Rx15 clinical tues_200_1_bianchi_2saenger

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

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

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

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.

Government and Industry Response to Rx Abuse

Robert BianchiPrescription Drug Research Center -

Chicago, ILAtlanta GA - April 7, 2015

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.

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

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)

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)

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

Contributing Causes

Doctor Shopping

Over prescribing

Stolen or forged prescriptions

Pharmacy thefts

Internet pharmacies

Pain clinics

Pain Clinic aka Pill Mill

Pill Mill seizure

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

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

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)

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®)


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®)


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).


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.

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)

Laboratory Manipulation and

Extraction StudiesEvaluate 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 alternativeroutes of administration

(3) separating the opioid antagonist, if present, from the opioidagonist, thus compromising the product’s abuse-deterrentproperties.

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

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.


• 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


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 & ADF4.Conduct on in tact and ground material

Extractability


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.

SMOKING APPARATUS


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.

INJECTABILITY

Photos by permission, Egalet, Copenhagen DK, 2010.

INJECTABILITY


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

DOSE DUMPING


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

IN-VITRO EXPERIMENTSaka 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

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

Thank you

Robert P. BianchiVice-President and Chief of Scientific and Technical affairsPrescription Drug Research Center134 N. LaSalle StreetChicago, IL 60602312-726-8620 - Office571-233-4780 – Cell [email protected]@AOL.com

Reframing Medical Home Team’s

Diagnosis and Treatment of Complex Chronic Pain

Michael Saenger, MD, FACPRx Drug Abuse Summit

April 7, 2015

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

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.

That to which we give

attention, grows!

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

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

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

Historical Swing

• From: “Not much we can do”, besides:

– TLC

– Grandma’s chicken soup

– Prayer

• To: Many new choices of:

– Pharmaceuticals and

– Procedures

“Find it and Fix it”

• “Reductionistic Science” Model

– Produces many advances in

• Diagnosis

• Therapy

– May miss complexity of Whole

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

Opioids

Symptom/

Disease

Focused

Care

ObesityLBP

Depression

AnxietyGERD

Neuropathy

Insomnia

HA

Appetite

Suppressant

SSRI

Benzodiazepine

PPI

Gabapentinoid

Z Drug

Triptan$$

$Modified from VHA Office of Patient Centered Care and Cultural Transformation; Tracy Gaudet, MD, Director; David Rakel, MD, US Director of Whole Health Clinical Education Program; Used with Permission

“The greatest barrier to discovery

is not ignorance

but the illusion of knowledge.”

David Borstein

The Cycle of Chronic Pain in the Clinic

Modified from VA VISN 20 Chronic Pain Education for Providers; Anthony Mariano, PhD; Used with Permission

Re-Framing

“All models are wrong, some are useful.”

George E. P. Box

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

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

Whole Person Perspective Explains Gap between

Objective Evidence and Subjective Pain


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

Break the Cycle of Frustration


Bio-Psycho-Social-Spiritual ModelAffects 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

Bio-Psycho-Social-Spiritual ModelAffects How to Diagnose Chronic Pain

• Hear the Client’s Life Story

• Gather detailed Social History

Complex Chronic PainDiagnostic 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


Bio-Psycho-Social-Spiritual ModelAffects How to Treat Chronic Pain

• Collaborative Self-Management

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


Collaborative Self-Management

• Values Clients as people

– Identifies Functional Goals

– Supports addressing other life problems

• Challenges dysfunctional beliefs


Reframing Pain


“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

Model ofProactive 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?

VEMA Process

• Validation– “We believe you have real pain”

• Education– Shared model

• Motivation– Enhanced: “Motivational Interviewing”

• Activation– Offering new way to react to pain


“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

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


Roll with Resistance

• Avoid arguments

• “Yes… and…”

– Reflect back Client’s concerns

– Reframe the problem, avoiding false “dualism”

– Acknowledge difficulty

– Emphasize autonomy and responsibility


Pain is Inevitable;

Misery is Optional

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”


SMART Goals

• Specific

• Measurable

• Achievable

• Realistic

• Timely

• Answering the 5 “Ws”: What, When, How…

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

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”


Prepare for “Bad Days”

• Exacerbations are “predictable ebb and flow” of chronic pain

• Stress may precipitate Bad Day

– “Be prepared”

– “Be proactive”


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

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

Using Re- Education in Neuropsychology: “Re-Train the Brain”

The Hunter Group; used with Permission: http://www.youtube.com/watch?v=4b8oB757DKc

http://www.youtube.com/watch?v=4b8oB757DKc

That to which we give

attention, grows!

“Neurons that fire together, wire together”

Donald Hebbs; “The Theory of Hebbian Learning”

From Where is Pain Coming?

Walter Reed Medical Center; http://www.youtube.com/watch?v=YL_6OMPywnQ

Re-Training the Nervous SystemSt

rain

on

Bo

dy

Tissue Damage

Graphic thanks to Neil Pearson, Jennifer Gansen and others

SensitizedNervous System

Alarm

DesensitizedNervous System

Alarm

DeconditionedExercise Capacity

ReconditionedExercise Capacity

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

http://www.youtube.com/watch?v=gN-WwxfPIZo

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

Collaborating with Other CoachesWho Excel in:

• Motivational Enhancement

• Assessment and therapies for:

– Psychological care

– Movement needs

– Existential/Spiritual care

– “Biological” and other needs

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

Pendulum Balance

• Reductionistic AND Holistic Science

• Bio-Psycho-Social-Spiritual Model

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

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

Questions?

Web ResourcesChronic Pain Overview for Clients

• Understanding Pain: What to do about it in Less than Five Minutes http://www.youtube.com/watch?v=4b8oB757DKchttps://www.youtube.com/watch?v=MI1myFQPdCEhttps://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

http://www.youtube.com/watch?v=4b8oB757DKc

https://www.youtube.com/watch?v=MI1myFQPdCE

https://www.youtube.com/watch?v=jIwn9rC3rOI

http://youtu.be/BOjTegn9RuY

http://www.theacpa.org/a-car-with-four-flat-tires

Web ResourcesDeep Breathing & Exercise for Clients

• Deep Breathing Exercise for Relaxation Response: Breathe2Relax-Demo

http://www.youtube.com/watch?v=YdsipKCACac

• Neil Pearson’s Exercise Guidelines


• Leslie Sansone (first 5 minutes) Starting Walking at Home

http://www.youtube.com/watch?v=ykPr0t2KutY&feature=youtu.be

http://www.youtube.com/watch?v=YdsipKCACac


http://www.youtube.com/watch?v=ykPr0t2KutY&feature=youtu.be

Web ResourcesMotivational Story for Clients

• Never, Ever Give Up. Arthur's Inspirational Transformation!http://www.youtube.com/watch?v=qX9FSZJu448

http://www.youtube.com/watch?v=qX9FSZJu448

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/

http://theacpa.org/

http://theacpa.org/conditions

http://theacpa.org/Communication-Tools

http://healthskills.wordpress.com/2009/03/05/youtube-mirror-box-videos/

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/

http://www.lifeisnow.ca/

http://www.theacpa.org/

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

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

Away from therapies:DangerousIneffectivePassive

High Dose OpioidsBenzodiazepinesChronic “Muscle Relaxants”Chronic “Sleep Medications”

Transition From

Transition To


Towards therapies:Safe

Moderately effectiveSelf-efficacious

Deep BreathingRelaxationAlexander TechniqueYoga / Tai ChiMindfulness

“Bridging Therapies”For Those Needing Temporary Help




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” TherapiesE.g. while tapering opioids; UsingAcupuncture orSpinal Manipulation orMassage

Goal: Thriving Self-Management



Deep BreathingRelaxationAlexander TechniqueYoga / Tai ChiMindfulness

Re-Learning, Inter-Professionally

Really ALL in Patient Centered Medical Home…:

Clerk, LPN, Social Worker, Clinical Pharmacist,

Psychologist , Dietician …

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


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?


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?

“Draw me your story”

• Consider “homework” of one page drawing

“My Life”

Pain (1)Began

Pain (1)Worsened

SignificantLife Event 1

SignificantLife Event 2

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

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

Rx15 clinical tues_200_1_bianchi_2saenger

Healthcare

Transcript of Rx15 clinical tues_200_1_bianchi_2saenger