Improving safety and efficacy of opioid prescribing for pain in

primary care

William C. Becker, MD, FASAMInstructor

Section of General Internal MedicineYale University School of Medicine

Disclosure

I have no potential or actual conflict of interest related to this presentation.

Learning objectives

• To understand terminology related to use of opioids for chronic non-cancer pain

• To appreciate the prevalence of chronic non-cancer pain, opioid prescribing and adverse events related to opioids

• To review fundamental components of effective management of chronic non-cancer pain

• To understand practical techniques for improving safety and efficacy of opioid prescribing for pain

Chronic Pain• Pain lasting most of the day during most days for > 3

months• Point prevalence in U.S. adults: 15-20%• Lifetime prevalence in U.S. adults: 50-75%• Pain is most often-reported symptom in office visits

after URI• Multi-faceted disorder that, by definition,

has bio- psycho- social components

Prescription opioids• Full opioid receptor agonists used to treat pain (acute

and chronic)– e.g. morphine, oxycodone, hydrocodone, methadone,

codeine, hydromorphone, fentanyl

Reward pathways

Adverse effects of opioidsAddiction: compulsive substance use despite harm =

DSM-IV dependence, at least 3 of the following:

Tolerance Withdrawal

Greater amounts/longer period than intended

Persistent desire/unsuccessful efforts to cut down

Inordinate amount of time obtaining, using, or recovering

Important social, occupational or recreational activities given up or reduced due to substance use

Use continued despite knowledge of having a persistent or recurrent physical or psychological problem likely caused or exacerbated by substance

Incidence in opioid treatment for pain: ~2% per year

Contrast with: “Physiologic Dependence”

Adverse effects, continued

• Misuse Use other than how prescribed:– To get high– More than prescribed– Selling, trading = “diversion”

Adverse effects, continued

• “Drug-seeking Behavior” requests for opioid medications for the purpose of getting high

• “Aberrant Behaviors” among patients on opioids for chronic pain, behaviors that may be indicative of misuse or addiction– Early refills– Frequent phone calls– Doctor shopping– Prescription forgery

Adverse effects, cont’d

• Constipation• Nausea• Itching• Dizziness• Clouded mentation• Sedation• Falls• Overdose• Death

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Opioid sales (mg perperson)

Annual sales of Rx opioids and unintentional overdose death

1990 - 2006

Source: Paulozzi, CDC, Congressional testimony, 2007

How did we get here?

• 1990s– Under-treatment of pain– Pain as the 5th vital sign– Pain as a human rights issue– Early data that opioid risks were low, some of

which intentionally minimized– Interwined cultural and medical trend towards

“a pill for what ails ya’”

Juggling?

Balancing

BENEFITS HARMS

Case57 M w/ chronic low back pain for 15 years after being thrown out of a

jeep• Worked as officer in NHPD until 50• Lives with wife and 3 daughters, active in community• Admits to cocaine and speed for 1-2 years 25 years ago• Pain has been worsening and interferes with functioning• Dx based on hx/PE/MRI: spinal stenosis• You prescribe NSAIDS, capsaicin, physical therapy • After 8 weeks pt still experiencing significant pain that is negatively

affecting function; you start opioids (MSContin 15 mg TID titrated to 30 mg TID) to good effect: improved pain and function

• One month later, routine UDT positive for cocaine

What do you do now?

We’ll get to that discussion but also…

What should you have done in the first place?

Practical techniques for improving efficacy and safety of opioid prescribing

Where it all begins

Comprehensive approach to high-quality management of chronic pain

• Empathize, partner with the patient• Perform a complete history and physical• Set functional goals• Utilize shared decision-making• Employ multi-modal treatment plan• Employ rational polypharmacyWhen using opioids:• Follow the harm/benefit paradigm• Perform frequent monitoring, reassessment and

DOCUMENTATION

Empathize/Partner with your patient

“Identification with and understanding of another person's situation or feelings”

PainPain

StressStress

Loss of Loss of FunctionFunction

DepressionDepression

Breaking the cycle• “You’ve been through a lot.”• “My goal is help *you* manage this better” –

EMPOWER the patient to be the locus of control/change

• “Your pain will not go away entirely. Our goal is to get better control of it.”

• “Moving, stretching, activity will help you reach your goal.”

• “Uncontrolled pain makes mood worse, bad mood makes pain worse – have to work on both.”

Complete history and physical

• Region/systems involved • Quality of pain • Temporal characteristics • Degree of intensity • Time since onset

This is the biological approach…. necessary but not sufficient

Biopsychosocial Model of Pain

Overall functional status

• Tumors

• Fractures

• Infection

• Cauda Equina Syndrome

• Addiction

• Suicidality

• ‘B’ symptoms: fever, weight loss, night sweats, malaise

• Sudden focal neurologic symptoms

• Acute worsening of chronic pain

• Failing to thrive

Don’t Miss the Red Flags

Complete history and physical, cont’d

Full standard exam plus:– Focus on function –

• Watch the patient walk• Ask the patient to transition from seated to

standing position• Ask the patient to stand on the floor, flex the back,

extend the back

Set Functional Goals

Functional Status:• What’s a typical day like?• What’s the most active thing you do?• Do you ever stay in bed all day?• Do you get any exercise?• How have these things changed over the

past weeks/months/years?What would you (realistically) like to be able

to do?

Utilize Shared-Decision Making

• Uncontrolled chronic pain is found more often in patients who– Are passive– Catastrophize– Perceive an external locus of control

• Counteract these by requiring the patient to make decisions and set goals with you.

SELF CARE

SELF EFFICACY

Employ multi-modal approach

Behavioraltherapies

Pharmacologictreatment Physical activity

Employ Rational Polypharmacy

• Anti-nociceptive agents– NSAIDs– Acetaminophen– Opioids

• Anti-neuropathic agents– Anti-convulsants– Tricyclics

• Anti-depressants

When Using Opioids, Follow the Harm/Benefit Paradigm

CONTINUE IF BENEFIT OUTWEIGHS HARM.

DISCONTINUE IF HARM OUTWEIGHS BENEFIT.

Perform frequent monitoring, re-assessment and DOCUMENTATION

Initiating opioid treatment: When?

• When functional goals have not been achieved with non-opioid therapies (acetaminophen, ibuprofen, lidocaine, capsaicin, TCAs, gabapentin, physical therapy)

• New patient already on opioids

Initiating opioid treatment: Who?• Active addiction (alcohol, illicit drugs, prescription

medications) is a contraindication

• Risk factors for misuse that should prompt closer follow up but do not necessarily preclude opioid therapy– Younger age– Personal history of substance abuse

• Illicit, prescription, alcohol, smoking– Family history of substance abuse– Legal history (DUI, time in jail)– Mental health disorders

• Patient who is showing engagement with process

Initiating opioid treatment: How?

• Therapeutic trial in the harm/benefit paradigm– Set specific, functional goals– Refer back to those goals to assess benefit

• Which medication?– Long/short acting– Strength– Formulation– Abuse potential

Informed consent

• Communication of risks, potential benefits, goals/expectations, and treatment and monitoring plans

• Written agreements or ‘contracts’– Educate patient about safe opioid use– Clearly define acceptable behavior

Opioid treatment agreements

Tone is important:

“This is so you know what to expect from us and what we expect from you”

“This is about keeping you safe”

“We do this for all patients”

What should be in your OTA?

• What patient can expect of the practice:– A good faith effort to manage patient’s pain

• What practice can expect of patient:– No unsanctioned dose escalation– No early refills– No replacement for lost or stolen prescriptions– Single prescriber– Safeguard meds and no sharing– Keep regular appointments– Follow-through with referrals and adjuvant treatment– No use of illicit drugs or non-prescribed controlled substances– Urine drug testing– Whom/When to call for refill– If agreement not followed, may taper opioids off and/or refer to

addiction treatment

Monitoring: the 5 A’s

1. Analgesia – 11- pt Numeric Rating Scale2. Activities of daily living (function) – ‘Your goal

was to get back in your walking routine. How is it going?’

3. Adverse effects: constipation, sedation, etc – ASK!

4. Addiction/overuse – Is the patient oversedated? Does pt think he is addicted? Does the patient use other illicit drugs?

5. Adhering to the treatment agreement

CT prescription monitoring program

www.ctpmp.com

Log of every scheduled medication filled in any Connecticut pharmacy

Sortable by patient

1-2 week lag time

Urine drug testing

• Identifies more misuse than self-report or physician impression

• Which test to order?– Immunoassay is screen– Gas chromotography/mass spectroscopy for

confirmation – would recommend doing this any time you get an unexpected result

• Always ask and document recent intake before sending test

How to discuss UDT

“This is our routine practice.”

“We want to ensure your safety.”

UTox8

• Federal “5”– Marijuana– Cocaine– Opiates– PCP– Amphetamine/

methamphetamine

• Plus– Methadone– Benzodiazepines– Barbiturates

Interpreting UDT

• Common errors:– Standard Utox8 does not include oxycodone or

fentanyl: you must include tests of medications patient is prescribed

– In most cases, oxycodone will NOT cause opiate assay to be positive; however, it can in high doses. Therefore, you MUST do confirmatory testing

– Hydrocodone metabolizes to hydromorphone so pt who takes hydrocodone may frequently have + hydromorphone on opiate GC/MS.

Responding to problems

• Reassess

• Document findings and plan

• Structured risk management– Short courses and follow-up– Frequent UDT and/or pill counts

• Referral to pain or addiction specialist

• Taper off opioids

Stay in the harm/benefit paradigm

• Explain how patient’s behavior or the outcome of the treatment is not in line with the treatment agreement.

• Firm but empathic -- you will still work with pt on pain treatment and primary care

• Pt is not bad; treatment is not effective, not safe, not appropriate.

• Benefits no longer outweighing harms. “Cannot responsibly continue prescribing opioids as I feel it would cause you more harm than good.”

Case57 M w/ chronic low back pain for 15 years after being

thrown out of a jeep

• After 8 weeks pt still experiencing significant pain that is negatively affecting function; you start opioids (MSContin 15 mg TID titrated to 30 mg TID) to good effect: improved pain and function

• One month later, routine UDT positive for cocaine

What was done/should have been done in advance

• Comprehensive approach to high-quality management of chronic pain

• Treatment agreement: discussion with pt about risk and benefits

• “Fair warning” that UDTs would be done• “Fair warning” that + UDT might mean

discontinuing opioids• Practice-wide decision about how

treatment agreement violations handled

What to do now?

• Get GC/MS confirmation of any unexpected result• (if confirmed) Talk to patient, reveal result of test, ask

him why he used• Show empathy but do not allow patient to dispute results• Show empathy but do not allow patient to shift blame: ‘I

did it because my pain was out of control/you are not treating my pain’

• Based on practice policy, either begin opioid taper or ‘second chance’ with close monitoring (1-2 week follow up with UDT)

• Consider addiction referral based on your assessment

Opioid Management: Summary

• If prescribed, opioids for chronic pain must be part of a comprehensive pain management plan

• Treatment agreements are useful to keep everyone on the same page

• Patients must be monitored for the 5 As• Know the tools available to you for monitoring

and how to use them• Opioids should be continued when effective and

safe, discontinued if ineffective or unsafe• Use this harm/benefit paradigm to help you

communicate with patient• Document

Thank you

Brief Visits

ComplicatedPatients

Resourcesnot meetingdemand

Fear of feeding into addiction/safety problems

Fear of Litigation

Joint CommissionMandate toManage pain

Desire to relieve suffering Patient Expectations

Managing opioids in Primary Care

Bibliography•Caudill-Slosberg et al. Pain (2004)•Davis WR, Johnson DB. Prescription opioid use, misuse, and diversion among street drug users in New York City. Drug and Alc Dep. 2008;92:267-276.•Fleming MF et al. J Pain. 2007•Katz NP. Patient Level Opioid Risk Management. PainEDU.org Manual. 2007 •Olsen Y et al. J of Pain (2006);•Passik J Opi Manage 2005•R.K. Portenoy, “Opioid Therapy for Chronic Nonmalignant Pain: Current Status,” in H.L. Fields and J.C. Liebeskind, eds., Progress in Pain Research and Management (Seattle: IASP Press, Vol. 1, 1994): at 267.•Monitoring the Future•National Survey of Drug Use and Health•Drug Abuse Warning Network•TEDS•Zacny JP, Galinkin JL. Psychotropic drugs used in Anesthesia Practice: Abuse Liability and Epidemiology of Abuse. Anesthesiology. 1999;90(1):269-288.

Total Chronic Pain Population

Aberrant Drug Related Behaviors (ADRB)

A spectrum of patient behaviors that may reflect misuse

Prescription Drug Misuse

Addiction(Abuse/Dependence)

Adapted from Passik. APS Resident Course, 2007

Outline

• Case

• Context

• Achieving balance

• Initiating opioid treatment

• Informed consent and agreements

• Monitoring and documentation (the 4 As)

• Responding to problems

Opioids for chronic pain

• Increasing use for musculoskeletal pain: 1980 to 20001

• 6% of all primary care visits in 20012

1. Caudill-Slosberg et al. Pain (2004); 2. Olsen Y et al. J of Pain (2006);

Sources of misused opioids

• 19% directly from a doctor

• 56% given for free by a friend or relative– 81% of those friends/relatives received

them from a doctor

• 9% bought from a friend or relative

• 4% from a drug dealer or stranger

http://oas.samhsa.gov/nsduh/2k6nsduh/2k6Results.pdf

Increasing opioid misuse, morbidity, mortality

• incidence misuse1,2

• admissions for addiction treatment3

• ED visits4

• overdose deaths5

1. MTF; 2. NSDUH; 3. TEDS; 4. DAWN; 5. CDC