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

Pain & Policy Studies Group. Achieving

Balance in State Pain Policy: A Progress
Report Card. 3rd ed. 2007.
 Past-Year Initiates of Illicit
Drug Use: 2006

Persons aged ≥12 yrs

Number (in millions)

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
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
Neurochemical
Environment
 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
6. Periodically review pain diagnosis and comorbid
conditions, including addictive disorders
7. Documentation

Passik SD, Weinreb HJ. Adv Ther. 2000;17(2):70-83.

1

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 Mild Moderate Severe Very Worst
Pain Pain Pain Pain Severe Possible
 Stratifying Risk: Opioid Risk Tool
FEMALE MALE
Family history of substance abuse
♦ Five-question clinical Alcohol 1 3
interview to assess Illegal drugs 2 3
patients Prescription drugs 4 4
♦ Specifically developed to Personal history of substance abuse
screen patients with Alcohol 3 3
chronic pain who will be Illegal drugs 4 4
using opioids Prescription drugs 5 5
Age (if between 16-45) 1 1
♦ Quantifies the level of risk
for patient History of preadolescent sexual abuse
3 0
♦ Three risk categories
Psychological disease
− Low: 0 - 3 points Attention deficit disorder,
− Moderate: 4 - 7 points obsessive-compulsive
disorder, bipolar, schizophrenia
− High: 8 points and above 2 2
Depression 1 1

Webster LR, Webster RM. Pain Med. 2005;6:432-442. Scoring Totals

27
 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 1. Out of control with medications

medications
2. Medications cause decreased
2. Medications improve quality quality of life
of life

3. Will want to decrease 3. Medication continues or

medication if side effects increases despite side effects
are present

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 4. Unaware or in denial about any

problem problems

5. Follows the agreement for 5. Does not follow the agreement

the use of the opioids for use of the opioids

6. Frequently has medicines 6. Does not have medicines left

left over 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.”