The Nurse Practitioner Role in Increasing Access to Pain

Care

An introduction toStrategies and Tools for Safe and

Effective Practice

With thanks to Purdue Pharma for the use of their accredited slides, part of Purdue Pharma’s “Pain and Symptom Management” series.

Celina DaraRPh, ACPR, PharmD

ObjectivesObjectivesA review of current and future Ontario legislation

to enable Nurse Practitioner prescribing of opioids

A review of how prescriptions for opioids should be written in Ontario.

A review of assessment tools, screening tools and documentation necessary to assist in the management of chronic non-cancer pain (CNCP).

Understand how to use Universal Precautions to prescribe and manage opioids safely

Expanding the NP scope of Expanding the NP scope of practicepractice

Controlled Drugs and Substances Act (CDSA) “Addition of New Practitioner Regulations”, 2007◦ allow nurse practitioners to possess, administer, sell or provide,

prescribe, and/or transport certain controlled substances, only if the authorization to prescribe controlled substances within the scope of their practice is permitted by provincial/ territorial law where they practice.

Bill 179, the Regulated Health Professions Statute Law Amendment Act, 2009◦ considering the NP authority of open prescribing of pharmaceuticals and

other substances, ie, to prescribe, dispense, mix and sell drugs without restrictions.

Bill 101, the Narcotics Safety and Awareness Act 2010◦ In May 2010, the Government of Ontario developed a strategy to

address the health and safety concerns related to the use of narcotics and other controlled substances

Barriers◦ understanding of the role and scope for a NP◦ Licensing authority to address the core competencies of the regulated

profession

Legal requirements for a narcotic Legal requirements for a narcotic prescriptionprescription The registration number on the certificate of registration

issued to the prescriber by the College, as defined in the Regulated Health Professions Act, 1991, of which he or she is a member (Bill 101).

The name of the person for whom the monitored drug is prescribed.

The name, strength (where applicable) and quantity of the monitored drug.

The directions for use of the monitored drug. The name and address of the prescriber. The date on which the monitored drug is prescribed. Any other information, including personal information,

required by the regulations

Narcotic refills are specifically forbidden by the Narcotic Control Regulations, Section 37

Part-fills are legal for both Narcotics and Controlled drugs if the total quantity dispensed does not exceed that originally authorized.

The doctor must authorize the total quantity involved as a single figure and not as a smaller figure multiplied by the number of times the medication is to be dispensed.

1

                      2.

1.The prescription is valid for 20 tablets only, after which a new prescription is required.2. The prescription shown is valid for 60 tablets only. The total quantity could be interpreted as either 60 + 3 repeats

(240 tab), or 60 x 3 repeats (180 tabs). Thus, the quantity is not stated as a single figure and the “x 3” cannot be accepted

3

                      3. A legal part-fill. The pharmacist may dispense 20 tablets at weekly intervals until 100 have been dispensed. He/she should not dispense more than 20 per week, without documented prescriber authority. Each dispensing requires the record to reference to this original authority (Rx number), not the last-filled number. Once all 100 have been dispensed, the prescription is expired. Any new authorization becomes a new prescription authority. All subsequent part-fills dispensed must then cross-reference to the new authorization number.

Prescription Part-fills -- An Update. Ontario College of Pharmacists. http://www.ocpinfo.com/client/ocp/OCPHome.nsf/web/Prescription+Part-fills+-+An+Update

4

                     4. The pharmacist may dispense 60 tablets on three occasions at intervals of no less than 28 days.

Pain Management Goals Pain Management Goals

Decrease pain

Improve function

◦ physical

◦ psychosocial

Minimize adverse effects

◦ for the patient

◦ for the health care provider

◦ for society

6

Treat Pain Prevent Misuse

Maintaining the Balance

Elements of a Good Pain Elements of a Good Pain History: CNCPHistory: CNCP1. Current pain descriptions (including pain

scoring)2. Previous pain history (including treatments

& results)3. Other concurrent medical / psych problems4. Current treatments, effectiveness and

adverse effects5. Social history (family, work, income,

relationships)6. Addiction screening 7. Current functioning and patient future

goals

Descriptive, Numeric, Descriptive, Numeric, AnalogueAnaloguePain Rating ScalesPain Rating Scales

Williamson A and Hoggart B, 2005

No Pain Pain as Bad as it Could Possibly Be

10 cm Visual Analog Scale

No Pain

Unbearable Pain

0 1 2 3 4 5 6 7 8 9 10

0-10 Numeric Rating Scale (NRS)

No Pain

Mild Pain

Moderate Pain

Severe Pain

Very Severe Pain

Worst Possible Pain

Simple Descriptive Pain Intensity Scale

Brief Pain Inventory – BPIBrief Pain Inventory – BPI

9

CodeineOxycodoneTramadol(+/- nonopioid)(+/- adjuvants)

AcetaminophenASANSAIDs/COXIBs(+/- adjuvants)

The Analgesic Stepped The Analgesic Stepped Approach Approach

World Health Organization. Cancer Pain Relief, with a Guide to OpioidAvailability. Geneva, Switzerland: WHO, 1996.

Leppert W, Luczak J. The role of tramadol in cancer pain management – a review.

Support Care Cancer 2005;13:5-17.

MildPain

ModeratePain

SeverePain

Increasing Pain

FentanylHydromorphoneMethadoneMorphineOxycodone(+/- nonopioid)(+/- adjuvants)

Pharmacological: Pharmacological: Non-OpioidNon-OpioidTopical Non-Opioid Analgesics

◦ Acetaminophen◦ Anti-inflammatory medications

NSAIDs / COXIBs

Adjuvants (Co-analgesics)◦ Anticonvulsants◦ Antidepressants◦ Others

Initiating Opioid TherapyInitiating Opioid Therapy

Basic Considerations:

Patient opioid exposure and experience

Patient fears (stigma) Caregiver and physician attitudes, preferences &

biases Compliance Convenience Cost

Pharmaco-clinicalConsiderations:

Patient sensitivities/allergies Administration and

absorption limitations Metabolism and clearance Opioid profile

Fine PG. Journal of Pain, Aug. 2001

Starting Long Term Opioid Starting Long Term Opioid Therapy - OptionsTherapy - Options

1. Start with an IR opioid and titrate to effect. When dose stable CR opioid ◦ Fastest method for pain relief

2. Start with CR opioid baseline dose and use IR opioid to titrate ◦ Once weekly add the total daily dose of IR to the

CR dose and repeat weekly until dose stable

3. Start with oral CR opioid and titrate dose q3 days (or when adverse effects stable)◦ For stable, chronic pain

Patient Educational Material

Titrating Opioids - Titrating Opioids - PrecautionsPrecautions

During titration, temporary drowsiness can occur

Patients should be advised not to drive or perform potentially hazardous activities while titrating the opioid dose – until tolerance to drowsiness occurs

Rational PolypharmacyRational PolypharmacyTaper off of sedating medications

◦ i.e. sedatives, muscle relaxants, sleeping meds

For sleep try: tricyclics (amitriptyline, doxepin), trazodone, gabapentin, pregabalin, mirtazepine, quetiapine or olanzapine INSTEAD OF BENZODIAZEPINES

Optimize anti-depressant therapy (TCAs, venlafaxine, bupropion, duloxetine)

For anxiety and pain try SNRIs, SSRIs, gabapentin or pregabalin before resorting to benzodiazepines

15

Change the Dose or Dosing Change the Dose or Dosing Interval ?Interval ?

Start CR oral opioids on a q12h scheduleFor end of dose failure, first try increasing the dose

before changing schedule (most frequent q8h)Move up to the next agent in the analgesic stepped

approach Initiate transdermal patch on a q72 hr (3-day) dosing

scheduleOptions for end of dose failure on the third day

◦ Increase the dosage of the q72 hr patch

A “pharmacologically stable dose” when the total daily dose is fixed for at least two weeks and frequency is scheduled and spread throughout the day AND/OR at least 70% of the prescribed opioid is CR

Switching Opioids – How ?Switching Opioids – How ?Relative Opioid PotencyRelative Opioid Potency

Approximate dose ratio of two opioids required to produce a similar degree of analgesia◦ “equianalgesic tables”

Differs between acute and chronic dosing Influenced by a number of variables

◦ Age, prior opioid exposure, route of administration, metabolism, and clearance abnormalities

Opioid Equianalgesic Doses Opioid Equianalgesic Doses

OpioidOpioid OralOral ParenteralParenteral

morphine 30 mg 10 mg

codeine 200 mg 120 mg

hydromorphone 4-6 mg 2 mg

meperidine 300 mg 75 mg

oxycodone 30 mg N/A in Canada

60-134mg oral morphine /day = 25 mcg/hr transdermal fentanyl

Duragesic Product Monograph 2010

Switching Opioids – How Switching Opioids – How

1. Use opioid tables to calculate a total daily equianalgesic dose of the new opioid

2. Switch to 50-60% of the predicted dose of the new opioid and titrate to effect again• Decision to cut dose and by what percentage may

depend on the reason for switch

OR1. Start the new opioid and titrate while

decreasing the dose of the old opioid-SR morphine 15mg ~ CR oxycodone 10mg

~CR hydromorphone 3mg

Jovey R. et al. Managing Pain. p. 94

Cytochrome P450 Drug Cytochrome P450 Drug Interaction TableInteraction Table

University of IndianaDepartment of Medicine

www.drug-interactions.com

Most opioids metabolized by 2D6Fentanyl and methadone metabolized by 3A4

Acute Adverse Effects of Acute Adverse Effects of OpioidsOpioids

COMMON LESS COMMON RARE

Side effect • Nausea and vomiting • Constipation• Sedation and

drowsiness

• Confusion• Myoclonus• Dry mouth• Urinary retention• Sweats• GE reflux

• Pruritus• Respiratory depression

(very rare in properly titrated patients)

Treatment of Common Acute Treatment of Common Acute Opioid Side EffectsOpioid Side Effects

TREATMENT

Nausea and vomiting

• First line agents– Prochlorperazine 5-10 mg po q4-6h prn– Dimenhydrinate 12.5-50 mg po q4-6h prn (often too sedating)– Haloperidol 0.5-1 mg po daily-tid

• If motility is an issue– Metoclopramide 10-20 mg po qid– Domperidone 10-20 mg po qid

Constipation

• Use dietary measures first (bran, flax, prunes)– Osmotics-MOM, lactulose– Stool softeners - docusate– Stimulants-senna, bisacodyl– Suppositories-dulcolax– Enemas

Long-term Effects of Opioid Long-term Effects of Opioid TherapyTherapy

Apparent opioid “tolerance” can be due to:◦ Worsening underlying condition◦ Pharmacological tolerance ◦ Opioid-induced abnormal pain sensitivity

(hyperalgesia)◦ Opioid addiction / diversion

Endocrine effects effects on hypothalamic pituitary axis◦ Decreased serum testosterone, estrogen

Opioid adverse effects on immune function?◦ 2 studies in rats, 1 small study in humans with AIDs◦ But unrelieved pain also impairs immune function**

Ballantyne & Mao, NEJM 2003; 349(20): 1943-53**Page GG, Adv Exp Med Biol. 2003;521:117-25.

Discontinuing Long-term Discontinuing Long-term OpioidsOpioids

Why?◦ Resolution of underlying problem

Dramatic decrease in pain

◦ Persistent unacceptable adverse effects in spite of careful titration and switching

◦ Repeated behaviours consistent with addiction / diversion

◦ Opioid hyperalgesia in spite of switching◦ Patient wants to discontinue

Opioid Tapering ProtocolsOpioid Tapering Protocols

1. 50% of the previous daily dose x 2 days, then reduce the dose by 25% q2 days until the equivalent of 30mg/day of oral morphine, then D/C

2. 10% reduction per day, daily dispensing3. 10% of total daily dose q1-2 weeks

Once one third of the original dose is reached, slow the taper to one half or less of the previous rate

Explain withdrawal symptoms to the patient !! Manage withdrawal effects with clonidine,

NSAIDs, loperamide HCI

Essential Follow-up Essential Follow-up Documentation – the “6 A s”Documentation – the “6 A s”1. Analgesia (pain relief)2. Activities (physical and psychosocial

functioning)3. Adverse Effects (and your advice)4. Ambiguous Drug Taking Behaviour

(and your response)5. Accurate medication record6. Affect

Jovey R. et al. Managing Pain. 2002 p. 121Gourlay DL, Heit HA, Almahrezi A. Universal precautions in pain medicine: A rational approach to the treatment of

chronic pain. Pain Medicine 2005;6:107-112.

Appendix B-7: Example of documenting opioid therapy *

Date Jan 13, 2008 Mar 23, 2008

Opioid type Oxycodone Oxycodone

Opioid dose 20 tid 30 tid

Pain worst 8 6

Pain least 3 3

Pain average 6 5

Pain right now 6 4

BPI functional improvement

Sleep improved Back to work

Adverse effects Nil Nil

Medical complications UDS clear No concerns

Compliance Increase to 30 tid Keep this dose

Affect

Other comments

*The Canadian Guideline for Safe and Effective Use of Opioids For Chronic Non-Cancer Pain. May 2010. nationalpaincentre.mcmaster.ca/opioid

Screening for Screening for Addiction RiskAddiction Risk

Concurrent Pain & Addiction Concurrent Pain & Addiction

Both pain and addiction can co-exist in the same patient

This does not necessarily preclude the use of opioid therapy, but…

…does require more attention (and time):◦ More initial assessment◦ More careful prescribing◦ More behavioural monitoring◦ More documentation

DefinitionsDefinitions

Addiction:

Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations

It is characterized by behaviours that include one or more of the following:◦ Impaired control over drug use, compulsive use,

continued use despite harm, and craving

30

Douglas Gourlay, MD, FRCPCLiaison Committee for Pain and Addiction

DefinitionsDefinitions

Physical Dependence:

Physical dependence is a state of adaptation that often includes tolerance and is manifested by a drug class specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist.

31

Douglas Gourlay, MD, FRCPCLiaison Committee for Pain and Addiction

DefinitionsDefinitions

Tolerance:

Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug's effects over time

Tolerance develops at different rates, in different people, to different effects

32

Douglas Gourlay, MD, FRCPC

Primary Care Triage of Primary Care Triage of CNCP PatientsCNCP Patients

33

Group 1: Primary Care Patients – Low Risk

No past, current, or family history of substance use disorders

Represents the majority of patients who will present to the GP/FM

Gourlay D. Pain Med 2005;6:107

Screening for Addiction / Screening for Addiction / Misuse RiskMisuse Risk

Previous history of substance abuse / addictionFamily history of substance abuse / addictionPrevious “chemical coping” with life stressesSignificant psychiatric diagnoses

◦ Bipolar◦ Psychotic disorders◦ Borderline, anti-social or psychopathic personality

disordersPrevious high risk, impulsive behaviours (esp.

criminal activity)High risk home environment

Screening for Opioid Misuse Screening for Opioid Misuse RiskRisk

More detailed assessment:◦ Take a history around drug and alcohol use

Age of first use, routes of use, current use EtOH and other drugs

◦ History of adverse consequences of EtOH/drug use DWI, “black outs”, medical / social / legal complications

◦ Previous Treatment History Residential v outpatient, mutual support (i.e. AA,NA)

◦ 3rd party corroboration (old charts, doctors, spouse)

Assessing Addiction Risk: Assessing Addiction Risk: C.A.G.E. – AIDC.A.G.E. – AIDCut down on drinking or drug useAnnoyed or angered by others

complaining about drinking or drug useGuilty about consequences of drinking or

drug use Eye-opener drink or drug in the morning

to decrease withdrawal effects

• 1 point should raise concern in women

• 2 or more means further assessment required

Brown R. J Fam Pract 1997;44:151

Opioid Risk ToolOpioid Risk Tool

5 questions5 minutesSpecific to pain & opioid useQuantifies risk levelNon-confrontationalEasy to use

Webster LR. Pain Med 2005

38

Opioids for the Higher Risk Opioids for the Higher Risk PatientPatient

Generally younger age and/or Hx of substance abuse1

Confirm the diagnosis (addiction consult if available)Try other (non-opioid) options firstAssess and document function up frontWritten prescribing agreementCollateral information / supportive networkShort dispensing intervals (part-fills)Little or no use of IR/SA opioids for breakthrough painUrine drug screeningDocument follow-up carefully

1. Reid MC et al. J Gen Intern Med 2002;17:173-9.

Initiating Opioid Therapy: Initiating Opioid Therapy: Opioid Prescribing AgreementsOpioid Prescribing Agreements

Principle Goals: ◦ Promote adherence◦ Attain informed consent◦ Manage legal risk◦ Improve practice efficiency

Exercise caution before implementingThink about why using; is content

appropriate?May not effectively meet goals; lack of

evidenceMay lead to opiophobia; strain physician-

patient relationship; ethical considerations

Written Treatment Written Treatment AgreementsAgreementsRecommended in all guidelinesNOT a ‘contract’May help to demonstrate informed consentUsed to clearly set out patient AND physician

expectations/responsibilitiesEffective boundary setting toolMust be readable, reasonable and have

some flexibility

41

Creating and Implementing Opioid Agreementsby Howard A. Heit, MD, FACP, FASAM

Appendix B-5: Sample Opioid Medication Treatment AgreementI understand that I am receiving opioid medication from Dr. to treat mypain condition. I agree to the following:1. I will not seek opioid medications from another physician. Only Dr. willprescribe opioids for me.2. I will not take opioid medications in larger amounts or more frequently than is prescribed by Dr..3. I will not give or sell my medication to anyone else, including family members; nor will I accept any opioid medication from anyone else.4. I will not use over-the-counter opioid medications such as 222’s and Tylenol® No. 1.5. I understand that if my prescription runs out early for any reason (for example, if I lose the medication, or take more than prescribed), Dr. will not prescribe extramedications for me; I will have to wait until the next prescription is due.6. I will fill my prescriptions at one pharmacy of my choice; pharmacy name:______________________________________________________________7. I will store my medication in a secured location.I understand that if I break these conditions, Dr. may choose to ceasewriting opioid prescriptions for me.

Source: Modified from Kahan 2006

The Canadian Guideline for Safe and Effective Use of Opioids For Chronic Non-Cancer Pain. May 2010. nationalpaincentre.mcmaster.ca/opioid

Opioids for CNCP – Opioids for CNCP – Safeguarding Your PracticeSafeguarding Your PracticeDocument an adequate initial assessmentRecord a working diagnosis and DDxDocument pain severity and impact on QOLDocument trials of non-opioid treatments Record a treatment planScreen for addiction risk and psychosocial

factors

Opioids for CNCP – Opioids for CNCP – Safeguarding Your PracticeSafeguarding Your PracticeDocument informed consentRemember “a trial of opioid therapy”Use a written agreement for high risk

patientsRecord caution to avoid driving, etc. during

dose titrationOne prescriber, one pharmacist

Opioids for CNCP – Opioids for CNCP – Safeguarding Your PracticeSafeguarding Your PracticeStart with short dispensing intervals initially

(i.e. part fills for 1 wk at a time) until trust established

Schedule follow-up visits at appropriate intervals

Record the 6A’s at each visitPeriodically reassess the patient’s progress,

physical findings and the need for opioidsAvoid sedatives in patients on opioids – use

rational polypharmacyKnow your limits and when to ask for help

College of Physicians and Surgeons of Ontario College of Physicians and Surgeons of Ontario Evidence-Based Recommendations for Management of Chronic Evidence-Based Recommendations for Management of Chronic Non-Malignant Pain - 2000Non-Malignant Pain - 2000

Do…◦ Screen for current and past alcohol and drug problems◦ Try non-opioid medications and adjuvant treatments first◦ Focus on improving function, not complete pain relief◦ Implement a treatment agreement with your patient◦ Titrate opioids carefully, looking for analgesic

effectiveness, functional status, and adverse effects◦ Switch to long-acting opioids◦ Use breakthrough doses sparingly◦ Keep a narcotic prescription flow sheet on the patient’s

chart◦ Make prescriptions “tamper-proof”

46

College of Physicians and Surgeons of Ontario College of Physicians and Surgeons of Ontario Evidence-Based Recommendations for Management of Evidence-Based Recommendations for Management of Chronic Non-Malignant Pain - 2000Chronic Non-Malignant Pain - 2000

Use care and monitoring especially when:◦ prescribing short acting opioids◦ a prescription for opioids requested earlier than the

expected or agreed time◦ prescribing two or more different opioids at the same

time◦ prescribing two or more drugs with abuse potential, ie,

opioids and benzodiazepines

47

Don’t:◦ Prescribe large quantities of short acting opioids◦ Continue to prescribe opioids when there is evidence of

non-compliance, escalation, misrepresentation, or fraud, e.g. double-doctoring or forgery

◦ Feel compelled to prescribe opioid or any drug if it is against your honest judgment or if you feel uncomfortable prescribing the drug

48

College of Physicians and Surgeons of Ontario College of Physicians and Surgeons of Ontario Evidence-Based Recommendations for Management of Evidence-Based Recommendations for Management of Chronic Non-Malignant Pain - 2000Chronic Non-Malignant Pain - 2000

Take Home MessagesTake Home Messages

Screen for addiction risk in all patientsSet boundaries around medication use (Rx

agreement) Identify drug misuse behaviours early and

intervene Introduce opioids as a “trial of therapy” with

agreed upon goalsTaper opioids when goals not achievedThe Canadian Guideline for Safe and Effective

Use of Opioids For Chronic Non-Cancer Pain. May 2010. nationalpaincentre.mcmaster.ca/opioid

Gourlay D.L. Pain Med. 2005 Mar;6(2):107-12.

QuestionsQuestions

The Canadian Guideline for Safe and Effective Use of Opioids For Chronic Non-Cancer Pain. May 2010. nationalpaincentre.mcmaster.ca/opioid

Gourlay D.L. Pain Med. 2005 Mar;6(2):107-12.