1. Clinical Track:
FDA on Decreasing Opioid Risks and
VA on Exploring Non-Opioid Options
Presenters:
• Robert P. Bianchi, Vice President and Chief of Scientific
and Technical Affairs, Prescription Drug Research
Center
• Michael Saenger, MD, FACP, Lead Physician, Pain
Management, VISN 7, and Director, Empower Veterans
Programs, and Leader, Task Force for Opioid Safety,
Atlanta VA Medical Center
Moderator: Kelly J. Clark, MD, MBA, FASAM, DFAPA,
President-elect, American Society of Addiction Medicine
(ASAM), and Member, Rx Summit National Advisory Board
2. Disclosures
• Robert Bianchi and Michael Saenger, MD, FACP, have
disclosed no relevant, real or apparent personal or
professional financial relationships with proprietary
entities that produce health care goods and services.
• Kelly J. Clark, MD, MBA, FASAM, DFAPA –
Employment: Publicis Touchpoint Solutions;
Consultant: Grunenthal US
3. Disclosures
• All planners/managers hereby state that they or their
spouse/life partner do not have any financial
relationships or relationships to products or devices
with any commercial interest related to the content of
this activity of any amount during the past 12 months.
• The following planners/managers have the following to
disclose:
– Kelly Clark – Employment: Publicis Touchpoint Solutions;
Consultant: Grunenthal US
– Robert DuPont – Employment: Bensinger, DuPont &
Associates-Prescription Drug Research Center
– Carla Saunders – Speaker’s bureau: Abbott Nutrition
4. Learning Objectives
1. Explain a top-down and a bottom-up federal
response to the Rx drug abuse epidemic.
2. Evaluate abuse-deterrent opioids.
3. Advocate a framework for diagnosing and
treating chronic pain that de-emphasizes
opioids.
5. Government and Industry
Response to Rx Abuse
Robert Bianchi
Prescription Drug Research Center -
Chicago, IL
Atlanta GA - April 7, 2015
6. DISCLAIMER
• Robert Bianchi has disclosed no relevant,
real or apparent personal or professional
financial relationships with proprietary
entities that produce health care goods
and services.
7. Learning Objectives
• Government response to the Rx drug abuse
epidemic
• Industry Response to the Rx drug abuse
epidemic
• FDA Guidance to Industry
• In vitro testing to evaluate abuse-deterrent
opioids
8. Current Situation
• CDC has declared Rx abuse as an epidemic. More
americans abuse Rx than cocaine, heroin, inhalants
& hallucinogens COMBINED
• In 2013 approximately 43,982 overdose deaths
occurred, one death every 12 min*
• Of these deaths, 22,767 (51.7%) were attributed to
Rx drug abuse – 16,235 were attributed to opioids
– 6,973 were attributed to benzodiazepines*
*CDC Centers for Disease Control and Prevention. National Vital Statistics System
mortality data. (2015)
9. Insatiable Appetite - 2010
Rx abuse is the fastest growing drug problem in
the United States (5% of world population)
• 65% of the worlds supply of hydromorphone
(Dilaudid)
• 80% of the worlds supply of oxycodone
(OxyContin)
• US consumed 99% of the worlds supply of
hydrocodone (Vicodin)
10. What caused this phenomenon?
• Prescription drugs do not fall under the
clandestine cloud of illegal drugs such as heroin,
ecstasy or methamphetamine
• Prescription drugs are more available due to the
development of new products and increased
prescriptions
• Rx drugs are safe - FDA approved & Dr. prescribed
• Friends and family use them
• Drugs are frequently obtained free of cost
14. Industry Response
• Develop consortium to explore options and
advise FDA
• Develop formulations that deter abuse
• Educate prescribers and patients
• Conduct research to develop new pain
medications
15. Government Response
• Increased monitoring of
– Manufactures
– Distributors
– Pharmacies
– Doctors
• Prescription Drug Monitoring Programs
• DEA “Take Back Program” 309 tons of Rx
medications from nine collection events
• Increased criminal investigations
16. Government Response
• Educational programs and publications for prescribers and
patients
• Requires sponsors to develop REMS
• FDA issued draft guidance to industry in Jan 2013,
describing how to demonstrate if an opioid formulation
contains abuse deterrent properties.
• April 2013 FDA allows labeling concession to Purdue for
reformulated OxyContin (physical or chemical properties
that deter IV and nasal abuse). Original formulation
available 1995-2010
• Encouragement to develop abuse resistant formulations
(ADF)
17. ABUSE DETERRENT OPTIONS
1. Physical/Chemical barriers – Physical barriers can
prevent chewing, crushing, cutting, grating, or
grinding. Chemical barriers can resist extraction of
the opioid using common solvents like water, alcohol,
or other organic solvents. Physical and chemical
barriers can change the physical form of an oral drug
rendering it less amenable to abuse (e.g., reformulated
OxyContin®)
18. ABUSE DETERRENT OPTIONS
2. Agonist/Antagonist combinations – An opioid
antagonist can be added to interfere with, reduce,
or defeat the euphoria associated with abuse. The
antagonist can be sequestered and released only
upon manipulation of the product. For example, a
drug product may be formulated such that the
substance that acts as an antagonist is not clinically
active when the product is swallowed but becomes
active if the product is crushed and injected or
snorted. (e.g., Talwin Nx®, Suboxone, Embeda®)
19. ABUSE DETERRENT OPTIONS
3. Aversion – Substances can be combined to produce
an unpleasant effect if the dosage form is
manipulated prior to ingestion or a higher dosage
than directed is used. (Oxecta oxycodone/niacin)
4. Prodrug – A prodrug that lacks opioid activity until
transformed in the gastrointestinal tract. Can be
unattractive for intravenous injection or intranasal
routes of abuse (e.g. Vyvanse amphetamine).
20. ABUSE DETERRENT OPTIONS
5. Delivery System (including depot injectable formulations
and implants) – Certain drug release designs or the
method of drug delivery can offer resistance to abuse. For
example, a sustained-release depot injectable formulation
that is administered intramuscularly or a subcutaneous
implant can be more difficult to manipulate.
6. Combination – Two or more of the above methods can
be combined to deter abuse.
21. FDA GUIDANCE
The Guidance describes four categories of
recommended studies for supporting and
evaluating claims of abuse-deterrence:
–Premarket studies:
•Laboratory Manipulation and Extraction
Studies (Category 1)
•Pharmacokinetic Studies (Category 2)
•Clinical Abuse Potential Studies (Category
3)
-Post marketing Studies (Category 4)
22. Laboratory Manipulation and
Extraction Studies
Evaluate various simple and sophisticated
mechanical and chemical ways a drug can be
manipulated.
(1) defeating or compromising the controlled release of
an opioid from extended-release formulations
(2) preparing an IR or ER formulation for alternative
routes of administration
(3) separating the opioid antagonist, if present, from the opioid
agonist, thus compromising the product’s abuse-deterrent
properties.
23. Laboratory Manipulation and
Extraction Studies
Evaluate resistance to manipulation
1. Ease of particle size reduction using commonly
available manual tools (spoons, hammer, mortar &
pestle) & electrical appliances (coffee grinder,
blender)
• 2. Effects of heat & cold on manipulation efficiency
24. Coffee mills used to grind tablets
• Shown lids have been used for approx 15 runs each
• Examples on broken blades from two mills
Photos by permission, Egalet, Copenhagen DK, 2010.
25. Laboratory Manipulation and
Extraction Studies
• For a product with potential for snorting, the
particle size distribution should be
established.
• For a product with potential for snorting, the
particle size distribution should be
established, using various tools.
Photo by permission, National Medical Services Laboratories (NMS) 2014
26. Laboratory Manipulation and
Extraction Studies
Evaluate extractability of intact &
manipulated product
1.Commonly available aqueous solvents that have potentially
relevant solvent characteristics (pH, polarity such as water,
alcohol, cola, vinegar, acetone, mineral spirits)
2.Conduct at elevated temperature & room temperature.
3.Conduct on stirred & soaked comparator & ADF
4.Conduct on in tact and ground material
28. SMOKING ABUSE
• For a product with potential for smoking, the
vaporization temperature and degradation
temperature of the opioid in salt and base
form should be determined.
30. INTRAVENOUS ABUSE
• For a product with potential for intravenous
injection, the opioid concentration in a small
injection volume and the viscosity
(syringeability and injectability) of the
injection fluid should be determined.
33. DOSE DUMPING
• The ingestion of alcoholic beverages with
extended release opioids poses serious safety
concerns i.e. uncontrolled immediate release of
drug.
• The FDA now recommends in vitro drug release
studies to determine if alcohol causes enhanced
release of opioid using varying concentrations of
alcohol
35. IN-VITRO EXPERIMENTS
• Develop written protocols that produce statistically valid,
reproducible results.
– Include related comparator product
– Include controls
– Include quality assurance procedures
– All experiments must be conducted at least in triplicate
– Use graphs and charts to illustrate data
– Experiments should be conducted by an independent
laboratory that is blinded to the fullest extent possible in
addition to in house laboratory experiments
– Take photographs to illustrate results
36. IN-VITRO EXPERIMENTS
aka KITCHEN CHEMISTRY
• Every product is different; therefore each requires a unique
set of experiments developed under the standardized tests to
assess tamperability.
• Sponsor knows product’s vulnerabilities and should develop
experiments in concert with abuse experts based on product
knowledge and current abuse methods of similar products
using commonly available chemicals and equipment.
• Standardized laboratory extractions must be developed for
each dosage form, e.g. tablets, capsules, patches, liquids, IR,
SR using solvents & equipment commonly available.
• Consider testing all dosage strengths
37. Summary
• No objective measure exists to measure
tamperability/extractability
• Each product/system requires unique experiments designed
to address vulnerabilities
• Use independent laboratory (NMS) & abuse experts
• Consider all modes of abuse & all strengths
• Include photographs, graphs & charts where appropriate
• No product has addressed multiple pill abuse
• No product has been proven to be tamper proof
38. Thank you
Robert P. Bianchi
Vice-President and Chief
of Scientific and Technical affairs
Prescription Drug Research Center
134 N. LaSalle Street
Chicago, IL 60602
312-726-8620 - Office
571-233-4780 – Cell
RBianchi@pdrcllc.com
RBConsulting700@AOL.com
40. Conflicts of Interest
• Michael Saenger, MD, FACP, has disclosed no
relevant, real or apparent personal or
professional financial relationships with
proprietary entities that produce health care
goods and services.
• Biases toward:
– Bio-psycho-social-spiritual framework of Health
– Self-empowered care
– Evidence Based Practice (EBP)
– Systems of care / Team-based care
• Patient Centered Medical Home
– Model for Improvement
• Changing, and testing to see if it is improvement
41. Learning Objectives
• Discuss how to apply a “Whole Health”
Framework i.e. Bio-Psycho-Social-Spiritual Model
of Chronic Pain rather than Bio-Medical one
• Review how to become a “Coach” for
Collaborative Self-Management and draw out the
Client’s Internal Motivation for Change
• Review how to apply “Retraining the Brain” /
“Neuroplasticity” Model to chronic pain
management.
43. Mindful Moment,
IF You Feel Safe AND Choose To, Then:
• Practice of self-care
– Release tension in your muscles… through
Gently rolling your shoulders…
– Activate “Relaxation Response” through
Slowing and deepening your breathing
44. Client Scenario 1
35 year old woman with chronic pelvic pain is crying
in the exam room. She has already been told by a
Gynecologist and a Gastroenterologist that her
ultrasounds and scopes are normal.
Healthcare Team recommends:
A. Converting oxycodone IR to fentanyl patch
B. Adding alprazolam prn
C. Ordering MRI of pelvis
D. Understanding her goals and
more about her as a whole person
45. Client Scenario 2
30 year old man with phantom limb pain
“cannot sleep because of the pain”.
Healthcare Team recommends adding:
A. Zolpidem
B. Pregabalin
C. Topiramate
D. Mirror Therapy
46. Historical Swing
• From: “Not much we can do”, besides:
– TLC
– Grandma’s chicken soup
– Prayer
• To: Many new choices of:
– Pharmaceuticals and
– Procedures
47. “Find it and Fix it”
• “Reductionistic Science” Model
– Produces many advances in
• Diagnosis
• Therapy
– May miss complexity of Whole
48. Story of Pelvic Pain
• “Usual Care” = “Bio-Medical Model”
– Chief Complaint drives
• Subspecialty referral
(for “Diseased Part”) and
• Differential Diagnosis with
– Life threatening illnesses excluded with
» Advanced testing…
• Symptom management with
» Poly-pharmacy
53. Chronic Pain ≠ Acute Pain
Acute Pain, usually:
• Transient
• Simple
• Bio-Medical cause
• Curable
Complex Chronic Pain, usually
• Long lasting
• Complicated
• Bio-Psycho-Social-Spiritual
• Manageable, not curable
54. Chronic Pain often Driven by:
• Stress and Poor Coping Skills
• Deconditioning
• Central Sensitization
• Anxiety
• Depression
• Substance Use Disorder
– including Opioid Use Disorder
• Note that Sleep may be disrupted
by any of these
55. Whole Person Perspective
Explains Gap between
Objective Evidence and Subjective Pain
Modified from VA VISN 20 Chronic Pain Education for Providers;
Anthony Mariano, PhD; Used with Permission
56. What is “REAL” Pain?
• “Pain” is what the Client says it is
• “Psycho-social pain” is “Real” pain
– But enabling “Chemical Coping”
worsens whole person problems
57. Break the Cycle of Frustration
Modified from VA VISN 20 Chronic Pain Education for Providers;
Anthony Mariano, PhD; Used with Permission
58. Bio-Psycho-Social-Spiritual Model
Affects How to Diagnose Chronic Pain
• Initial thorough H&P and a few tests
• Assessments for
– Anxiety
– Depression
– Substance Use Disorders,
• including Opioid Use Disorder
• NOT additional CT/MRI… until
“real” “pain-generator” image captured
60. Complex Chronic Pain
Diagnostic Clues:
• “Enigmatic” presentations to multiple PCPs
• Declining function over time
• Severe emotional distress and disability
not responding to conventional treatments
• Significant dissatisfaction with medical care
Modified from VA VISN 20 Chronic Pain Education for Providers;
Anthony Mariano, PhD; Used with Permission
62. Collaborative Self-Management
• Chronic Care Model
• Primary Goal:
– NOT urgent nor complete pain relief
– Reduce suffering and disability
• Role of Healthcare Team
– Enhancing adaptive choices
Modified from VA VISN 20 Chronic Pain Education for Providers;
Anthony Mariano, PhD; Used with Permission
63. Collaborative Self-Management
• Values Clients as people
– Identifies Functional Goals
– Supports addressing other life problems
• Challenges dysfunctional beliefs
Modified from VA VISN 20 Chronic Pain Education for Providers;
Anthony Mariano, PhD; Used with Permission
64. Reframing Pain
Modified from VA VISN 20 Chronic Pain Education for Providers;
Anthony Mariano, PhD; Used with Permission
65. “What do you want your Health for?”
• Re-centering
– Rather than: “On a scale of 0-10…?”;
• Moving from passive to active role
– Quarterback
• Drawing out intrinsic motivation for change
Tracy Gaudet, MD; VHA Office of Patient Centered Care and Cultural Transformation
66. Model of
Proactive Health and
Well-being
VHA Office of
Patient Centered Care and
Cultural Transformation;
Tracy Gaudet, MD, Director;
Used with permission
Circle of Health; What is:
- In balance?
- Out of balance?
67. VEMA Process
• Validation
– “We believe you have real pain”
• Education
– Shared model
• Motivation
– Enhanced: “Motivational Interviewing”
• Activation
– Offering new way to react to pain
Modified from VA VISN 20 Chronic Pain Education for Providers;
Anthony Mariano, PhD; Used with Permission
68. “What you do
is more powerful
than any pill”
[or what is done to you]
Tracy Gaudet, MD; VHA Office of Patient Centered Care and Cultural Transformation
69. Facilitating Motivation
• Pre-contemplation
• Contemplation
• Preparation
• Action
• Maintenance
• Relapse
• Challenge false beliefs
• Explore change
• Assist in “Action Plan”
• Reinforce adaptive action
• Reinforce gains; adjust goals
• Explore reasons;
reassess readiness to change
Modified from VA VISN 20 Chronic Pain Education for Providers;
Anthony Mariano, PhD; Used with Permission
70. Roll with Resistance
• Avoid arguments
• “Yes… and…”
– Reflect back Client’s concerns
– Reframe the problem, avoiding false “dualism”
– Acknowledge difficulty
– Emphasize autonomy and responsibility
Modified from VA VISN 20 Chronic Pain Education for Providers;
Anthony Mariano, PhD; Used with Permission
72. Making Health Plan
• Responsibility for change is theirs
• Begin with small goals
• Start with social/recreational reactivation first
• Physical reactivation ≠ PT which “didn’t work”
– Encourage, “Think like an athlete”
Modified from VA VISN 20 Chronic Pain Education for Providers;
Anthony Mariano, PhD; Used with Permission
74. Setting a Goal
SMART Examples:
• Walk in place for 5 minutes
before each meal
• Practice 3 minutes of slow
deep “belly” breathing at 10
and 2 each day
Not so smart examples:
• Get more exercise
• Relax more
75. Follow-up
• Inquire about progress towards goals
• Identify barriers
• Minimize focus on urgent pain relief
• Help establish new goals
• “You know you’re providing high quality pain care when
you spend very little time talking about pain”
Modified from VA VISN 20 Chronic Pain Education for Providers;
Anthony Mariano, PhD; Used with Permission
76. Prepare for “Bad Days”
• Exacerbations are “predictable ebb and flow”
of chronic pain
• Stress may precipitate Bad Day
– “Be prepared”
– “Be proactive”
Modified from VA VISN 20 Chronic Pain Education for Providers;
Anthony Mariano, PhD; Used with Permission
77. We all can be Good “Therapists”,
Using “3 P’s”
• Pause: Relaxation Response
– When “Foaming in” or…
• Be Present: Attentive
– When “Crossing Threshold”
• Then Proceed
– With Whole Health Care
– Including those skills of our particular profession
http://www.fammed.wisc.edu/mindfulness/pip/pause
78. Roles for Primary Care Team:
• Affirming Client’s
– Worth (their story; their significance)
– Innate strengths to move toward Health
• Side-stepping non-value added care, which is:
– No better than standard care (or harmful or …)
– Passive
• Offering
– Motivational Enhancement
– Safe and effective options which promote Health
79. Using Re- Education in
Neuropsychology: “Re-Train the Brain”
The Hunter Group; used with Permission: http://www.youtube.com/watch?v=4b8oB757DKc
80. That to which we give
attention, grows!
“Neurons that fire together, wire together”
Donald Hebbs; “The Theory of Hebbian Learning”
81. From Where is Pain Coming?
Walter Reed Medical Center; http://www.youtube.com/watch?v=YL_6OMPywnQ
82. Re-Training the Nervous SystemStrainonBody
Tissue Damage
Graphic thanks to Neil Pearson, Jennifer Gansen and others
Sensitized
Nervous System
Alarm
Desensitized
Nervous System
Alarm
Deconditioned
Exercise Capacity
Reconditioned
Exercise Capacity
83. Neil Pearson’s “Exercise Guidelines”
for Stretching or Exercising
1. Go to “the Edge” for particular exercise;
2. Ask 2 questions
a. Am I safe? (if “yes”, then)
b. Will I pay for this later? (if “no”, then)
3. While at “the Edge”, keep
a. Body calm
b. Breathing calm
c. In touch with pain (not too much nor too little)
http://www.youtube.com/watch?v=gN-WwxfPIZo Modified; Used with Permission
84. Mindfully Aware
• I (We) cannot do:
– Everything
– Everything today
• I (We) can:
– Play significant role as Coach
– Educate re: range of safe and effective options
85. Collaborating with Other Coaches
Who Excel in:
• Motivational Enhancement
• Assessment and therapies for:
– Psychological care
– Movement needs
– Existential/Spiritual care
– “Biological” and other needs
86. Re-Framing our Care
FROM: TOWARDS:
Bio-Medical Model Bio-Psycho-Social-Spiritual Model
Symptom-driven Seeking Deeper Meaning / Values
Provider-driven Coaching / Motivational Enhancement
“Pharmaceuticals & Procedures” Activating Innate Healing
"Done to you" "You do"
Reactive Proactive / Reflective and Aware
1:1 Appointments Group Education and Support
88. Client Scenario 1
35 year old woman with chronic pelvic pain is crying
in the exam room. She has already been told by a
Gynecologist and a Gastroenterologist that her
ultrasounds and scopes are normal.
Healthcare Team recommends:
A. Converting oxycodone IR to fentanyl patch
B. Adding alprazolam prn
C. Ordering MRI of pelvis
D. Understanding her goals and
more about her as a whole person
89. Client Scenario 2
30 year old man with phantom limb pain
“cannot sleep because of the pain”.
Healthcare Team recommends adding:
A. Zolpidem
B. Pregabalin
C. Topiramate
D. Mirror Therapy
91. Web Resources
Chronic Pain Overview for Clients
• Understanding Pain: What to do about it in Less than Five Minutes
http://www.youtube.com/watch?v=4b8oB757DKc
https://www.youtube.com/watch?v=MI1myFQPdCE
https://www.youtube.com/watch?v=jIwn9rC3rOI
• Low Back Pain – Mike Evans
http://youtu.be/BOjTegn9RuY
• Four Flat Tires – American Chronic Pain Association
http://www.theacpa.org/a-car-with-four-flat-tires
92. Web Resources
Deep Breathing & Exercise for Clients
• Deep Breathing Exercise for Relaxation Response: Breathe2Relax-Demo
http://www.youtube.com/watch?v=YdsipKCACac
• Neil Pearson’s Exercise Guidelines
http://www.youtube.com/watch?v=gN-WwxfPIZo
• Leslie Sansone (first 5 minutes) Starting Walking at Home
http://www.youtube.com/watch?v=ykPr0t2KutY&feature=youtu.be
93. Web Resources
Motivational Story for Clients
• Never, Ever Give Up. Arthur's Inspirational Transformation!
http://www.youtube.com/watch?v=qX9FSZJu448
94. Other Web Resources for Clients
• The American Chronic Pain Association
http://theacpa.org/
• Conditions A to Z
http://theacpa.org/conditions
• Communication Tools (self rating logs…)
http://theacpa.org/Communication-Tools
• Mirror Box Therapy
http://healthskills.wordpress.com/2009/03/05/youtube-mirror-box-
videos/
95. Web Resources for Clinicians
• “Paths to Recovery” / “Retraining the Nervous System”; Neil Pearson
http://www.lifeisnow.ca/
• The American Chronic Pain Association
http://www.theacpa.org/
96. Other References
• The Pain Survival Guide: How to Reclaim Your Life. Turk. American
Psychological Association 2005
• Pain Management for Older Adults – A Self-Help Guide. Hadjistavropoulis.
International Association for the Study of Pain. 2008
97. What CAM to offer?
i.e. Integrative Health Therapy Options
• Complementary Medicine options for cLBP
– “Bridge” – useful short term
• Massage
• Spinal Manipulation
• Acupuncture
– “Active” – Client learns self management tools
• Alexander technique – “retrain the brain”
• Mindfulness – non-judgmental acceptance
• Yoga, Tai Chi ... movement training like Alexander
http://www.psychiatry.org/practice/professional-interests/addiction-psychiatry/learning-the-evidence-behind-alternative-complementary-chronic-pain-management---
emphasis-on-chronic-low-back-pain----part-two
http://www.psychiatry.org/practice/professional-interests/addiction-psychiatry/learning-the-evidence-behind-alternative-complementary-chronic-pain-management-
emphasis-on-chronic-low-back-pain----part-one
99. Transition To
Away from therapies:
Dangerous
Ineffective
Passive
Towards therapies:
Safe
Moderately effective
Self-efficacious
Deep Breathing
Relaxation
Alexander Technique
Yoga / Tai Chi
Mindfulness
100. “Bridging Therapies”
For Those Needing Temporary Help
Away from therapies:
Dangerous
Ineffective
Passive
Towards therapies:
Safe
Moderately effective
Self-efficacious
Saenger, APA PCSS-O Webinars, Evidence for CAM for Chronic LBP,
parts 1&2, 2013;
Saenger, American Chronic Pain Association Chronicle, June 2013;
Heckman, Heckman, Saenger and Marconi, HIV Specialist, Dec 2013
Temporary “Bridging” Therapies
E.g. while tapering opioids; Using
Acupuncture or
Spinal Manipulation or
Massage
101. Goal: Thriving Self-Management
Towards therapies:
Safe
Moderately effective
Self-efficacious
Deep Breathing
Relaxation
Alexander Technique
Yoga / Tai Chi
Mindfulness
103. Building Collaborative Relationship
• Set realistic expectations during initial meeting
• Take their concerns seriously
• Acknowledge their frustration with prior tx
• Listen to their story, not just their symptoms
• Express empathy for urgent pain relief
• Recognize current situation is unacceptable
• Commit to the relationship
Modified from VA VISN 20 Chronic Pain Education for Providers;
Anthony Mariano, PhD; Used with Permission
104. Personal Meaning of Pain
• Disabling beliefs
• Psychosocial factors
• Factors maintaining pain
• Factors influencing medical utilization
• How is person currently managing?
• How ready is the person for self-management?
Modified from VA VISN 20 Chronic Pain Education for Providers;
Anthony Mariano, PhD; Used with Permission
105. Story of Pelvic Pain, Revisited
• “Model of Illness”
• “What do you believe is:
– Causing this _____?
– Going to happen?
– Needed to find this?
– Needed to manage this?
106. “Draw me your story”
• Consider “homework” of one page drawing
“My Life”
Pain (1)
Began
Pain (1)
Worsened
Significant
Life Event 1
Significant
Life Event 2
107. Special Thanks to:
• “Tony” Mariano, PhD;
– VHA VISN 20
• Tracy Gaudet, MD;
– VHA Office of Patient Centered Care and Cultural Transformation
• “Mac” Gallagher, MD;
– VHA National Director for Pain Management
• Neil Pearson, MSc, BScPT, BA-BPHE, Cert MDT;
– Life is Now
• Ilene Robeck, MD;
– VHA VISN 6
• Anne Tomolo, MD, MPH;
– Atlanta VA National Quality Scholars Program
• Nadine Kaslow, PhD;
– American Psychological Association; Grady Health System; and Emory University
108. Clinical Track:
FDA on Decreasing Opioid Risks and
VA on Exploring Non-Opioid Options
Presenters:
• Robert P. Bianchi, Vice President and Chief of Scientific
and Technical Affairs, Prescription Drug Research
Center
• Michael Saenger, MD, FACP, Lead Physician, Pain
Management, VISN 7, and Director, Empower Veterans
Programs, and Leader, Task Force for Opioid Safety,
Atlanta VA Medical Center
Moderator: Kelly J. Clark, MD, MBA, FASAM, DFAPA,
President-elect, American Society of Addiction Medicine
(ASAM), and Member, Rx Summit National Advisory Board