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1 The Use of Opioids for Chronic Noncancer Pain while Preventing Abuse & Diversion September 20, 2016 Presenters: Cathy Carlson, June Oliver Based on ASPMN ® Advocacy Statement Revised 2016 Authors: June Oliver, MSN, APN/CNS, CCNS , RN-BC Cathy Carlson, PhD, APN, FNP-BC Susan Hagan, ARNP-C, RN-BC Pamela Bolyanatz, MS, FNP-BC, RN-BC Conflict of Interest Disclosure No Conflicts of Interest for ALL listed contributors. June Oliver, MSN, APN/CNS, CCNS – [email protected] Susan Hagan, ARNP-C, RN-BC – Susan.Hagan @va.gov Cathy Carlson, PhD, APN, FNP-BC – [email protected] Pamela Bolyanatz, MS, FNP-BC, RN-BC- [email protected] A conflict of interest is a particular financial or non-financial circumstance that might compromise, or appear to compromise, professional judgment. Anything that fits this should be included. Examples are owning stock in a company whose product is being evaluated, being a consultant or employee of a company whose product is being evaluated, etc. Taken in part from “On Being a Scientist: Responsible Conduct in Research”. National Academies Press. 1995.
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Page 1: The Use of Opioids for Chronic Noncancer Pain while ...€¦ · Mood disorders w/ COT highly associated w/ suicide attempts (Im et al., 2014) Increased risk opioid abuse/ SUD −

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The Use of Opioids for Chronic Noncancer Pain while

Preventing Abuse & Diversion

September 20, 2016Presenters: Cathy Carlson, June Oliver

Based on ASPMN® Advocacy StatementRevised 2016

Authors:June Oliver, MSN, APN/CNS, CCNS , RN-BC

Cathy Carlson, PhD, APN, FNP-BC Susan Hagan, ARNP-C, RN-BC

Pamela Bolyanatz, MS, FNP-BC, RN-BC

Conflict of Interest Disclosure

No Conflicts of Interest for ALL listed contributors.− June Oliver, MSN, APN/CNS, CCNS –

[email protected]− Susan Hagan, ARNP-C, RN-BC – Susan.Hagan

@va.gov− Cathy Carlson, PhD, APN, FNP-BC –

[email protected]− Pamela Bolyanatz, MS, FNP-BC, RN-BC-

[email protected] conflict of interest is a particular financial or non-financial circumstance that might

compromise, or appear to compromise, professional judgment. Anything that fits this should be included. Examples are owning stock in a company whose product is being evaluated, being a consultant or employee of a company whose product is being evaluated, etc.

− Taken in part from “On Being a Scientist: Responsible Conduct in Research”. National Academies Press. 1995.

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Objectives

1. State the history & purpose of the ASPMN®

advocacy statement2. Outline factors contributing to controversy re:

chronic opioid use for noncancer pain3. Discuss chronic opioids for noncancer pain as

a legitimate medical option4. Discuss ASPMN® Advocacy statement

recommendations

History & Purpose

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Purpose− Establish organizational voice on important issues− Aid for legislative advocacy efforts− Reference for health care providers in guiding practice− Information source for patients/public

Original Statement 2014 − Authored by Wade Delk

Revised 2016 in response to growing national concern over rise in opioid prescriptions & overdose− Emphasis on clinical & treatment issues− Added recommendations

Advocacy Statement on Use of Nonopioids for Chronic Pain History

1. Affirm pain management as essential to quality health care & as a patient right

2. Acknowledge the problem of rising overdose rates

3. Overview of contributing factors 4. Affirm chronic pain as a disease

a. Impact on society

5. Affirm chronic opioids as a legitimate prescription treatment option a. Careful patient selection b. Careful evaluation of risk & benefits

6. Recommendations7. Supporting references

Advocacy Statement Outline

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Contributions & Controversy

BZD = BenzodiazepineCNCP = Chronic Noncancer PainCNS = Central Nervous SystemCOT = Chronic Opioid TherapyDSM-V = Diagnostic & Statistical Manual 5th editionETOH = Ethyl AlcoholOD = OverdoseMEDD = Morphine Equivalent Daily DoseNIH = National Institute of HealthSAMHSA = Substance Abuse & Mental Health Services Administration

SUD = Substance Use Disorder

Abbreviated Terms

Increased opioid prescriptions− 100% increase 1988 - 2012 (Frenk, Porter, & Paulozzi, 2015)

Increased opioid related overdose deaths− 200% increase 2000-2014 (Rudd et al., 2016)

Goal #1− Compassionate care for people with chronic

noncancer pain

Goal #2− Adequate response to rise opioid abuse & overdoses

Often pitted against each otherBetter & more effective goal to pursue both (Vonkorff, 2011)

Controversy Overview

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Pendulum of Opioid Therapy

Late 1980-1990

Pain is undertreated

Risk of addiction less than 10%

Long acting opioids

Opioids are lower risk

Joint Commission standards 5th

vital sign

Present state

Pain over treated?

Addiction rates up.

Opioids discouraged

& feared

CMS removes pain

question from patient

satisfaction survey.

1. Increased number of opioid prescriptions2. Change in type of opioids prescribed3. Higher opioid doses prescribed 4. Drug Combinations

− BZD, ETOH, sedatives, other CNS depressants5. Overlap mental health disorders

− Stats often include accidental & intentional overdoses6. Increasing Substance Use Disorders

− Stats often include licit & illicit opioids (CDC, 2014)

− 200% increase OD deaths includes heroin & prescription opioids

− SUD treatment admissions rose in parallel to opioid OD stats (Paulozzi et al., 2011)

Rise of Opioid Overdose Deaths:Controversy & Contributing Factors

Can the Numbers Make Sense?

“There are three kinds of lies: lies, damn lies and statistics!” − Mark Twain

“Statistics [is] the only science that enable different experts using the same figures to draw different conclusions”.− Evan Esar, from the Comic Dictionary

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No standard accepted definition of “ high dose” opioid− NIH >200 MEDD

Studies differ in: (Chou et al., 2015)

− Definitions of misuse, abuse, addiction− Methods used to identify these outcomes− Many done prior to DSM-V definition of Opioid Use

DisorderUnclear Databases from autopsies/death certificates (Rudd et al., 2016)

− Variations state to state toxicology testing − Variable state practices re: specific drugs listed on

overdose death certificates − 22% (2013) & 19% (2014) of drug overdose deaths w/o specific

drugs listed on death certificate

− Possible misclassification of heroin deaths as morphine deaths due to similar metabolism

Variable Numbers in the Debate

“People who take prescription painkillers can become addicted with just one prescription” (CDC Injury Center - no secondary reference listed within the document)

“Women may become dependent on prescription painkillers more quickly than men .. & more likely to ‘doctor shop’ ” (CDC Vital Signs, 2015)

Statements: Fear & Unclear

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“In 2014, there were approximately one & a half times more drug overdose deaths in the United States than deaths from motor vehicle crashes” (Rudd et al., 2016)

Fatal MVAs= 29,989(National Highway Traffic Safety Administration, 2016)

Drug overdose deaths = 47,055 − Opioids involved in 61% = 28,647 deaths

Actually 1,342 LESS Opioid related deaths than fatal MVA − 4.4% less opioid deaths than MVA fatalities

More Unclear Fear

CDC Injury Prevention & Control: Deaths by Opioid Type− Natural/semisynthetic (MS, oxycodone, hydrocodone, hydromorphone)− Synthetic (fentanyl, tramadol)

− Methadone (separate tracking)Increased deaths from 16,000 (2013) to 19,000 (2014)

− Methadone = 0% increase− Natural/semisynthetics = 9% increase− Heroin = 26% increase− Synthetic = 80% increase − Law enforcement reports illegal fentanyl seizures− Overdose deaths do not distinguish legal from illegal

fentanyl− Separating out synthetic opioids the 2014 deaths =14,000

− “SEEMS TO RESULT IN DECREASED DEATHS WITH PRESCRIPTION OPIOIDS” (Rudd et al., 2016)

Unclear Fear – Prescriptions vs Illicits

NATIONAL DRUG EARLY WARNING SYSTEM REPORT: 12/7/2015

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1. Increased number of Opioid Prescriptions

Escalated from around 76 million in 1991 to nearly 207 million in 2013 (Volkow, 2014)

− Doubled 1988 - 2012 (Frenk, Porter, & Paulozzi, 2015)

− 4x increase opioid annual prescription sales 1999-2014 (CDC, National Center for Injury Prevention, 2016)

− NOTE: This cites another CDC publication of 1999-2008 ODs)

United States biggest consumer globally?− Close to 100% of total world use of hydrocodone ?

− Most other countries do NOT report script use− Europe, Canada, Australia use other opioids (Fudin 2013)

− 81 percent for oxycodone (Volkow, 2014)

Numbers vary but still large increase in recent 2 decades

Increased Opioid PrescriptionsNumbers Vary

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Increased available supply for abuse & diversion (Dart et al., 2015)

− Unintentional BZD OD deaths in WV, 46.3% w/ NO prescription (Toblin, 2010)

Conclusion supported by:− Slight decrease in opioid diversion/abuse & opioid

related deaths 2011-2013− Paralleling slight decrease in number opioid

prescriptions written 2011-2013 (Dart et al., 2015)

− 1999- 2011 opioid annual sales increased 4x while SUD Treatment admissions increased 6x. (Paulozzi et al., 2011)

Link to Heroin use?− 1960s = 80% started w/ heroin as first opioid use− 2000s = 75% started w/ script opioid before heroin− 2010-2013 = heroin as first use & script opioid first use

(Cicero et al., 2014)

Impact of Increased Opioid Prescriptions

Opioid Prescription Rates (Volkow, 2014)

2. Change in Type of Opioids Prescribed

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Type of Opioids Prescribed

Change in Type of Opioids prescribed − 7 year changes (2004-2011)− Weaker opioids (i.e. codeine) decreased 20% − Stronger opioids increased

− Hydromorphone up 140%− Oxycodone up 117%− Morphine up 64%− Fentanyl up 35% (Atluri et al, 2014)

Rise in prescribed methadone− Retail sales up 1173% over 9 years (1997-2006) (Coben,

2010)

− OD deaths increased 400% over 7 years (1999-2006)

− Disproportionately high death rate in case series & epidemiological studies

− Believed r/t long & variable half life− QTc prolongation

168 Study Review of methadone safety (Weimer & Chou, 2014)

− Weak evidence of risks − studies w/ poor controls, limited strength, none on dosing

strategies

− No clear mortality/ side effect risk difference from other opioids

− 1 study w/ lower risk w/ methadone

− No studies on follow-up frequency effect on adverse outcomes

− QTc prolongation risk- observational w/ weak designs

− Methadone death risk associated w/ BZDs VA study = risk of death w/ methadone than long-acting morphine (28,554 pts & 79,938 pts) (Chou et al., 2015)

Methadone: Increased Scrutiny

3. Higher Doses Prescribed

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9940 pts w/ 3 or more opioid scripts (Dunn et al., 2010)

− 51 ODs = 0.5% of pts (fatal & nonfatal)− Compared to 1-20 mg MEDD− 50-99 MEDD= 3.7 x increase in OD risk− > 100 MEDD = 8.9 x increase in OD risk

607,156 pts on opioids (Gomes et al., 2011)

− 498 OD deaths (0.08% of pts)− Compared with < 20mg MEDD/day− >200 MEDD = 3x risk of opioid related death

Higher Dose & Risk Variations

OVERDOSE Rate (any OD serious or nonserious)− 0.256% with prescribed opioids (256/100,000 person-

years) − 0.001% without prescribed opioids (36/100,000

person-years)

Risk increased with dose increases − Compared to 1-19 MEDD− 20-49 MEDD Hazard ratio (HR) 1.44 − 100 MEDD HR 8.87− > 200 MEDD Odds Ratio (OR) 2.88

Risk of Opioid Harms:Review for National Institutes of Health Pathways to Prevention Workshop (Chou et al., 2015)

DOSE RISK of Overdose (Fatal & Nonfatal)

MEDD Dunn Study(Fatal &

nonfatal)

Gomes Study(fatal)

Chou Review(any OD event)

20-49 ------- -------- 1.44 HR (1.44 x more risk)

(Hazard ratio)

50-99 3.7x -------- -------

>100 8.9x --------- 8.87 HR

>200 ------ 3x 2.88 OR ( odds ratio)

Dose Associated Risk

Hard to Compare Data!!!

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4. Drug Combinations

Hospitalized overdoses (ODs) opioids, sedatives & tranquilizers 1999-2006 (Coben et al., 2010)

− Which problem is the worst? − Total number affected, trends of increase?

Opioids & Other Drug Combinations

Drug Methadone Other Opioids BZDs

7 year increase (2006 vs 1999)

4,289 9,803 10,379

% increase 400% 77% 39%

2006 hospitalized ODs

5,362 17,545 36,700

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Fatal opioid deaths in UK (Oliver & Keen, 2003)

− BZD most common additional drug− BZD found in 64% of methadone fatalities− BZD blood levels were in therapeutic ranges

VA study (French et al., 2005)

− 2x increased risk of injury w/ BZD & another drug vs BZD alone

2400 Veterans with fatal opioid related deaths (Park et al., 2015)

− Half occurred with concurrent BZD & opioids− Risk increased as BZD dose increased− Temazepam with decreased risk of OD death vs.

clonazepam478 Opioid overdose deaths-NC in 1 yr (Dasgupta, 2016)

− 10x higher OD death with BZD & opioid vs opioid alone2802 people who inject drugs in Canada (Walton, 2016)

− BZD use with higher mortality risk than all other substances

Benzodiazapines

Lesser known: Carisoprodol misuse, ED visits doubled from 2004 – 2009, usually in combo with opioids, BZDs, ETOH (DAWN, 2011)

“Because most prescription drug injury reports have focused on opioids, it is possible that poisonings from BZDs have been somewhat overlooked” (Coben et al., 2010)

“Restricting benzodiazepine prescriptions to a 30-day supply with no refills might be considered” (Toblin et al, 2010)

Other Combos & Quotes

5 & 6. Mental Health & Substance Use Disorders

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Re: BZD, opioids, sedatives 1999-2006 (Coben et al., 2010)

− 37% rise unintentional OD− 130% rise intentional OD

Mood disorders w/ COT highly associated w/ suicide attempts (Im et al., 2014)

Increased risk opioid abuse/ SUD− Younger age & psychiatric conditions (Chou et al., 2009 &

2015)

− Use of psychotropic meds (Chou et al., 2015)

Mental Health &Substance Use Disorder

2002-2014 Heroin overdose deaths up by 286% (CDC Vital Signs, 2015)

Overdose Trends 2001 - 2014 − Heroin = 6 fold increase− BZDs = 5 fold increase− Prescription Opioids = 3.4 fold increase (National Institute on

Drug Abuse, 2015)

9 in 10 heroin users use 1 other drug; most use 3 other drugs (CDC Vital Signs, 2015)

Rise in Heroin Use

CDC Record of Opioid Deaths

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CDC Heroin Use & Overdose Deaths

CDC Opioid Overdose Deaths by Race (including heroin)

Personal OR family history of ETOH or drug abuse (Chou et al., 2009 & 2015)

− Strongly predictive of abuse/aberrant drug behaviors

Highest risk for heroin addiction = other addictions− Prescription opioids (40x more likely)− Cocaine (15x more likely)− Marijuana (3x more likely)− Alcohol (2 x more likely) (CDC Vital Signs, 2015)

SUD History Impact (Fishbain, 2008)

− 3.3 - 11.5% on COT pt with history of SUD develop opioid addiction

− 0.19 - 0.59% on COT without history of SUD develop opioid addiction

− AGAIN, NUMBERS HARD TO COMPARE FROM DIFFERENT SOURCES!

ADDICTION LEADS TO ADDICTION!

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CDC Drug of Choice Record

1.9 million people with SUD involving prescription opioids− 586,000 with SUD involving heroin (SAMHSA, 2014)

SUD in chronic pain patients − SUD rates 3-48% in 21 study review (Morasco, 2011)

NIH/AHRQ: 4209 articles; 39 fair-good quality (Chou et al., 2015)

− Opioid Abuse: 1 fair quality study commercial health plan

− 0.7% with 1-36 MEDD− 6.1% with >120 MEDD− 0.004% with no opioids

− 10 fair quality studies− Primary care opioid abuse 0.6-8%− Pain clinic opioid misuse 8-16%; addiction 2-14%− Aberrant drug behaviors 6-37% (UDT results, agreement

violations)

Chronic Opioid Use & Addiction:How common is it ?????

There is a problem!− Rising opioid scripts− Rising opioid deaths

− Prescription & illicit opioids

There are unclear & variable statistics detailing this− Reader beware!

Higher opioid doses raise riskMental health conditions add risk of overdoseThere is a concurrent rise in SUD/heroin addictionCNS depressant drug combinations add major risk The surrounding intensity & political/public pressure to control the problem contributes to confusion & reactionary responses.

Summary of Rise in Opioid Deaths

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Comparison of Selected Published Guidelines for Chronic Noncancer Pain

APS Opioid Treatment Guidelines for Chronic Pain 2009 (APPM)Veteran’s Administration Management of Opioid Therapy for Chronic pain 2010Canadian Guideline for Safe & Effective Use of Opioids for Chronic Non-Cancer Pain 2010Washington State Interagency Guideline on Prescribing Opioids for Pain 2015American Chronic Pain Association 2016CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016

Selected Guidelines

Plan for Managing COT Risk: Universal Precautions 2005

What is it? (Gourlay, Heit, & Almahrezi, 2005)

− A systematic approach to the assessment & on-going management of chronic pain patients

What does it offer?− A triage scheme for estimating and managing the

risk of SUD/addiction with COT patients

Why is it needed?− Impossible to reliably determine who will develop

SUD− Especially on initial encounter

What benefits result?− Systematic evaluations− Decreased provider fear & reactive responses− Early detection & Rx of aberrant behaviors

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1. Establish a pain diagnosis

2. Psychological assessment including SUD risk

3. Informed consent – risks & benefits of COT

4. Treatment Agreement Use

5. Pre and post intervention assessment of pain & function

6. Trial of opioids; consider adjunctive medications

7. Reassess pain & function at each visit

8. Regularly assess 5A’s ( analgesia, activity, adverse reactions, aberrant behaviors, affect).

9. Periodically review pain diagnosis, other conditions including SUD.

10. Documentation

10 Universal Precautions

Name Of

Guideline

APS

2009

(AAPM)

VA

2010

Canadia

n 2010

Washington

State

2015

American

Chronic Pain

Association

2016

CDC

2016

IntendedAudience

Primary care & specialty settings

Primary careclinicians, researchers & other health

professionals

Physicians who treat CNCP

patients

Primary care clinicians

Consumers PCP

Intended Audience of the Guidelines

Name of Guideline

APS 2009

(AAPM)

VA 2010

Canadian 2010

Washington State

2015

ACPA 2016

CDC 2016

Criteria for

Initiating

Opioid Tx

1. Moderate or severe

2. Adverse impact on function or quality of life

1. Moderate to severe

unresponsiveto nonopioid & nondrug Rx

2. Benefits outweigh risks

3. Informed/ consents to therapy

Documentation of:

1. Pain condition

2. General medical condition

Specifics foracute,

subacute, chronic pain, & peri-operative pain

Benefits outweigh

the risks & negative side effects

1. Nonpharmacologic

therapy & nonopioidtherapy preferred

2. Establish treatment goals

Comparison of Criteria for Initiating Opioids

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Name of Guideline

APS2009

(AAPM)

VA2010

Canadian 2010

Washington State

2015

ACPA2016

CDC2016

Establishing Pain

Diagnosis

Establishor

confirmdiagnosis

Determine cause of

pain

Thorough H & P to

determine type,

cause & nature of

pain

Define cause &

type of pain with

accurate diagnosis

Not stated

Establish, confirm

diagnosis; diagnostic

testing, contributing

factors

Comparison of Establishing a Pain Diagnosis Among Guidelines

Name of Guideline

APS2009

(AAPM)

VA2010

Canadian 2010

Washington State

2015

ACPA2016

CDC2016

Dosing Caution/

Limitations(MEDD)

200 200 200 120 80 >50≥90

Recommended

Response

Monitor more

frequently & more

intensely

Consider a consult

if function not

improved

Watchful Dose

Consult a Pain

Specialist

Increasedvigilance

Carefully

reassess

benefits &

risks ≥50

MEDD &

avoid ⬆⬆⬆⬆

≥90

MEDD

Comparison of Dosing Limitation Among Selected Guidelines

Name of Guideline

APS2009

(AAPM)

VA2010

Canadian 2010

Washington State

2015

ACPA2016

CDC2016

Risk Evaluation

H & P, including risk assessment for SUD

Identify conditions that mayinterfere with the appropriate & safe use

1. SUD eval2.Use of Opioid Risk Tool 3. Treatmentagreement4. UDT5. Taper BZD

Lists risks to avoid for COT & best practices to minimize adverse outcomes

Discusses opioid dilemma & riskstrategies

1. Usestrategies to mitigate risk

2. Use statePDMP

3. Use UDT before Tx &annually

4. Avoid prescribing with BZD.

5. Refer for SUD Tx

Comparison of Risk Evaluation Recommendations Among Guidelines

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Name of Guideline

APS2009

(AAPM)

VA2010

Canadian 2010

Washington State

2015

ACPA2016

CDC2016

Nonopioid Medications

& Therapies

Briefly mentions nonopioid medications &

therapies

Briefly mentions nonopioid medications

& nonpharma-cologicmodalities

Not mentioned

Extensive discussion of non-opioid medications &

nonpharmaco-logic interventions

Provides large sections on nonopioid

medications & complementary, alternative, & integrated

medicine

Brief mention of Nonphar-macologic

therapy & nonopioid pharmaco-logic therapy being

preferred for chronic pain.

Comparison of Recommendations Nonopioid Medications & Therapies

Name of Guideline

APS2009

(AAPM)

VA2010

Canadian 2010

Washington State

2015

ACPA2016

CDC2016

Multiple

Drug Use:

Interactions/

Synergy

Risk for respiratory depression with opioids

& drugcombinations(such as BZDs)

Briefly mentions drug-to-drug

interactions

Taper BZDs, particularly for elders

Do not combine opioids with BZDs,

sedative-hypnotics, or barbiturates

Briefly mentions drug interactions

with BZDs

Discusses BZDs risk forrespiratory

depression& briefly mentions other CNS depressants

Comparison of Recommendations for Multiple Drug Use: Interactions/Synergy

Governmental Pressures & Response

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Professional advocates for opioid limitations− Physicians for Responsible Opioid Prescribing (PROP)− American Medical Association Statement (AMA)− College of Neurology

Potential conflict of interest in pharmaceutical industry information/promotion of opioidsGrowing congressional attentionCDC as a government agency must respond to governmental concerns & mandates

Governmental Pressures

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PROP Petition for Non cancer pain

Strike “ moderate” from indication for opioids

Max 100 MEDD

Max duration 90 days

FDA Decision

Make labeling changes but did not remove “moderate”

Denied request

Denied request

Physicians for Responsible Opioid Prescribing Citizens Petition

Recommendations

Sir Francis Bacon’s Latin saying in 1597

can motivate us.

‘Ipsa scientia potestas est’

Knowledge itself is powerWe must use what we know to advocate for the patient in pain

Clinical Application

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Recommendation 1

Investigate patient history of medical, psychiatric & substance use disorders including records from other providers.

Clinical Application

All providers should access the Prescription Monitoring Program for your state, each time a prescription is written for a patient.Case Study:A 50 year old male was admitted to the ICU on a naloxone drip for an apparent overdose. He was found in his car with a prescription bottle of morphine at his side.

Further investigation revealed he was on buprenorphine/naloxone from one provider and Morphine ER from another.

It is our recommendation to investigate every patient for their use of opioids and BZD, at every encounter.

Advocacy Statement Recommendations Include: Providers

Recommendation 2

Refer to specialists promptly with high-risk conditions, including obesity, OSA, psychiatric & substance use disorders, & when higher opioid doses are required

Management Pearls

Partner with Physical Therapy

Monitor for sleep disorders

Remind patients ‘Do not take opioid to sleep’

Flare managementPatient education for non opioid coping techniques

Advocacy Statement Recommendations Include: Providers

Recommendation 3

Maximize the use of pain medications other than opioids

Clinical Application

Multimodal options can include:• Systemic Pharmacological

Therapies (Acetaminophen, celecoxib, gabapentinoids)

• Topical/local Pharm Therapies

• Peripheral anesthesia• Neuraxial Therapies• Physical Modalities• Cognitive-behavioral

modalities (relaxation methods, music therapy)

Advocacy Statement Recommendations Include: Providers

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Recommendation 4

Cautious use or avoidance of high-risk medications, such as BZDs, when opioids are used

Clinical Application

Black Box warningPublic Health Officials Petition FDA for Black Box Warnings and Medication Guides Regarding Serious Risks of Combining Opioids With Benzodiazepines

March 22, 2016

FDA announces enhanced warnings for immediate-release opioid pain medications related to risks of misuse, abuse, addiction, overdose and death

New safety warnings also added to all prescription opioid medications to inform prescribers and patients of additional risks related to opioid use

Advocacy Statement Recommendations Include: Providers

Recommendation 5

Initiate opioid therapy as a trial with the understanding if it decreases pain & increases activity tolerance it may be maintained

Always use the lowest effective dose

Instead if increasing dose consider rotating

Consider opioids as an adjunct to nonopioids vs automatic first line treatment.

Advocacy Statement Recommendations Include: Providers

Recommendation 6

Use published clinical guidelines to identify & decrease risk of opioid misuse

Clinical Application52 yo female admitted multiple times for pain and weakness.

While in the hospital was observed taking medication from her purse.

Based on guideline interpretation of her aberrant behavior, this patient was referred for admission for detoxification and rotation to buprenorphine/naloxone.

Refer for detoxification if aberrant behavior

Advocacy Statement Recommendations Include: Providers

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• Examples of large scale change• Specific PCP medical group in Illinois has

based their recent practice change on published guidelines (CDC) & exhibits many of the recommendations in our advocacy statement.

• For example:− Opioid Agreements− One provider to prescribe− Small amounts of opioids for a specified time

duration− Focus on non opioid treatment − Urine drug screening− Close monitoring for side effects− Clause for discontinuation of opioids

Application of Pain Management Guidelines

Recommendation 7

Advocacy Recommendations Include: Government & Society

Actions

Recommendation 7.1

Require comprehensive prescriber education on opioid pharmacology & management –including risks, benefits, & alternatives

Clinical Application

Require Risk Evaluation and Mitigation strategy (REMS) for all providers (FDA, 2007)

www.accessdata.fda.gov.scripts

Development of protocols and order sets to assist with risk stratification and safe opioids prescribing for opioid naïve and tolerant patients

Advocacy Recommendations Include: Government & Society Actions

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American Society of Addiction Medicine, Public policy statement, 2012 recommendations:1. Require comprehensive prescriber education

− Opioid pharmacology & management− Benefits vs risk assessments− Paired functional & pain assessments− Alternatives & adjuncts to opioids− Recognition of SUD and intervention/referral

response− Outline patient education before using COT− Consider coprescribing naloxone

2. Impartial Education development − Exclude pharmaceutical industry− Exclude individuals/groups w/ significant pharmaceutical tie

Practitioner Education Advocacy:A Step Further

Recommendation 7.2

Advocate for increased funding of research & access to care for pain management & mental health services –including substance use disorder

Potential research topics and advocacy for enhanced funding

• Longitudinal research on safe & effect of COT

• Genetic variability - pain and Rx

• Earlier total joint surgery

• Biologicals to slow degenerative disease

• Insurance coverage for complementary ‘holistic’ relief of pain

• Stem cell research for the relief of pain

• Psychological & emotional care Cognitive behavioral therapy

• Talk therapy• Medication management• Individual & family therapy

Advocacy Recommendations Include: Government & Society Actions

Recommendation 7.3

Develop safe, convenient and environmentally friendly medication disposal programs

Take Back programs can decrease circulating opioids in the communities

Advocacy Recommendations Include: Government & Society Actions

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Recommendation 7.4

Expand Prescription Monitoring Program (PMP) features

Clinical Examples

Support expand access for all health professionals, licensed & unlicensed, to PMP websites

Support interstate/national sharing of information

Simplify & standardize state requirements for account registration

Advocacy Recommendations Include: Government & Society Actions

Pain practitioners need SUD & Mental Health Skills− Up to date knowledge

− Brain disease model of addiction

− Regular risk assessments− Adherence monitoring− Early SUD detection− Intervention skills

− Screening, brief intervention & referral to treatment (SBIRT)− Alternative treatment options

Suicide attempt rate lowers in COT pts with:− Increased drug screens− Follow up within 4 weeks after new scripts− Lower sedative co-prescriptions

Helpful & Hopeful Responses

Clinician ResourcesScreening, Brief intervention, Referral to treatment

www.sbirttraining.com

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SAMHSA strives to close the gap (of delivering behavioral & SUD treatment) by raising awareness that:

− Behavioral health is essential to health− Prevention works− Treatment is effective− People recover

SAMHSA Statement

Mental Health Treatment Resources

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Know Patient Education Resources

We as pain practitioners can make a difference in the lives of the patients we serve.

We can make a difference

Chronic Pain as a Disease with Societal Impact

Balanced approach

to patient care

Improve Public

Policy

Opioids are a

legitimate treatment

See ASPMN® Website for posted reference list

Resources

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Questions??

PCSS-O Colleague Support Program

• PCSS-O Colleague Support Program is designed to offer general information to health

professionals seeking guidance in their clinical practice in prescribing opioid medications.

• PCSS-O Mentors comprise a national network of trained providers with expertise in addiction

medicine/psychiatry and pain management.

• Our mentoring approach allows every mentor/mentee relationship to be unique and catered

to the specific needs of both parties.

• The mentoring program is available at no cost to providers.

• Listserv: A resource that provides an “Expert of the Month” who will answer questions

about educational content that has been presented through PCSS-O project. To join email: [email protected].

For more information on requesting or becoming a mentor visit:

www.pcss-o.org/colleague-support

PCSS-O is a collaborative effort led by American Academy of Addiction Psychiatry

(AAAP) in partnership with: Addiction Technology Transfer Center (ATTC), American

Academy of Neurology (AAN), American Academy of Pain Medicine (AAPM), American

Academy of Pediatrics (AAP), American College of Physicians (ACP), American Dental

Association (ADA), American Medical Association (AMA), American Osteopathic

Academy of Addiction Medicine (AOAAM), American Psychiatric Association (APA),

American Society for Pain Management Nursing (ASPMN), International Nurses Society

on Addictions (IntNSA), and Southeast Consortium for Substance Abuse Training

(SECSAT).

For more information visit: www.pcss-o.org

For questions email: [email protected]

Twitter: @PCSSProjectsFunding for this initiative was made possible (in part) by Providers’ Clinical Support System for Opioid Therapies (grant no. 1H79TI025595) from SAMHSA. The views expressed

in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services;

nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.