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| Body: | The Opioid Epidemic
and the
Practice of Medicine
James Arnold
Chief of Liaison
Diversion Control Division
Practitioner Diversion Awareness Conference
Hershey, Pennsylvania
December 17-18, 2018
2
LEGAL DISCLAIMER
The following presentation was accompanied by an oral
presentation on December 17-18, 2018, 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 Pennsylvania placed on Schedule 2 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,
...one death every 11.16 minutes,
...approximately 128 per day,
...19,000 were due to prescription opioid pain
relievers
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 2015, there were 52,404 drug overdose deaths,
...one death every 10.06 minutes,
...approximately 143 per day,
...22,598 were due to prescription opioid pain
relievers
National Institute on Drug Abuse. 2017. https://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates
Public Health Epidemic
In 2016, there were 63,632 drug overdose deaths,
...one death every 8.28 minutes,
...approximately 174 per day,
...42,249 were due to opioids
National Institute on Drug Abuse. 2017. https://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates
Public Health Epidemic
In 2017, there were 70,237 drug overdose deaths,
...one death every 7.5 minutes,
...approximately 192 per day,
...30,000 were due to fentanyl and other synthetic
analogs
National Institute on Drug Abuse. https://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates
Lincoln Financial Field
Capacity: 69,176
Beaver Stadium
Capacity: 106,572
18
Center for Disease Control and Prevention
19
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
21
U.S. Drug Enforcement Administration
Ten Most Commonly Prescribed
Controlled Substances in the U.S.
.
Hydrocodone
.
Oxycodone
.
Alprazolam
.
Tramadol
.
Zolpidem
.
Clonazepam
.
Lorazepam
.
Dextroamphetamine
.
Codeine
.
Methylphenidate
22
IMS Data on file.
The Most Common Drugs Involved in
Prescription Opioid Overdose Deaths
23
Oxycodone
Hydrocodone
Methadone
CDC. https://www.cdc.gov/drugoverdose/data/overdose.html. Accessed: May 2017
Unfortunately,
The United States
has a Long History
of
Drug Use
and
Abuse
24
1804
Morphine is Distilled from
Opium for the First Time
25
Sam Quinones, 2015, Dream Land: The Tale of America's Opiate Epidemic
26
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
27
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
28
1861-1865
Morphine Addiction
The Civil War
The "Soldier's Disease"
29
1898
Bayer Chemist Invents
diacetlymorphine,
Names It Heroin
Sam Quinones, 2015, Dream Land: The Tale of America's Opiate Epidemic
30
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.
31
32
33
34
35
36
37
38
39
40
February 9, 1909
Congress
Public Law 221
"An Act to Prohibit the Importation and Use of
Opium for Other Than Medicinal Purposes"
41
1914
U.S. Congress Passes Harrison
Tax Act
Sam Quinones, 2015, Dream Land: The Tale of America's Opiate Epidemic
42
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
43
1951
Arthur Sackler Revolutionizes
Drug Advertising
With Campaign for the
Antibiotic Terramycin
Sam Quinones, 2015, Dream Land: The Tale of America's Opiate Epidemic
44
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
45
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
46
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/NEJM19800110
30020221
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."
47
48
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
49
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
50
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
51
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
52
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
53
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
54
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
55
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
56
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
57
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
58
2011
Ohio passes House Bill 93,
regulating pain clinics
Sam Quinones, 2015, Dream Land: The Tale of America's Opiate Epidemic
59
2013
The College on the Problems of Drug
Dependence turns seventy-five without
finding the Holy Grail of a nonaddictive
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
61
No one
Is
Un-Affected
62
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 October 25, 2018:
1,789,748
Importers 272
Manufacturers 582
Narcotic Treatment
Programs 1,669
Research/Analysis
13,397
Distributors 922
71,797 1,305,997 18,042
Pharmacies Practitioners Hospitals
Patients (U.S. pop.)
327,109,224
63
Exporters 268
64
Livonia doctor, 7 others charged in $18M
prescription drug scheme
January 9, 2018
http://www.fox2detroit.com/news/local-news/livonia-doctor-7-others-charged-in-18m-prescription-drug-scheme
"Great Falls pharmacy manager
charged with stealing drugs"
January 12, 2018
Seaborn Larson, Great Falls Tribune,
https://www.greatfallstribune.com/story/news/crime/2018/01/12/great-falls-
pharmacy-manager-charged-stealing-drugs/1029290001/
65
66
"Police: Maryland officer arrested
after he stole opioids from a
bedridden citizen"
February 2, 2018
Brad Bell, WJLA News, http://wjla.com/news/local/md-police-officer-arrested-
sources-say-he-was-allegedly-stealing-opioids-from-citizens
U.S. Drug Enforcement Administration
Diversion Control Division
67
"Ex-dentist pleads guilty to
illegally prescribing drugs"
February 5, 2018
Fox 61, http://fox61.com/2018/02/05/ex-dentist-pleads-guilty-to-illegally-
prescribing-drugs/
U.S. Drug Enforcement Administration
Diversion Control Division
68
"More than a dozen people arrested
in Bloomington drug investigation"
February 6, 2018
Fox59 News, http://fox59.com/2018/02/06/more-than-a-dozen-people-arrested-in-
bloomington-drug-investigation/
U.S. Drug Enforcement Administration
Diversion Control Division
69
"Doctor prescribed needless pills
and bilked Medicare, feds say"
February 12, 2018
Paula McMahon, Sun Sentinel, http://www.sun-sentinel.com/local/broward/fl-
reg-doctor-arrested-fraud-pain-pills-20180212-story.html
U.S. Drug Enforcement Administration
Diversion Control Division
70
"Las Vegas doctor charged with
unlawful distribution of opioid,
health care fraud"
February 14, 2018
Brenda Yahm, Fox 5 Vegas, http://www.fox5vegas.com/story/37505788/las-vegas-
doctor-charged-with-unlawful-distribution-of-opioid-health-care-fraud
U.S. Drug Enforcement Administration
Diversion Control Division
71
"Nurse arrested for forging opioid
prescriptions"
February 18, 2018
Jesse Leavenworth, EMS1, https://www.ems1.com/opioids/articles/375512048-
Nurse-arrested-for-forging-opioid-prescriptions/
U.S. Drug Enforcement Administration
Diversion Control Division
72
"Federal agents raid doctor's
office and suspected 'pill mill'"
February 27, 2018
Lee Zurik, Megan Luther, and Andy Miller, WTXL News,
http://www.wtxl.com/news/federal-agents-raid-doctor-s-office-and-suspected-
pill-mill/article_0e8a0064-1bf3-11e8-b409-cb776b750102.html
U.S. Drug Enforcement Administration
Diversion Control Division
73
"Doctor accused of trading
prescription drugs for sex; 44
arrested in massive bust"
March 1, 2018
Mark Winne, WSBTV, http://www.wsbtv.com/news/local/doctor-accused-of-trading-
prescription-drugs-for-sex-44-arrested-in-massive-bust/709268909
U.S. Drug Enforcement Administration
Diversion Control Division
74
Philadelphia doctors charged in $5M prescription drug bust
By Dann Cuellar
Thursday, May 12, 2016
SOUTH PHILADELPHIA (WPVI) --
According to a federal indictment, three doctors illegally sold over $5 million
worth of prescription drugs out of their now-defunct Philadelphia clinic on
South Broad Street.
Two Mobile Pain Doctors Arrested On
Drug And Fraud Charges
Wednesday, May 20, 2015
United States Attorney Kenyen R. Brown of
the Southern District of Alabama, along with
FBI-Mobile Special Agent in Charge Robert
Lasky, and DEA-Mobile Special Agent in
Charge Keith Brown, New Orleans Field
Division, announce the arrests of Dr. John
Patrick Couch and Dr. Xiulu Ruan.
What's Trending ?
Some Good News ?
79
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, 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
80
81
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
Total Prescriptions Filled : Hydrocodone 2009-2017
(x 1,000)
IMS Data
82
48,000
50,000
52,000
54,000
56,000
58,000
60,000
62,000
64,000
2009
2010
2011
2012
2013
2014
2015
2016
2017
Total Prescriptions Filled: Oxycodone 2009-2017
(x 1,000)
IMS Data
83
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
Total Prescriptions Filled: Methadone 2009-2017
(x 1,000)
IMS Data
Total Controlled Substance Rx's Filled
IMS Data
480,000
500,000
520,000
540,000
560,000
580,000
600,000
2010
2011
2012
2013
2014
2015
2016
2017
In
Thousands
Total Controlled Substance Rx's 2009-2017 (In Thousands)
0.0000
500.0000
1,000.0000
1,500.0000
2,000.0000
2,500.0000
2012
KG
2013
KG
2014
KG
2015
KG
2016
KG
2017
KG
INJECTIBLE HYDROMORPHONE SALES 2012-2017
HYDROMORPHONE
IMS Data
0
50
100
150
200
250
300
350
400
450
500
2012
KG
2013
KG
2014
KG
2015
KG
2016
KG
2017
KG
INJECTIBLE FENTANYL SALES 2012-2017
FENTANYL
IMS Data
0
200
400
600
800
1,000
1,200
1,400
1,600
1,800
2012
KG
2013
KG
2014
KG
2015
KG
2016
KG
2017
KG
INJECTIBLE MEPERIDINE SALES
2012-2017
MEPERIDINE
IMS Data
88
0
2,000
4,000
6,000
8,000
10,000
12,000
14,000
16,000
2009
2010
2011
2012
2013
2014
2015
2016
2017
Total Prescriptions Filled: Buprenorphine 2009-2017
(x 1,000)
IMIMS
IMS
*As of October 25, 2018: DEA Data
Opioid Treatment Programs (OTPs)
1,375
1,418
1,509
1,595
1,669
0
200
400
600
800
1,000
1,200
1,400
1,600
1,800
2014
2015
2016
2017
2018
Opioid Treatment Program (OTP) Totals
4
25
166
78
28
82
4
13
4
71
17
DC 5
43
22
45
7
19
10
10
83
86
10
45
16
17
5
4
71
3
4
9
16
41 16
130
19
38
93
19
6
83
15
21
1
95
16
42
1
10
27
20
9
0
DEA Registered
Opioid Treatment Programs (OTP)
Drug Enforcement Administration, Diversion Control Division Updated September 18, 2018
Total: 1,662
91
*As of October 25, 2018 (NPs and PAs as of 01/01/2017)
DEA Registered Qualifying
Practitioners
14,778
27,719
52,375
0
10,000
20,000
30,000
40,000
50,000
60,000
2010
2015
2018
Data Waived Physician (DWP)/Qualifying Practitioner Totals
265
538
5228 922
1006
200
157
179
885
174
DC 200
1009
956
996
163
804
178
538
2704
1637
694
1328
592
580
243
138
1304
70
99
425
590
1496 364
4831
372
2516
2725
904
458
418
847
557
71
1680
607
858
342
1920
702
406
71
DEA Registered Qualifying Practitioners
Drug Enforcement Administration, Diversion Control Division Updated 9/18/2018
Guam: 2
Qualifying Practitioners (US)
.
Practitioner DW-30 29,621
.
Practitioner DW-100 9,389
.
Practitioner DW-275 4,539
.
Nurse Practitioner DW-30 5,917
.
Physician Assistant DW-30 1,542
93
Qualifying Practitioners (PA)
.
Practitioner DW-30 1550
.
Practitioner DW-100 567
.
Practitioner DW-275 349
.
Nurse Practitioner DW-30 250
.
Physician Assistant DW-30 104
94
Nationwide Efforts
to
Combat
the Problem
96
States
Practitioners
Hospitals
Treatment Providers
Medical Schools
Pharmacies
States with Limits CII
Alaska 7 Day Supply (initial prescription)
Arizona 7 Day Supply (initial prescription)
7 Day Supply (for minors)
Connecticut 7 Day Supply (initial prescription)
7 Day Supply (for minors)
Delaware Up to 100 dosage units or a
31 day supply, whatever is greater
97
States with Limits CII
.
District of Columbia 7 Day Supply
(emergency situation)
.
Florida 3 Day Limit/Acute Pain
7 Day Supply/Medically Necessary
.
Hawaii 30 Day Supply
.
Illinois 30 Day Supply: CII (Some exceptions under
certain conditions)
.
Indiana 7 Day Supply (initial prescription)
7 Day Supply (for minors)
98
States with Limits CII
99
Kansas 30 Day Supply
(Substances to treat obesity)
Kentucky 3 Day Supply (acute pain) with
exceptions: e.g. Chronic Pain, Cancer
Pain, End of Life, Hospice, Narcotic
Drug Treatment, Major Surgery.
Louisiana 10 Day Supply: CII-III
(Prescribers not licensed in Louisiana)
Maine 30 Day Supply (chronic pain)
7 Day Supply (acute pain)
States with Limits CII
100
Massachusetts 7 Day Supply (unless more in
indicated)
7 Day Supply (all opioids for minors)
Massachusetts 30 Day Supply: CII-III
60 Day Supply (Dextroamphetemine)
Missouri 30 Day Supply: CII
90 Day (If medical reason given)
New Hampshire 34 Day Supply: CII
60 Day Supply (ADD/ADHD)
States with Limits CII
101
New Jersey First prescription: 5 Day Supply
New York 30 Day Supply
7 Day Supply (initial prescription)
North Carolina 5 Day Supply (acute pain)
Ohio 7 Day Supply
5 Day Supply (for minors)
Oregon 7 Day Supply (initial prescription)
7 Day Supply (for minors)
States with Limits CII
102
Pennsylvania 7 Day Supply (for minors/consent)
7 Day Supply (emergency department;
urgent care centers; observation status in
hospitals) with some exceptions.
Rhode Island 20 Doses for opioids (initial
prescription)
No more than 30 morphine
MME/day
South Carolina 31 Day Supply
(Except Transdermal patches)
90 Day Supply: CIII-V
States with Limits CII
103
Tennessee 30 Day Supply of Opioids and
Benzodiazepines
Texas 90 Day Supply (multiple
prescriptions)
Utah 30 Day Supply: CII
Vermont 90 Day Supply
72 MME (first prescription for
minors)
350 MME - 7 Day limit (acute pain,
first prescription)
States with Limits CII
104
Virginia Limitations on Number of Days
7 Day Supply (acute pain)
14 Day Supply (surgical procedures)
(Some exceptions)
Washington 7 Day Supply (initial prescription)
3 Day Supply (dentist)
West Virginia 4 Day Supply ER (Initial Script Adults)
3 Day Supply ER (Children)
7 Day Supply Private Practice
3 Day Supply Dentists/Optometrists
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
105
106
Walmart giving away solution to dispose
of unused prescription pills
January 26, 2018
Gene Myers, Staff Writer, @myersgene
107
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.
108
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.
109
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
110
Vanessa Romo, May 8, 2018
111
"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/
Non-opioid medication outperforms
opioids for chronic pain, study shows
The Washington Times
By Laura Kelly
Journal of the American Medical Association,
March 6, 2018
113
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."
114
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.
115
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
116
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
The Heal Initiative
The NIH HEAL Initiative will bolster research across NIH to:
.Improve Treatments for Opioid Misuse and Addiction
Develop New Treatments for Addiction, Overdose Prevention and Reversal
Enhance Treatments for Infants with Neonatal Abstinence Syndrome/Neonatal Opioid
Withdrawal Syndrome
Optimize Effective Treatments for Opioid Addiction
.Enhance Pain Management
Understanding Biological Underpinnings of Chronic Pain
Accelerate the Discovery and Pre-Clinical Development of Non-Addictive Treatments
for Pain
Advance New Non-Addictive Treatments for Pain through the Clinical Pipeline
Guidelines for the Chronic
Use of Opioid Analgesics
Federation of State
Medical Boards
April 2017
119
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.
120
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 2018
*As of September 30, 2018
191
784
1254
1913
0
500
1000
1500
2000
2500
2015
2016
2017
2018
EOY Total
123
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.
124
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 their
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 indiv
iduals 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:
125
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.
126
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.
127
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
129
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
131
... while ensuring an adequate and
uninterrupted supply of controlled
substances to meet legitimate medical,
commercial, and scientific needs.
Mission
132
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.
133
U.S. Drug Enforcement Administration
Diversion Control Division
Prevention/Detection
Education
Treatment
Enforcement
Solutions to the Problem
134
Post Questions
1.
What are some basic limits Pennsylvania
has placed on Schedule 2 opioid controlled
substance prescriptions?
A. 7 Days (ER and Urgent Care)
B. 7 Days (Minors)
B. 15 Days (ER and Urgent Care)
C. A & B
Post Questions
2.
What are the top three most commonly
prescribed controlled substances in
the U.S. ?
A.
Hydrocodone
B.
Methadone
C. Oxycodone
D. Alprazolam
E.Tramadol
F. A,C, & D.
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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