Responsible Prescribing Practices National Rx Drug Abuse Summit 4-11-12

1. Responsible
Prescribing Practices
April 10-12, 2012
Walt Disney World Swan Resort

2. The Best Risk Management is Effective Pain
Management:
The Stepped Pain Care Model in the Veterans
Health System
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

3. 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

4. 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.

5. What is Pain?
To hear about pain is to have doubt;
to experience pain is to have
certainty.
Elaine Scarry, The Body in Pain

6. There Are Many Painful Diseases and Pain Diseases
Inflammatory / Immunological Mediation
Nociceptive pain Neuropathic pain
MIXED PAIN STATES:
Caused by activity in Initiated or caused by a
neural pathways in primary lesion or dysfunction
cancer, low back, pelvic,
response to potentially in the nervous system
tissue-damaging stimuli
facial, crush injury, amputation
Peripheral
neuropathy CRPS*
Postoperative
pain
SENSITIZATION
Arthritis
Postherpetic
neuralgia Trigeminal
Sickle cell neuralgia
Mechanical crisis
low back pain radiculopathy Central post-
(sciatica) stroke pain
Sports/Exercise Diabetic
injuries Phantom neuropathy
*Complex regional pain syndrome. pain

8. Transition to the VHA: Frequency of Dx, OEF/OIF Veterans
Frequenc
Diagnosis (Broad ICD-9 Categories) Percent
y
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
157,823 27.9
(240-279)
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
231,524 41.0
(320-389)
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
300,752 53.2
(710-739) = PAIN
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

9. 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

10. 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

11. 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

12. Courtesy of C. Buckenmaier, MD

13. A New Injury with an Uncertain Course
NERVE INJURY /
SENSITIZATION
TBI BLAST FEAR
COGNITIVE /
BEHAVIORAL
IMPAIRMENTS
PTSD

14. Prevalence of Chronic Pain, PTSD and TBI in a
sample of 340 OEF/OIF veterans
Chronic PTSD
Pain 16.5% N=232
N=277 10.3% 2.9% 68.2%
81.5%
42.1%
6.8%
12.6%
TBI 5.3%
N=227
66.8%
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)

15. “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:

16. THE CONSEQUENCE – PAIN HURTS!
Causalgia (CRPS 2) in artist: Injury Vietnam
Courtesy of N. Wiedemer, CRNP

17. Pain affects the whole person

18. Established (by research) effects of chronic pain
• Quality of life • Psychological / CNS morbidity
– Physical functioning
– Fear, anger, suffering
– Ability to perform
activities of daily living – Sleep disorders
– Ability to work – Cognitive impairments
– Pleasurable activity • Medical consequences
– Accidents
• Social consequences – Medication side effects
– Marital/family relations – Immune function
– Intimacy/sexual activity – Clinical depression / suicide
– Social roles and – Neuroplasticity
friendships
Mismanaged chronic pain is
• Societal consequences
often a personal,
• Health care costs
biopsychosocial catastrophe!
• Disability, lost workdays
….and is a huge public health
• Business failures
• Higher taxes problem.

19. 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

20. Chronification to Maldynia: The Chronic Pain Cycle (Gallagher , Pain Med 2011)
Pathophysiology of Maintenance: Pathology:
- Radiculopathy - Muscle atrophy,
- Neuroma / traction weakness;
- Myofascial sensitization - Bone loss;
- Brain, SC pathology
- Immunocompromise
(atrophy, reorganization)
Central -Depression
Neuro-
Sensitization
psychopathology Acute injury
- Neuroplastic
of maintenance: and pain changes Disability
- Encoded anxiety Less active
dysregulation Kinesophobia
- PTSD Decreased
Peripheral
-Emotional motivation
allodynia Neurogenic Sensitization: Increased
-Mood disorder Inflammation: New Na+ channels isolation
-Cognitive cause lower Role loss
- Glial activation
disorder threshold Sleep disorder
- Pro-inflammatory
- Substance cytokines
abuse - blood-nerve barrier
dysruption
Gallagher RM in Ebert & Kerns 2010

21. 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

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

23. 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

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

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

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

27. 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

28. 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?

29. Managing PAIN in Primary Care:
Issues and Challenges
Brief visits
Complex patients
JCAHO & VHA
Mandate to Little training in
Manage pain pain mgmt /
addictions
Economic Lack of reliable
pressures for pain medicine /
pts to be able to addictionology
work and avoid access
disability
Minimal program
Policies resources (doc-in-
Guidelines box)
Expectations

30. “I medicate first and ask questions later.”

31. 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

32. 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?

33. 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

34. 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.
34

35. Stepped Pain Tertiary Interdisciplinary Pain Centers
Care Advanced diagnostics & interventions
Commission on Accreditation of
RISK
Rehabilitation Facilities accredited pain STEP
rehabilitation 3
Integrated chronic pain and Substance Use
Disorder treatment
Comorbidities
STEP
2
Treatment
Refractory
Patient Aligned Care Team (PACT)
Routine screening for presence & intensity of pain STEP
Post-Deployment Teams 1
Complexity 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 35

36. Organization,
VHA Pain Management Strategy
National Pain Management Office
Robert Kerns PhD, Pam Cremo; Rollin Gallagher MD, Merry Dziewit

37. 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
37

38. 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

39. Pharmacy Pain Medication Management Clinic
Total Clinic Referrals
(47%)

40. Aberrant Outcomes

41. VA Specialty Care Access Network – Extension of
Community Healthcare Outcomes (VA SCAN-ECHO)
"knowledge network, force multiplier, and promotion of chronic disease self-
management." Aurora et al, NEJM 2011
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
41

42. Patient Education Initiatives
• Patient Education Working Group
– Development of Patient/Family
Education Toolkit
• Veteran Education Resource
Coordinators
• MyHealtheVet
42

43. Tertiary care: Evidence-based Continuum Relative proportion
of pain care, by
PM Subspecialties of Patient Centered Care setting
- Neuroremodeling
- Gene therapies (Gallagher, AAPM 2008;
Dubois , Gallagher, Lippe
- Neurostimulation Pain Med 2009) tertiary prevention
- Rehabilitation Centers
Secondary care: Pain Medicine
- Biopsychosocial assessment PAIN
** pain generators, mechanisms SPECIALTY Secondary / tertiary
** perpetuating factors
- - - peripheral, CNS, psychosocial - Practice prevention
- Biopsychosocial Formulation - Training
- Collaborative care models with PCP - Research
Primary care
- Mech. Based Drug Algorithms Primary /
- Stepped Behavioral Medicine Care secondary / tertiary
- Physical Therapies prevention
- Office procedures
- CAM, pain school
Self-care , Community Care Primary / secondary /
- meditation - exercise - tertiary prevention
web-training - social modeling
-social supports
DISEASE MANAGEMENT IN A POPULATION OF PATIENTS IN PAIN

44. ABOVE ALL, MAINTAIN INTELLIGENT AND
INFORMED EMPATHY – BE PATIENT
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