The Opioid Contract: New Perspectives

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Critical Issues: Providing Relief
and Preventing Abuse
C. Scott Anthony, D.O.
Tulsa Pain Consultants, Inc.
Opioid Prescribing in Chronic Pain
Legitimate practice
Evidence of improved quality of life and
functionality
But… issues remain:
Serious concerns about regulatory agencies
Confusion and fear
Skyrocketing abuse and diversion
Federal and State
Controlled Substance Law
Analgesia
Abuse
Joint Statement of 21Health
Organizations and the DEA
Undertreatment of pain is a serious problem in
the United States. Effective pain management
is an integral and important aspect of quality
medical care and pain should be treated
aggressively
Opioid analgesics, when used as recommended
may be the most effective and only treatment
option to manage pain
Joint Statement of 21Health
Organizations and the DEA
In spite of regulatory controls, drug abusers
obtain these medications by diverting them
from legitimate channels: fraud, theft, forgery
and dishonest physicians
Drug abuse is a serious problem. Those who
prescribe must be diligent to prevent diversion
Focusing only on the abuse potential can lead
to undertreatment of pain
Opioid Diversion
Public health and safety issue
Methods:
Theft, forgery of prescription
Illegal sale of drugs and prescriptions
Fraudulent patient contact with physicians
Impaired, dishonest physicians
What about the honest physician trying to
help? Should we worry?
National All Schedules Prescription
Electronic Reporting (NASPER) Act
2005 Federal Law that provides for the
establishment of a state monitoring system
Electronic monitoring for Schedule II-IV drugs
Requires dispensers to report to the state
Each state develops an electronic database that
is easily searchable by prescribers and
dispensers
Prevention of diversion and abuse
Physicians Should Be Aware
Pain and Policy Study Group
FAQ Document in combination with the DEA
Co-sponsored document released Aug. 2004
Removed from DEA website Oct. 2004
PPSG with significant concerns
American College of Physicians voice concern
National Association of Attorneys General
express concern in letter to DEA
DEA Concerns Outlined in the Federal
Register (Nov. 2004)
Multiple Schedule II prescriptions
What constitutes a refill?
Dealing with patients who knowingly abuse
their medications
Under no circumstances can a physician dispense
with the knowledge…
Concerns of family members
Physicians should seriously consider any
expressed concern…
Recurring “Condemned Behavior” per
the DEA Federal Register
Inordinately large number of prescriptions
Inordinately large quantity prescribed
Known prescribing to drug addicts or dealers
Prescribing inconsistent with legitimate
medical practice
Physician used “street slang” when discussing
No logical relationship between drugs
prescribed and treatment of the condition
Legal Precedence
United States vs. Morton Salt Co.
It is a longstanding legal principle that the
Government “can investigate merely on
suspicion that the law is being violated, or even
that it wants assurances that it is not”
PPSG Response (Mar. 2005)
DEA must reassure physicians that there are
specific indicators of diversion that are not
confused with appropriate prescribing
Clarify clearly what constitutes “unlawful
conduct” regarding prescribing
Avoid sending messages of fear
Embrace the commitment to a “balanced
Federal policy”
Drug Abuse
Rapid escalation of epidemic proportion
7.3% of the population abuse illegal drugs
Hydrocodone, oxycodone and methadone
show >100% increase in abuse since 1994
Increases seen in:
ER visits
Health care costs
Loss of productivity
Non-Medical Use of Prescription
Drugs
1992-2003: 94% increase
3rd most abused substances
DAWN data 1992-2002:
154% increase in prescription drugs prescribed
90% increase in number of people admitting to use
There indeed is a link between increase in
prescribed drugs and abuse per the DAWN and
CASA data
Oxycodone Abuse
166% increase in abuse 1994-2000
ER visits for overdose up 100% since 1996
Multiple reasons
Pharmacological
Easy to obtain/street cost lower
Abusers “knowledge”
Potent high
Concern about generic Oxycontin
Hydrocodone Abuse
116% increase in abuse since 1994
Most commonly abused opioid
Schedule III
Phone-in prescriptions
Less tracking
Acetaminophen issues
Methadone Abuse
140% increase since 1994
Significant problem in Oklahoma with marked
increase in deaths
Nationwide increase in deaths due to abuse
Pharmacology
Long, variable half-life
Potent, difficult to convert, titrate
Pain and Addiction
Continued use despite adverse consequences
Impaired control and compulsive use
Preoccupation with obtaining drugs
CAGE Questionaire
Have you tried to Cut down?
Do you get Annoyed with people discussing your
use?
Do you feel Guilty about using drugs?
Do you need an Eye-opener?
Pain and Drug Abuse
Addiction and abuse are not the same
Abuse as defined by the DSM-IV
Overuse in cases of celebration, stress, anxiety,
despair, ignorance or self medication
Examples: “rational abuser” or “chemical
coper”
Multiple studies suggest abuse rate may be
3.2-28% of those with chronic pain
Detecting Abuse
Using opioids for
psychological relief
Using opioids when
mad, sad, happy or glad
Using opioids with
other illicit drugs
Using illegal means to
obtain opioids
Using opioids against
medical advice
(compulsive, overuse)
Using opioids with
alcohol
“Doctor shopping”
Using deception to
obtain more opioids
Important “Red Flags” at TPC
Past substance abuse
Nonfunctional
Medicaid
Disability
Work comp
Excessive opioid needs
Dose escalations
ER visits
Asking for higher doses
Multiple phone calls
Deception or lying
Doctor shopping
Asking for specific
opioids or Soma
Current or prior use of
illicit drugs
Pharmacy concerns
Intolerance to opioids
Common Signs of a Drug Seeker or
Abuser
Physical signs
Poor compliance
Lost prescriptions
Stolen prescriptions
Funny stories
No interest in workup
Knowledge of opioids
Lengthy travel to see
you
Appointments late in the
day
Night and weekend
phone calls
Manipulative
Speak poorly of other
physicians
History of many doctors
That “gut feeling”
A Comparative Evaluation of Illicit Drug
Use in Patients With or Without Controlled
Substance Abuse in Pain Management
Pain Physician, 2003;6:281-285
Methods
Consecutive, double blind, clinical evaluation
150 patients
Group I: 100 patients without signs of abuse
Group II: 50 patients with signs of abuse
All underwent urine drug screen to test for
marijuana, methamphetamine, amphetamine
and cocaine
Results
Group I (without signs of drug abuse)
10% positive for marijuana
4% positive for cocaine
None positive for methamphetamine or
amphetamine
Group II (with signs of drug abuse)
22% positive for marijuana
12% positive for cocaine
None for meth or amphetamine
The Reality
The national drive to eliminate under-treatment
of pain and relieve suffering has given drug
abusers and addicts an added advantage and
opportunity to obtain opioids from physicians
thus contributing to the risk of under treatment
of those patients who would legitimately
benefit from opioid therapy
Essential Components of Pain
Evaluation and Assessment
Assess pain intensity and character
Evaluate the psychosocial status of the patient
Perform physical and neurological
examination
Perform a diagnostic evaluation to determine
pathology, recurrence or progression
Frequently reassess pain and side effects of
treatment
The Importance of Medical Records
H&P, diagnostic studies and consultations
Attempted treatment modalities
Treatment objectives
Informed consent
Periodic review of treatment plan
Record of prescribed medications
Optimizing Management of
Chronic Pain
Goals to increase function and decrease pain
To achieve goals a combination of
pharmacological and non-pharmacological
treatment is often required
Opioid therapy alone is usually not sufficient
Multidimensional approach works best
Issues That Must Be Considered When
Using Opioids
Pain is subjective
Only appropriate in well selected patients
Some patients are focused on obtaining drugs
rather than pain relief
Most opioid abuse is a consequence of written
prescriptions
Detecting abuse is paramount
Critical Issues When Using Opioids
Well-defined goal
Patient selection (disease state, age etc.)
Address psychological and social support
Case by case basis
Trial of therapy
Documentation and follow-up care
Types of Chronic Pain Patients
Type I Patients
Type II Patients
“chronic pain patients
Poorly defined pain
Multiple complaints
Using opioids poorly
Overlying psych issues
Ongoing legal issues
Unemployed or poor
function
Well defined etiology
Appropriate pain
mannerisms
Few or no psych issues
Functional
Compliant with
therapy
Common Mistakes
Continued escalation of medication with no
improvement in function
Opioids used in pain syndromes known to be
poorly responsive
Not addressing psychological issues
Lenient with abuse behaviors
Fear of converting to long acting medications
Addressing Obvious Abuse
WEAN!
Treat withdrawal
Contact other physicians and pharmacies
Discharge letter
30 day supply of opioids?
Remember: An abuser will always find drugs
but do all you can to protect yourself
The Opioid Contract
Mandatory for patients on chronic opioids
Surprisingly the majority of our patients agree
and understand why we must do this
Key points:
No function = no opioids
Lost, stolen, misplaced opioids
One pharmacy
Urine drug screens
Privacy issues
Urine Drug Screens
Types
Drug screen 9
OPGCMS
Useful tool but not often used randomly
Some studies suggest high incidence of abuse
Not taking prescribed drug
Taking opioids not prescribed
Illicit drug use
Informed Consent
Malpractice lawsuits becoming more common
“my doctor addicted me!”
The informed consent discusses:
Risk of addiction
Risks of overuse and overdose
Risks of side effects
Key Points
Thoroughly evaluate the pain complaint
Consider psychological issues
Consider opioids as a treatment of last resort
Use a contract and informed consent
Patients should demonstrate a high level of
responsibility
An accountability system must be in place
Practice a zero-tolerance policy
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