Chronic Opioid Therapy

Safe Prescribing in Primary Care

Nancy Wiedemer,CRNP

VISN 4 Pain Management POC

Pain Management Coordinator

Philadelphia VA

Michael Mangione, MD

Chief of Anesthesia and Director of Pain Service

VA Pittsburgh Health Care System

Objectives

Facility level: Participants will identify strategies to work

toward an institutional commitment to evidence based

opioid prescribing

Pact level: Identify strategies that can be implemented in

Primary Care to promote consistent opioid prescribing

utilizing the expertise of all PACT members to their

fullest

Individual prescriber level: Utilize recognized expert

clinical guidelines for managing opioid therapy

Agenda

Background- why are we still talking about OPIOIDS !!!

Briefly outline the major tenets of Chronic Opioid Therapy (VA/DOD Clinical Practice Guidelines)

Through case scenarios and audience polling, discuss specifics of practice especially hot topics:

high dose opioids

short-acting vs long-acting

decreasing /stopping opioids

methadone

Address questions and cases from the audience

Avoidance (70s to 90’s)

Total fear of

prescribing opioids

even in dying patients

No ceiling (mid 90’s – 2003-04)

Widespread use of

opioids using cancer

model of treatment

Opioid Opioid

Pendulum

Pain as the 5th VS

VHA in 98 ---- JC in 2000

Unintended outcome of Pain as the 5th Vital Sign

Epidemic of Unintentional Rx Drug Overdose and Death

CDC’s Issue Brief: Unintentional drug poisoning in the United States. Unintentional drug poisoning includes drug

overdoses resulting from drug misuse, drug abuse, and taking too much of a drug for medical reasons.

5

WHO

ANALGESIC

LADDER

5TH VITAL SIGN

Heroin

Crack

Cocaine

Rx Drugs (Opioids)

Avoidance (70s to 90’s)

Total fear of

prescribing opioids

even in dying patients

No ceiling (mid 90’s – 2003-04)

Widespread use of

opioids using cancer

model of treatment

Opioid Opioid

Pendulum

Pain as the 5th VS

VHA in 98 ---- JC in 2000

Balance/Risk

Stratification

Opioids only one part of a

comprehensive multimodal

The good news is ….

We have 15 years of experience with expert clinical

guidelines for opioid management :

VA/DOD Practice Guidelines for Management of

Opioid Therapy for Chronic Pain, May 2010

Chronic disease management guidelines: arthritis, back pain,

fibromyalgia, chronic pain syndromes

VHA Stepped Care Model for Pain Care (VHA Directive

2009)

Research identifying populations of patients at risk for

poor outcomes when prescribed opioids

Recent Research Identifies Risk for

Inadvertent Opioid Drug Overdose

Substance Use Disorders

Depression, PTSD, Anxiety Disorder

Benzodiazepine Use

Underlying lung disease

Underlying liver disease

On 100 mg or more of Morphine equivalents per day

Patients over 65

Veterans Health Administration patients had nearly twice the rate of fatal accidental poisoning compared with adults in the general US population

Reference: # 1,2,3,4,5

Association of Mental Health Disorders With

Prescription Opioids and High-Risk Opioid Use in

US Veterans of Iraq and Afghanistan

Veterans with mental health issues were more likely to receive

opioids, about 3X as likely with PTSD, about 2X as likely with

other mental health issues

Veterans with PTSD were more likely to receive higher-dose

opioids, 2 or more opioids, sedative hypnotics, and get early

refills

Receiving opioids was associated with an adverse clinical

outcome for all veterans, more pronounced in veterans with

PTSD

Reference # 5

(N= 291,205 soldiers who entered VA 2005-2008)

Impact of Mental Health Conditions

at the Philadelphia VA

Breakdown of Psychiatric Diagnoses in Chronic Opioid Users

(n=1453)

16%

16%

21%

2%

29%

17%

Substance Abuse

Disorders PTSD

Schizophrenia

No Psych Dx Anxiety

Depression

The good news is ….

CDC, FDA, DEA focus on Opioid Risk Mitigation Strategies

State Prescription Monitoring Programs

Functioning in NJ,WV, Ohio

PA: still 100% Law Enforcement;

Delaware: not fully operational yet

VHA

OIG will be examining VA facilities for policies for opioid prescribing. Focus is on protection from risks of long-term opioid therapy and misuse of opioids

Joint Commission Sentinel Event Alert

“Safe Opioid Prescribing in Hospitals” Issue 49, 8/8/12

Solutions for VISN 4

Opioid Risk Mitigation Strategies

≠ just decreasing opioids

GOAL to provide the best possible pain care

with opioids if indicated and

with safeguards against harm and abuse

Minimal to no

opioids

prescribed

Develop strategies in PC to

promote Consistent opioid

prescribing based on Expert

Guidelines

Strategies to standardize

and ease the workload

for opioid renewals

Prescribing

without

assessment of

risk factors

Continuing

opioids

without

monitoring

High dose

short-acting

opioids

#240 # 360

As a VISN/Facility/Individual prescriber,

we have to work together to move to the middle of the bell curve

Routine screening for presence & intensity of pain

Comprehensive pain assessment

Management of common pain conditions

Support from MH-PC Integration, OEF/OIF, &

Post-Deployment Teams

Expanded care management

Opioid Renewal Pain Care Clinics

Pain Medicine

Rehabilitation Medicine

Behavioral Pain Management

Multidisciplinary Pain Clinics

SUD Programs

Mental Health Programs

Advanced pain medicine

diagnostics & interventions

CARF accredited pain

rehabilitation

STEP 1

STEP 2

STEP 3

VA Stepped Pain

Care

Complexity

Treatment Refractory

Comorbidities

RISK RISK

Surgical

Interventions

Advanced

Interventional

Long-Term Opioid

Therapy

Short-term / Short –acting Opioids

Non-opioid Pharmacological Therapy

Non-pharmacologic Therapy

Physical Therapy

Psychological/Activating Interventions

Lifestyle Change / Self-Management

Patient Education/Activation

Comprehensive Assessment - - - - - Identification/Treatment of Comorbidities

Primary Provider Education/Activation

Biopsychosocial

Rehabilitation Model (Dobsha & Wiedemer, 2011)

Targeted Treatment

Evidence-Based

Standard of Care

(Algorithms

Guidelines)

Standard

Spine

Injections

and Blocks

Switch to Chronic Opioid Therapy Algorithm

Chronic Pain Model

“Simple” chronic pain

– Patient is generally functional

– Responds to standard treatments

– Interactions are mutually satisfying

“Complex” chronic pain (Chronic Pain Syndrome , IASP)

– Syndrome across all painful conditions - BACK PAIN > 90%

– Behavioral Health Co-morbidities

– Does not respond to standard treatments

– Declining function over time in spite of progressively more

aggressive, expensive, and risky medical treatments

– Hx “enigmatic” presentations to multiple providers

– Mutually unpleasant interactions

Anthony Mariano, PhD , National VA Pain Management Leadership group, May,2012

Primary Care Provider

Goals of Assessment of Chronic Pain

Complete a biopsychosocial analysis of pain disorder:

Identify: Pain Mechanisms/ Pain Generators Activating Factors(i.e. movement, emotions ...) Salient co-morbidities – Pain Amplifiers Depression PTSD Anxiety Substance Abuse Disorders

Gallagher RM. Am J Phys Med & Rehab 2005;84(3):S64-76

Best 1st step to identify

Pain Mechanism & Pain Generator??

Onset/course

Location

Quality

Radiation

Alleviating/Aggravating

Temporal (constant, episodic, flare-ups)

Severity (or intensity)

Affect on ADLs/psychosocial functioning

Aberrant behaviors

Brief Pain Inventory

Patient Self Report

Pain Drawing

Pain Intensity ( 0-10) ----------- 4 Items

worst- best- now- average

Pain Interference (0-10)-------- 7 Items

general activity- work-walking- relationships-

sleep - mood- enjoyment in life

% improvement from Pain Management Plan

Cases

Case # 1

25 yo Iraq veteran with low back pain, PTSD.

Injured his back when he fell 8 feet from a loading platform.

Recently discharged from the military and transferring care to

the VA.

Back pain is uncontrolled on 20mg oxycontin BID and four

percocets per day. Has been through extensive PT and had

epidural steroid shots.

MRI reveals mild bulging disc at L4 without central stenosis.

DAU positive for opiates.

Patient is unemployed and trying to increase service

connection which is currently at 20%.

Poll Question #1

Treatment Approaches

Biopsychosocial evaluation to identity pain amplifiers

From a physical standpoint- Persistent MSK pain in the

absence of identifiable pathology is common in returning

OEF/OIF veterans.

Amplifying factors: underlining depression, PTSD, anxiety,

TBI, substance abuse disorder, financial/disability issues

Continue Oxycontin as you lay the groundwork for:

Targeted multimodality treatment

Biopsychosocial care: help the patient to make the connection

between psychosocial factors and physical pain

Treatment Approaches: the evidence

Evidence supports that there is a greater chance for

successful outcomes when the psychological components

of pain are treated with CBT, fear avoidance training and

interdisciplinary rehabilitation compared with

conventional medical interventions (IASP, January 2011)

Evidence that the attitude and message delivered by the

provider has a substantial effect on reports of pain relief

(Moerman & Jonas, Lancet,2003)

The message to your patient about

prolonged opioid treatment….

It was appropriate that your acute injury was treated with opioids BUT there is strong evidence that prolonged opioid therapy has significant long-term negative effects:

1. Endocrine dysfunction:

Decreased testosterone levels

Osteoporosis, fractures

Decreased libido

Decreased size of testes

Erectile dysfunction

Increased prolactin levels: Gynecomastia

Opioid-induced menopause

References: 7, 8

2. Tolerance develops overtime and increasing doses to high dose opioids is risky and has resulted in worse outcomes (Ballantyne,2003)

3. Opioid induced hyperalgesia – opioids can actually be a cause of increased pain

4. You are dependent on living your life around 30 day renewals which will affect you freedom in going away on vacations

5. Strong evidence that high doses increase risk of overdose, increase in health services utilization encounters for withdrawal, intoxication, overdose (Krebs et al, 2011; Bohnert et al, 2011;Gomes et al, 2011)

As the Primary Care Provider although it is difficult and likely not to be received well by the patient, you are emphasizing long term

treatment & the welfare of your patient

Case # 2

PMH: Type 2 Diabetes, HTN, Stage 2 Chronic Kidney Disease, ETOH abuse in sustained remission for 15 years, no psychiatric history, has had one prior back surgery, failed epidural injections

Social History: Worked as a police officer, retired at age 55, active in community, lives with wife and 2 daughters

Description of pain: achy throbbing pain in low back with episodic radiation of burning and numbness and tingling down backs of both legs

Pain diagnosis and pain generators: Spinal stenosis with episodic neurogenic claudication secondary to facet arthropathy and ligamentum flavum hypertophy causing central canal stenosis at L4-5 & L5-S1

62 yo male with chronic low back pain that started after being

thrown out a jeep in Viet Nam

Case # 2 Pain Management Regimen

PCP prescribed appropriate multimodal treatment

including:

Gabapentin, nortriptylline, capsaicin, TENS, follows HEP

from physical therapy, avoids NSAIDs due to CKD

Spine injections are no longer helpful

Percocet 5/325 for 3 years- has escalated to 8-10 tabs a

day(40-50 mg oxycodone /day)is no longer effective.

Patient states that it is not relieving his pain as well as in the

past and is only providing 2-3 hours of relief.

( Morphine is listed in allergy section “ cognitive impairment

and hallucination”)

Poll Question #2

Starting Methadone

Can cause QT prolongation at high doses but precaution with patients with concomitant cardioarrhythmic meds (i.e. TCAs) and history of arrhythmia or syncope

Protocol

EKG

before starting methadone

once the dose is stabilized

annually thereafter

additional monitoring if dose > 100mg /day or if unexplained syncope or seizures

QTc

If the QTc is > 450 but < 500 re-evaluate and discuss with the patient the potential risks and benefits of therapy and need for monitoring QTc more frequently

If QTc is > 500 don’t start discontinue (with a taper)

1.Methadone Guidelines from National Pain Management Strategy Committee Pharmacy Workgroup;

2.VA/DOD Guidelines,2010

Start low and go slow: 2.5 – 5 mg q 8 hours

If elderly or opioid naïve: q 12 or even q day

Increase dose as tolerated every 7 days

With close telephone contact

Provide short-acting opioids when starting if pain is severe

Instill FEAR: Patients must take exactly as prescribed, caution

them NOT to increase even if they think it is not working

Explain that methadone takes time, don’t expect that it will

relieve pain at starting dose

** Methadone is the only long-acting opioid that can be crushed

Starting Methadone

Methadone Cheat Sheet ☺ Start Low Go Slow

Opioid Tolerant Converting PO Morphine to Methadone:

Morphine < 200mg/day-use Methadone 5mg q 8 hours

Morphine 200-500mg/day-Use 7% of the Morphine equivalent divided doses q 8hrs

Greater than-500mg/day Morphine: Seek expert assistance

Titrate no more than on a once-a-week basis

Risk Factors

Age (Seniors), Gender (Female), Bradycardia,

SHD; Advanced Heart Disease; Syncope (cardiac related or unexplained)

Drug to Drug Interactions

QT prolongation agents (high doses)

CYP mediated interactions

Electrolytes: Hypomagnesium; Hypokalemia

EKG

Baseline & Annually

QTc > 500ms or > 30ms over the baseline; Choose another class

VA Pharmacy Boot Camp Program, based on VA/DOD CPGs

Case #3

59 yo with LBP and severe two level DDD of the lumbar

spine.

Patient had been maintained on 15mg MS-contin BID and

two percocets a day.

Three months ago patient had a DAU that was positive

for opiates but the oxycodone screen was negative.

Today patient admits to being out of both meds for

several days because he has been taking extra because his

pain is so severe.

Poll Question #3

Aberrant Drug Taking Behaviors

(ADRBs)

Can result from a variety of causes:

Poor provider-patient communication

Addiction

Pseudoaddiction ( undertreated pain, worsening pathology)

Confusion and/or memory impairment

Psychiatric disorders

Emotional distress

Financial gain(diversion)

Determination of etiology requires thorough evaluation by

provider

VA/DOD Chronic Opioid Therapy CPG, 2010

ADRBs defined by VA/DOD CPG: Level I

Minor variations in adherence to prescribed med schedules

and other recommended treatments

Calling for early refills

Misplacing medications

Lending borrowing medications from friends/family

Marijuana, isolated nonprescribed opioid or benzo, isolated cocaine

with no or remote history of substance abuse

Management of Level 1 ADRBs in Primary Care

Education, re-review Treatment Agreement

Increase clinical structure for renewals – Opioid Renewal Clinic

Behavioral interventions

ADRBs defined by VA/DOD CPG: Level II

Behaviors that persistently demonstrate deviation from treatment agreement Frequently calling in for early refills, frequent reports of lost

prescriptions

Persistence of aberrant behaviors despite education and warnings

Represent serious co-morbidities Mood disorder

Personality disorder

PTSD

Addiction

Psychosis

Cognitive dysfunction

Management requires consultation or co-management with one or more specialists: pain management, mental health, addiction or may require discontinuation of opioids

ADRBs defined by VA/DOD CPG: Level III

Addiction: compulsive use of a substance resulting in physical, psychological and social harm to the user and continued use despite that harm (Rinaldi, RC JAMA 1988:259)

Illegal Criminal or dangerous behaviors

Management

Document, and offer referral to addiction treatment

Discuss nonopioid pharmacotherapy options

If there is clear unsafe or illegal behaviors, opioid prescribing should stop immediately and withdrawal should be addressed

In the setting of clear addiction, continuation of opioids for noncancer chronic pain will most likely be contraindicated

Minimal to no

opioids

prescribed

Develop strategies in PC to

promote Consistent opioid

prescribing based on Expert

Guidelines

Strategies to standardize

and ease the workload

for opioid renewals

Prescribing

without

assessment of

risk factors

Continuing

opioids

without

monitoring

High dose

short-acting

opioids

#240 # 360

As a VISN/Facility/Individual prescriber,

we have to work together to move to the middle of the bell curve

References

1.Dunn et al, Opioid Prescriptions for Chronic Pain and Overdose. Ann Int Med, 2010;152:85-92.

2. Gomes, et al Opioid Dose and Drug Related Mortality in Patients with Nonmalignant Pain. Arch Int Med, 2011;171(7):686-691.

3. Bohnert AS, Ilgen MA, Galea S et al. Accidental poisoning mortality among patients in the Department of

Veterans Affairs Health System. Med Care 2011;49:3936 4. Bohnert AS, Ilgen MA, Ignacio RV et al. Risk of death from accidental

overdose associated with psychiatric and substance use disorders. Am J Psychiatry 2012;169:64-70.

5.Bohnert AS, Valenstein M, Bair MJ et al. Association between opioid prescribing patterns and opioid overdose-related deaths. Jama 2011;305:1315-21

6.Seal, K et al. JAMA. 2012;307(9):940-947

References 7Rhodin, A., Stridsberg, M and Gordh, T. (2010) Opioid Endocrinopathy; A

clinical problem in patients With Chronic Pain and Longterm Oral Opioid

Treatment. Clinical Journal of Pain. 23(5), pp. 374-380.

8 Daniell, H.W. (2002) Hypogonadism in Men Consuming Sustained-

Action Oral Opioids. The Journal of Pain, 3(5), pp. 377-384.