Practical Approaches to Opioid Prescribing:

Working Within the GuidelinesAdapted from Dr. Brenda Lau MD, FRCPC,

FFPMANZCA, MM

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Incorporate the Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain and apply elements into a busy practice

Help you effectively utilize supporting tools such as the

› Brief Pain Inventory (BPI) and the

› Opioid Risk Tool (ORT), and

Implement improved opioid monitoring practices, including documenting the

› 6 A’s and using the Opioid Manager*

› Weaning guidelines

Learning Objectives

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What is it?

› An evidence-based guideline with 24 recommendations outlining how to use opioids to treat patients with CNCP

Why was it developed?

› Existing treatment information and guidelines were found to be outdated

Why was it necessary?

› To improve the safety and care of CNCP patients being treated with opioids, and to safely manage potential side effects (including addiction) and the risk of opioid misuse

The Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain

http://nationalpaincentre.mcmaster.ca/opioid/,

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Available at: http://nationalpaincentre.mcmaster.ca/opioid/

The Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain

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CNCP = Chronic Non-Cancer Pain *Courtesy of: “Toronto Rehabilitation Institute” Available at: http://nationalpaincentre.mcmaster.ca/opioid/

The Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain

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Moods

Depression

Anxiety

Anger

Irritability

Social Functioning

Diminished social relationships (family/friends)

Decreased sexual function/intimacy

Decreased recreational and social activities

Societal Consequences

Health care utilization

Disability

Loss of work days or employment

Substance abuse

Physical Functioning

Mobility

Impaired Immununity

Sleep disturbances

Fatigue

Loss of appetite

Ashburn MA, et al. Lancet. 1999;353:1865-1869. Harden RN. Clin J Pain. 2000;16:S26-S32. Agency for Health Care Policy and Research. Clinical Practice Guideline No. 9. 1994. Meyer-Rosberg, K et al. Eur J Pain. 2001;5:379-389. Zelman D, et al. J Pain. 2004;5:114. Manchikanti L, et al. J Ky Med Assoc. 2005;103:55-62. Hoffman NG, et al. Int J Addict. 1995;30:919-927.

Effects of Chronic Pain on the Patient

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Pain is moderate to severe

Pain has significant impact on function and QOL

Non-opioid pharmacotherapy has been tried and failed

Opioids indicated for specific pain condition

Opioid risk assessment has been done & documented

Informed consent (goals, risks, benefits, AEs, complications …)

Patient agreeable to have opioid use closely monitored (UDS, treatment agreement, freedom of information …)

Responsible prescribing of opioids

Deciding to Initiate Opioid Therapy – Cluster 1

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Opioid Risk Tool & Checklist

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1. Diagnosis with appropriate differential

2. Psychological assessment

› Including risk of addictive disorders

3. Informed consent

› Verbal v. written/signed

4. Treatment agreement

› Verbal v. written/signed

5. Pre trial assessment of pain/function and goals

Universal Precautions in Pain Medicine

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One prescriber (include name) One dispensing pharmacy (include name) Will comply with safe/secured storage of opioid; Will comply with no driving while

titrating No sharing/selling of opioid; No accepting of any opioid medications from anyone else Will not change the dose or frequency of taking the medication without consulting the

doctor Strict rules with respect to medication loss, early refills, possible abuse or diversion

(e.g. Dr._________ will not prescribe extra medication for me. I will have to wait until the next prescription is due.)

Strict rules with respect to concomitant usage of other sedating medications, OTC/prescription opioids, recreational drugs (e.g. 222’s, Tylenol® #1 …)

Will comply with scheduled office visits and consultations Will comply with pill/patch counts and random UDS when requested, and with limited

quantity of opioid dispensed per prescription Adverse effects, medical complications and risks (including addiction) of opioids

understood Freedom of information permitted Understanding and agreement that if there is no demonstrable improvement in

functionality, the physician reserves the right to wean patient off his/her opioid medications.

Understanding that if these conditions are broken, Dr. _______ may choose to cease writing opioid prescriptions for me

Patient’s Signature Date Physician’s Signature Date

Content of a Treatment Agreement

11(Passik 2000)

6. Appropriate trial of opioid therapy

› +/- adjuvants

› Replace short-acting opioid with long-acting opioid at equivalent dose

› Limit the number of pills/patches that a patient may have at one time7. Reassessment of pain score and level of function

8. Regular assess the “Six A’s” of pain medicine

› Analgesia

› Activities

› Adverse effects

› Ambiguous drug taking behaviur

› Accurate medication record

› Affect

9. Periodically review Pain Diagnosis and co morbid conditions including addictive disorders

10.DOCUMENT, DOCUMENT, DOCUMENT

Universal Precautions in Pain Medicine

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Start low, go slow

› Titrate to “optimal dose”

› Remember safety issues when selecting opioids, including altered pharmacokinetics (e.g. liver/kidney) &/or drug interactions

› Comprehensive review before nearing the “watchful dose”

Document progress / opioid effectiveness

Monitor adverse effects, medical complications, risks

› Opioid Manager*

› 6 A’s

If risks outweigh benefits, then: switch, taper ± discontinue

*Courtesy of: “Toronto Rehabilitation Institute” Available at: http://nationalpaincentre.mcmaster.ca/opioid/.

Conducting an Opioid Trial Summary – Cluster 2

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Opioid Manager

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Physical / RehabilitativePsychological

MedicalPharmacologicalInterventional

Goals

Adapted from Jovey RD, 2008

Complementary and Alternative Medicine

Chronic pain self-management programs

Goals Guide Treatment Options

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The Analgesic Toolbox

Non-opioid

Acetaminophen, ASA, COXIB, NSAID

Opioid Buprenorphine transdermal system, codeine, fentanyl transdermal system, hydromorphone, morphine, oxycodone, tramadol

Choice exists between IR (immediate release) and CR (controlled release)

formulations for many agents

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Basis for Opioid SelectionSelection Criteria:

Current /past efficacy and side effect profile of short-acting opioid

Convenience and compliance potential

Cost (coverage by drug plan or ability to pay)

Patient preference

History of abuse/misuse/diversion (screen)

Concomitant health conditions necessitating adjustments in dosage and/or dosing interval of some opioids (e.g., morphine or codeine in renal failure)

Compromised oral route

Evidence of molecule efficacy for different pain characteristics

Chou R et al, 2009; Gardiner-Nix; Wisconsin Medical Journal, 2004 ; Jovey RD et al, 2002

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Opioid StartDose

Convert to CR when reaching

Minimum time

interval for increase

Suggested dose increase(max)

Codeine 15-30mg q4h 100mg daily 1 week 15-30mg/day (600mg/d)

CR Codeine 50mg q12h 2 days 50mg/d (300mg q12h)

Tramadol + Tylenol

1 tab q4-6h prn (4/d)

3 tabs 1 week 1-2 tab q4-6h prn (8/d)

CR Tramadol Zytram XL 150mgTridural 100mgRalivia 100mg

1 week

2 days5 days

(400mg/d)

(300mg/d)(300mg/d)

IR Morphine 5-10mg q4h prn up to 40mg /d

20-30mg 1 week 5-10mg/d

CR Morphine 10-30 mg q12h

Min 2 d 5-10mg/d

Opioids: Initial Dose and Titration

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Opioid StartDose

Convert to CR when reaching

Minimum time

interval for increase

Suggested dose increase

(max)

IR Oxycodone 5-10mg q6h prn up to 30mg/d

20mg daily 1 week 5mg/day

CR Oxycodone

10-20mg q12h up to 30mg/d

Min 2 days 10mg/d

IR Hydromorphone

1-2mg q4-6h prn up to 8mg/d

6mg 1 week 1-2 mg/d

CR Hydromorphone

3mg q12h up to 9mg/d

Min 2 days 2-4mg/d

OROSHydromorphone

8mg OD 2 days 25-100% of starting doseMaalis-Gagnon, Elafi Altlas 2010

Opioids: Initial Dose and Titration

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Morphine 10mg

Codeine 60mg

Oxycodone 7.5mg (O:M= 2:1 acute1.5:1 chronic)

Hydromorphone 2mg(H:M=5:1)

Meperidine 100mg

Methadone Variable

Transdermal fentanyl 25ug/h = 60-134 mg37ug/h = 135-179mg50ug/h = 180-224mg62ug/h = 225-269mg75ug/h = 270-314mg100ug/h = 360-404mg

PO Opioid Analgesic Equivalence table

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When patient: Does not realize meaningful pain relief from therapy

Has adverse reactions to opioids, such as depression or respiratory depression

Does not achieve reasonable therapeutic goals such as improved physical or social functioning, even with effective pain relief

When to Stop Opioid Therapy

Ballantyne JC et al, 2003; Benyamin R et al, 2008; Chou R et al, 2009; Porreca F et al,2009; Slatkin NE, 2009

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Discuss with the patient and other responsible persons who may be helpful. Patients with aberrant behaviour or addiction may refuse to comply and leave treatment, seeking opioids elsewhere.

› Controlled withdrawal from opioids is not dangerous

› May experience discomfort, anxiety, restlessness, nausea, sweating, etc.

Reassure patient of alternative plan for pain control.

Document discussions and provide a written treatment plan

If the patient is taking a sedative or benzodiazepine, these should be maintained

Tapering Opioid Therapy

Ballantyne JC et al, 2003; Chou R et al, 2009

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2010 National Opioid Use Guidelines (NOUG) serve to improve the responsible use of opioids in Canada

When considering the use of long-term opioid therapy, screening for addiction risk must be a part of the assessment process

Improvement in function as measured with the BPI is a key factor supporting the continuation of CR opioids in CNCP

Management of CNCP is multi-modal using non-opioid medications, interventional techniques and self-management strategies.

Key Learning Points

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Opioid Tapering Protocol

Use controlled-release products for 24 hour coverage Decrease by 10% of total daily dose ( ranging from

every day to) every 1 to 2 weeks. Once one-third of original dose is reached, decrease

by 5% every 2 to 4 weeks. Hold the dose when appropriate: The dose should be

held or increased if the patient experiences severe withdrawal symptoms, a significant worsening of pain or mood, or reduced function during the taper

Taper can usually be completed between 2 weeks… to 4 months.

http://nationalpaincentre.mcmaster.ca/opioid

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Distinguishing between dependence, tolerance & addiction

Physical dependence: withdrawal syndrome arises if drug abruptly discontinued, dose substantially reduced, or antagonist administered

May start after two weeks of regular use Withdrawal symptoms:

Early: agitation, anxiety, insomnia, muscle aches, tears, runny nose, sweating, yawning

Late: nausea, vomiting, abdominal cramping, diarrhea, dilated pupils, goose bumps

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Distinguishing between dependence, tolerance & addiction

Tolerance: greater amount of drug needed to maintain therapeutic effect, or loss of effect over time

Pseudoaddiction: behavior suggestive of addiction; caused by undertreatment of pain (e.g., increased focus on obtaining medications or “drug seeking,” “clock watching,” use of illicit drugs, or deception) American Pain Society (2006).

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Distinguishing between dependence, tolerance & addiction

Addiction (psychological dependence):a primary, chronic, neurobiologic disease, with

genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following:

(the 4 C`s of addiction) impaired control over drug usecompulsive usecontinued use despite harmful consequencesCravingAmerican Academy of Pain Medicine, the American Pain Society and the American Society of Addiction Medicine (2001).

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Addiction risk with chronic opioid therapy

Between 4% and 26% of patients have an opioid use disorder

One out of ten misuse opioids by: intentional over-sedation, concurrent alcohol use for pain relief, hoard medications, increase dose on their own, borrow opioids from others

Andrea Furlan www.support PROP.org Ballantyne J and LaForge S Opioid dependence and

addiction during opioid treatment of chronic pain Pain 129 (2007) 235–255

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Addiction risk of opioids for chronic pain A comprehensive systematic review to assess the incidence and

prevalence of dependence syndrome (ie, addiction) associated with opioid therapy for pain relief in adults with and without a previous history of substance abuse

Of 2,871 potentially relevant studies identified (excluding duplicate studies), data were extracted from 17 investigations that qualified for inclusion, involving a total of 88,235 patients

Minozzi et al. found that the incidence of addiction reported across the various studies ranged from 0% to 24% (median 0.5%), while prevalence ranged from 0% to 31% (median 4.5%). However, there was a great amount of variation among the studies, or heterogeneity, in terms of design, definitions of addiction, data collection, and other factors, so a data meta-analysis could not be conducted. Overall, the researchers rated the evidence as being of very low quality

Authors conclusion :“The available evidence suggests that opioid analgesics for chronic pain conditions are not associated with a major risk for developing dependence [addiction].”

Minozzi S, Amato L, Davoli M. Development of dependence following treatment with opioid analgesics for pain relief: a systematic review. Addiction. 2012(Oct18);

Thank You

Questions?