Chronic, Non-Terminal Pain: Ethics and Risk
Management at the Family Medicine Residency
Program
Rachel Franklin, M.D.
Professor, Medical Director
rachel-franklin@ouhsc.edu
Office Phone: 405 271-4224
@yourfamilydoc
8th Annual Bioethics and Palliative Care
Conference
Conflict of Interest
Under Accreditation Council for Continuing Medical Education
guidelines disclosure must be made regarding financial relationships
with commercial interests within the last 12 months.
Rachel Franklin, M.D.
I have no financial relationships or affiliations to disclose.
Learning Objectives
Upon completion of this presentation, participants should be
able to:
1. Identify the ethical and medico-legal issues related to the
treatment of chronic, non-terminal pain.
2. Create a patient-centered and goal-directed chronic pain
management regimen.
3. Organize the evaluation and management of patients with
chronic pain, including follow up care.
4. Identify and manage barriers to effective pain control
through integrated interprofessional care teams.
The Clinical Challenge
• NIH/IOM: effective pain management is
– “Moral imperative”
– “Professional responsibility”
– “Duty of people in the healing professions”
• Pain versus “suffering”
• LITTLE good evidence; plus…
–
–
–
–
Plenty of pain “procedurists”
Few pain “management” specialists
Poor training of primary care providers
Poor access to multidisciplinary care of “suffering”
Source: Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education and Research. The National
Academies Press, 2011.
Background: The Burden of Pain
100
Million Americans
75
50
25
0
Chronic Pain
Diabetes
Coronary Heart
Disease
Stroke
Cancer
Chronic Health Condition
Sources:
Institute of Medicine Report from the Committee on Advancing Pain Research, Care, and Education: Relieving Pain in America, A Blueprint for Transforming Prevention,
Care, Education and Research. The National Academies Press, 2011. http://books.nap.edu/openbook.php?record_id=13172&page=1.
American Diabetes Association http://www.diabetes.org/diabetes-basics/diabetes-statistics/
Heart Disease and Stroke Statistics—2011 Update: A Report From the American Heart Association. Circulation 2011, 123:e18-e209, page 20.
http://circ.ahajournals.org/content/123/4/e18.full.pdf
American Cancer Society, Prevalence of Cancer http://www.cancer.org/docroot/CRI/content/CRI_2_6x_Cancer_Prevalence_How_Many_People_Have_Cancer.asp
Background: The Spectrum of Pain
• Disability
– Low Back Pain leading cause in <45 y/o
– 26M in U.S. 20-64y/o report frequent LBP
• Lost productivity
– “In past 2 weeks:” 12.7% lost production time
– Workers lose 4.6 hrs/wk due to pain
– $61.2B due to lost production time
– 76.6% due to reduced work performance
Sources: National Centers for Health Statistics, Chartbook on Trends in the Health of Americans 2006, Special Feature: Pain.
http://www.cdc.gov/nchs/data/hus/hus06.pdf. Accessed 11/20/13 and Results from the American Productivity Audit.
http://www.ncbi.nlm.nih.gov/pubmed/14665809
Accessed 11/20/13
Background: The Costs of Pain
• Pain changes life trajectory
–
–
–
–
20% took disability
17% change jobs
13% require help with ADLs
13% moved to new home
• Patients seek relief
–
–
–
–
63% saw Family Doctor (that’s ~63 million people)
40% saw specialist
25% saw chiro
38% saw more than one provider
Source: Peter D. Hart Research Associates. Page 3. KEY FINDINGS. Americans in Pain. Much of America is hurting:
http://www.researchamerica.org/uploads/poll2003pain.pdf Accessed 11/20/13
Top Five Prescription Drugs Sold in
U.S.
Prescribing: Out of Control?
Source: CDC http://www.cdc.gov/vitalsigns/opioid-prescribing/infographic.html
Prescribing: Out of Control?
Source: CDC http://www.cdc.gov/vitalsigns/opioid-prescribing/infographic.html
Drug Overdose Deaths Compared to
Other Accidents
Sources: “Prescription Painkiller Overdoses in the US.” CDC Vital Signs, November 2011
http://www.cdc.gov/vitalsigns/PainkillerOverdoses/;
Opioid Overdose Deaths Compared
to Other Drugs
Sources: “Prescription Painkiller Overdoses in the US.” CDC Vital Signs, November 2011
http://www.cdc.gov/vitalsigns/PainkillerOverdoses/;
Pregnancy and Neonatal Period
• 55-94% of exposed neonates will develop
NAS
• Maternal detox increases fetal distress/fetal
loss
• Methadone worse than heroin
Sources: Neonatal Abstinence Syndrome and Associated Health Care Expenditures, United States 2000-2009.
JAMA. 2012;307(18):1934-1940. doi:10.1001/jama.2012.3951 accessed online at
http://jama.jamanetwork.com/article.aspx?articleid=1151530 November 20, 2013
Hudak, ML and Tan, R. Neonatal Drug Withdrawal. Pediatrics 2012; 129;e540 www.pediatrics.aappublications.org Accessed
from Bird Library 2/28/13
Pregnancy and Neonatal Period
• 2000-2009: neonatal abstinence syndrome (NAS)
triples
• 2009 - 3.4:1,000
• Length of stay: 1 week-2 months
• Hospital Charges average $53,400 (77.6% Medicaid)
• Risks
–
–
–
–
Respiratory distress syndrome (30.9% vs. 8.9%)
Low birth weight (19.1% vs. 7.0%)
Feeding difficulty (18.1% vs. 2.8%)
Seizure (2.3% vs. 0.1%)
Source: Neonatal Abstinence Syndrome and Associated Health Care Expenditures, United States 2000-2009.
JAMA. 2012;307(18):1934-1940. doi:10.1001/jama.2012.3951 accessed online at
http://jama.jamanetwork.com/article.aspx?articleid=1151530 November 20, 2013
Nonmedical Use of Painkillers
• 7 million Americans (2.7%)
• 1 in 12 Oklahomans (#1 in nation)
• High school seniors:
– 1:12 Vicodin
– 1:20 OxyContin
– 70% obtained from family or friend
Sources: “Prescription Painkiller Overdoses in the US.” CDC Vital Signs, November 2011
http://www.cdc.gov/vitalsigns/PainkillerOverdoses/; Fact Sheet on Prescription Drug Abuse, Misuse and Consequences
Among Oklahoma (sic). Oklahoma Department of Mental Health and Substance Abuse Services.
http://ok.gov/odmhsas/documents/PR%20RxAbuse-FactSheet.pdf ;
Oklahoma is OK?
• #1: illicit use of prescription pain meds (all age
categories)
• #9: overdoses due to prescription pain meds
• Top ten: Kilos of prescription painkillers per
10,000
• Top five: prescriptions painkillers per person
(1.28)
Sources: “Prescription Painkiller Overdoses in the US.” CDC Vital Signs, November 2011
http://www.cdc.gov/vitalsigns/PainkillerOverdoses/; Fact Sheet on Prescription Drug Abuse, Misuse and Consequences
Among Oklahoma (sic). Oklahoma Department of Mental Health and Substance Abuse Services.
http://ok.gov/odmhsas/documents/PR%20RxAbuse-FactSheet.pdf ; Automation of Reports and Consolidated Orders System
(ARCOS) of the Drug Enforcement Administration (DEA), 2010
The Challenges – Patient Factors
• Sociocultural
– Blacks: bias prevents adequate treatment
– Whites: more likely to OD
– Youth: highest OD risk age 26-35
• Noncompliance
– Non-opiate: approaches 90%
– Opiate: over, rather than underuse
• Failure to disclose
– Alcohol
– Illicit drugs
The Challenges – Patient Factors
• Unrealistic expectations
– Opioids always = pain relief
– More opioids = more relief
– “I need more pain medicine”
• Potential for harm:
–
–
–
–
–
Overdose
Loss of function
Hyperalgesia
Hypogonadism
Osteoporosis
Sources: REMS strategy for rational pain control. www.scopeofpain.com
The Challenges – System Factors
• Time limitations
• Patient expectations/satisfaction drive compensation
• Provider
–
–
–
–
Lack of education
Wrong focus: pain versus function
Lack of oversight/patient education
Bias
• Process
– Staff education
– Clinical guidelines
– Patient flow management
The Challenges – Results
• Undertreatment
• Wrong treatment
– Underutilization of non-pharmacologic therapies
– Overutilization of opiates rather than non-opiates
– De-emphasis of patient autonomy/responsibility
• Accidental death
– 2012: 534 in Oklahoma
– Half took meds prescribed by their own doctors
The Challenges – Results
The Charge
• Develop standardized, evidence-based
curriculum for evaluation of chronic pain
• Create clinical environment within which to
deliver curricular care to patients
• Vision: OB intake/followup
• Resources: LEAN/Six Sigma team, faculty,
residents and staff
Source: Charge to the Chronic Pain Curriculum Committee, Steven Crawford, M.D.
Committee Members:
Rachel Franklin, M.D. – committee chair
Kalyanakrishnan Ramakrishnan, M.D.
Audra Fox, M.D.
Bryan Billings, M.D.
Chris Shadid, M.D.
Reuben Walia, M.D.
Annette Prince, J.D., LCSW
Cynthia Thomas, MSW, LCSW
Sherrie Moser, patient advocate
Ex-Officio: Steven Crawford, M.D. and
James Barrett, M.D.
Findings: Fundamentals
• Patient as the center of care
–
–
–
–
Include patient in care plan
Assess understanding of condition
Educate regarding illness at every visit
Overall goal: empower patient, set realistic
expectations
• Quantify pain
– Written instruments are essential
– History must be standardized
– Watch for pain “generators” – other factors that
influence pain experience
Fundamentals
• Identify yellow/red flags early
– Red flags: potentially serious cause present
• Cancer
• Infection
• Autoimmune disease
– Yellow flags: adverse prognostic indicators
• Age
• Unemployment/disability/work comp/litigation
• Severity of presenting symptoms compared with
findings
Fundamentals
• Treatment is a negotiation
–
–
–
–
–
Goal: relief sufficient to improve function
Mechanism-based treatment plan
Multimodal non-opiate therapy is first
Complementary therapies must be used as appropriate
Opiate treatment is a trial of therapy (communicate!)
• Opiates not appropriate for every patient!
• Focus on function, not pain
– Physical function
– Effect on biopsychosocial factors
Fundamentals
• Account for culture/gender differences
– AA have more trouble accessing care
– AAF>CF to present with “severe” pain
– Whites more likely to OD
– Nonverbal cues can mislead
• Symptom magnification
• Symptom denial
– Identify/reduce miscommunication and bias
Fundamentals: The Treatment Plan
• Individualized
– Understand mechanism
– Understand patient risk profile
– Understand/negotiate patient goals
• Pain tolerability – NOT “pain free”
• Improved physical/psychosocial function
– Realistic expectations
• Patient responsibilities – PT, others
• Physician options/limitations
Fundamentals: The Treatment Plan
• Measurable
– Pain disability index
– Quality of life/functional performance scores
• Monitored – set follow up goals
– More studies?
– Non-opioid treatments?
– Other modalities?
•
•
•
•
Trigger point injection
PT
Osteopathic manipulation
Interventional therapies/surgery
• Opioids are a “trial”
Fundamentals: Emphasis
• Objectivity
– Measure function rather than pain level
– Display function over time to patient
• Balance risk:benefit
– Patient risk level
– Risk of medicine/adverse effects
• Target likely mechanism
EMR Templates
Conduct of the Visit/Presentation
•
•
•
•
History
Prior studies/results
Prior treatment/results
Patient perception of pain
– What’s causing it?
– What bothers them most about it?
– What do they fear about it?
– What are their goals?
Conduct of the Visit/Presentation
• Patient’s goals for care
– Identify expectations
– Prepare for, but don’t start, negotiation
• Mental health evaluation
– History of mental illness
– Any psychotropic meds/anxiolytics?
• Biopsychosocial evaluation
– Limitations on access to care/compliance
– Stressors
– Family support
Conduct of the Visit/Presentation
• Physical examination
– General health
– Comprehensive exam of affected area
•
•
•
•
Neurologic
Musculoskeletal
Vascular
Other as indicated (trigger points?)
• Review of available studies
– Are more needed?
– Is referral needed for diagnostic evaluation?
Conduct of the Visit/Presentation
• Determine pain etiology
–
–
–
–
Inflammatory: RA, OA, SLE
Neuropathic: neuropathies, radiculopathies, CVA/MS
Mixed
Functional
• Determine nature of maladaptive pain
– Peripheral sensitization
– Central sensitization
• Determine biopsychosocial comorbidities – is
multidisciplinary care needed/available?
Risk Factor Assessment
• Based on patient completed self-assessment
– Opiate Risk Tool
– CAGE-AID questionnaire
• Adjustable based on prior knowledge
• Scores place patient in risk category
– Low – appropriate for our practice
– Intermediate – appropriate with additional support
– High – refer to pain management
Risk Stratification
• Anxiolytics
• High risk medicines
– Methadone
– Suboxone
– High dose opioids
The Agreement
• Required for all FMC patients on chronic
opioid therapy
• Informed consent document
– Risks/benefits of medicine
– When to notify provider
– Mutual responsibilities
• Must be renewed with new provider
Urine Drug Screening
• Required for intermediate risk patients
– At first prescription
– Randomly: up to 2 times per year
– At suspicion of trouble – team lead nurse authorized
to order (standing orders)
• Is it covered?
– Yes
– Best diagnosis: V58.69 (long-term [current] use of
other medication)
– Caveat: new Medicaid guidelines
Urine Drug Screening
• Standard screen (~$50)
– Reliable for morphine, codeine, heroin, drugs of
abuse
– Unable to detect oxy/hydrocodone, methadone,
fentanyl, buprenorphine, tramadol
– Do not use for therapeutic monitoring
• Comprehensive screen
– Not done at point of care
– 4 times the cost ~($200)
– May limit access to care for uninsured patients
Urine Drug Screening
• Use screen to:
– Confirm treatment compliance
– Confirm absence of illicit/non-prescribed drugs
– Reinforce risk/benefit discussion with patient
Source: Standridge J, Adams A and Zotos A. Urine Drug Screening: A Valuable Office Procedure.
Am Fam Physician 2010 Mar 1;81(5):635-640 http://www.aafp.org/afp/2010/0301/p635.html
Accessed 1/18/13
Urine Drug Screening – Unexpected
Results
• GC/MS MS
• Med review is mandatory – before UDS done
• False positives - examples
– Amphetamine: SSRI, decongestants,
promethazine
– Benzodiazepine: sertraline
– Opiates: dextromethorphan, diphenhydramine,
fluoroquinolones, verapamil
– THC: NSAIDs, pantoprazole (Protonix)
Follow Up
• Low risk: 3-4 months or with routine comorbid
conditions
– OBNDD report review
– UDS if indicated
• Intermediate risk: monthly or more often, then
individualized
– OBNDD report review
– UDS routinely and as indicated
– Consider pill counts
Workflows
• Refills
– OBNDD review, last and next visit, compliance
– Attending checks prior to authorizing
• Office visits
–
–
–
–
Scheduling “hot words”
2 day chart check: OBNDD, EMR templates
Check in: EMR template, nurse reviews last dose
Check out: confirm agreement, flag in EMR
Discussing Continued Lack of
Benefit
•
•
•
•
•
Empathize, empathize, empathize
Express your frustration
Focus on patient’s strengths
Encourage coping strategies
Commit to continued care for patient and pain,
even without opioids
• Schedule close follow ups
Source: REMS strategy for rational pain control. www.scopeofpain.com
Phase 2
• Hiring second LCSW/LADC for clinic
integration
– Goals
– Reimbursement
• Pfizer grant: if awarded
– Support second LCSW/LADC beyond initial grant
– Add RN patient navigator
• Disseminate best practices
Conclusion and Clinical Pearls
• Effective treatment of chronic pain is our duty
• Opiate misuse/abuse is a deadly epidemic
• Treatment goal: improved function despite
pain
• Standardizing clinic process improves care
– Standardized histories, status assessments
– PMP reports, UDS, contracts
• Not all treatment failure is patient’s “fault”
• Not all pain can be managed in primary care