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Responsible Prescribing PracticesNational Rx Drug Abuse Summit 4-11-12TRANSCRIPT
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
Over 30 years a major shift occurred in the use of opioids for chronic pain
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)
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
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
Over 30 years a major shift occurred in the use of opioids for chronic pain
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