspx
132
DEA RX Drug Take Back - Saturday, October 27, 2018
DEA National RX Drug Take Back Day
DEATakeBack.com
On Saturday, October 27, 2018, from
10:00am to 2:00pm, the Drug Enforcement
Administration (DEA) will hold its 16
th
National Prescription Drug Take Back
Day. Held on the last Saturday of April
and October of every year, this national
event addresses a crucial public safety and
public health issue. Since its introduction
to the public on September 25, 2010, the
DEA has collected and incinerated over
4,982 tons of unwanted, unused, and
potentially dangerous medications.
According to the 2016 National Survey on Drug Use and Health 6.2 million
Americans misused controlled prescription drugs. Unfortunately, a
majority of misused prescription drugs are obtained from family, friends, and
relatives from their kitchen, bedroom or medicine cabinet.
The DEA's National Take Back Day is an opportunity for Americans to help
prevent drug addiction and overdose deaths and to raise awareness about the
dangers of opioid misuse.
The DEA is asking for your help in getting the word out. As a DEA-
registered doctor, dentist, nurse practitioner, physician's assistant,
veterinarian and/or state authorized dispensing pharmacist, you are perfectly
situated to help DEA spread the word about this important initiative. You
can help by providing patients with information on how to locate a safe,
convenient and anonymous collection location on October 27
th
.
For more information please visit DEAtakeback.com. We have also created
a "Partnership Toolbox" where you will find posters and pamphlets, in both
English and Spanish, that you can print and place in your waiting
rooms. This site may also be used to identify a collection location in close
proximity to your office.
Please help DEA in its effort to help keep unused prescription drugs out of
the wrong hands. The DEA thanks you for your support!
Safe Prescribing Saves Lives
Use the resources below to learn more about DEA, SAMHSA, and CDC
working together to help you prescribe with confidence
www.cdc.gov/RxAwareness
www.getsmartaboutdrugs.gov
134
Do You or a Family Member
Need Help with Drugs?
1-800-662-HELP (4357)
A Final Note
The mission of the Diversion Control
Division is to prevent, detect, and
investigate the diversion of
pharmaceutical controlled substances
and listed chemicals from legitimate
channels of distribution...
Mission
136
... while
ensuring an adequate and
uninterrupted supply of controlled
substances to meet legitimate medical,
commercial, and scientific needs.
Mission
137
21 C.F.R. § 1306.04 (a)
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.
138
U.S. Drug Enforcement Administration
Diversion Control Division
Prevention/Detection
Education
Treatment
Enforcement
Solutions to the Problem
139
Post Questions
1. What are some basic limits Louisiana has placed
on Schedule 2 opioid controlled substance
prescriptions?
A. 5 Day Supply for Minors
B. 15 Days (ER and Urgent Care)
C. No Special Restriction
D. 7 Day Supply for Initial Prescription
Post Questions
2. What are the top three most commonly
prescribed controlled substances in the U.S. ?
A. Hydrocodone
B. Oxycodone
C. Alprazolam
D. Methadone
E. A,B, & C
Post Questions
3. According to the CDC approximately how many
people died from drug overdoses in the year 2017?
A. 47, 055
B. 52,404
C. 63,632
D. 70,237
Post Questions
4. Under Federal Law what is the primary responsibility of
practitioners when it comes to issuing prescriptions for
controlled substances?
A. A prescription must be issued for a legitimate medical
need.
B. A prescription must issued in the usual course of
professional practice.
C. A&B
Post Questions
5. According to IMS Data the total number of
prescriptions being filled for oxycodone for the
last three years has declined?
A. Yes
B. No
Thank You
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