balance chronic pain management and responsible opioid...

Balance

chronic pain management

and responsible opioid

prescribing

Michelle Bardack, M.D.

Family & Community Medicine

April 27, 2011

Opioid – Narcotic Discussion April 27, 2011

• Frame the dilemma

• Federation of State Medical Boards

• Discussion and questions

Overview

2


United States Statistics

• 70 - 100 million adults have chronic pain1

• 5 -33% of outpatient visits to primary care clinics2

• Unrelieved pain is a public health epidemic

• 2003 JAMA published overall costs to society of $61 billion3, similar to that of cancer and CVD4

3


It’s the law! 2005 - WHO

“…relief of pain is a basic human right…”5

JCAHO “….Patients have the right to appropriate assessment and management of pain….”6

Pain Relief Act NM January 20, 2003, “….every New Mexican shall receive appropriate treatment for pain,” further, “….health providers have an obligation to treat chronic pain….including the use of controlled substances…”7

4


• Psychological approach - CBT, Biofeedback, hypnosis

• Injection - TPI, ESI, joint

• Neural blockade - celiac plexus block

• Implants - intrathecal pump, nerve stimulator

• Surgical - cordotomy, neurotomy

• Non-opioid drugs - NSAIDS, acetaminophen

• Adjuvant analgesics - antidepressants, anticonvulsants

• Rehabilitative approaches - hot/cold packs, nerve stim, PT/OT

• CAM - acupuncture, chiropractic, massage

• Lifestyle changes - Etoh, tobacco, sedentary life, wt loss

• Opioids - morphine, oxycodone, fentanyl, methadone

Categories of Pain Treatment

5


Fear influences us

Last week’s JAMA: Opioid overdose is now the second leading cause of

unintentional death in the USA 8

The 'Oxy Express': Florida's Drug Abuse Epidemic

NPR Morning Edition, March 14, 20119

"If you're a clinic owner or a doctor or an employee knowingly working

at one of these pill mills, we have probably bought dope from you.

And we are probably coming to see you soon.”10

6


2002 2003 % Change Total drug overdose deaths 253 307 21

Rx drug overdose deaths 66 108 64

Illicit drug overdose deaths 187 199 6

Morphine/heroin 133 (55%) 121 (44%) -9

Cocaine 94 (39%) 110 (40%) 17

Alcohol 76 (31%) 78 (28%) 3

Methadone 28 (11%) 34 (12%) 21

Oxycodone 14 (6%) 26 (9%) 86

Methamphetamine 11 (5%) 21 (8%) 91

Propoxyphene 10 (4%) 18 (6%) 80

Diazepam 12 (5%) 16 (6%) 33

Hydrocodone 18 (7%) 15 (5%) -17

Amitriptyline 8 (3%) 14 (5%) 75

Fentanyl 2 (1%) 8 (3%) 300

Table 1. The Most Common

Drugs Causing Death Among

Total Drug Overdose Deaths in

New Mexico, 2002-2003

Drug Deaths in New Mexico11

7


DILEMMA

How do we responsibly prescribe opioids and balance management of chronic pain?

Opiophobia12 8


A New Approach

You will no longer cringe, hide head in

the sand

Rewarding for patient and provider

9


1. One of the oldest known drugs - opium

2. Appeared in Europe and US in 1800s, — 1890’s 1st Congressional Act--opium taxed — 1914 Harrison Tax Act--criminalized non-clinical

use

3. Where we are today: – Controlled Substances Act 1970’s (CSA) – Schedule classification (Class I - V)

Opioid history

10


1. Mechanism of action: mu-opioid receptor – Highly variable receptor with a range of responses -

producing wide inter-individual variations

2. Types: short, long, rapid-acting 3. Common side effects

– nausea – sedation – constipation

– pruritus

Pharmacology

11


An opioid trial is the only way a clinician can determine the efficacy and tolerability of a particular agent in a particular a patient13

Which one to choose?

12


Patient 14

Doctor14

Regulatory 15

What are barriers to prescribing?

13


Barriers

Patient barriers • Patient: Fear if adverse affects

• Fear that pain is irreversible and inevitable

• Fear of addiction

• Fear of focusing on symptoms and not cause

14


Barriers

Doctor barriers = opiophobia – Lack of education about opioids and current

standards

– Fear of toxicity

– Fear of addiction

– Fear of being “scammed or had” by patient

– Fear of regulatory scrutiny

15


1. States laws restrict Schedule II

– prescription quantity or duration

– prescription validity period

2. Prescription series

3. Triplicates/duplicates

4. Prescription monitoring programs

Regulatory Barriers

16


Federation of State Medical Boards (FSMB) 2005

Seven Step Process 1. Patient evaluation 2. Treatment plan 3. Informed consent and agreement (contract) 4. Periodic review 5. Consultation 6. Documentation 7. Compliance with controlled substances laws and

regulations

17


Step 1

Patient evaluation

– Document H & P

– Comorbidities - anxiety, depression, cancer

– History of substance abuse - CAGE, ORT

– Document the indication for opioid use

18


Step 2

Treatment plan

– Objectives

– Adjust over time

– Don’t forget other modalities

19


Step 3

Informed consent and agreement contract

– Discuss

– Document

– Contract

– Violation

20


Step 4

Periodic review

– Evaluate progress toward treatment objective

– FOUR A’s - analgesia, activities, adverse effects, aberrant behaviors16

–Satisfactory response – “Zero pain” vs improved quality of life

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Step 5

Consultation

– Be willing to refer patients at risk

• Misuse, abuse, or diversion

• Substance abuse

• Psychiatric disorder

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Step 6 - Documentation Accurate and complete medical records

– Treatment objective – Discussion of risks and benefits – Informed consent – Treatments

– Past tried, why failed; Current; Future ideas

– Medications: – Date, type, dosage, and quantity

– Instructions and agreements – Periodic reviews

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Step 7

Regulations

– Licensed in the state you are prescribing

– Federal regulations www.usdoj.gov/dea

– State regulations www.nmmb.state.nm.us

https://www.pmp.state.nm.us/pmp/webcenter

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http://www.usdoj.gov/dea

http://www.nmmb.state.nm.us/

https://www.pmp.state.nm.us/pmp/webcenter


Physical Dependence - a state of adaptation that is manifested by drug class-specific signs and symptoms that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug and/or administration of antagonist,

physical dependence, by itself, does not equate with addiction

Vocabulary

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Pseudoaddiction - iatrogenic syndrome from the misinterpretation of relief seeking behavior as though they are drug -seeking behaviors that are commonly seen in addiction.

BUT relief of seeking behavior resolves with the institution of effective analgesia

Vocabulary

26


Substance Abuse - use of a substance for non therapeutic purposes or use of medication for purposes other than those it was prescribed for

Tolerance - a physiologic state resulting from regular use of a drug in which an increased dosage is needed to produce a specific effect or a reduced effect is observed with a constant dose over time.

Tolerance may or may not be evident during opioid treatment and does not equate with addiction.

Vocabulary

27


Finally Multiple focus areas

for scholarly project/publication

Public

Health

Individual

Health

Public

Policy

Pharmaceutical

Companies

Government

State

National/ International Regulations

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2005 National survey on drug use and health www.oas.samhsa.gov

University of Wisconsin – Pain Policy www.painpolicy.wisc.edu

New England Journal of Medicine – Opioid http://www.nejm.org/search?q=opioid+therapy+for+chronic+pain&asug=opio

National Alliance Of Advocates - Buprenorphine Treatment http://www.naabt.org/laws.cfm

Websites

29

http://www.oas.samhsa.gov/

http://www.painpolicy.wisc.edu/

http://www.nejm.org/search?q=opioid+therapy+for+chronic+pain&asug=opio

http://www.naabt.org/laws.cfm


References 1. Gottlieb S. Speech before the American Pain Foundation. Remarks by the Deputy Commissioner for Medical and Scientific Affairs,

Food and Drug Administration to the U.S. House of Representatives Committee on Energy and Commerce, Subcommittee on

Health; December 8, 2005; Washington, DC.

2. Reid MC, Engles-Horton LL, Weber MB, et al. Use of opioid medications for chronic noncancer pain syndromes in primary care. J

Gen Intern Med 2002;17:173-179.

3. Stewart WF, Ricci JA, Chee E, et al. Lost productive time and cost due to common pain conditions in the US workforce. JAMA

2003;290:2443-2454.

4. International Association for the Study of Pain and European Federation of IASP Chapters. Unrelieved Pain is a Major Global Health

Care Problem. November 16, 2006. Available at: http://www.iasp-pain.org.

5. World Health Assembly, Cancer Prevention and Control, 58.22 Geneva, Switzerland;

http://www.who.int/medicines/areas/quality_safety/Framework_ACMP_withcover.pdf

6. Joint Commission on Accreditation of Healthcare Organizations pain management Standards Effective January 1, 2001

http://www.jointcommission.org/pain_management/

7. http://www.nmmb.state.nm.us/pdffiles/Rules/NMAC16.10.14_PainManagement.pdf

8. Volkow Nora D. MD et al, Curtailing Diversion and Abuse of Opioid Analgesics Without Jeopardizing Pain Treatment, JAMA April 6,

2011 vol.305. No. 13

9. http://www.npr.org/programs/morning-edition/

10. ′Prescription Drug Overdoses: An American Epidemic; http://www.cdc.gov/about/grand-rounds/archives/2011/01-February.htm

11. Shah, Nina MS, NM Epidemiology Report Volume 2004 number 8, October 1, 2004.

12. Forbes, K. Opioids: Beliefs and Myths Journal Pain Palliative Care Pharmacotherapy 2006; 20(3):33-35

13. Opioid Prescribing: Clinical Tools and Risk Management Strategies, Anderson, Alfred V. MD et al, December 31, 2009

14. 4th Edition 2010 Bonica’s Management Of Pain, Chapter 14, Laws And Policies Affecting Pain Management, Aaron M. Gilson

15. Cancer Pain Management Policy Review Group. American Cancer Society Position Statement on Regulatory Barriers to Quality

Cancer Pain Management. National Government Relations Department, American Cancer Society; 2001.

16. Passik SD, Weinreb HJ. Managing chronic nonmalignant pain: overcoming obstacles to the use of opioids. Adv Ther. 2000; 17(2);

70-83.

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http://www.iasp-pain.org/



http://www.who.int/medicines/areas/quality_safety/Framework_ACMP_withcover.pdf

http://www.jointcommission.org/pain_management/

http://www.nmmb.state.nm.us/pdffiles/Rules/NMAC16.10.14_PainManagement.pdf

http://www.npr.org/programs/morning-edition/



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