the truth about opioid pain management: patient evaluation, addiction, physical dependence, and...

The Truth About Opioid Pain Management:

Patient Evaluation, Addiction, Physical Dependence, and Federal Regulations

Howard A. Heit, MD, FACP, FASAMBoard Certified in Internal Medicineand Gastroenterology/Hepatology

Certified in Addiction Medicineand 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

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.`

Num

ber

(in m

illio

ns)

Persons aged ≥12 yrs

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 UseIssue 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


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

SocialEnvironment

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


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 theGeneral 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

Gourlay D, Heit HA et al. Pain Med. 2005;6(2):107-112.

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


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



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?


No Pain

MildPain

Moderate Pain

Severe Pain

Very Severe

Worst Possible

27

Family history of substance abuse

Alcohol 1 3

Illegal drugs 2 3

Prescription drugs 4 4

Personal history of substance abuse

Alcohol 3 3

Illegal drugs 4 4

Prescription drugs 5 5

Age (if between 16-45) 1 1

History of preadolescent sexual abuse 3 0

Psychological disease

Attention deficit disorder, obsessive-compulsive

disorder, bipolar, schizophrenia 2 2

Depression 1 1

Scoring Totals

Stratifying Risk: Opioid Risk Tool

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

Low: 0 - 3 points

Moderate: 4 - 7 points

High: 8 points and above

FEMALE MALE

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

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

1. Not out of control with medications

2. Medications improve quality of life

3. Will want to decrease medication if side effects are present

Addicted Patient

1. Out of control with medications

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

4. Concern about the physical problem

5. Follows the agreement for the use of the opioids

6. Frequently has medicinesleft over

Addicted Patient

4. Unaware or in denial about any problems

5. Does not follow the agreement for use of the opioids

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. *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; 2004Policy 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 BoundarySetting

Inform, Set and Enforce Boundaries with Your Patient Based on Mutual Trust and Honesty

Discharge Patient


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.”

the truth about opioid pain management: patient evaluation, addiction, physical dependence, and...

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