Transcript Haven’t got Time For The Pain

Pain Management
Updates and Issues
Robert Twillman, PhD
The University of Kansas Medical Center
Pain is a major public health issue




80% of patients present for health care
because of pain
Chronic pain affects 30-40% of the
population
Over 40% of hospital patients report poor
pain control
Unrelieved pain costs our economy over
$100 billion each year
Prescription Opioid Abuse is
a Public Health Issue

2007 National Survey on Drug Use and
Health (NSDUH):

33.5 million Americans had used a pain
reliever non-medically at least once in their
lifetimes (13% increase from 2002)
Sources of Abused Drugs,
NSDUH 2007
Source of Pain Relievers for Most Recent Nonmedical Use, Past Year,
Users 12 or Older
Bought on internet
1%
Drug dealer/stranger
4%
Other
4%
More than one doctor
3%
One doctor
18%
Free from friend/relative
56%
Bought/Took from
friend/relative
14%
“Other” includes “Wrote Fake Prescription”, “Stole from Doctor’s
Office/Clinic/Hospital/Pharmacy”, and “Some Other Way”
Sources of Abused Drugs,
NSDUH 2007
Sources Where Friend/Relative Obtained Drug
Drug dealer/stranger Bought on internet
2%
0%
Other
Bought/took from
2%
friend/relative
6%
Free from friend/relative
7%
More than one doctor
3%
One doctor
80%
“Other” includes “Wrote Fake Prescription”, “Stole from Doctor’s
Office/Clinic/Hospital/Pharmacy”, and “Some Other Way”
NSDUH Data Are Unreliable


Definition of “nonmedical use” is
problematic
Asking about source of drug is problematic

High social desirability factor


Asking your research subject where he got his
drug is affected by this
Asking your research subject where his
source got the drug is tremendously
unreliable
Prescription Opioid Abuse is
a Public Health Issue

2002 Drug Abuse Warning Network data
(DAWN; ED visits) :


108,320 for opioid analgesics (153% increase from
1995)
2006 Treatment Episode Data Set (TEDS):

Non-heroin opioids were primary drug of abuse for
74,750 patients entering substance abuse treatment
nationwide (550% increase from 1996)
Drug Treatment Admissions, NonHeroin Opioids as Primary Drug
74,750
80,000
70,000
60,000
50,000
40,000
30,000
16,605
20,000
10,000
0
1996
1997
1998
1999
2000
2001
2002
2003
2004
Number of Admissions
450% Increase over 10 years
2005
2006
Recent Survey

Teen-agers now say it is easier to get
prescription drugs than it is to get beer
Sources of Diverted Prescription
Opioids







Supply chain thefts
Internet pharmacies
Thefts from patients
“Purchases” from patients
Prescription forgery
Illegal prescribing practices
Prescribing to individuals who deceive
prescribers
Measuring and Controlling Drug
Diversion




Due to the nature of the problem, measuring the
extent of drug diversion is extremely difficult
Pharmacy thefts can be tracked, as can
prescriptions
Most other sources are virtually impossible to
examine
Can drug abuse statistics be used as a
surrogate? Are all abused drugs diverted?
HCP-Related Reasons for
Inadequate Pain Management

Survey of 1177 Oncologists:




Inadequate Pain Assessment (79%)
Patient Reluctance to Report Pain (62%)
Patient Reluctance to Take Opioids (62%)
MD Reluctance to Prescribe Opioids (61%)
Why are physicians anxious about
managing chronic pain with opioids?






Uncertainty related to assessment
Concern about detrimental side effects
Unfamiliarity with opioids, adjuvants
Fear of addiction
Fear of lawsuits
Fear of regulatory scrutiny
Means of Improving Pain
Management
 Changes to policies and standards
 Education of providers and patients
 Development of practice guidelines
 Monitoring and continuous quality
improvement
Patient-Related Reasons for
Inadequate Pain Management






Fear of addiction
Fear of side effects
Expectations are low
MD might have to choose which to treat-disease or pain
Fear of distracting the doctor
Complaining about pain might annoy the
doctor
What We Hear From Patients




Many have difficulty finding physicians who will
treat their pain adequately
A few report problems with pharmacies filling
prescriptions for pain medications
Some have difficulty getting insurance
companies and Medicaid to pay for pain
treatment
Many have (incorrectly) been told they either are
addicted or at high risk for addiction
National Pain Policy Issues
Current Issues

Federal legislation



National Pain Care Policy Act
Methadone Treatment and Protection Act
FDA activities



Propoxyphene
Acetaminophen recommendations
REMS for long-acting opioids
Current Issues

DEA activities



ePrescribing
Disposal of Controlled Substances
American Geriatric Society pain treatment
guidelines
National Pain Care Policy Act


Originally introduced in early 2000s
In last session of Congress



Current session



Passed House near end of session
Stalled in Senate HELP Committee
Passed House quickly
Stalled in Senate HELP Committee
Now amended to health care reform bills in both
houses
National Pain Care Policy Act

Background




Pain affects about 80% of people presenting for
health care
Pain research funding at NIH represents 0.1% of all
NIH grant funding
There are 23 review groups to evaluate pain-related
grants, which must compete against very unlike grant
applications
Ongoing significant deficits in healthcare provider
education related to pain management
National Pain Care Policy Act

Provisions




IOM to convene a Conference on Pain ($500K
appropriated)
Director of NIH encouraged to expand, through Pain
Consortium, an aggressive program of basic and
clinical research
Pain Consortium to issue yearly recommendations on
research initiatives
NIH to establish Interagency Pain Research
Coordinating Committee
National Pain Care Policy Act


Secretary of HHS is to establish grant
program for education and training in pain
care ($5M annually appropriated)
Secretary shall establish and implement a
national pain care education outreach and
awareness campaign (focused on
consumers; $2M appropriated for FY
2010, $4M for FY 2011 and FY2012)
Methadone Treatment and
Protection Act


Introduced by Senator Rockefeller (D-WV)
on 3/31/09
Referred to Senate HELP Committee
Methadone Treatment and
Protection Act

Background





Methadone is a highly effective, very inexpensive
long-acting opioid analgesic
It is difficult to use because of its pharmacological
properties
It has a long half-life (up to 100 hours for some of its
metabolites)
Does not produce significant euphoria
Effects of dose change not completely seen for about
4 days
Methadone Treatment and
Protection Act

Methadone uses

Methadone maintenance for opioid addicts
Intended to prevent withdrawal, curb cravings
 Administered daily at clinics
 Typically a life-long treatment


Management of pain
Very low doses may be very effective
 Administered 2-4 times per day
 May be stopped if pain is no longer present

Methadone Treatment and
Protection Act




1998-2006: Prescriptions increased 700%
In 2005, there were 4462 methadonerelated deaths, up by 468% since 1999
Other poisoning deaths increased by 66%
over same period
Rate of methadone deaths in 15 to 24year-olds increased 11-fold, and may be
underreported
Methadone Treatment and
Protection Act

Bill calls for:




Consumer education campaign ($15M each
year FY2010-2014)
Practitioner education (funded through portion
of DEA registration renewal fees)
No use of 40 mg diskette doses outside of
maintenance programs
Secretary of HHS to establish Controlled
Substances Clinical Standards Commission
Methadone Treatment and
Protection Act

Bill calls for:


Funding of 1995 National All-Schedules
Prescription Electronic Reporting (NASPER)
program at $25M per year for FY2010-2014
Improved reporting standards for methadonerelated deaths
Food and Drug Administration
Activities
Propoxyphene





Propoxyphene is an opioid analgesic
Research suggests it is may be only marginally
effective, if at all, in treating pain
It has a long-lived metabolite that irritates the
nervous system and causes heart rhythm
disturbances
Found in Davron, Darvocet; marketed since
1957
Pain guidelines recommend not to use this drug
Propoxyphene

FDA was asked to review drug because:




Insufficient evidence to suggest it is an effective
analgesic
It was withdrawn from the UK market because of the
risk of deliberate and accidental overdose
It is cardiotoxic and has narrow therapeutic index
It is widely prescribed, especially in elderly, and is
associated with a large number of deaths
Propoxyphene


FDA advisory committee voted 14-12 to
recommend withdrawal from the market
FDA decided to keep drug on the market



“Benefits outweigh risks”
Manufacturer required to do safety studies
FDA to work with other agencies to conduct
additional studies
Acetaminophen





Active ingredient in Tylenol
Found in a multitude of over-the-counter
medications
Also found in some prescription medications,
combined with opioids
High acute doses can cause fulminant liver
failure and death
High chronic doses can cause chronic liver
failure
Acetaminophen




Frequently, problems arise because patients are
prescribed medications containing
acetaminophen while also taking OTC
acetaminophen
FDA decided to review this medication to see if
there were ways to improve its safety
Advisory panel meeting was held June 29-30
Votes taken on a number of questions
Acetaminophen

Question: Do you recommend current maximum
dose be allowed?




Strong yes: 11
Yes: 10
No: 16
Question: Should max single dose be 650 mg?



Strong yes: 12
Yes: 12
No: 13
Acetaminophen

Question: If current doses of OTC
products are lowered, should current
maximum dose (2 X 500 mg) be switched
to prescription-only?



Strong yes: 8
Yes: 18
No: 11
Acetaminophen

Question: Do you recommend pack size limits
for OTC products?




Strong yes: 2
Yes: 15
No: 20
Question: Should OTC combination products be
eliminated?



Strong yes: 2
Yes: 11
No: 24
Acetaminophen

Question: Should only one concentration of OTC
liquid be available?




Strong yes: 19
Yes: 17
No: 1
Question: Should prescription combination
products be eliminated?



Strong yes: 10
Yes: 10
No: 17
Acetaminophen

Question: Should all prescription combination
products be blister-packed?




Strong yes: 5
Yes: 22
No: 10
Question: Should there be a boxed warning on
prescription combination products?



Strong yes: 25
Yes: 11
No: 1
Opioid Risk Evaluation and
Mitigation Systems (REMS)



The FDA Amendments Act of 2007 gave
FDA authority to require that drugs and
biological products have a REMS to insure
that the benefits of drug or product
outweigh the risks
FDA has been requiring this more often
Now considering applying this to longacting opioids
Why a REMS for Long-Acting
Opioids?



Perception is that there have been
massive increases in abuse of these
medications
Perception is that there have been many
overdose deaths due to this abuse
Considerable pressure being exerted by
Congress to do something about this
What Might a REMS for LongActing Opioids Look Like?




Might require registration of prescribers,
pharmacies, and patients
Might require specific education for
prescribers and pharmacists
Might restrict outlets for medications
Might require ongoing evaluation of effects
of REMS
Why is This a Concern?

Research shows that any barrier to prescribing
opioids results in significant decrease it their
use, regardless of the appropriateness of that
use




Example: Triplicate prescription forms
Provides an easy way for providers to “opt out”
of prescribing
People with pain already have major issues in
accessing appropriate care
The chilling effect of REMS may worsen this
What Has FDA Done So Far?





Series of meetings with Pharma and pain
advocacy groups
Series of public meetings
Many discussions individually with pharma
companies
Threatened to withdraw all opioids from the
market
Established a REMS for a new short-acting
opioid analgesic
Onsolis REMS




Onsolis is a BEMA (bioerodable mucoadhesive)
product containing fentanyl
Adheres to inside of cheek and dissolves,
releasing fentanyl into the bloodstream
Works very rapidly and does not require the
patient to swallow
Occupies a niche in pain management that is
similar to two existing drugs, Actiq and Fentora
Onsolis REMS
On July 16, 2009, FDA approved Onsolis to
manage breakthrough pain in cancer
patients, with a REMS
Onsolis REMS

REMS requires:





Prescribers, pharmacies, and patients must register
with the manufacturer
Registration program will provide educational
materials to prescribers and pharmacies
Patients will receive a counseling phone call prior to
dispensing
Only participating pharmacies will fill prescriptions,
which must be mailed to patients’ homes
Boxed warning: no use for migraine, dental pain,
postoperative pain, or in patients not using opioids
continuously
Onsolis REMS



FDA says this REMS is specifically
tailored to Onsolis and should not be
viewed as a model for long-acting opioids
Still, it contains many of the elements
discussed for long-acting opioids
Evaluation of effects of this REMS is not
mentioned in the press release
DEA: ePrescribing


DEA has undertaken a rule-making
process designed to allow for the
electronic transmission of prescriptions
from prescriber to pharmacy
Proposed rule first issued June 27, 2008
ePrescribing

Benefits:





Reduction of prescription forgery
Reduction of errors caused by illegible
handwriting or misunderstood oral orders
Easier integration into electronic medical
records
Reduction of paperwork
Improved efficiency in filling of prescriptions
ePrescribing

Concerns:

Security, security, security
Are prescribers qualified?
 Who in the practice “signs” these?
 ID/password security
 Intermediaries may open, alter record
 Records held by third parties, requiring subpoena
 Records will need to be downloaded, translated


Cost
ePrescribing

Proposed Level 4 authentication



Requires two identifying factors
One of these must be stored on a “hard
token” such as a PDA, cell phone, smart card,
thumb drive, or multi-factor one time
password token
This is a work in progress, but has much
to recommend it
Disposal of Controlled
Substances


Research previously cited suggests that a
major source of drug diversion is stealing
from people with legitimate prescriptions
People who do not finish prescriptions
frequently keep remaining doses rather
than disposing of them, creating the
opportunity for theft
Disposal of Controlled
Substances


Pharmacies are legally allowed to receive
controlled substances back from patients
for disposal, but doing so creates so many
difficulties that it is very rarely done
Prescribers are not permitted to receive
and dispose of controlled substances
without doing the same paperwork
Disposal of Controlled
Substances

Current advice from federal agencies
conflicts



Some say to crush tablets/capsules, mix with
kitty litter or coffee grounds, and dispose of
them in the trash
Others say to flush them down the toilet
The EPA says flushing them down the toilet
causes water pollution
Disposal of Controlled
Substances


A simple coherent system would provide
significant benefits by reducing
opportunities for diversion
There is potential that some medications,
if packaged appropriately, could even be
reused, although there may be reasons
not to risk this
Disposal of Controlled
Substances


DEA is working on a method to allow
pharmacies and/or prescribers to take
back unused controlled substances
without undue paperwork
Private companies are starting to explore
getting into this business as well
American Geriatric Society
Guideline on Management of
Persistent Pain in Older Persons
Background


AGS previously published a guideline on
management of pain in older persons in
1998 and 2002
This update is intended to include new
evidence, new medications, and new
techniques since 2002
What’s New?

Emphases in this guideline include the
following:


Acetaminophen may be preferable to
traditional NSAIDs because of a preferable
side effect profile
Opioids may be preferable to NSAIDs in
patients for whom they are appropriate
Conflict with FDA?



AGS recommends acetaminophen and
opioids vs. NSAIDs
FDA is trying to limit use of
acetaminophen and opioids
Resolution of these conflicts requires
achievement of a certain kind of balanced
policy
State Level Issues
Pain Management in Kansas
Faces Few Actual Barriers




No major provisions in any state statute,
regulation, or guideline significantly
interfere with good pain management
Disciplinary actions are relatively few
Per capita morphine consumption parallels
national trends
Continuing education interest is high
Pain Management in Kansas
Faces Perceived Barriers



Many physicians fear that peer review or
peer opinions will significantly impede
good pain management
Significant impact from two high-profile
legal cases
Physicians perceive that they are at high
risk of being investigated
The Principle of Balance

Public policy needs to strive to achieve
balance, such that policies


Encourage appropriate pain management,
including access to controlled substances, for
those with pain, while they
Discourage and prevent access to controlled
substances for individuals utilizing them solely
for purposes of diversion and/or abuse
Criteria for Evaluating State Pain
Policies




Formulated by Dave Joranson and staff of
Pain and Policy Studies Group, University
of Wisconsin
Most recent publication July, 2008
Surveys all state pain statutes,
regulations, and guidelines
8 “positive” criteria, 9 “negative” criteria
Positive Criteria




Controlled substances recognized as
necessary for public health
Pain management recognized as part of
general medical practice
Medical use of opioids recognized as
legitimate professional practice
Pain management is encouraged
Positive Criteria




Practitioners’ fears of regulatory scrutiny
are addressed
Prescription amount alone not sufficient to
determine legitimacy of prescribing
Physical dependence and tolerance NOT
confused with addiction
Other provisions enhancing pain
management
Negative Criteria





Opioids considered treatment of last resort
Medical use of opioids implied to be
outside legitimate professional practice
Physical dependence or tolerance
confused with addiction
Medical decisions are restricted
Length of prescription validity is restricted
Negative Criteria



Practitioners subject to undue prescription
requirements
Other provisions that may impede pain
management
Provisions that are ambiguous
PPSG Report Card Grades, July 2008
A Grade
B Grade
C Grade
The Pain Policy Landscape
Beyond the Report Card

PPSG Report Card has been tremendously
helpful





Snapshot of current situation
Impetus for improvement
Guidance on changes to make
Covers much of what is needed to allow good pain
management
But it does not cover all important areas of policy
What’s Missing?





Report Card only covers some laws and their
associated regulations and licensing board
guidelines
Only refers to controlled substances policy
Doesn’t cover some applicable laws
Doesn’t cover laws/regulations governing
managed care/worker’s comp
Doesn’t cover continuing education mandates
Examples from Beyond the
Report Card




Prescription monitoring programs
Managed care/worker’s comp
Mandated continuing education
Ongoing issues with law enforcement
Prescription Monitoring Programs



Designed to track prescriptions for
controlled substances as an means of
identifying patterns indicative of abuse and
diversion
Initially set up in 1939 in California
Spreading rapidly due, in part, to federal
grant funding
PMPs Could be a Boon to
Balanced Pain Policy



Detection of substance abuse through these
programs could lead to greater utilization of
substance abuse treatment, reducing “demand
side” of diversion
Clinicians could use programs to feel more
confident in their prescribing for patients
Detection of diversion is a more thorny issue
because of law enforcement involvement
Prescription Monitoring Programs:
Do They Work?

General Accounting Office evaluation, 2002,
said these programs work because:


They shorten law enforcement investigation times by
> 80% in 3 states questioned for the report
They reduce OxyContin prescribing


Only 2 of top 10 OxyContin-prescribing states have PMPs,
while 6 of the bottom 10 states have PMPs
When states establish programs, you see increases
in diversion in adjoining states, according to law
enforcement sources
Prescription Monitoring Programs:
Do They Work?



Shorter investigations do not necessarily
mean fewer, or more appropriate,
investigations
Decreased prescribing may affect
legitimate pain patients as well as
diverters
Shift in diversion activities to adjoining
states may reflect chilling effect on
prescribing in monitored states
State PMP Status, 2003
No PMP
Operating
Programs
States With Prescription Monitoring
Programs, August 2009
“Current”
Legislation
No PMP
PMP Pending
PMP Operating
Impact of PMP vs. no PMP on
Retail Opioid Distribution, 2003
Drug
Oxycodone
Morphine
Fentanyl
Hydromorphone
Meperidine
Codeine
Hydrocodone
No PMP
Mean
11292
4927
117
216
2246
6937
6938
PMP
Mean
9540
4397
114
197
1739
8451
10076
%
Difference
-15.5
-10.8
-2.6
-8.8
-22.6
+21.8
+45.2
All amounts expressed in grams/100,000 population
p
.167
.359
.657
.434
.184
.026
.014
Impact of PMP vs. no PMP on
Measures of Drug Abuse
Indicator
PMP Mean
p
TEDS
No PMP
Mean
25.36
27.29
.816
NSDUH
4.51
5.31
.014
TEDS = Treatment Episode Data Base, admissions/100,000
population, non-heroin opioid as primary substance of abuse
NSDUH = National Survey on Drug Use and Health, percent
of respondents > 12 years of age with non-medical use of
prescription opioids in past year
Survey of State PMP Programs



Electronic survey targeting the 23
operating PMPs in 2006
18/23 (78%) responded
Schedules monitored:




II-V: 6
II-IV: 3
II-III: 1
II: 7
Katz, et al., Pain Medicine, 2008:9(5), 587-594
Survey of State PMP Programs

Number providing data to clinicians:




Upon request: 9
Upon request + unsolicited: 2
Not at all: 7 (5 planning to do so)
Turnaround time for requests



< 1 hour: 8
1 hour – 1 day: 1
1 day – 1 week: 1
Katz, et al., Pain Medicine, 2008:9(5), 587-594
Survey of State PMP Programs

Guidelines for use: 10 said these were
important




3 states had existing guidelines
4 were developing guidelines
5 were planning guidelines
Education programs: 8 had developed
these
Katz, et al., Pain Medicine, 2008:9(5), 587-594
Survey of State PMP Programs

Evaluation efforts


2 states developing criteria to evaluate validity
of classifying patients into groups; 4 states
said this was “not at all” important
2 had conducted evaluation of public health
impact
Katz, et al., Pain Medicine, 2008:9(5), 587-594
BJA Harold Rogers Grant
Requirements: Outcomes

Grants require certain “outcome”
measures be reported:





# of prescribers, dispensers, investigators
trained
Coroner reports of Rx CS as cause of death
# of reports generated from system
# of individuals using multiple pharmacies
# of prescribers/distributors trained to share
data
PMP Programs: Needs




Access for prescribers/dispensers
Education for prescribers, dispensers,
investigators
Proactive and reactive reporting
Adequate provisions for referral to
substance abuse treatment
PMP Programs: Needs

Outcomes research (positive and negative
impacts)


Legal
Public Health
Pain
 Addiction


Information sharing across states
Managed Care and its Impact on
Pain Management

Managed care has a great stake in
controlling costs of treating pain




Many people have chronic pain
Treatment for chronic pain can be costly
Treatment for chronic pain can be indefinite
Attempts to control costs have, in many
cases, fallen prey to a “silo mentality”
Managed Care’s Silo Mentality



Efficacy, safety, and cost: Which comes
first?
Efforts to control costs often focus on
single arenas without consideration of
unintended consequences
Reducing costs in one silo may result in
increased costs in other silos, and may, in
fact, produce increased costs overall
Managed Care’s Silo Mentality

Strict control of prescriptions can result in:






More ER visits
More physician office visits
More hospitalizations/hospital days
More nursing home days
Decreased effectiveness of pain
control/decreased quality of life
Perhaps even patient deaths
Examples of Problematic Controls

Step therapies


Requirements that less expensive
medications be tried and found to fail before
more expensive medications can be used
May even mean that use of medications
WITHOUT appropriate FDA indications is
required before those WITH appropriate
indications are used
Step Therapy Example

Treatment for fibromyalgia



Poorly-understood, difficult to treat chronic
pain syndrome
Characterized by highly sensitized nervous
system
Three medications currently have FDA
indications to treat: duloxetine (Cymbalta),
milnacipran (Savella), and pregabalin (Lyrica)
Step Therapy Example

For any of these to be covered, one insurer
requires that patients first try:




One tricyclic antidepressant AND
One muscle relaxant AND
Non-pharmacological therapies (e.g. cognitivebehavioral, exercise, etc.) AND
At least TWO of the following:



Any SSRI, or
Tramadol, or
Gabapentin
Step Therapy Example

Quality of evidence and estimated duration for
each step:






Tricyclic antidepressants: , > 2 months
Muscle relaxants: , > 1 month
Non-pharmacological therapies: , at least 3-4 months
SSRI: , > 4 months
Tramadol: , 1 month
Gabapentin: , > 2 months
Examples of Problematic Controls

Requirements that more “problematic”
medications are used



Some programs have been known to require
use of morphine and methadone before
patients can access other opioids
Methadone in untrained/inexperienced hands
is a dangerous proposition
Has this resulted in harm? If so, how much?
Examples of Problematic Controls

Limitations on number of pills allowed


Companies have been known to place limits
on the number of PILLS allowed in a given
prescription, as opposed to the number of
DOSAGE UNITS allowed
Given the need to individually titrate doses,
this can create problems for patients and
prescribers
Examples of Problematic Controls



Problematic controls are not limited to just
medications
Consider therapies such as physical
therapy, occupational therapy,
psychotherapy
Some patients fall into on/off therapy
patterns, with accompanying on/off
symptoms and healthcare utilization
Mandated CME for Pain
Management/Palliative Care

Mandates can either be legislative or nonlegislative



In some states, requires passage of law
In other states, licensing board is free to set
CME requirements; in these states, passing a
law is a way to produce this mandate
Some states have chosen to “encourage”
CME rather than require it
Mandated CME for Pain
Management/Palliative Care



Education alone is not sufficient to change
practice
Education IS necessary to change
practice, however; “You can’t do what you
don’t know”.
One-time requirement vs. requirement for
each license renewal period
Mandated CME for Pain
Management/Palliative Care



Jury is still out with respect to
effectiveness of this approach
Need to work closely with practitioner
groups, as many are likely to oppose
mandates if they are not part of the
process
May wish to choose a step-wise approach,
starting with a practitioner survey
States Mandating or Encouraging CME for
Pain/Palliative Care (as of October 2005)
CME Encouraged
CME Mandated
Pain Management and
the Legal System



Prescribers frequently cite fear of
prosecution and loss of license as reasons
they fear trying to manage pain
Certainly, if this is a significant risk, it
presents a barrier
But, is it a significant risk? What do the
data tell us? Is this an urban myth?
Needed: balanced pain policy

Physicians need to:




Know how to treat pain patients knowledgeably using opioid-based
medications
Be aware of federal and state laws governing the prescribing and
handling of controlled-substance pain medications
Prescribe opioids without fear of unwarranted investigation or
prosecution
Law enforcement and regulatory officials need to:



Make opioid-based medications available for legitimate medical use
Prevent the diversion and abuse of such opioid-based medications
Know how to distinguish criminal prescribing behaviors from medical
malpractice
The Balanced
Pain Policy Initiative

Since 2005, a unique, ongoing partnership of three organizations:




Center for Practical Bioethics
National Association of Attorneys General
Federation of State Medical Boards
Purpose: develop policy-level recommendations and training
opportunities to help physicians and law enforcement agencies
address, and seek to resolve, prescribing- and enforcement-related
problems that contribute to the undertreatment of pain.
Good ethics start with good facts
The Initiative’s first step: address the “chilling effect” of high-profile
cases by obtaining factual answers to questions that include:
How many physicians actually have been prosecuted or sanctioned for
opioid-prescribing or –handling offenses in recent years?
How many physicians involved in these opioid-related cases have been
pain specialists?
Have the charges brought against these physicians had mostly to
do with mis- or over-prescribing, or with causing harm to patients?
Have most of the physicians who have been criminally charged,
pled not guilty?
Have most of the physicians brought before state medical boards
for opioid-handling or –prescribing offenses, had their licenses
revoked?
How the physician cases
were identified









Archived news stories
Agency Websites (DEA, state criminal courts, state medical boards)
Organization Websites (including patient-advocacy organizations)
Federal of State Medical Boards database (accessed by FSMB
staff)
Drug Enforcement Administration databases (accessed by DEA
staff)
Lexis/Nexis
PACER (Public Access to Court Electronic Records)
Federal Register
Contacts with federal and state prosecutors, court clerks, offices of
state attorneys general
How physicians’ demographic characteristics
and medical specialties were identified





American Board of Medical Specialties database (ABMS specialty
certifications)
American Osteopathic Association database (AOA specialty
certifications)
American Academy of Family Physicians database (AAFP
certifications)
American Medical Association database (physician demographics,
medical specialties, general workforce characteristics)
Online commercial physician-directory databases (physicianprovided medical specialties, demographics, medical schools)
Numbers of Cases
and Physicians
By researching opioid-related cases filed or heard over a nine-year
period (1998-2006) The Balanced Pain Policy Initiative identified:
996 Cases…
Criminal —
Federal
State
335
Administrative — 651
Federal (DEA)
State medical boards
…involving 725 physicians
— 157
— 178
— 126
— 525
Study limitations included:

Lack of information on investigations. Medical boards and
enforcement agencies are reluctant to release, and often do not
retain, data and information on investigations that do not result in
prosecutions or board hearings.

Limited information on physician characteristics. More
information is needed on additional, potentially-relevant
characteristics of study physicians, such as race/ethnicity, years in
practice, and practice settings.
Key findings: Question #1
Q.
How many physicians actually have been
prosecuted or sanctioned for opioid-prescribing or
–handling offenses in recent years?
A.
Very few. We were able to identify only 725 individual
physicians who were involved in criminal or state
medical board cases of this type between 1997-2006.
They represent 0.1% of approximately 700,000 active
U.S. patient-care physicians.
Key findings: Question #2
Q.
Have most of the physicians involved in these cases been
pain specialists?
A.
No. Almost 40% of the 725 physicians involved in these cases
were general practice/family medicine specialists. Only 3.5%
were board-certified or self-identified pain specialists.
These general practice/family medicine physicians involved also
were over-represented (i.e., had higher prevalence rates/1,000
physicians) compared with the numbers of physicians of this type
in the workforce.
Pain medicine specialists also were over-represented compared
with their numbers in the workforce, but to a lesser degree.
Key findings: Question #3
Q.
Have most of the charges against these physicians been for
misprescribing, overprescribing, or for causing harm to
patients?
A.
No. Most of the criminal charges (over 75% of charges) were for
diversion offenses such as drug trafficking, fraud, illegal
possession, or conspiracy to obtain. Only a small percentage of
charges (5%) were for murder, manslaughter, or
harmful/inappropriate relationships with patients.
Most medical board charges (35% of charges) were for sloppy or
falsified record-keeping or for violating practice standards (e.g.,
failure to give physical exams). A smaller percentage (15% of
charges) were for misprescribing, overprescribing, prescribing to
addicts, or harmful/inappropriate relationships with patients.
Key findings: Question #4
Q.
Have most of the physicians who were criminally
charged, pled not guilty?
A.
No. Four out of five (80%) pled guilty or no contest to
at least one of the criminal charges brought against
them.
Ultimately, nine our of ten of the prosecuted physicians
(90%) either pled guilty or subsequently were found
guilty on at least one count.
Key findings: Question #5
Q.
Have most of the physicians called before state medical
boards for opioid-handling or –prescribing offenses had their
medical licenses revoked?
A.
No. Medical boards were more likely to impose temporary
suspensions or to require temporary surrenders of medical
licenses (38% of cases), usually during the time the physician
attended required, relevant continuing education courses.
Boards permanently revoked or refused to renew these
physicians’ licenses in only 18% of cases.
Next steps




Disseminate study findings. Publicize facts identified in this study
among medical, regulatory, and enforcement audiences.
Study possible additional reasons for the “chilling effect.”
Reasons may include persistent media use of terms such as “the
war on pain” and “pill-mill doctors” in describing recent high-profile
cases.
Educate. Physicians need to learn how to prescribe opioids safely
and how to comply with laws and regulations that surround their
prescribing and use. Law enforcement officials and medical board
members may need to learn more about acceptable dosages and
patient-caused problems involving prescribed opioids.
Encourage dialogue. Provide opportunities for physicians and
enforcement officials to address and resolve prescribing- and
enforcement-related problems contributing to the undertreatment of
pain.
Questions and Discussion