Transcript The Truth About Opioid Pain Management: Patient Evaluation, Addiction, Physical Dependence, and Federal Regulations Howard A.

The Truth About Opioid
Pain Management:
Patient Evaluation, Addiction, Physical
Dependence, and Federal Regulations
Howard A. Heit, MD, FACP, FASAM
Board Certified in Internal Medicine
and Gastroenterology/Hepatology
Certified in Addiction Medicine
and as a Medical Review Officer
Chronic Pain Specialist
Assistant Clinical Professor
Georgetown University
Pain
An unpleasant sensory and emotional
experience that is associated with actual or
potential tissue damage, or described in
terms of such injury
— IASP, 1994
Pain is the most common complaint for which
individuals seek medical attention!
Foley K. JAMA. 2000;283(1):115.
 Chronic pain
 Pain that has outlived its usefulness
 Acute pain
 An adaptive, beneficial response necessary
for the preservation of tissue integrity
Oaklander AK. Neuroscientist. 1999;5(5):302-310.
Principle of Balance
 Dual obligation of governments
 Establish system of controls to prevent abuse,
trafficking, & diversion of CS
 Ensure medical availability
Analgesia
Pain & Policy Studies Group. Achieving
Balance in State Pain Policy: A Progress
Report Card. 3rd ed. 2007.
Abuse
Number (in millions)
Past-Year Initiates of Illicit
Drug Use: 2006
Persons aged ≥12 yrs
SAMHSA. (2007). Results from the 2006 National Survey on Drug Use and Health: National Findings (Office
of Applied Studies, NSDUH Series: H-32, DHHS Publication No. SMA 07-4293). Rockville, MD.`
Sources of Diverted Rx Drugs
 Thefts & losses
 Armed robberies
 Night break-ins
 Employee & customer pilferage
 Growing number of “rogue” Internet pharmacies
 International smuggling
 Study within Eastern 22 states from 2000-2003
 Almost 28 million CS dosage units diverted
• Approximately 7 million (25%) were opioids
 Media focus on diversion stemming only from prescribers
can hinder patient access to care
Joranson DE, Gilson AM. J Pain Symptom Manage. 2005;30:299-301. Brushwood DB, Kimberlin CA. J Am
Pharm Assoc. 2004;44:439-44. Inciardi JA, et al. Pain Med. 2007;8:171-83. National Center on Addiction & Drug Abuse at Columbia
University. “You’ve Got Drugs!” Prescription Drug Pushers on the Internet. 2007.
N a t i o n a l S u r v e y o n D r u g Use
a n d H e a l t h (NSDUH)
 Source of prescription pain relievers of
persons aged 18 to 25 in the 2005
 Who obtained the drug for their most
recent non-medical use
• Who were dependent on or abused
prescription pain relievers
Prescriptions from one doctor
(12.7% to 13.6%)
NSDUH Report: How Young Adults Obtain Prescription Pain Relievers for Nonmedical Use
Issue 39, 2006
Barriers to Pain Management
 Addiction/Misuse/Diversion
of Controlled Substances
Addiction
 Addiction is a primary, chronic, neurobiologic
disease, with genetic, psychosocial, and
environmental factors influencing its
development and manifestations. It is
characterized by behaviors that include one
or more of the following: impaired control
over drug use, compulsive use, continued
use despite harm, and craving (5 C’s)
Consensus Document. The American Academy of Pain Medicine. The American Pain Society. The
American Society of Addiction Medicine. 2001.
Physical Dependence
 Physical dependence is a state of adaptation
that is manifested by a drug class-specific
withdrawal syndrome that can be produced
by abrupt cessation, rapid dose reduction,
decreasing blood level of the drug, and/or
administration of an antagonist
Consensus Document. The American Academy of Pain Medicine. The American Pain Society. The
American Society of Addiction Medicine. 2001.
 Physical dependence and addiction
can coincide, but physical dependence does
not equal addiction in all cases. Physical
dependence is a neuro-pharmacological
phenomenon while addiction is both a
neuropharmacological and behavior
phenomenon
Triangle of the Disease of Addiction
Genetics
Social
Environment
Neurochemical
Tolerance
 Tolerance is a state of adaptation in which
exposure to a drug induces changes that result
in a diminution of one or more of the drug’s
effects over time
 Key: All other conditions being constant
• BAD: Disease or syndrome is progressing
• GOOD: Functional activity is increasing
Consensus Document. The American Academy of Pain Medicine. The American Pain Society. The
American Society of Addiction Medicine. 2001.
History of AA
 AA/NA compatible with treatment of all medical
and mental disorders
 Should be considered essential in treatment of
addictive disorders
John Chappel, MD, FASM, Professor Emeritus, University of Nevada at Reno
ASAM Review Courses on the 12-Step Programs
Prevalence of Addiction in the
General Population
Approximately 10% (3% - 16%)
 Relapse rate with long-term opioid use
is unknown
Portenoy RK, Savage SR. J Pain Sympt Manage. 1997;14(3):S27-35.
Opioid Treatment for Pain and Addiction
 Addiction to opioids in the context of pain
treatment has been reported to be rare in
those with no history of addictive disorders.
Portenoy, R.K., Savage, S.R. Journal of Pain and Symptom Management. Vol. 14 No. 3 (Suppl.) Sept. 1997
Fishbain DA, Cole B et al. Pain Medicine 9(4): 2008; 444-459
Iatrogenic Addiction
 Iatrogenic addiction occurs when a patient, with
a negative personal or family history for alcohol
or drug addiction or abuse, is appropriately
prescribed a controlled substance &
subsequently in the therapeutic course meets
the diagnostic criteria for addiction to that
substance
Heit HA, Gourlay DL. Treatment of Pain in Substance Abuse Disordered Population. Ballantyne JC, Rathmell JP, Fishman SM
(eds). Bonica’s Management of Pain. 4th ed. Lippincott Williams & Wilkins. In Press.
Treatment of Pain with Opioids
 “All substances are poisons. The right dose
differentiates a poison and a remedy.”
- Paracelsus, 1493- 1541 AD
Goals of Treating Chronic Pain
 Decrease pain
 Increase function
 Use medications that do not have
unacceptable side effects
Patient Evaluation
 Initial evaluation
 Each appointment
Universal Precautions in Pain Medicine
 The term “Universal Precautions” originated from the
infectious disease model
 Careful 10-point assessment of all persistent pain
patients within the biopsychosocial model
 Appropriate “boundary setting” before writing the first
prescription
 By using this approach to the pain patient
 Stigma can be reduced
 Patient care improved
 Overall risk of pain management be reduced
Gourlay D, Heit HA et al. Pain Med. 2005;6(2):107-112.
Universal Precautions in Pain Medicine
1. Diagnosis with appropriate differential
2. Psychological assessment including risk of
addictive disorders
3. Informed consent (verbal vs written/signed)
4. Treatment agreement (verbal vs
written/signed)
5. Pre/post intervention assessment of pain level
and function
Gourlay D, Heit HA et al. Pain Med. 2005;6(2):107-112.
Universal Precautions in Pain Medicine
6. Appropriate trial of opioid therapy +/- adjunctive
medication
7. Reassessment of pain score and level of function
8. Regularly assess the “Four A’s” of pain medicine
– Analgesia, Activity, Adverse reactions, & Aberrant
behavior 1
9. Periodically review pain diagnosis and comorbid
conditions, including addictive disorders
10. Documentation
1Passik
SD, Weinreb HJ. Adv Ther. 2000;17(2):70-83.
Gourlay D, Heit HA et al. Pain Med. 2005;6(2):107-112.
Universal Precautions: Patient Triage
 Group I: Who is your patient?
 Group II: Who is our patient?
 Group III: Who is my patient?
Gourlay D, Heit HA et al. Pain Med. 2005;6(2):107-112.
No
Pain
Mild
Pain
Moderate
Pain
Severe
Pain
Very
Severe
Worst
Possible
Stratifying Risk: Opioid Risk Tool
FEMALE
 Five-question clinical
interview to assess
patients
 Specifically developed to
screen patients with
chronic pain who will be
using opioids
 Quantifies the level of
risk for patient
 Three risk categories
MALE
Family history of substance abuse
Alcohol
Illegal drugs
1
2
3
3
4
4
Alcohol
Illegal drugs
3
4
3
4
Prescription drugs
Age (if between 16-45)
5
1
5
1
Prescription drugs
Personal history of substance abuse
History of preadolescent sexual abuse
3
Psychological disease
 Low: 0 - 3 points
 Moderate: 4 - 7 points
 High: 8 points and
above
Webster LR, Webster RM. Pain Med. 2005;6:432-442.
0
Attention deficit disorder,
obsessive-compulsive
disorder, bipolar, schizophrenia
Depression
Scoring Totals
27
2
2
1
1
One Drink:
12 oz Beer = 5 oz Wine = 1.5 oz Liquor (80 proof)
Differences Between a Chronic Pain
Patient and an Addicted Patient
Pain Patient
Addicted Patient
1. Not out of control with
medications
1. Out of control with medications
2. Medications improve quality
of life
3. Will want to decrease
medication if side effects
are present
2. Medications cause decreased
quality of life
3. Medication continues or
increases despite side effects
Schnoll SH, Finch J. J Law Med Ethics. 1994;22(3):252-256.
Differences Between a Chronic Pain
Patient and an Addicted Patient
Pain Patient
Addicted Patient
4. Concern about the physical
problem
4. Unaware or in denial about any
problems
5. Follows the agreement for
the use of the opioids
5. Does not follow the agreement
for use of the opioids
6. Frequently has medicines
left over
6. Does not have medicines left
over, loses prescriptions, and
always has a “story”
Schnoll SH, Finch J. J Law Med Ethics. 1994;22(3):252-256.
Federal Regulations for Prescribing a
Scheduled Controlled Substance .
Federal vs State Regulations
 Health care professionals must comply with
both federal and state regulations that govern
prescribing a scheduled controlled substance
(CS)*
 When federal law or regulations differ from
state law or regulation, the more stringent
rule would apply
*Model Policy for the Use of Controlled Substances for the Treatment of Pain.
Policy Statement: Federation of State Medical Boards of the United States, Inc; 2004
Federal Regulations
 May administer, prescribe or dispense a
schedule II CS to a person with intractable pain,
in which no relief or cure is possible or none has
been found after a reasonable effort
21 CFR 1306.07
 This language has served as the basis to
define “intractable pain” in state law.
Federal Regulations
 May treat acute/chronic pain with a schedule
II CS in a recovering narcotic-addicted patient
21 CFR 1306.07
• One must keep good records to
document the physician is treating a
pain syndrome, not the disease of
narcotic addiction
Teamwork With the Dispensing Pharmacist
 The pharmacist is a critical link in the chain of
medication distribution to the patient, dispensing drugs
that are available by prescription only
 All prescriptions for opioids should have written on them
 Chronic pain patient
 Acute pain patient
 Patient should use one pharmacy for obtaining their
medications
 Provide the pharmacist with a copy of the
“Agreement For Opioid Maintenance Therapy For
Noncancer/Cancer Pain”
Inform, Set and Enforce Boundaries with Your
Patient Based on Mutual Trust and Honesty
Consultation with
Appropriate Specialist:
Example:
Addiction Medicine,
Mental Health
Basic Boundary
Setting
Enhanced Boundary
Setting
Gourlay D, Heit HA et al. Pain Med. 2005;6(2):107-112.
Inform, Set and Enforce Boundaries with Your
Patient Based on Mutual Trust and Honesty
Discharge Patient
Gourlay D, Heit HA et al. Pain Med. 2005;6(2):107-112.
Conclusion
 Health care practitioners can prescribe
scheduled controlled substance (CS)
approved by the FDA consistent with state
and federal regulations to give their patients
the best quality of life possible given the
reality of their medical condition
Conclusion: Wisdom From Lilly
 After placement of the Deep Brain Stimulator
on December 19, 2007, I was walking hand in
hand with my granddaughter Lilly. She looks
up at me and says:
 “PopPop you are not crooked
any more.”
•
Visual physical exam
 “Your boo boo is getting better!”
•
Assessment of my pain generator
 “That means you can play me with more
– right?”
•
Assessment of my functional activity
AA Serenity Prayer
“God, grant me the Serenity to accept
the things I cannot change; Courage to
change the things I can; and the
WISDOM to know the difference.”