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
Number (in millions)

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

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 6. Periodically review pain diagnosis and comorbid conditions, including addictive disorders 7. Documentation
Passik SD, Weinreb HJ. Adv Ther. 2000;17(2):70-83. Gourlay D, Heit HA et al. Pain Med. 2005;6(2):107-112.
1

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 MALE
3 3 4 3 4 5 1

♦ 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

Family history of substance abuse Alcohol Illegal drugs Prescription drugs Personal history of substance abuse Alcohol Illegal drugs Prescription drugs Age (if between 16-45)

1 2 4 3 4 5 1

History of preadolescent sexual abuse 3 Psychological disease Attention deficit disorder, obsessive-compulsive disorder, bipolar, schizophrenia 2 Depression

0

2 1

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

Scoring Totals

27

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 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 medicines left 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. 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.”

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