Framing the issue of OxyContin use in KFL&A

and Ontario

Dr. Ariella Zbar, PGY-1 Public Health & Preventive Medicine

Queen’s University March 22nd, 2012

Conflict of interest

None declared

Opioids in Canada & Ontario

Canada is the world’s third largest per capita consumer of opioids1.

Ontario has the highest rate of narcotics use in the country2:

900% increase in # oxycodone prescriptions written in the last 20 years.

Each year, 300-400 people die from overdoses involving prescription opioids.

Recently, the opioid most commonly implicated is

oxycodone. 1. International Narcotics Control Board. Narcotic drugs: estimated world requirements for

2010; statistics for 2008. New York, United Nations, 2010 (E/INCB/2009/2). 2. Ontario Public Drug Programs Division. Notice from the Executive Officer: RE:

Important Notice Regarding Change in Funding Status of Oxycodone Controlled Release Tablet. Toronto: Ontario Public Drug Programs Division; 2012.

Opioids in Ontario

Gomes T, et al. Geographical variation in

opioid prescribing and opioid-related mortality

in Ontario. Healthcare Q. 2011;14(1):22-4.

Investigated the association between opioid prescribing and opioid-related mortality in Ontario.

Between Jan 1st, 2004 and Dec 31st, 2006, the following relationship was described…

Opioids in Ontario

Opioids in Ontario

Each additional opioid prescription dispensed per OPDP beneficiary annually = increase in annual opioid-related mortality rate by 0.54 per 100,000 residents.

In context, annual mortality rates3 for… Malignant neoplasms = 163.6 Heart disease = 107.9 Tuberculosis = 0.2 Meningitis = 0.1

3. Statistics Canada. Age-standardized mortality rates by selected causes, by sex. 2008. Reproduced and distributed on an "as is" basis with the permission of Statistics Canada.

Health Unit Mortality Rate per

100,000 averaged over 2004-

2006 Hastings and Prince Edward Public Health Unit 3.49

Huron Public Health Unit 2.17

Kent-Chatham Public Health Unit 3.27 Kingston-Frontenac-Lennox and

Addington PHU 4.54

Lambton Public Health Unit 3.52 Leeds-Grenville-Lanark Public Health Unit 1.59

Opioids in KFL&A

Upcoming presentations

Dr. Roger Skinner, Regional Supervising Coroner, East Region Coroner Inquest in Brockville and recommendations of the jury

Dr. Keith Duggan, Department of Anesthesiology and Perioperative Medicine Use of opioids for chronic non-cancer pain

Sherri Elms, Pharmacist, Queen’s Family Health Team Pharmacology of OxyContin and OxyNeo, equianalgesic dosing of opiates

and constructing a narcotics contract

Dr. Meredith MacKenzie, Street Health Centre, Kingston Substitution therapy and managing opioid withdrawal

Ron Shore, Director, Clinical Services, Kingston Community Health Centres

Dr. Wayne Spotswood, Assistant Professor, Emergency Medicine, Queen’s University

Opioid Management in Times of Change: The Use of Opioids for

Chronic non-Cancer Pain (CNCP)

Dr. Scott Duggan, MSc, FRCPC Assistant Professor – Queen’s University

Department of Anesthesia and Perioperative Medicine

Clinic Fellow – Chronic Pain Clinic

The Ottawa Hospital

Disclosures

2011 Clinical Pain Fellowship Award Canadian Pain Society/Pfizer Canada

Opioid prescribing in the media…

The Pain and Addiction Continuum

Improves Function

Impairs Function (Addiction)

Opioid Effect on the Pain Patient

Opioid Prescribing…Opioid Misuse

• Minimal training for safely prescribing opioids

• Applying the WHO analgesic ladder to non-cancer pain

• The (mis)perception that – “no ceiling dose with

opioids” – physicians should “dose

to effect”

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

• 2007 – National Opioid Use Guideline Group formed – Aim

• Assist physicians in managing patients with Chronic non-Cancer Pain (CNCP) through safe and effective opioid prescribing

– Principles • Patients deserve to have their chronic pain treated • Best available evidence should be used to create a

national consensus of expert opinion • Collaborative and autonomous effort involving clinician and

patient input • The guideline is an evidence-based resource intended to

educate/inform clinicians and to guide practice decisions

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

• 6580 studies (184 used) to create 49 draft recommendations

• 24 practice recommendations… – Deciding to initiate opioid therapy – Conducting an opioid trial – Monitoring long term opioid therapy – Treating specific populations – Managing opioid misuse and addiction in CNCP

• Guideline published in 2010

Recommendation Grading

• Grade A: Recommendations are supported by evidence from RCT(s)

• Grade B: Recommendations are supported by: – Evidence from controlled trial(s) without randomization or – Evidence from cohort or case-control analytic studies,

preferably from more than one centre or research group, or – Evidence from comparisons between times or places with or

without the intervention; dramatic results in uncontrolled experiments could be included here

• Grade C: Recommendations are supported by consensus opinion of the National Advisory Panel

Canadian Guideline for Safe and Effective Use of Opioids for CNCP

Cluster 1: Deciding to Initiate Opioid Therapy Recommendations

• Before initatiating opioid therapy.. 1. Conduct comprehensive assessment of patients pain

condition, general medical condition, psychosocial history (Grade C), psychiatric status and substance abuse history (Grade B)

2. Addiction risk screening (Grade B)

Canadian Guideline for Safe and Effective Use of Opioids for CNCP

Brief Pain Inventory

Opioid Risk Tool Designed to predict which patients may develop aberrant, drug related behavior • Low (0-3) • Medium (4-7) • High (≥8) Low risk: 6% chance of developing problematic behaviors High risk: >90% chance of developing problematic behavior

Cluster 1: Deciding to Initiate Opioid Therapy Recommendations

• Before initiatiating opioid therapy.. 1. Conduct comprehensive assessment of patients pain condition,

general medical condition, psychosocial history (Grade C), psychiatric status and substance abuse history (Grade B)

2. Addiction risk screening (Grade B) 3. Urine drug screening for baseline risk and compliance

(Grade C) 4. Consider evidence for opioid efficacy in CNCP (Grade A) 5. Obtain informed consent of benefits risks, adverse

effects and complications (Grade B). Consider treatment agreement? (Grade C)

6. Consider benzodiazepine tapering or slow opioid titration (Grade B&C)

Canadian Guideline for Safe and Effective Use of Opioids for CNCP

Cluster 2: Conducting an Opioid Trial

• During dosage titration 7. Advise patients to avoid driving until stable dosage

(Grade B&C)

8. Select the most appropriate opioid using a stepped approach (Grade C)

9. Start low, increase slow, monitor effectiveness (Grade C)

10. CNCP can be managed effectively in most patients with dosages ≤ 200 mg/day of morphine or equivalent (Grade A)

11. For high risk patients prescribe for only well-defined somatic or neuropathic pain conditions…start low, increase slow, and monitor for signs of aberrancy (Grade A,B,C)

Canadian Guideline for Safe and Effective Use of Opioids for CNCP

Cluster 3: Monitoring Long-Term Opioid Therapy

12.Assess opioid effectiveness, adverse effects, complications or aberrancy (Grade C)

13.Switch or discontinue if unacceptable or insufficient effectiveness (Grade B)

14.Consider factors that impair driving safety – severe pain rating, sleep disorders, sedating medication (Grade C)

15.Ensure long term therapy is warranted - revisit opioid trial steps (Grade C)

16. If employing collaborative care, communicate and clarify roles to ensure opioid effectiveness and safety (Grade C)

Canadian Guideline for Safe and Effective Use of Opioids for CNCP

Cluster 4: Treating Specific Populations with Long-Term Opioid Therapy

17.Start lower, titrate slower, longer dosing, frequent monitoring and taper benzodiazepines for elderly patients (Grade B)

18.Adolescent patients present a hazard (Grade B&C)

19.Pregnant patients should be tapered to lowest effective dose and tapered slowly to avoid withdrawal symptoms (Grade B)

20.Co-morbid pyschiatric diagnoses are greater risk for adverse effects (Grade B)

Canadian Guideline for Safe and Effective Use of Opioids for CNCP

Cluster 5: Managing Opioid Misuse and Addiction in CNCP Patients Recommendations

21.CNCP patient addiction treatment options – Methadone or buprenorphine (Grade A)

– Structured opioid therapy (Grade B)

– Abstinence-based therapy (Grade C)

22.Reduce prescription fraud (Grade C)

23.Prepare an approach for Patient unacceptable behaviour (Grade C)

24.Develop policies to avoid opioid misuse or diversion (Grade C)

Canadian Guideline for Safe and Effective Use of Opioids for CNCP

Canadian Guideline for Safe and Effective Use of Opioids for CNCP

Canadian Guideline for Safe and Effective Use of Opioids for CNCP

Universal Precautions in Pain Medicine: Minimizing Risk – Maximizing Relief

1. Make a diagnosis with appropriate differential 2. Psychological assessment, including risk of addictive

disorders 3. Informed consent 4. Treatment agreement 5. Pre-/post intervention assessment of pain level and function 6. Appropriate trial of opioid therapy ± adjunctive medication 7. Reassessment of pain scores and level of function 8. Regularly assess the “Four As” of pain medicine (Analgesia,

Activities, Adverse Effects and Aberrant Behaviour) 9. Periodically review pain diagnosis and comorbid conditions,

including addictive disorders 10. Document in the medical records

Gourlay DL, Heit HA et al. Pain Med. 2005;6:107-12

Pain and Addiction Continuum

• Pain and addiction may exist as co-morbid conditions but can also present as a dynamic continuum

• The treatment can be both the problem and the solution

• Important to identify which factor is dominant

• Many experts feel that chronic pain can not be effectively treated until the addiction issue is first addressed

Gourlay DL and Heit HA. J Add Dis. 2008;27:23-30.

Take home points

• Before prescribing opioids… – Do a comprehensive assessment of the pain problem – Assess for addiction risk – Set goals and patient expectations – Review with the patients – opioid adverse effects;

complications and risks (informed consent) – Document, Document, Document

• The Canadian Opioid Guideline

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

Canadian Guideline for Safe and Effective Use of Opioids for CNCP

Some good advice from one of my Ottawa mentors

The approach to the Chronic Pain Patient is a mixture of…

Science

Placebo

Voodoo

It’s alright to use any of these approaches as long as you remember

which is which…

Pharmacology of

OxyContin and OxyNEO,

Equianalgesic Doses of Opioids and

Constructing a Narcotic Contract

Sherri Elms RPh ACPR

Out with the old, in with the new

Why?

To reduce abuse

◦ Harder to break

◦ Forms a gummy gel with water or alcohol –

cannot be drawn into a syringe or snorted

BUT …

◦ Not all abuse is snorting or injecting

◦ Reports of choking in patients with

swallowing difficulties

Pharmacists Letter Jan 2012 (28)

Pharmacokinetics

Bioequivalent – meaning the same amount

of drug is absorbed

BUT

◦ Peak is delayed (perceived as less effective?)

◦ Peak is slightly higher (more adverse effects?)

Availability

OxyContin OxyNEO

5mg -

10mg 10mg

15mg 15mg

20mg 20mg

30mg 30mg

40mg 40mg

60mg 60mg – not covered by ODB

80mg 80mg – only covered for palliative patients

Equianalgesic Doses

670mg

• Codeine

100mg • Morphine

75mg • Oxycodone

20mg • Hydromorphone

25mcg * • Fentanyl

Incre

asing P

ote

ncy

* topically/24hrs

Equivalences

http://nationalpaincentre.mcmaster.ca/opioid/cgop_b_app_b08.html#table_b_app_b01_01

Easier Way

Convert oxycodone 24 hour dose to another

agent

◦ Oxycodone (mg) x 0.3 = hydromorphone (mg)

◦ Oxycodone (mg) x 1.5 = morphine (mg)

Reduce dose by 25-50% for incomplete cross-

tolerance

Breakthrough? If any – 10% of the 24 hour dose

– more for planned incident pain

Policy at Queen’s

OPIOID TREATMENT AGREEMENT

Written, signed, dated

Only one prescriber, one pharmacy

Consequences to early or replaced prescriptions

Regular follow-up

Drug testing as required

Open communication with others including family, other doctors and pharmacy

Dr Ruth Dubin - Universal Precautions for Opioid Prescribing July 2011

Useful References

Canadian Guideline for Safe and Effective

Use of Opioids for Chronic Non-Cancer

Pain

www.nationalpaincentre.mcmaster.ca/opioid/

• Urine Drug Testing in Clinical Practice www.familydocs.org/files/UDTMonograph_for_web.pdf

Opioid Dependency Treatment Options

KFLA March 22, 2012

Meredith MacKenzie

Physician, Street Health Centre

Kingston, ON

Conflicts: NONE

DSM 4 Definitions: Opioid Abuse

1 or more in a 12 month period:

Recurrent use resulting in failure to fulfill major roles in work, school or home

Recurrent use in physically hazardous situations

Recurrent substance related legal problems

Continued use despite persistent or recurrent social or interpersonal problems caused or exacerbated by substance

Opioid Dependence: 3 or more in a 12 month period:

Tolerance (marked increase in amount; marked decrease in effect)

Characteristic withdrawal symptoms; substance taken to relieve withdrawal

Substance taken in larger amounts and for longer period than intended

Persistent desire or repeated unsuccessful attempts to quit

Treatment Options: Abstinence

Psychosocial Treatment Programs

Medical Detoxification

Opioid Agonist Therapies

Opioid Antagonist Therapy

Abstinence: Consider this option when:

Highly motivated

Good existing supports in place

Medical Detoxification: Consider this in patients who:

Are dependent only on opioids and in particular, ORAL users

Have a brief duration of dependence (ie less than one year)

Are younger

Have no major psychiatric comorbidity

Are socially stable with a supportive network

Withdrawal Management: Clonidine 0.1 mg 1-2 tabs po bid-qid prn agitation,

diaphoresis, and sympathetic overdrive

Dimenhydrinate 50 mg po or pr; prn nausea

Ibuprofen 200 mg 1-2 tabs tid prn myalgia

Loperamide 2 mg po prn (max of 6/day) prn diarrhea

Trazodone 50-100 mg po qhs prn insomnia

Clonidine Precautions: Do not prescribe clonidine if BP < 90/60, patient is pregnant, on antihypertensives or has

heart disease

Warn patients about postural symptoms and drowsiness. Postural symptoms are dose-related.

Warn about mixing with opioids, or having prolonged hot baths (both lead to hypotension).

Keep prescription to less than 14 days (rebound HTN).

Warn about risk of overdose if they relapse (loss of tolerance).

Always use clonidine in conjunction with treatment plan.

Buprenorphine/naloxone Management of Acute Withdrawal:

Initial dose is similar to maintenance protocol (4-8 mg per day)

Increase dose by 2-4 mg daily until therapeutic dose achieved (usually 8-16 mg)

Reduce dose by 2 mg every week

Use adjuvant medications as necessary (anti-inflam/anti-diarrheals etc.).

Psychosocial Treatment Programs:

Inpatient and outpatient programs have similar results.

Offer comprehensive assessment, group and individual therapy, patient education and long-term follow-up.

www.drugandalcoholhotline.ca

Agonist Therapy: MMT and Suboxone

Agonist therapy results in improved treatment retention and decreased substance use compared to all forms of acute opioid detoxification.

Agonist therapy reduces mortality and drug use and retains patients in treatment.

Methadone Maintenance: Prescription opioids in varying forms have become

the predominant form of illicit opioid use (Fisher et al. 2005)

Prescription opioid users can be treated at least as effectively as heroin users (Banta-Green et al. 2009).

Methadone Eligibility: Meet DSM 4 criteria for opioid dependency for at least

one year (or intermittent use for longer periods).

Physical signs of chronic drug use (eg. Track marks).

Physical signs of withdrawal.

Recently released from incarceration (relapse prevention).

Age 18 or above (with exceptions).

MMT Pharmacology (BRIEF): Long acting, pure mu-agonist

Half life 22 hours (huge variability)

Peaks at 4 hours

SE similar to opioids

Prolongs QT interval

Risk of death is highest in the first TWO weeks of treatment

Avoid prescribing BDZ or let MMT provider know

Indications for MMT in Opioid Dependency:

Pregnancy

Where withdrawal during induction is clinically dangerous

Failure of Suboxone

History of injecting buprenorphine

SE or allergy to buprenorphine

Xerostomia

Past history of success with MMT

MMT Precautions: Recent benzodiazepine use or use of other sedating

drugs

Respiratory illnesses

Alcohol dependent patients

Over 60 years old

Respiratory Illness

Taking drugs that inhibit methadone metabolism

Lower opioid tolerance

Decompensated liver disease

Suboxone: Buprenorphine + naloxone

Partial opiate agonist (mu) + opiate antagonist (K)

Naloxone addition intended to reduce IV misuse.

Suboxone Pharmacology: Very high affinity for mu-receptor and will displace

methadone, morphine and other full opioid agonists...sits at the receptor site for a long time (binds tightly but only partially stimulates).

Partial agonist activity means better safety profile; limited ability to cause respiratory depression.

Withdrawal syndrome milder, therefore easier to taper off

Suboxone Pharmacology: Starts to work within 30-60 minutes

Peaks 1-4 hours

Max plasma concentration after SL ranges from 40 min to 3.5 hours.

Elimination ½ life 24-36 hours

Duration of action dose dependent

Maximum daily dose 24 mg

Probably less effective than MMT at doses above 60-80 mg.

Indications for Suboxone in Opioid Dependency:

Good prognosticators

Prior addiction treatment

Those who have not done well on MMT

Those with significant SE to MMT

MMT contraindicated

Patient choice

Access (drug plans and geography)

Suboxone Contraindications: Pregnancy

Allergy

Severe liver dysfunction

Acute severe respiratory illness

Decreased level of consciousness

Paralytic ileus

Inability to provide informed consent

Elevated transaminases (>3-5 x ULN)

Suboxone vs Methadone:

Antagonist Therapy: Naltrexone

Resources: ConnexOntario Health Services Information (drugandalcoholhelpline.ca)

DART

ACCS 1-888-720-2227

Suboxone and MMT guidelines available online: www.cpso.on.ca

CAMH “toolkit” for MMT and buprenorphine providers www.camh.net

Canadian guideline for safe and effective use of opioids for CNCP: http://nationalpaincentre.mcmaster.ca/opioid