Rollin Gallagher

Responsible Prescribing Practices

April 10-12, 2012 Walt Disney World Swan Resort

Rollin M. Gallagher, MD, MPH Deputy National Program Director for Pain

Management. Veterans Health Administration

Co-Chair, Workgroup on Pain Management DoD-VA Health Executive Council

Clinical Professor of Psychiatry and Anesthesiology Director of Pain Policy and Primary Care Research, Penn

Pain Medicine University of Pennsylvania

The Best Risk Management is Effective Pain Management:

The Stepped Pain Care Model in the Veterans Health System

Disclosures

•  Board of Directors of the American Academy of Pain Medicine

•  Editor-in-Chief, Pain Medicine

•  Board of Directors of the American Pain Foundation

•  Board of Directors, Audubon Pennsylvania

Learning Objectives:

1. Identify the factors contributing to the public health problem of chronic pain and prescription opioid abuse

2. Identify a population-based, patient-centered approach to managing pain in a health system and describe “best practice” strategies that can be used by clinicians for pain management treatment as risk management for prescription drug abuse.

To hear about pain is to have doubt;

to experience pain is to have certainty.

Elaine Scarry, The Body in Pain

What is Pain?

radiculopathy (sciatica)

There Are Many Painful Diseases and Pain Diseases

*Complex regional pain syndrome.

Nociceptive pain Caused by activity in neural pathways in

response to potentially tissue-damaging stimuli

Neuropathic pain Initiated or caused by a

primary lesion or dysfunction in the nervous system

Postoperative pain

Mechanical low back pain

Sickle cell crisis

Arthritis

Peripheral neuropathy

Postherpetic neuralgia

Diabetic neuropathy

Sports/Exercise injuries

Central post- stroke pain

Trigeminal neuralgia

Inflammatory / Immunological Mediation

MIXED PAIN STATES: cancer, low back, pelvic,

facial, crush injury, amputation

CRPS*

Phantom pain

SENSITIZATION

Diagnosis (Broad ICD-9 Categories) Frequency Percent

Infectious and Parasitic Diseases (001-139) 78,869 14.0

Malignant Neoplasms (140-209) 6,816 1.2

Benign Neoplasms (210-239) 30,053 5.3 Diseases of Endocrine/Nutritional/ Metabolic Systems (240-279) 157,823 27.9

Diseases of Blood and Blood Forming Organs (280-289) 16,917 3.0

Mental Disorders (290-319) 277,112 49.0 Diseases of Nervous System/ Sense Organs (320-389)

231,524 41.0

Diseases of Circulatory System (390-459) 108,940 19.3

Disease of Respiratory System (460-519) 135,699 24.0

Disease of Digestive System (520-579) 195,631 34.6

Diseases of Genitourinary System (580-629) 73,772 13.1

Diseases of Skin (680-709) 107,616 19.1 Diseases of Musculoskeletal/Connective System(710-739) = PAIN

300,752 53.2

Symptoms, Signs and Ill Defined Conditions (780-799) 267,745 47.4

Injury/Poisonings (800-999) 149,000 26.4 Cumulative from 1st Quarter FY 2002 through 2nd Quarter FY 2010

Transition to the VHA: Frequency of Dx, OEF/OIF Veterans

Why chronic pain in OEF-OIF troops?

Wear and tear of military duty during war a) Prolonged, repeated deployments b) Osteoarthritis and spinal / limb injuries c) Post-traumatic stress

90% survival, battlefield injuries: a)  Physical wounds b)  Blast injuries and TBI c)  Psychological wounds

Organizational issues in health care

Sarah, a 28 y/o woman reservist discharged after training camp spine and foot injury:

–  failed back surgery syndrome with radiculopathy (sciatica) • Back and shooting leg pain on sitting or

standing > 30 minutes

–  CRPS foot after multiple surgeries • Foot pain on weight bearing or walking • Difficulty wearing shoes

–  finishing legal degree

–  marital stress

Michael, 25 y/o decorated combat veteran, married, one son:

– MVA multiple R leg fractures 2001 – MVA 2002, concussion – blast injury 2003 with shoulder dislocation,

cervical injury, brachial plexus injury – Residual:

•  TBI with HA, cognitive impairments, seizure disorder

•  CRPS II R leg •  back, neck, shoulder pain •  PTSD, depression

– Family stress

Courtesy of C. Buckenmaier, MD

A New Injury with an Uncertain Course

BLAST TBI

NERVE INJURY / SENSITIZATION

FEAR

COGNITIVE / BEHAVIORAL IMPAIRMENTS

PTSD

PTSD N=232 68.2% 2.9% 16.5%

42.1% 6.8%

5.3%

10.3%

12.6%

TBI N=227 66.8%

Chronic Pain

N=277 81.5%

Prevalence of Chronic Pain, PTSD and TBI in a sample of 340 OEF/OIF veterans

Lew et al., (2009). Prevalence of Chronic Pain, Posttraumatic Stress Disorder and Post-concussive Symptoms in OEF/OIF Veterans: The Polytrauma Clinical Triad. Journal of Rehabilitation Research and Development, 46, 697-702)

“If you cannot control their pain, you will never be able to help them with their PTSD and depression”

Congressman John Murtha, at the opening of the Acute Pain Research Unit at Walter Reed, discussing the NEJM article describing 350,000 returning troops with mental health problems:

THE CONSEQUENCE – PAIN HURTS! Causalgia (CRPS 2) in artist: Injury Vietnam

Courtesy of N. Wiedemer, CRNP

Pain affects the whole person

Mismanaged chronic pain is often a personal,

biopsychosocial catastrophe! ….and is a huge public health

problem.

•  Quality of life – Physical functioning – Ability to perform

activities of daily living – Ability to work – Pleasurable activity

•  Social consequences – Marital/family relations – Intimacy/sexual activity – Social roles and

friendships

•  Psychological / CNS morbidity – Fear, anger, suffering – Sleep disorders – Cognitive impairments

•  Medical consequences – Accidents – Medication side effects – Immune function – Clinical depression / suicide – Neuroplasticity

•  Societal consequences • Health care costs • Disability, lost workdays • Business failures • Higher taxes

Established (by research) effects of chronic pain

Pain has an element of blank.

It knows not where it began, or

If there was a day when it was not.

It has no future but itself.

Its infinite realms contain its past,

Enlightened to perceive

new periods of pain.

Emily Dickinson

Chronification to Maldynia: The Chronic Pain Cycle (Gallagher , Pain Med 2011)

Pathology: - Muscle atrophy, weakness; - Bone loss; - Immunocompromise -Depression

Less active Kinesophobia Decreased motivation Increased isolation Role loss Sleep disorder

Disability

Pathophysiology of Maintenance: - Radiculopathy - Neuroma / traction - Myofascial sensitization - Brain, SC pathology (atrophy, reorganization)

Neuro-psychopathology of maintenance: - Encoded anxiety dysregulation - PTSD -Emotional allodynia -Mood disorder -Cognitive disorder - Substance abuse

Neurogenic Inflammation: - Glial activation - Pro-inflammatory cytokines - blood-nerve barrier dysruption

Acute injury and pain

Peripheral Sensitization: New Na+ channels cause lower threshold

Central Sensitization - Neuroplastic changes

Gallagher RM in Ebert & Kerns 2010

Key elements, continuum of pain care

•  Primary prevention: Avoid –  injury, nociception, nerve damage

•  Secondary prevention: Once pain starts, minimize –  access to the CNS –  concurrent augmenting factors (e.g. high stress)

–  neuroplastic pathophysiology of the CNS

•  Tertiary prevention: Once “chronification” starts –  reverse its impact on quality of life by functional, emotional,

physical, and spiritual rehabilitation –  restore social networks (love, support, fun) –  provide motivation (goals) –  reverse neuroplastic damage

1) Growing societal expectation of pain relief: 2) Cancer pain specialists document that patients with cancer-

related pain: 3)  Emphasis on short-term cost-containment in managed systems

to maximize profitability: Brief visits; Cost-shifting; Elimination of rehabilitation

4)  Recognition that: CP is common, damages the nervous system, has major morbidity, and if uncontrolled pain, is a major public health problem

5) COT demonstrates efficacy / effectiveness, safety and tolerability in cross-sectional and short-term studies of patients in structured clinical and experimental settings

6) Documented dangers of alternatives: NSAIDs, Cox 2, surgery

7) Opioid efficacy in neuropathic pain conditions 8) After severe trauma, early use of opioids associated

with reduced chronicity

Over 30 years a major shift occurred in the use of opioids for chronic pain

1) Growing societal expectation of pain relief:   Terminal cancer pain (Hospice movement)   Pain as 5th Vital Sign in the VA health system   JCAHO standards

2) Cancer pain specialists document that patients with cancer-related pain:   Are under-treated   When in remission from cancer, tolerate opioids

long-term without difficulty



3) Emphasis on short-term cost-containment in managed systems to maximize profitability:

- Brief visits: Synergy with marketing of biomedical model and short-term clinical trials that promote: * pharmaceuticals * procedures

- Cost-shifting of treatment failures to public sector (ERs, workers compensation, SSDI)

- Drastic reduction of integrated, rehabilitation despite demonstrated cost-effectiveness (e.g., return-to-work)


4) Recognition that:

  Chronic pain is common

  Poorly controlled pain damages the nervous system leading to neuroplastic changes, that are often difficult to reverse

  Pain becomes a chronic disease with major morbidity

  Uncontrolled pain is a public health problem   Costs to businesses   Costs to taxpayers

5) Regular, daily opioids demonstrate efficacy / effectiveness, safety and tolerability in cross-sectional and short-term studies of patients in structured clinical and experimental settings –  Nursing homes (effectiveness) –  Clinical trials (efficacy) –  Laboratory (psychomotor safety)

6) Documented dangers of alternatives:   Under-treated pain: disability, depression, suicide   Analgesic options and organ system damage (e.g., NSAID,

COX 2, TCA)   Back surgery failure rate

7) Opioid efficacy in neuropathic pain conditions

8) After severe limb trauma, early use of opioids associated with reduced chronicity


567 severe single extremity trauma patients •  Predictors of poor outcome before injury include:

•  Alcohol abuse 1 month before injury (Marker, depression & substance abuse) •  Older age, lower education, low self efficacy (Gallagher et al Pain 1989)

•  Predictors of poor outcome at 3 months post-injury •  Acute pain intensity, anxiety, depression and sleep disturbance

Opioid protective effect

“Patients treated with narcotic medication for pain at three months post-discharge were protected against chronic pain, despite the fact that these patients had higher pain intensity levels and were thus at higher risk.”

“The results presented here appear to lend support to the theory that…

..early aggressive pain treatment may protect patients from central sensitization and chronic pain.”

WHO DEVELOPED HYPERALGESIA? WHO DEVELOPED ADDICTION?

Brief visits

Complex patients

Little training in pain mgmt / addictions

Lack of reliable pain medicine / addictionology access

Minimal program resources (doc-in-box)

JCAHO & VHA Mandate to Manage pain

Economic pressures for pts to be able to work and avoid disability

Policies Guidelines Expectations

Managing PAIN in Primary Care: Issues and Challenges

“I medicate first and ask questions later.”

Effects of these changes on clinical practice

•  More opioids prescribed, by providers with little training in pain, psychiatry or addictions

•  More patients obtaining pain relief

•  More opioids in circulation

•  Rapid rise in prescription drug abuse and in unintentional overdose

•  The 21st Century Opioid Analgesia Debates

Which pain patients, amongst the many millions being treated in primary care, should be considered for treatment with opioids ??

Patients •  Without addiction? •  With a remote history of addiction? •  With active/recent addiction?

–  Smokers? •  On opioid agonist therapy for addiction? •  Who misuse medications? •  Who are chemical copers? •  Are disorganized or impulsive? •  Have low self-esteem? •  Have major depression or PTSD?

INSTITUTE OF MEDICINE Pain is a public health problem

• Affects at least 100 million American adults

• Reduces quality of life • Costs society $560–$635 billion annually

• Medical and health care educaAon and training needs to be revamped at every level

• Research to establish evidence-‐based care is needed

• Society must incenAvize outcomes-‐based care

National Pain Management Strategy

Objective is to develop a:   comprehensive, multicultural, integrated,

system-wide approach to pain management   that reduces pain and suffering for Veterans

experiencing acute and chronic pain associated with a wide range of illnesses, including terminal illness.

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Stepped Pain Care

STEP 1

STEP 2

STEP 3

Tertiary Interdisciplinary Pain Centers Advanced diagnostics & interventions Commission on Accreditation of Rehabilitation Facilities accredited pain rehabilitation Integrated chronic pain and Substance Use Disorder treatment

Patient Aligned Care Team (PACT) Routine screening for presence & intensity of pain Post-Deployment Teams Comprehensive pain assessment Management of common acute and chronic pain conditions Mental Health-Primary Care Integration Expanded nurse care chronic illness management Opioid Renewal Clinics

Complexity

Treatment Refractory

Comorbidities

RISK

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Organization, VHA Pain Management Strategy

National Pain Management Office Robert Kerns PhD, Pam Cremo; Rollin Gallagher MD, Merry Dziewit

Implementation initiatives •  Communication/education infrastructure

–  VA Pain List Serve –  National Pain Management Website (www.va.gov/painmanagement) –  Monthly Pain Management Leadership Teleconference –  Monthly “Spotlight on Pain Management” webinar (educational

teleconference) –  National Pain Management Leadership Conference

•  Guidelines –  Chronic Opioid Therapy –  Peri-operative pain management –  Dissemination of American Pain Society/American Academy of Pain

Medicine guidelines •  Web-based education

–  General, opioid therapy for acute and chronic pain, polytrauma •  Pain and Operation Enduring Freedom/Operation Iraqi Freedom

–  Pain and polytrauma initiatives –  Posttraumatic Stress Disorder-Traumatic Brain Injury-Pain Practice

Recommendations Consensus Conference –  “A Team Approach to Veterans with Comorbid Conditions”

Conference •  Nursing

–  Veteran Affairs Nursing Outcome Database Nursing Assessment and Reassessment Initiative (initial focus on management of acute pain in inpatient settings)

–  Pain Resource Nursing (PRN) Initiative

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Promoting safe and effective use of opioids

•  Opioid – High Alert Medication Initiative –  Implementation of opioid safety practices in inpatient and

outpatient settings, including use of opioids for acute (including Patient Controlled Analgesia) and chronic pain management

•  VA-DoD Chronic Opioid Therapy – Clinical Practice Guideline –  Opioid Pain Care Agreement; Written Informed Consent

•  Opioid Therapy for Acute and Chronic Pain Web Course •  Pharmacy Benefits Management Initiatives (Dr. Sproul)

•  Directive and Clinical Considerations regarding state-authorized use of marijuana

•  Pharmacy Pain Management Clinics (Opioid Renewal Clinics) (Wiedemer et al, Pain Med 2007)

•  SCAN-ECHO 38

Pharmacy Pain Medication Management Clinic Total Clinic Referrals

(47%)

Aberrant Outcomes

VA Specialty Care Access Network – Extension of Community Healthcare Outcomes (VA SCAN-ECHO)

The mission of VA SCAN-ECHO is to:

•  Meet the needs of primary care providers and PACT teams for access to specialist consultation services and support

•  Provide case-based learning modules to improve core competencies and provider satisfaction

•  Facilitate referrals to secondary care and tertiary care centers when indicated

•  Ultimately to improve veteran access to specialty care and treatment outcomes

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"knowledge network, force multiplier, and promotion of chronic disease self- management." Aurora et al, NEJM 2011

Patient Education Initiatives

•  Patient Education Working Group –  Development of Patient/Family

Education Toolkit •  Veteran Education Resource

Coordinators •  MyHealtheVet

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Self-care , Community Care - meditation - exercise - web-training - social modeling -social supports

Primary care -  Mech. Based Drug Algorithms -  Stepped Behavioral Medicine Care -  Physical Therapies -  Office procedures -  CAM, pain school

Secondary care: Pain Medicine - Biopsychosocial assessment ** pain generators, mechanisms ** perpetuating factors - - - peripheral, CNS, psychosocial - Biopsychosocial Formulation - Collaborative care models with PCP

Tertiary care: PM Subspecialties - Neuroremodeling - Gene therapies - Neurostimulation - Rehabilitation Centers

DISEASE MANAGEMENT IN A POPULATION OF PATIENTS IN PAIN

Relative proportion of pain care, by

setting

Primary / secondary / tertiary prevention

Secondary / tertiary prevention

PAIN SPECIALTY

- Practice - Training

-  Research

tertiary prevention

Evidence-based Continuum of Patient Centered Care

Primary / secondary / tertiary prevention

(Gallagher, AAPM 2008; Dubois , Gallagher, Lippe Pain Med 2009)

If I can stop one heart from breaking I shall not live in vain;

If I can ease one life the aching Or cool one pain,

Or help one fainting robin Unto his nest again,

I shall not live in vain

Emily Dickinson

ABOVE ALL, MAINTAIN INTELLIGENT AND INFORMED EMPATHY – BE PATIENT

Rollin Gallagher

Health & Medicine

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