Responsible Prescribing Practices April 10-12, 2012Walt Disney World Swan Resort
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
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 publichealth problem of chronic pain andprescription opioid abuse2. Identify a population-based, patient-centered approach to managing pain in ahealth system and describe “best practice”strategies that can be used by clinicians forpain management treatment as riskmanagement for prescription drug abuse.
What is Pain?To hear about pain is to have doubt; to experience pain is to have certainty. Elaine Scarry, The Body in Pain
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
Transition to the VHA: Frequency of Dx, OEF/OIF Veterans FrequencDiagnosis (Broad ICD-9 Categories) Percent yInfectious and Parasitic Diseases (001-139) 78,869 14.0Malignant Neoplasms (140-209) 6,816 1.2Benign Neoplasms (210-239) 30,053 5.3Diseases of Endocrine/Nutritional/ Metabolic Systems 157,823 27.9(240-279)Diseases of Blood and Blood Forming Organs (280-289) 16,917 3.0Mental Disorders (290-319) 277,112 49.0Diseases of Nervous System/ Sense Organs 231,524 41.0(320-389)Diseases of Circulatory System (390-459) 108,940 19.3Disease of Respiratory System (460-519) 135,699 24.0Disease of Digestive System (520-579) 195,631 34.6Diseases of Genitourinary System (580-629) 73,772 13.1Diseases of Skin (680-709) 107,616 19.1Diseases of Musculoskeletal/Connective System 300,752 53.2(710-739) = PAINSymptoms, Signs and Ill Defined Conditions (780-799) 267,745 47.4Injury/Poisonings (800-999) 149,000 26.4 Cumulative from 1st Quarter FY 2002 through 2nd Quarter FY 2010
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 stress90% survival, battlefield injuries: a) Physical wounds b) Blast injuries and TBI c) Psychological woundsOrganizational 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
A New Injury with an Uncertain Course NERVE INJURY / SENSITIZATION TBI BLAST FEAR COGNITIVE / BEHAVIORAL IMPAIRMENTS PTSD
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/OIFVeterans: 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 PainResearch Unit at Walter Reed, discussing the NEJM articledescribing 350,000 returning troops with mental health problems:
THE CONSEQUENCE – PAIN HURTS! Causalgia (CRPS 2) in artist: Injury VietnamCourtesy of N. Wiedemer, CRNP
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.
Pain has an element of blank. It knows not where it began, orIf 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) Pathophysiology of Maintenance: Pathology: - Radiculopathy - Muscle atrophy, - Neuroma / traction weakness; - Myofascial sensitization - Bone loss; - Brain, SC pathology - Immunocompromise (atrophy, reorganization) Central -DepressionNeuro- Sensitizationpsychopathology Acute injury - Neuroplasticof 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
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
Over 30 years a major shift occurred in the use of opioids for chronic pain1) 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 rehabilitation4) Recognition that: CP is common, damages the nervous system, has major morbidity, and if uncontrolled pain, is a major public health problem5) COT demonstrates efficacy / effectiveness, safety and tolerability in cross-sectional and short-term studies of patients in structured clinical and experimental settings6) Documented dangers of alternatives: NSAIDs, Cox 2, surgery7) Opioid efficacy in neuropathic pain conditions8) 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 pain1) Growing societal expectation of pain relief: Terminal cancer pain (Hospice movement) Pain as 5th Vital Sign in the VA health system JCAHO standards2) 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 pain3) 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 pain4) 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
Over 30 years a major shift occurred in the use of opioids for chronic pain5) 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 rate7) Opioid efficacy in neuropathic pain conditions8) 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?
Managing PAIN in Primary Care: Issues and Challenges Brief visits Complex patientsJCAHO & VHAMandate to Little training inManage pain pain mgmt / addictionsEconomic Lack of reliablepressures for pain medicine /pts to be able to addictionologywork and avoid accessdisability Minimal programPolicies resources (doc-in-Guidelines box)Expectations
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 StrategyObjective 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
Stepped Pain Tertiary Interdisciplinary Pain CentersCare 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
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
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%)
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 2011The 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
Patient Education Initiatives• Patient Education Working Group – Development of Patient/Family Education Toolkit• Veteran Education Resource Coordinators• MyHealtheVet 42
Tertiary care: Evidence-based Continuum Relative proportion of pain care, byPM Subspecialties of Patient Centered Care setting- Neuroremodeling- Gene therapies (Gallagher, AAPM 2008; Dubois , Gallagher, Lippe- Neurostimulation Pain Med 2009) tertiary prevention- Rehabilitation CentersSecondary 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 - ResearchPrimary care- Mech. Based Drug Algorithms Primary /- Stepped Behavioral Medicine Care secondary / tertiary- Physical Therapies prevention- Office procedures- CAM, pain schoolSelf-care , Community Care Primary / secondary /- meditation - exercise - tertiary preventionweb-training - social modeling-social supports DISEASE MANAGEMENT IN A POPULATION OF PATIENTS IN PAIN
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
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