Transcript Safe Prescribing of Drugs with Potential for Misuse and

Practical Approaches to
Opioid Prescribing:
Working Within the Guidelines
Adapted from Dr. Brenda Lau MD, FRCPC,
FFPMANZCA, MM
Learning Objectives
 Incorporate relevant guidelines and apply elements into a busy
practice:
› Canadian Guideline for Safe and Effective Use of Opioids for
Chronic Non-Cancer Pain
› College of Physicians and Surgeons of BC’s Standards and
Guidelines on Safe Prescribing of Drugs with Potential for
Misuse/Diversion
 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
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College of Physicians and Surgeons of BC’s
Standards and Guidelines on Safe Prescribing of
Drugs with Potential for Misuse/Diversion
 What is it?
› The College’s standard and guidelines for professional behaviour on
the prescribing of drugs with potential for misuse/diversion.
› The standard reflects legal requirements and is enforceable under
the Health Professions Act.
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Why was it developed?
› To support physicians in understanding and upholding their ethical
responsibilities in prescribing and in mitigating the problem of
prescription drug misuse.
 Why was it necessary?
 To provide clarity around legal requirements impacting physicians.
https://www.cpsbc.ca/files/pdf/PSG-Safe-Prescribing.pdf
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College of Physicians and Surgeons of BC’s
Standards and Guidelines on Safe Prescribing of
Drugs with Potential for Misuse/Diversion
 Available at:
https://www.cpsbc.ca/files/pdf/PSGSafe-Prescribing.pdf
 Included in the standard:
› Assessment and reassessment
requirements
› Documentation requirements
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The Canadian Guideline for Safe and Effective
Use of Opioids for Chronic Non-Cancer Pain
 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outdated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
http://nationalpaincentre.mcmaster.ca/opioid/,
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The Canadian Guideline for Safe and Effective
Use of Opioids for Chronic Non-Cancer Pain
CNCP = Chronic Non-Cancer Pain
*Courtesy of: “Toronto Rehabilitation Institute” Available at: http://nationalpaincentre.mcmaster.ca/opioid/
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Effects of Chronic Pain on the Patient
Physical
Functioning
Moods
Mobility
Depression
Impaired Immununity
Anxiety
Sleep disturbances
Anger
Fatigue
Irritability
Loss of appetite
Social Functioning
Diminished social
relationships (family/friends)
Societal
Consequences
Health care utilization
Disability
Decreased sexual
function/intimacy
Loss of work days or
employment
Decreased recreational and
social activities
Substance abuse
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.
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Deciding to Initiate Opioid Therapy – Cluster 1
 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, physician access
to PharmaNet profile)
 Responsible prescribing of opioids
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Who to be Careful with Prescribing Opioids
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Obese
Congestive Heart Failure
Sleep Apnea
Chronic Lung Disease
Renal Insufficiency
Hepatic Insufficiency
Elderly
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Opioid Risk Tool & Checklist
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Universal Precautions in Pain Medicine
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
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Content of a Treatment Agreement
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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
Physician’s Signature
Date
Date
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Universal Precautions in Pain Medicine
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 time to one month’s
supply
7. 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 behaviour
› Accurate medication record
› Affect
9. Periodically review Pain Diagnosis and co morbid conditions including addictive disorders
10. Offer take home naloxone prescription to patients at risk for respiratory depression as a
consequence of receiving opioid medication.
11. DOCUMENT, DOCUMENT, DOCUMENT
(Passik 2000)
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Naloxone
 The 2016 College of Physicians and Surgeons of BC’s Standard on the
Safe Prescribing of Drugs with Potential for Misuse and Diversion
requires that:
Physicians offer take home naloxone prescription to patients at risk
for respiratory depression
 Dosage 0.4mg/ml – 1 ml im, iv or sq
 Side-effects – main symptoms related to abrupt opioid withdrawal in
physically dependent persons
College of Physician and Surgeons' Safe Prescribing of Drugs with Potential for Misuse and Diversion
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Conducting an Opioid Trial Summary – Cluster 2
 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/.
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Things to avoid:
 Physicians must not:
› Prescribe benzodiazepines, or other sedative/hypnotic
medications to patients on Long Term Opioid Treatment,
other than as a documented taper.
› Prescribe combinations of prescription drugs that are
pharmacologically irrational, such as combinations of
stimulants, opioids and/or sedatives.
› Initiate treatment with drugs with a high risk-profile such
as methadone and fentanyl without relevant training and
experience.
Professional Standards and Guidelines – Safe Prescribing of Drugs with Potential for
Misuse/Diversion June 1, 2016; College of Physicians and Surgeons of BC
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Opioid Manager
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Goals Guide Treatment Options
Psychological
Chronic pain
self-management programs
Physical / Rehabilitative
Goals
Complementary and
Alternative Medicine
Medical
Pharmacological
Interventional
Adapted from Jovey RD, 2008
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The Analgesic Toolbox
Nonopioid
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 Selection
Selection 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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Opioids: Initial Dose and Titration
Opioid
Start
Dose
Codeine
15-30mg q4h
CR Codeine
50mg q12h
Tramadol +
Tylenol
1 tab q4-6h prn
(4/d)
CR Tramadol
Zytram XL
150mg
Tridural 100mg
Ralivia 100mg
IR Morphine
5-10mg q4h prn
up to 40mg /d
CR Morphine
10-30 mg q12h
Convert to CR
when reaching
Minimum
time interval
for increase
100mg daily
1 week
15-30mg/day
(600mg/d)
2 days
50mg/d
(300mg q12h)
1 week
1-2 tab q4-6h prn
(8/d)
1 week
(400mg/d)
2 days
5 days
(300mg/d)
(300mg/d)
1 week
5-10mg/d
Min 2 d
5-10mg/d
3 tabs
20-30mg
Suggested dose
increase
(max)
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Opioids: Initial Dose and Titration
Opioid
Start
Dose
Convert to CR
Minimum
when
time interval
reaching
for increase
IR Oxycodone
5-10mg q6h
prn up to
30mg/d
CR Oxycodone
10-20mg q12h
up to 30mg/d
1 week
5mg/day
Min 2 days
10mg/d
1 week
1-2 mg/d
CR
3mg q12h up
Hydromorphone to 9mg/d
Min 2 days
2-4mg/d
OROS
8mg OD
Hydromorphone
2 days
25-100% of
starting dose
IR
1-2mg q4-6h
Hydromorphone prn up to
8mg/d
20mg daily
Suggested dose
increase
(max)
6mg
Maalis-Gagnon, Elafi Altlas 2010
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Urine Drug Screen
 Order at least annual random urine drug testing (rUDT) and/or
random pill counts for all patients on long-term opioids,
sedatives or stimulants.
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PO Opioid Analgesic Equivalence table
Morphine
10mg
Codeine
60mg
Oxycodone
7.5mg
(O:M= 2:1 acute
1.5:1 chronic)
Hydromorphone
2mg(H:M=5:1)
Meperidine
100mg
Methadone
Variable
Transdermal fentanyl
25ug/h = 60-134 mg
37ug/h = 135-179mg
50ug/h = 180-224mg
62ug/h = 225-269mg
75ug/h = 270-314mg
100ug/h = 360-404mg
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When to Stop Opioid Therapy
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
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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Tapering Opioid Therapy
 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
Ballantyne JC et al, 2003; Chou R et al, 2009
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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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Key Learning Points
 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.
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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 use
 Compulsive use
 Continued use despite harmful consequences
 Craving
American 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 oversedation, 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
 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%).
 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);
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Thank You
Questions?