OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL...

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OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT

Transcript of OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL...

Page 1: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

OPIOID MANAGEMENT and REMS PRINCIPLES:

WHAT WOULD YOU DO?

• JAMES W. ATCHISON, DO (MODERATOR)

• MEDICAL DIRECTOR• RIC CENTER FOR PAIN MANAGEMENT

Page 2: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

DISTINGUISHED PANEL• STEVEN STANOS, DO

– SWEDISH MEDICAL CENTER, SEATTLE, WA

• BRIAN BRUEHL, MD– MD ANDERSON, HOUSTON, TX

• MICHAEL BRENNAN, MD– PAIN CENTER OF FAIRFIELD, FAIRFIELD, CT

• R. NORMAN HARDEN, MD– ANALGESIC RESEARCH CONSULTANTS, ATHENS, GA

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DISCLOSURES• JAMES W. ATCHISON, DO

– SITE INVESTIGATOR, PFIZER/PARAXEL STUDY OF PREGABALIN FOR TRAUMATIC NERUOPATHIC PAIN

– MEDICAL REVIEW ACTIVTY – BEST DOSCTORS, INSPE

• STEVEN STANOS, DO– VERBAL DISCLOSURE

• MICHAEL BRENNAN, MD– SPEAKER/CONSULTANT

• PURDUE, TEVA, DEPOMED, ASTRZENECA, PERNIX, IROKO, KALEO, CAVA

– PRIOR STOCKHOLDER• CAVA

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DISCLOSURES• BRIAN BRUEHL, MD

– CONSULTANT FOR MEDTRONIC NEUROMODULATION, SPINE AND RESTORATIVE THERAPIES

– CONSULTANT FOR BOSTON SCIENTIFIC NEUROMODULATION

– UNRESTRICTED RESEARCH SUPPORT FROM JAZZ PHARMACEUTICALS

– SITE PRIMARY INVESTIGATOR, JAZZ PHARMACEUTICALS (PRIZM STUDY)

• R. NORMAN HARDEN, MD– NO DISCLOSURES

Page 5: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

LEARNING OBJECTIVES

• Participants will be able to:

– Direct patient education according to reference guidelines regarding safe prescribing, storage, and dose adjustments of opioids.

– Utilize concepts of rational polyp pharmacy in chronic pain management.

– Evaluate and recommend appropriate adjunct of treatments beyond medications for chronic pain management

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REMS BLUEPRINT REVIEW• MAJOR HEADINGS

– Why Prescriber Education is Important– I. Assessing Patients for Treatment with

ER/LA Opioid Analgesic Therapy– II. Initiating Therapy, Modifying Dosing, and

Discontinuing Use of ER/LA Opioid Analgesics

– III. Managing Therapy with ER/LA Opioid Analgesics

04/21/23 presentation 6

Page 7: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

REMS BLUEPRINT REVIEW

• MAJOR HEADINGS– IV. Counseling Patients and Caregivers

about the Safe Use of ER/LA Opioid Analgesics

– V. General Drug Information ER/LA Opioid Analgesic Products

– VI. Specific Drug Information

04/21/23 presentation 7

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CASE PRESENTATION

• 48 y/o F presents for Tx w/ Hx of chronic Rt UL pain. S/P Fx of Radius & Ulna 2 y/a after fall. Pain level 5-8/10 ; referred due to completion of all w/u & Tx from ortho. Increased pain w/ all movements of arm and restricted use. Left knee pain w/ walking and standing tolerance of 25 minutes. Works as Administrative Assistant. Current Rx for Hydrocodone 5/325 to be used 1-2 q 4-6 hours as needed, and now taking 8 tabs per day. All records available for review.

04/21/23 presentation 8

Page 9: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

WHAT WOULD YOU DO?

PROCESSES BEFORE RX

• Hx/visit includes Risk Stratification

• Review possible risks & side effects

• Review Patient Counseling Document

• Review/sign Patient Agreement

• Complete UDS

INITIAL RX?

1. Hydrocodone 5/325 up to 4/day

2. Hydrocodone 10/325 up to 4/day

3. Rotate to other Short Acting opioid

4. Transition to Long Acting opioid

5. No Rx on 1st visit

04/21/23 presentation 9

Page 10: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

RISK STRATIFICATION

04/21/23 presentation 10

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WHAT WOULD YOU DO?

COMMONLY USED TOOLS

• ORT

• SOAPP-R

• PSYCOLOGY INTERVIEW

• COMM

WHICH IS BEST?

04/21/23 presentation 11

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REVIEW & SIGN PATIENT AGREEMENT

04/21/23 presentation 12

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OPIOID ANALGESICS

• PATIENT AGREEMENTS– OPIOID THERAPY UTILIZED ONLY AFTER ALL

OTHER REASONABLE ATTEMPTS HAVE FAILED

– SINGLE PHYSICIAN PRESCRIBER & PHARMACY

– PT MUST AGREE TO COGNITIVE-BEHAVIORAL TX

– PRESCRIPTIONS MUST LAST UNTIL THE NEXT VISIT

• BRING IN ALL UNUSED MEDICATIONS

Page 14: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

OPIOID ANALGESICS

• PATIENT AGREEMENT– PT MUST INFORM DOCTOR OF ALL OTHER

MEDICATIONS AND CHANGES• NO BENZOS OR CARISOPRODOL• ? PREGABLIN

– PT MUST AGREE TO RANDOM URINE TESTING

– INFORM PATIENT OF ALL RISKS (LIST)• INCLUDING TOLERANCE, DEPENDANCE, ADDICTION• SIDE EFFECTS

Page 15: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

OPIOID ANALGESICS

• PATIENT AGREEMENT

– ANY EVIDENCE OF DRUG HOARDING, DRUG DIVERSION, UNAGREED-UPON DOSE CHANGES, LOSS OF RX, OR FAILURE TO FOLLOW THE AGREEMENT WILL (MAY?) RESULT IN TAPERING OF MEDICINE AND DISCONTINUATION OF DOCTOR-PATIENT RELATIONSHIP

• DESIGNED TO LIMIT DIVERSION

Page 16: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

WHAT WOULD YOU DO?DO YOU REGULARLY USE THESE?

• YES

• NO

04/21/23 presentation 16

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REVIEW RISKS AND SIDE EFFECTS OF OPIOIDS

04/21/23 presentation 17

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Clinical Effects of Opioids

Circumstantial effects

Sedation Euphoria

Cough Suppression Decreased Bowel Motility

Undesirable effectsNausea/vomiting Urinary Retention

Mental Status Changes Respiratory Depression

Tolerance / Dry Mouth / Drug Dependence

Desirable effectsAnalgesia Relief of Anxiety

Mycek, et al., eds. Pharmacology, 2d ed. Philadelphia; Lippincott-Raven, 1997.

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Opioid Adverse Effects

04/21/23 presentation 19

Usually dose related and some are drug specificCommon

ConstipationDry mouthNausea/VomitingSedationSweating

Less CommonRespiratory depressionBad dreams/hallucinationsDysphoria/deliriumMyoclonus/seizuresArrhythmiaPruritis/urticariaUrinary retentionAmenorrhea/sexual dysfunction

Page 20: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

04/21/23 presentation 20

Anticipate/Manage Side Effects

Respiratory Depression- Sedation precedes respiratory depression

Role of sedation scales?- Respiratory rate alone is not an indication of respiratory function.- Use Naloxone sparingly

Respiratory depression reverses before analgesiaLimit to doses of 100 micrograms at a timeOne amp (0.4mg) in 4ml NS

Inject 1 ml at a time- can always give more.

Page 21: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

WHAT WOULD YOU DO?

UPDATED HISTORY

• Continues Hydrocodone at 10/325 QID

• She experiences:– Constipation– Sleepiness in the afternoon– Occasional nausea – Occasional SOB

• She is not sleeping well at night

OPTIONS

• Add Colace, Sennakot, Miralax, etc, daily

• Start Provigil in am & noon• Use compazine PRN• Use Albuteral inhaler PRN• Start Clonazepam at HS?• Repeat UDS

04/21/23 presentation 21

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REVIEW OF PATIENT COUNSELING DOCUMENT

04/21/23 presentation 22

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Patient Counseling Document (PCD)

• The DOs and DON’Ts of Extended-Release / Long - Acting Opioid Analgesics

• DO: – Read the Medication Guide – Take your medicine exactly as prescribed – Store your medicine away from children and in a

safe place – Flush unused medicine down the toilet – Call your healthcare provider for medical advice

about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Page 24: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

Patient Counseling Document (PCD)

• DON’T: Do not give your medicine to others Do not take medicine unless it was prescribed for you Do not stop taking your medicine without talking to your

healthcare provider Do not break, chew, crush, dissolve, or inject your

medicine. If you cannot swallow your medicine whole, talk to your healthcare provider.

Do not drink alcohol while taking this medicine

• For additional information go to: dailymed.nlm.nih.gov

Page 25: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

Secure prescriptions the same way as other valuables in the home, like

jewelry or cash

•Take prescription medications out of the medicine cabinet and hide them in a place only you know about

•Encourage relatives and friends to secure their medications

•If possible, keep all medicines in a safe place

• An existing fire safe or gun safe

• Use a cut-proof bag designed for travel safety

• Locking medicine box or cabinet

Safe Storage of Opioids

APF. PainSAFE™. Problems with Opioids Can Be Prevented. Available at: http://www.painfoundation.org/painsafe/healthcare-professionals/pharmacotherapy/opioids/

preventing-problems.html. Accessed February 3, 2012.

SecureMonitor

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OPIOID SAFETY

• STORAGE OF MEDICATIONS– LIMIT NUMBER OF PERSONS THAT ARE

AWARE YOU ARE USING PAIN MEDS• BE AWARE OF OTHER PATIENTS OR PERSONS

AROUND PHYSICIAN’S OFFICE• BE AWARE OF PERSONS WATCHING AT

PHARMACY• LIMIT DISCUSSIONS WITH FAMILY AND FRIENDS

– KEEP MEDS AWAY FROM FAMILY MEMBERS• DO NOT ASK THEM TO GET MEDICATIONS FROM

STORAGE

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OPIOID SAFETY

• DATA FROM 2009-2010 National Survey on Drug Use and Health

– 70% of the 2.4 million Americans who abuse prescription drugs for the first time each year get them from friends and family

• 1/3 are teenagers

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OPIOID SAFETY

• DATA FROM 2009-2010 National Survey on Drug Use and Health

– Casual Abusers of Rx Drugs(< 1x/wk)• 55% got substances FREE from friends/family• 11% PURCHASED substance from friends or

family• 5% TOOK WITHOUT PERMISSION

substances from family/friends

Page 29: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

OPIOID SAFETY

• DATA FROM 2009-2010 National Survey on Drug Use and Health– Chronic Users/Abusers of Rx Drugs(>

1x/wk for more than a year)• 41% got substances WITH OR WITHOUT

PERMISSION from friends/family• 25% PURCHASED substance from dealer or

the internet• 25% OBTAINED THEM FROM A DOCTOR

Page 30: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

WHAT WOULD YOU DO?

UPDATED HISTORY

• After 4 months, she calls into clinic for early refill as she is out of her pills and is not sure why?

OPTIONS

• Manage this over the phone until next visit

• Review Patient Agreement and DC from the clinic

• Review pharmacy issues• Review storage issues• Repeat UDS?

04/21/23 presentation 30

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UDS MONITORING

04/21/23 presentation 31

Page 32: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

WHAT WOULD YOU DO?

UDS RESULTS

• No Substances present?• Hydrocodone and

Hydromorphone present– w/ Oxymorphone– w/ benzodiazepine– w/ ETOH– w/ THC– w/ Cocaine– w/ Morphine, codeine, and

oxycodone

OPTIONS

• Repeat the test w/ Inc sensitivity – continue Tx

• Counsel pt and repeat at next visit – continue Tx

• Counsel pt and DC from clinic – Give 1 month Rx?

• Counsel pt and Refer to Addiction Medicine– Give 1 month Rx?

04/21/23 presentation 32

Page 33: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

Choosing Opioid Therapy• Chronic pain management should be

individualized • Selection of a specific opioid based on criteria:

efficacy, tolerability, safety, and ease of use. • Initiated at a low dose and gradually increase-

monitor pain reduction and side effects. • Patients must be fully informed about the nature

of their treatment, benefits and harmful effects • Long acting versus breakthrough doses

Page 34: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

WHAT WOULD YOU DO?

ADDITIONAL HISTORY

• Received Rx for Hydrocodone 10/325 QID for 6 months (compliant!).

• She previously split some pills in ½, but is now receiving less response to whole pills. Pain 7-9/10

• Having a difficulty time working.

OPTIONS1. Increase Hydrocodone to 6-

8 tabs/day

2. Rotate to other SA Opioid

3. Initiate LA/ER Opioid

4. Test UDS & Continue current Hydrocodone

5. Stop the medication

6. Refer to Addiction Medicine

7. Further Work-up?

04/21/23 presentation 34

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ROTATING SA THERAPY

04/21/23 presentation 35

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WHAT WOULD YOU DO?

SA OPTIONS

• Oxycodone– w/ Aceteminophen?

• Hydromorphone• Morphine Sulphate• Oxymorphone• Tapentadol

• How many MEQ?

OPTIONS

• Taper the Hydrocodone, then start new med

• Stop Hydrocodone; start new med at lower MEQ

• Stop Hydrocodone; start new med at same MEQ

• Stop Hydrocodone; start new med at Inc MEQ

04/21/23 presentation 36

Page 37: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

DEPENDENCE IS NOT ADDICTION

• Physical dependence: – “Physical dependence is a state of

adaptation that 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.”

Page 38: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

DEPENDENCE IS NOT ADDICTION

• Addiction: – “Addiction is 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: impaired control over drug use, compulsive use, continued use despite harm, and craving.”

Page 39: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

OPIOID ANALGESICS

• TOLERANCE

– NEED FOR INCREASING AMOUNT OF THE DRUG TO ACHIEVE THE SAME EFFECT DUE TO THE PROGRESSIVE LOSS OF EFFECTIVENESS OF THE DRUG WITH ALL OTHER CONDITIONS CONSTANT

Page 40: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

INITIATING LA THERAPY

04/21/23 presentation 40

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WHAT WOULD YOU DO?

LA OPTIONS• Oxycontin

• MSContin/Oramorph/ MSER/Avinza

• Duragesic, Fentanyl Patch

• Opana ER

• Exalgo

• Nucynta ER

• Dolphine, Methadone

• Butrans Patch

• Zohydro ER, Hysingla ER

OPTIONS

• Taper the Hydrocodone, then start new med

• Stop Hydrocodone; start new med at lower MEQ

• Stop Hydrocodone; start new med at same MEQ

• Stop Hydrocodone; start new med at Inc MEQ

• Start new med and use Hydrocodone for BTP

04/21/23 presentation 41

Page 42: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

WHAT WOULD YOU DO?

INFLUENCES

• Dosage Issues• Insurance coverage• Side Effects/History• Current Medications• Social History• REMS rules

START/DON’T START

• MS Contin• Fentanyl• Avinza• Oxycontin• Opana ER• Nucynta ER• Methadone• Butrans• Zohydro ER

04/21/23 presentation 42

Page 43: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

INITIATING THERAPY OF ER/LA OPIOIDS

• According to Blueprint - may be used for initial dosing in non-tolerant pts.– Avinza 30 mg daily

– Butrans patch 5 mcg/hr every 7 days

– Dolophine 2.5-10 mg every 8-12 hours

– Embeda 20 mg/0.8 mg every 12-24 hours

– Nucynta ER 50 mg every 12 hours

– Opana ER 5 mg every 12 hours

– Oxycontin 10 mg every 12 hours

Page 44: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

INITIATING THERAPY OF ER/LA OPIOIDS

• According to Blueprint - should not be used for initial dosing in non-tolerant pt– Duragesic patch– Exalgo– Kadian– MS Contin (?)

• Require a calculation of dose from current use – Based on conversion tables?

• There are increasing concerns with this!

Page 45: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

INITIATING THERAPY OF ER/LA OPIOIDS

• According to Blueprint - Initial titration interval: – (minimum number of days before it

can be changed again)• Oxycontin – 1-2 days• Kadian – 2 days• MS Contin – 2 days• Opana ER – 2 days• Avinza – 3 days

Page 46: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

INITIATING THERAPY OF ER/LA OPIOIDS

• According to Blueprint - Initial titration interval: – (minimum number of days before it

can be changed again)• Butrans – 3 days• Embeda – 3 days• Nucynta ER – 3 days• Duragesic – 72 hours• Exalgo – 3-4 days• Dolophine – Not reported – should be 7 days or

more

Page 47: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

MODIFYING DOSING OF ER/LA OPIOIDS

• Titrate increase in ER/LA opioid medication on regular intervals– 25-33% changes for 1-2 visits– 10-20% for continuing visits

• Eventually titrate SA opioid to return to only PRN use

Page 48: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

MODIFYING DOSING OF ER/LA OPIOIDS

• Stop further titration of ER/LA opioid when:– Adequate analgesic effects– Unacceptable side effects– No increase in analgesic response for 1

– 2 changes– Ceiling levels

• Avinza, Butrans, Nucynta, ?Dolphine

Page 49: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

SIGNS/SYMPTOMS OF ONSETRESPIRATORY DEPRESSION

• Any Trouble Breathing– Hypopnea or apnea

• Cannot be easily aroused– Intoxicated behavior – confusion, slurred

speech, stumbling

• Unusual snoring, gasping, or snorting (especially with sleep)

• Fingertips/lips are blue/purple

Page 50: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

SIGNS/SYMPTOMS OF ONSETRESPIRATORY DEPRESSION

• Recent Review Article in NEJM– Edward Boyer, MD, PhD

N Engl J Med 2012; 367; 146-155

• Internet Education/Assistance– Opioids911.org– Many Others

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WHAT WOULD YOU DO?

WHAT ABOUT NALOXONE?

• I’ve thought about it!

• I regularly prescribe it!

• I don’t see the need for it!

04/21/23 presentation 51

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ROTATING LA TREATMENT

04/21/23 presentation 52

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WHAT WOULD YOU DO?

UPDATED HISTORY

• She returns a year later no better and wishes to change medications.

• Currently on Opana ER 40 mg q8h/MSIR 15 mg qid

• DC Opana ER; change to Duragesic Patch @ 100 mcg/hr

• DC Opana ER; start Oxycontin at 80 mg q12 h

• Begin tapering Opana ER by 10 mg per dose daily until off and then start MSER at 15 mg q 12 h

04/21/23 presentation 53

Page 54: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

II. Initiating Therapy, Modifying Dosing, and Discontinuing Use of ER/LA Opioid Analgesics

• e. (LO3) Prescribers should understand the concept of incomplete cross-tolerance when converting patients from one opioid to another.

• f. (LO4) Prescribers should understand the concepts and limitations of equianalgesic dosing and follow patients closely during all periods of dose adjustments.

Page 55: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

MODIFYING DOSING OF ER/LA OPIOIDS

• Equianalgesic Dosing– Based on Morphine Equivalents– Some meds much less reliable– Conversion Tables

• Lots of variability• May be cause of some deaths/injuries?

Page 56: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

OPIOID DOSING:CONVERSION AND RISK

CONVERSION TO MORPHINE MEQ LOW MODERATE HIGH VERY HIGH

MORPHINE x 1 0 - 30 mg 31 - 100 mg 101 - 200 mg > 200 mg

HYDROCODONE x 1 0 - 30 mg 31 - 100 mg 101 - 200 mg > 200 mg

OXYCODONE x 1.5 0 - 20 mg 21 - 66 mg 67 - 133 mg > 133 mg

HYDROMORPHONE x 4 0 - 7.5 mg 7.6 - 25 mg 26 - 50 mg > 50 mg

OXYMORPHONE x 3 0 - 10 mg 11 - 33 mg 34 - 66 mg > 66 mg

TAPENTADOL x 0.33 0 - 75 mg 76 - 250 mg 251 - 500 mg > 500 mg

METHADONE x 3 0 - 10 mg 11 - 30 mg 31 - 60 mg > 60 mg

FENTANYL PATCH x 5 NONE 12 mcg/hr 24 - 50 mcg/hr > 50 mcg/hr

BUPRENORPHINE PATCH ? 0 - 35 mcg 36 - 52.5 mcg 52.6 - 105 mcg > 106 mcg

TRAMADOL ? 0 - 200 mg 201 - 400 mg > 400 mg

Page 57: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

Methadone Conversion

04/21/23 presentation 57

Relative potency based on Morphine Equivalent dose per day- MEDD < 500mg, Conversion 5:1- MEDD < 1000mg, Conversion 10:1- MEDD > 1000mg Conversion 20:1

Ratios are starting points. Different variations in potency ratios

Page 58: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

INCOMPLETE CROSS-TOLERANCE

• Current doses of ER/LA med not providing adequate analgesia– ?Tolerance vs Receptor responses

• A new/different ER/LA med may not have similar potency– Will act differently at the receptors

• Overdose is possible

Page 59: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

MODIFYING DOSING OF ER/LA OPIOIDS

• Best Option– Taper current med to easier level

• Lower dose of current ER/LA med to make easier conversion

• Start new ER/LA with low dose of current med• Complete transition without change in SA opioid• Begin to increase new ER/LA • Still needs frequent FU due to inc pain

Page 60: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

WHAT WOULD YOU DO?

UPDATED HISTORY

• Some concerns about the safety of storage and family members accessing the medications.

WHICH IS A TAMPER RESISTANT ER/LA OPIOID?

• Fentanyl Patches• Avinza (morphine)• Opana ER (oxymorphone)• Embeda (MS/Naltrexone)• Oxymorphone ER

04/21/23 presentation 60

Page 61: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

CURRENTLY APPROVED ABUSE DETERRENT LA/ER

OPIOIDS• Oxycontin (Oxycodone)

• Opana ER (Oxymorphone)

• Exalgo (Hydromorphone)

• Embeda (Morphine/Naltrexone)

• Hysingla ER (Hydrocodone)

• Suboxone (Buprenorphine/Naloxone) 04/21/23 presentation 61

Page 62: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

DISCONTINUE TREATMENT

04/21/23 presentation 62

Page 63: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

WHAT WOULD YOU DO?

UPDATED HISTORY

• She returns a year later no better and wishes to stop treatment.

• Currently on Opana ER 40 mg q8h/MSIR 15 mg qid

INITIAL TREATMENT

• Refer to detox unit• Stop the MSIR• Lower LA Opana ER to

30 mg q8h, and reduce monthly

• Lower LA Opana ER to 30 mg q8h, and reduce weekly

04/21/23 presentation 63

Page 64: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

WHAT IF THERE IS A PROBLEM OR THEY ARE NOT WORKING?

04/21/23 presentation 64

Page 65: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

DEPENDENCE IS NOT ADDICTION

• Physical dependence: – “Physical dependence is a state of

adaptation that 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.”

Page 66: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

DISCONTINUING USE OF ER/LA OPIOIDS

• Dependance is not addiction– Withdrawal symptoms include:

• Severe dysphoria• Sweating• Nausea• Rhinorrea• Depression• Severe fatigue• Vomiting • Pain

Page 67: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

AVOIDING WITHDRAWAL

Page 68: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

DISCONTINUING USE OF ER/LA OPIOIDS

• Tapering recommendations– Variable rate and pattern

• 10% of dose per day to q weekly

– Have a detailed patient agreement• May write out entire schedule?• Removing from clinic/starting other Tx?

– Frequent FU visits• Limit amount of Rx per visit

Page 69: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

DISCONTINUING USE OF ER/LA OPIOIDS

• Tapering recommendations– Slow the taper after reaching 1/3 of

original dose– Monitor for withdrawal, worsening pain

or mood and associated function• Objective measures

– Consider urine testing - compliance

Page 70: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

WHY ARE YOU TAPERING:COMPLIANCE vs INEFFECTIVENESS?

04/21/23 presentation 70

Page 71: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

DISCONTINUING USE OF ER/LA OPIOIDS

• Use SA opioids to complete taper?– The last step off the ER/LA meds– Follow similar % reduction with the

SA meds– Monitor for reduction in mood and

function

Page 72: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

II. Initiating Therapy, Modifying Dosing, and Discontinuing Use of ER/LA Opioid Analgesics

• RECOMMENDATIONS

– STRUCTURE

– COMPLIANCE

– DOCUMENTATION

Page 73: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

DISCONTINUING USE OF ER/LA OPIOIDS

• DISPOSING OF MEDICATIONS

– FDA INSTRUCTIONS

• FLUSH MEDICATIONS

• DRUG TAKEBACK DAYS

• NEW PHARMACY REGULATIONS

– CONCERNS

• ENVIRONMENTAL

Page 74: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

Counseling Patients and Caregivers about the Safe Use of

ER/LA Opioid Analgesics• HOW DO YOU WANT YOUR OFFICE TO

HANDLE ALL OF THIS?– WRITTEN MATERIALS/HANDOUTS/DVD/WEB

• PATIENT COUNSELING FORM• SPECIFIC MEDICATION INFORMATION• SIDE EFFECT AWARENESS• PATIENT AGREEMENT• OFFICE POLICIES

– DRIVING OR OPERATING MACHINERY

– SHOULD THEY SIGN ALL OF THESE?• DOCUMENT THAT THEY RECEIVED THEM ALL?

Page 75: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

Counseling Patients and Caregivers about the Safe Use of

ER/LA Opioid Analgesics• HOW DO YOU WANT YOUR OFFICE TO

HANDLE ALL OF THIS?– TELEPHONE POLICIES/ISSUES

• SAME DAY APPOINTMENTS?– MEDICATION NOT WORKING?– SIDE EFFECTS?– THEFT OR LOSS?

• DAYTIME vs NIGHTTIME NUMBERS?• DOCUMANTATION OF PHONE CALLS?

– IS THIS REALLY A GOOD PT TO HAVE ON OPIOIDS?

• HOW OFTEN ARE THEY CALLING?

Page 76: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

Counseling Patients and Caregivers about the Safe Use of

ER/LA Opioid Analgesics• HOW DO YOU WANT YOUR OFFICE TO

HANDLE ALL OF THIS?– FOLLOW-UP QUESTIONS

• DID YOU SHARE YOUR MEDS?– ANY LOST OR STOLEN?

• DID YOU BREAK/CHEW/ALTER MEDS OR ADJUST THE DOSE?

• DID YOU DRINK ALCOHOL?• DID ANY OF YOUR OTHER MEDS CHANGE?

– DO WE NEED TO ASK THESE AT EVERY VISIT?• CAN IT BE DONE ON A COMPUTER KIOSK?

Page 77: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

WHAT WOULD YOU DO?

I FIND REMS PRINCIPLES:

• Helpful

• Not Helpful

04/21/23 presentation 77

Page 78: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

CDC Guideline for Prescribing Opioids (Pre-Decisional)

Dowell, D; Haegerich T, Chou R. (authors)

Page 79: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

Background• New CDC guidelines needed to clarify

recommendations based from other groups

• Based on AHRQ systematic review of opioid effectiveness and risks 2014

• Development of clinical practice guidelines with public financing decreases potential for COI

• Scope: non-cancer pain, chronic, > 18 yrs age

• Recommendations into 3 areas (I, II, III) based on 5 clinical questions

Page 80: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

I. Determining when to initiate or continue opioids

1. Non-pharmacologic and non-opioid pharmacologic therapy

2. Before initiating, provders should establish realistic goals for pian and functinon and conitinue based on clinically meaninful improvement in pain and function

3. Discussion with patients risks and realistic benieftis of opioid therapy and patient/provider responsibilities for managin pain

Page 81: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

II. Opioid selection, dosage, duration, follow-up, and discontinuation

4. When starting opioid therapy, prescirbe short-acting and not ER/LA opioids5. When starting opioids, prescribe lowest effective dose and implement caution when increasing6. When opioids used for acute pain, start with lowest effective dose, and limit treatment duration besides for major surgery7. Providers should evaluate pateints early, and regularly for patients that continue on long-term opioids

Page 82: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

III. Assessing risk and addressing harms of opioid use

8. Before starting and during coninuatino, evaluate risks for harms, incorporate into management plans strategies to mitigate risk, inclding offering naloxone9. Review patient’s state PDMP data initially and on regular basis10. Use urine drug testing prior to initiating and on regular basis11. Avoid prescribing opioids and benzodiazepines concurrently12. Offer or arrange evidence-based treatment for patients with opioid use disorder

Page 83: OPIOID MANAGEMENT and REMS PRINCIPLES: WHAT WOULD YOU DO? JAMES W. ATCHISON, DO (MODERATOR) MEDICAL DIRECTOR RIC CENTER FOR PAIN MANAGEMENT.

QUESTIONS