Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July...

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Mary Jo Cerepani, DNP, FNP-BC CEN Patricia Gilliam, PhD, MEd, ANP-BC PCNP Annual Conference November 5, 2016 Safe and Effective Prescribing of Analgesics -a component of a longitudinal project with PAFP Primary Care Pain Management in Pennsylvania: Optimizing Treatment, Minimizing Risk

Transcript of Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July...

Page 1: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

Mary Jo Cerepani, DNP, FNP-BC CEN

Patricia Gilliam, PhD, MEd, ANP-BC

PCNP Annual ConferenceNovember 5, 2016

Safe and Effective Prescribing of Analgesics-a component of a longitudinal project with PAFP

Primary Care Pain Management in Pennsylvania:

Optimizing Treatment, Minimizing Risk

Page 2: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

Chronic Pain Management in Primary Care

Performance Improvement-CME Project

December, 2014 - June, 2016

Primary Care Pain Management in Pennsylvania:Optimizing Treatment, Minimizing Risk

Page 3: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

SPONSORSHIP STATEMENT

This activity was jointly sponsored by the Pennsylvania Academy of Family Physicians

Foundation andIntegrated Learning Partners, LLC in

collaboration withPennsylvania Coalition of Nurse Practitioners.

Page 4: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

SUPPORTER STATEMENT

This activity was supported via an educational grant

from Pfizer, Inc.

Page 5: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

Prevalence of Pain in Pennsylvania

Significance of the Problem

Primary Care Pain Management in Pennsylvania:Optimizing Treatment, Minimizing Risk

Page 6: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

IOM REPORT, 2011

In 2011, at least 100 million adult

Americans have common

chronic pain conditions

A direct and indirect cost of

$560-635 billion dollars per year

Approximately 40% of patients

with chronic pain do not achieve

adequate pain relief

IOM. Relieving Pain in America: A Blueprint for Transforming

Prevention, Carel Education and Research. 2011. Washington, DC.

The National Academies Press:58.

Page 7: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

TRENDS IN PRESCRIPTION OPIOID DISPENSING IN U.S.1999 TO 2013

• The amount of

prescription opioids

dispensed in the U.S.

nearly quadrupled

• Yet there has NOT been

an overall change in the

amount of pain that

Americans report

http://www.cdc.gov/drugoverdose/epidemic/providers.html

Page 8: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

Pennsylvania’s problems

Pennsylvania has the 14th Highest Drug Overdose

Mortality Rate in the United States

In 2013 there were 15.3 per 100,000 people suffering drug overdose fatalities

No Prescriber Education Required or Recommended

Has NO law requiring or permitting a pharmacist to require an ID prior to

dispensing a controlled substance

Lacking Support for Substance Abuse Treatment Services: Is not participating in

Medicaid Expansion, which helps expand coverage of substance abuse services

and treatment

http://healthyamericans.org/reports/drugabuse2013/release.php?stateid=PA

Page 9: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

PENNSYLVANIA PRESCRIPTION DRUG MONITORING PROGRAM

Attorney general office 1990’s had a prescription monitoring program but only schedule 2, physician could not access the data

Pennsylvania Department of Health Injury Prevention Committee developed a committee for Unintentional Poisonings in 2005

ABC-MAP Act 191 of 2014 was developed

PA PDMP access www.doh.pa.gov/PDMP

Single County Authorities(SCAs) apps.ddap.pa.gov/GetHelpNow/CountyServices.aspx – offers assistance for your patients who need drug and alcohol treatment services

Page 10: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

PDMP UPDATE

May 2016 October 2016June 2016 July 2016 August 2016 September 2016

May 17, 2016

National Association Board of Pharmacy (NABP) PMP InterConnect MOU

signed with PA

June 6, 2016

PA PDMP Website updated

May 3, 2016

Data Submitter's (Dispensation) Guide

May 2016 - July 2016

OAG to DOH (OTech to PMP AWARxE) data transfer –

approx. 45 million records complete

June 24, 2016

Reporting to the new PDMP system begins

August 25, 2016

New PDMP System Go-Live – Registered users began

patient searches

August 8, 2016

Online Registration opened

June 2016 - October 2016

Continuously Monitor Pharmacy Compliance

September 2016

PMP Interconnect Data Sharing with all states

Page 11: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

CONTINUING MEDICAL EDUCATION UNITS

Partnered with Pennsylvania Medical Society (PAMED) and developed the PA PDMP CME.

Addressing Pennsylvania’s Opioid Crisis: What the Health Care Team Needs to Know

The CME program is divided into four sessions and each session consists of four, 15-minute modules. The program covers a variety of tools and resources for prescribers and dispensers to better address opioid addiction with their patients. Sessions include:

1: Opioid Prescribing Guidelines for Non-Cancer Pain

2: Naloxone

3: Referral to Treatment

4: PA PDMP Database

These are free CMEs until June 30, 2017, for all medical professionals that need to renew license this year.

Page 12: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

Performance Improvement CME Project:

Primary Care Management of Patients with Chronic non-cancer pain

December, 2014 - May, 2016

Primary Care Pain Management in Pennsylvania:Optimizing Treatment, Minimizing Risk

Page 13: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

PAFP & ILP PROJECT TEAM

Our Team:

Co-Leaders:

Angie Halaja-Henriques, Chief Officer of QI and Public Health Programs (PAFP)

Sherlyn Celone, President and Chief Learning Officer (ILP)

Project Team Members:

Elizabeth Shaw, Project Manager (PAFP)

Patricia Gilliam, PhD, NP Clinical Leader/Practice Coach (ILP)

Peter Gamache, PhD, MBA, MPH, RN Outcomes Specialist (ILP)

David DePalma, PhD Sr. Creative Change/Patient Engagement Specialist (ILP)

Debra Hammaker, CHTS-CP, CHTS-IS, PCMH CCE, EHR Practice Liasion for PAFP

Suzanne Hockenberry, PCMH CCE, Practice Liaison (PAFP)

Sherrie Whisler, Data/Reporting Specialist (PAFP)

Page 14: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

PROJECT FACULTY

Mary Jo Cerepani, DNP, FNP-BC, CEN

University of Pittsburg

David DePalma, PhD

Integrated Learning Partners

Westport , CT

Patricia Gilliam, PhD, MEd, ANP-BC

Course Education Director and,PerformanceImprovement Coach

Integrated Learning Partners

Jeff Gudin, MD

Englewood Hospital and Medical Center

Englewood, NJ

Elizabeth Khan, MD

Course Medical Director

Tilghman Medical Center

Allentown, PA

Mary Lynn McPherson, PharmD, MA, BCPS, CPE

University of MD College of Pharmac

Baltimore

Lee Radosh, MD

Director, Family Medicine Residency

Reading, PA

Page 15: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

BEST PRACTICES IN PAIN MANAGEMENT

Comprehensive Assessment

REMS

Screening for Substance Use & Abuse Potential

Controlled Substance Agreement

Comprehensive Plan of Care

Interprofessional collaboration and treatment

Community Partners and Resources

Medication Management

Patient-Provider Relationship and Communication

Page 16: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

PROJECT METRICS

Closing the Referral Loop: Receipt of Specialist Report

Percentage of patients with referrals, regardless of age, for which the referring provider receives a report from the provider to whom the patient was referred.

PQRS # 374

Pain Assessment and Follow-Up

Percentage of visits for patients aged 18 years and older with documentation of a pain assessment using a standardized tool(s) on each visit AND documentation of a follow-up plan when pain is present.

PQRS # 131

Preventive Care and Screening: Screening for Clinical Depression and Follow-Up Plan

Percentage of patients >12 y.o. screened for clinical depression using a standardized depression screening tool AND if positive, a follow-up plan is documented on the date of the positive screen.

PQRS # 134

Page 17: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

PROJECT METRICS: SPECIFIC TO CHRONIC PAIN

% of Controlled Substance Agreements (CSA) on file for the patients prescribed an opioid for > 6mos whose pain medications are being managed by the PCP

Will work with practices to build a field to add the executed CSA agreement

Click yes/no and attach CSA

90%

% of chronic pain patients on an opioid medication, whose pain medications are managed by the PCP, who are being screened for opioid abuse/addiction according to the practice or provider protocol

Identifying those patients with chronic pain who are currently being treated with an opioid medication who may be at risk for opioid abuse or addiction by using a validated screening tool.

90%

Page 18: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

OTHER MARKERS OF SUCCESS

Improvements in Providers’ Knowledge, Skills and Confidence around Chronic Pain Management

Improved Patient Engagement

Communication Skills, Patient Education & Shared decision-making

Use of Comprehensive Evaluation, Planning and Treatment Guidelines

Provider Surveys, Patient Surveys

CME Pre-Post Tests

Review of Performance Improvement and PDSA Cycle Development and Implementation

Review and analysis of Comprehensive Care of Patients with Chronic Pain randomized into project database using a project developed Chronic Pain Managment Checklist

Page 19: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

PROJECT MODELProject Components

1) InterprofessionalTraining/Coaching

2) Provider-patient Experience Study

3) Patient/Caregiver Education Resources

4) Outcomes Measures (e.g., clinical, patient satisfaction, professional development, comprehensive patient care, etc.)

Provider/Patient

ExperienceStudy

(2-Surveys)

Patient Ed Group Visits

(Live)

Patient/Caregiver

Educational Tool Kit(Print & Digital)

QI CME

Workshop

(1)

CME

Webinars

(4)

PDSA

Plans

Practice

Coaching

(1-2)

Baseline Follow-UpContinuous Needs

Assessment Process

Interventions/Activities

Page 20: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

Patricia Gilliam, PhD, MEd, ANP-BC

Clinical Education and Research ConsultantClinical Study Center of Asheville

Asheville, NC

Safe and Effective Prescribing of Analgesics-a component of a longitudinal project with PAFP

Primary Care Pain Management in Pennsylvania:

Optimizing Treatment, Minimizing Risk

Page 21: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

LEARNING OBJECTIVES:SAFE AND EFFECTIVE PRESCRIBING OF ANALGESICS

Discuss the appropriate use of non-opioids and adjuvant drugs including basic

pharmacology, risk/benefit and safety concerns in the treatment of chronic non-

cancer pain

Discuss the appropriate use of opioids including basic pharmacology, risk/benefit

and safety concerns in the treatment of chronic non-cancer pain

Calculate conversions between equianalgesics.

Convert dose of short-acting opiate to the appropriate dose of a long-acting

opiate

Page 22: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

COMPONENTS: SAFE AND EFFECTIVE PRESCRIBING OF ANALGESICS

Appropriate Provider Education

Comprehensive Assessment of Patients’ Pain (H&P plus)

Screening for Abuse and Addiction

Comprehensive Treatment Plan with updates (agreed upon with patient)

Contract-Controlled Substances Agreement

Network of referral sites

Physical Therapy, Mental Health, Abuse/addiction, other Community Resources

Risk Evaluation and Mitigation Strategies (REMS)

Page 23: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

WHAT IS PAIN?

“Pain is whatever the person experiencing it says it is” (McCaffery).

An unpleasant sensory and emotional experience associated with

actual or potential tissue damage, or described in terms of such

damage (IASP).

“Total” Pain (Dame Cicely Saunders)

Physical (due to disease or treatments)

Psychological (anger, fear of suffering, depression, past experience of illness)

Social (loss of role, status, job; financial concerns, worries about

future/family, dependency)

Spiritual (anger, loss of faith, finding meaning, fear of the unknown

www.iasp-pain.org/AM/Template.cfm?Section=Home&Template=/CM/ContentDisplay.cfm&ContentID=8705

Page 24: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

Chronic Pain Affects Many Dimensions of a Patient’s Life

Borneman T, et al. Oncol Nurs Forum. 2003;30:997-1005.

Physical Social

Anger/

Fear

• Relationships

• Ability to show affection/sexual function

• Isolation

• Function

• Activities of daily living

• Sleep/rest

Psychological

Anxiety/

Depression

Page 25: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

NOCICEPTIVE , MIXED & NEUROPATHIC PAIN

Postoperativepain

Mechanicallow back pain

Sickle cellcrisis

ArthritisPostherpetic

neuralgia

Neuropathic low back pain

CRPS*

Pain from injuries

Central post-stroke

pain

Trigeminalneuralgia

Distalpolyneuropathy

(eg, diabetic, HIV)

1 Portenoy RK, Kanner RM. Definition and Assessment of Pain. In: Portenoy RK, Kanner RM, eds. Pain Management: Theory and Practice.

Philadelphia, Pa: FA Davis Company; 1996:4.

2 Galer BS, Dworkin RH. A Clinical Guide to Neuropathic Pain. 2000:8-9. Wright, 2015

Caused by a combination of both primary injury and secondary effects

Caused by activity in neural pathways in

response to potentially tissue-damaging stimuli1

Initiated or caused by primary lesion or dysfunction in the nervous system2

Nociceptive Pain Mixed Type Neuropathic Pain

Pancreatitis

Page 26: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

IMPACT OF THE TYPE OF PAIN ON THE STEPWISE APPROACH TO THE PATIENT WITH PAIN

Onset

Acute or Chronic

Etiology

Neuropathic Inflammatory

Mechanical/compressive Visceral Muscular

Impacts Treatment Choices

Page 27: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

PAIN ASSESSMENT-HISTORY

Onset of pain

Precipitating factors

Palliative factors [current and past treatments for pain]

Location, intensity and radiation pattern of pain

Characteristics of pain

Neuropathic pain (Burning, stabbing or shooting pain)

Musculoskeletal pain or Mechanical compression pain (Aching, soreness, stiffness)

Inflammatory pain (Aching, swelling, hot, red)

Grading of pain and impact on level of functioning; Define goals

Psychosocial assessment

Comorbidities

History of Substance Abuse

Chronic medical conditions

Page 28: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

PAIN TREATMENT HISTORY

Pain management

Include treatments that worked and those that did not and WHY

Referring clinicians

Radiologic studies

Past Surgeries

Psychiatry/Mental Health Assessments and Treatments

Other

Page 29: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

PAIN PHYSICAL EXAMINATION

General Examination: Fever, Tachycardia, Thyromegaly, Proximal Muscle Weakness, Joint inflammation, Dermatitis, Neurologic abnormalities, Hepatomegaly or Splenomegaly, Lymphadenopathy

Focus on the area of reported pain (consider that pain may be referred)

Observe patient's gait, movementd and posture

Assess for Trigger Points

Myofascial Pain Syndrome and Tender Points

Complete Musculoskeletal Exam

Shoulder, scapular, iliac crest.Muscle, facet, SI, piriformis, hip

Complete Neurologic Exam

Sensory, Motor, Reflex, CN, Cerebellar

Psychiatric

Page 30: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

MULTIDIMENSIONAL PAIN ASSESSMENT TOOLS

Brief Pain Inventory (BPI)

7 Domains that assess the impact of pain on:

General Activity

Work

Mood

Ability to Walk

Relationships

Sleep

Enjoyment of Life

Page 31: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

SAFE PRESCRIBING OF ANALGESICS MUST INCLUDE OPIOID RISK MANAGEMENT-----REMS

Patient Interview

Screening Tools for for Abuse/Addiction

State Prescription Drug Monitoring database (PDMP)

Urine Drug Testing

CLIA waived immunoassay

GC LC/MS

Criminal background check

Page 32: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

National Institute of drug abusehttps://www.drugabuse.gov/nidamed-medical-health-professionals/tool-resources-your-practice/screening-assessment-drug-testing-resources/chart-evidence-based-screening-tools-adults

Page 34: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

3 •Opioid Analgesics

2 •Adjuvant Analgesics

1 •Non-opioid Analgesics

Page 35: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

ACETAMINOPHEN

Other names – Tylenol, APAP, Paracetamol

APAP (N-acetyl-para-aminophenol)

Analgesic, antipyretic

Widely available in US

Legend prescription combinations – 228

OTC monotherapy and combinations – > 60

31,580 individual NDC codes for mono and combo prescription and OTC products

28 billion doses purchased yearly in US

Single ingredient OTC 8 billion doses

Combination OTC 9.7 billion doses

Acetaminophen / opioid combos 11 billion doses

Retrieved from National Drug Code Directory database: (http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm)

IMS Health, IMS National Sales Perspectives™, Year 2005, Extracted 9/06.

Page 36: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

ACETAMINOPHENMECHANISM OF ACTION

Active metabolite of phenacetin

Not clearly understood; centrally active

Weak COX-1 and COX-2 inhibitor

Equivalent to ASA as an analgesic and antipyretic agent

Lacks anti-inflammatory properties

Does not affect uric acid levels

Does not inhibit platelet function

Role in therapy

Minimal role in OA of knees; no role in low back pain

Smith HS. Potential analgesic mechanisms of acetaminophen. Pain Physician; 2009;12:269-280.

Page 38: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) AGENTS

• Diclofenac*

• Indomethacin

• Sulindac

• Tolmetin

• Celecoxib **

• Meclofenamate

• Mefenamic acid

• Nambumetone

• Piroxicam

Meloxicam

Fenoprofen

Flurbiprofen

Ibuprofen ***

Ketoprofen

Naproxen

Oxaprozin

Etodolac

Ketorolac ***

*Available as topical; **COX-2 selective; ***Available as injectablewww.online.factsandcomparison.com

AnalgesicAntipyretic

Anti-inflammatoryAntiplatelet

Page 39: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

NSAID TOXICITY

Gastrointestinal

Perforation, ulcers, bleeding

Cardiovascular/cerebrovascular

MI, heart failure, CVA

Renal adverse effects

Decreased GFR, progression of CKD

Other adverse effects

Page 40: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

3 •Opioid Analgesics

2 •Adjuvant Analgesics

1 •Non-opioid Analgesics

Page 42: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

WHAT IS AN ADJUVANT?

What is an adjuvant?

“Serving to help or assist; auxiliary.”

“Serving to aid or contribute.”

What is an adjuvant analgesic?

“Drugs with a primary indication other than pain that have analgesic properties in some painful conditions.”

“Medications whose primary indication is the treatment of a medical condition, with secondary effects of analgesia.”

Also referred to as “co-analgesics”

www.ask.com; www.merriam-webster.com; http://theoncologist.alphamedpress.org/content/9/5/571.fullAm J Hospice Pall Med 2012:29(1):70-79

Page 43: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

ADJUVANT ANALGESICS

• Multipurpose Analgesics

• Antidepressants, NSAIDs, α-2 adrenergic agonists, neuroleptics

• Adjuvants for Neuropathic Pain

• Anticonvulsants, Na+ channel blockers, NMDA antagonists, cannabinoids

• Topical Analgesics

• Capsaicin, local anesthetics, NSAIDs

• Adjuvants for Bone Pain

• NSAIDs, calcitonin/bisphosphonates, Radiopharmaceuticals

• Other

• Adjuvants for bowel obstruction, musculoskeletal pain

Portenoy, Ahmed. http://www.futuremedicine.com/doi/abs/10.2217/ebo.11.340

Page 44: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

ANTIDEPRESSANTS

Classpa Examples Analgesic effects

Tricyclic antepressants (TCAs) Nortriptylineamitriptyline

++++++

Selective serotonin reuptake inhibitors (SSRIs)

ParoxetineCitalpramSertraline

+++

Serotonin-norepinephrine reuptake inhibitors (SNRIs)

DuloxetineVenlafaxineMilnacipram

+++ FDA indication:pain++++++ FDA indication:pain

Atypical agents BupropionMirtazapine

+++

Dharmshaktu, Taylor & Kaira (2102). Efficacy of antidepressants as analgesics: a review. J.

J. Clin. Pharacol, 52 (1), 6-17.

Page 45: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

Which of the following antidepressants

is LEAST likely to provide pain relief?

A. Nortriptyline (Pamelor)

B. Duloxetine (Cymbalta)

C. Sertraline (Zoloft)

D. Venlafaxine (Effexor)

Page 46: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

PRINCIPLES OF ADJUVANT ANALGESIC USE

General principles of adjuvant analgesic use:

Multiple pathways of pain transmission provide multiple targets of pain relief

Use specific adjuvant for specific condition

Titrate only one drug at a time

May take several days-weeks to notice improvement in pain

Adjuvants usually do not provide full pain relief

Educate patients about trial-and-error nature of adjuvant use

Select rational combinations of analgesics/adjuvant analgesicsPortenoy, Ahmed. http://www.futuremedicine.com/doi/abs/10.2217/ebo.11.340

Page 47: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

3 •Opioid Analgesics

2 •Adjuvant Analgesics

1 •Non-opioid Analgesics

Page 49: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

OPIOID CATEGORIES

Category Examples

Phenanthrenes • Morphine• Codeine• Hydromorphone• Levorphanol• Oxycodone• Hydrocodone• Oxymorphone• Buprenorphine• Nalbuphine• Butorphanol

Benzomorphans • Pentazocine

Phenylpiperidines • Fentanyl, alfentanil, sufentanil• Meperidine

Diphenylheptanes • Methadone• (Propoxyphene) – off market

Pain Physician 2008;11:S133-S153.

Page 50: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

ATYPICAL OPIOIDS

Tramadol and Tapentadol

Indicated for the management of moderate to severe acute or

chronic pain

Tramadol: Weak mu opioid agonist, increases serotonin and

norepinephrine levels

Tapentadol: Mu opioid agonist and primarily inhibits reuptake of

norepinephrine

Page 51: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

OPIOID INDICATIONS AND USES

Analgesia for Moderate to Severe pain

Anesthesia

Cough

Detoxification

Diarrhea

Dyspnea

Page 52: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

OPIOIDS IN CHRONIC NON-

CANCER PAIN?

Until latter part of the 1990’s, long-term opioid therapy for CNCP was prohibited in most US states.

Data on long-term safety emerged; advocacy groups lobbied to lift the relative prohibition on opioid use in CNCP

Franklin GM. AAN; Neurology 2014; 83(14):1277-1284.

Page 53: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

OPIOIDS IN CHRONIC NON-

CANCER PAIN?

Data on efficacy for opioid use in CNCP lacking

Increasing mortality from accidental poisoning, concomitant with dramatically increasing average daily morphine equivalent doses developed quickly

Franklin GM. AAN; Neurology, 2014; 83(14):1277-1284.

Page 54: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

AHQR, 2014

The Effectiveness and Risks of Long-Term

Opioid Treatment of Chronic Pain

“Evidence on long-term opioid therapy for chronic pain

is very limited but suggests an increased risk of serious

harms that appears to be dose-dependent. More

research is needed to understand long-term benefits,

risk of abuse and related outcomes, and effectiveness of

different opioid prescribing methods and risk mitigation

strategies.”

http://www.ahrq.gov/research/findings/evidence-based-reports/opoidstp.html

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OPIOID RESPONSIVENESS

Pseudo-resistant

Dose too low, patient not absorbing opioid, genetic variation

Semi-opioid resistant pain

Bone metastases, some neuropathic pain, activity-related (some musculoskeletal pain)

Skin ulceration, bladder and rectal tenesmus

Opioid-resistant pain

Some neuropathic pain, muscle spasm

Chronic visceral or central pain syndromes

Abdominal or pelvic pain; pancreatic pain

Fibromyalgia

Headaches

Chronic low back pain

http://www.eperc.mcw.edu/EPERC/FastFactsIndex/ff_215.htm; Am Fam Phys 2012;86(3):252-258.

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AMERICAN ACADEMY OF NEUROLOGY, 2014

Opioids for chronic noncancer pain: A position paper

of the American Academy of Neurology

Franklin GM. Neurology 2014; 83(14):1277-1284.

Opioids are not recommended for treating:

Tension-type headaches

Fibromyalgia

Chronic low back pain

Page 57: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

FIRST LINE OPIOIDS

Morphine

Oxycodone

Hydromorphone

Methadone

Buprenorphine

Fentanyl

Pain Pract 2008;8:287-313.

Page 58: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

MORPHINE

Agonist at mu and kappa opioid receptors

Metabolized in the liver to morphine-3-glucuronide (M3G, 55%) and morphine-6-glucuronide (M6G, 10%). 10% eliminated unchanged.

Both pharmacologically active

M6G analgesic; both can cause toxicity

Accumulated in renal impairment and may cause toxicity

Reduce dose/avoid in renal impairment

Use cautiously with hepatic impairment

Oral morphine may become more bioavailable

May require increase in dosing interval

Available as:

SA tablets, capsules, oral solution, oral intensol

LA tablets, capsules; Rectal suppositories; Injectable formulation

Page 59: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

OXYCODONEPLUS ACETAMINOPHEN=VICODIN, PERCOCET

Agonist at the mu opioid receptor

Metabolized in the liver to noroxycodone

Threefold greater affinity for mu receptor than oxycodone but poorly penetrates CNS

Ten percent of oxycodone excreted unchanged

Parent drug and active metabolites accumulate with renal impairment

Use with caution and at lower doses

• Consider SA formulations in hepatic impairment

• Available as SA tablets, capsules, oral solution, oral intensol, long-acting tablet

Frequently given in combination with acetaminophen (e.g., Percocet), and to a lesser extent with aspirin (e.g., Percodan)

Page 60: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

HYDROMORPHONE- DILAUDID

Agonist at the mu and kappa opioid receptors

Metabolized in the liver to hydromorphone-3-glucuronide, which is pharmacologically active

Moderate to severe renal failure increases hydromorphone area under the curve and half-life of elimination 2-4 fold, respectively

Reduce dose or avoid in renal impairment

Use cautiously with hepatic impairment

Oral hydromorphone may become more bioavailable with severe hepatic impairment

May require longer dosing interval

Available as oral tablets, long-acting tablets, oral solution, injectable formulation and rectal suppository

Page 61: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

FENTANYL - SUBLIMAZE, DUROGESIC

Agonist at the mu opioid receptor

Metabolized by the liver to inactive metabolites; little parent drug excreted unchanged

Bolus doses require no dosage adjustment

Continuous infusion and transdermal fentanyl (TDF) doses should be reduced in severe renal impairment

Avoid TDF in severe hepatic disease, fever, cachexia

Available as injectable, transmucosal, intranasal and transdermal formulations

All but injectable may ONLY be used in opioid-tolerant patients

Oral morphine > 60 mg/day for > 7 days or equivalent opioid

Fentanyl is approximately 100 times more potent than morphine

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BUPRENORPHINE -SUBOXONE

Partial agonist at the mu opioid receptor, antagonist at the kappa opioid receptor

Metabolized to norbuprenorphine (weak mu agonist) and buprenorphine-3-glucuronide

No dosage adjustment needed in renal impairment/failure or mild to moderate hepatic impairment (Not evaluated in severe hepatic impairment)

Available as sublingual tablets and injection

SL tablets with and without naloxone

Available as transdermal formulation

5 mcg/hour, 7.5 mcg/hour, 10 mcg/hour, 15 mcg/hour, 20 mcg/hour

May be started in opioid-naïve patients

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METHADONE

Agonist at the mu receptor, antagonist at the N-methyl-D-aspartate receptor (NMDA)

Metabolized to inactive metabolites

No dosage adjustment is needed in renal impairment but use caution with end-stage renal disease

Half-life may be prolonged with hepatic impairment; allow extra time to achieve steady-stage and dose with caution

Available as oral tablets, oral solution, concentrated oral solution and injectable formulation

Caution when switching from other opioids to methadone

Allow 4-7 days or longer to achieve steady state; do not adjust dose before

Page 64: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

PATIENT-RELATED VARIABLES

Age, ethnicity, body habitus

Opioid-use history (naïve, tolerant?)

Ability to use/manipulate dosage formulation

Renal and hepatic function

History of opioid responsiveness in past (therapeutic or toxic; allergic)

Patient’s lifestyle and dosing interval considerations

Patient health care beliefs, cognitive status

Patient febrile, pregnant, breast-feeding

History of substance abuse, medical conditions worsened by opioid

adverse effects

Page 65: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

OPIOID-INDUCED ADVERSE EFFECTS

Gastrointestinal adverse effects

Nausea and vomiting

Constipation

CNS adverse effects

Sedation, mental clouding, impaired psychomotor function

Cardiorespiratory

Cardiac effects of opioids (methadone, buprenorphine)

Respiratory depression

Other adverse effects (pruritus, immunologic effects, hormonal change, hyperalgesia, bladder dysfunction)

Benyamin R et al. Pain Physician 2008;11:S105-S120. Swegle JM et al. Am Fam Physician 2006;74:1347-1354

Page 66: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

REASONS FOR CHANGING OPIOIDS

Lack of therapeutic response

Development of adverse effects

Change in patient status

Other considerations

Opioid/formulation availability

Formulary issues

Patient/family health care beliefs

Opioid rotation, substitution, switching

Page 67: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

PUTTING IT ALL TOGETHER…

Topiramate,

pregabalin,

ziconotide

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Page 68: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

MORPHINE, GABAPENTIN, OR BOTH

41 patients with neuropathic pain randomized to four groups (x 5 weeks)

SR morphine

Gabapentin

SR morphine + gabapentin

Placebo (lorazepam)

Group Pain Rating (0-10)

Baseline 5.72

Placebo 4.49

SR morphine 4.15

Gabapentin 4.15

MS + Gabapentin 3.06

• Morphine + gabapentin doses were lower than the morphine or gabapentin arms, with better pain relief.

• Combination treatment had more constipation and dry mouth.NEJM 2005;352:1324-1334

Page 69: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

USING OPIOIDS SAFELY IN CNCP

Opioid Responsive Pain / Minimize Use

Minimize Dose / Combination Therapy

Stay Safe (Corresponding Responsibility)

Show Functional Improvement

Exit Strategy

Page 70: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

POINTS TO TAKE HOME…

Evaluate the utility of non-opioids (risks and benefits; acetaminophen and

NSAIDs)

Maximize the use of lifestyle modification for chronic non-cancer pain

Maximize the use of adjuvant analgesics and other non-pharmacologic

interventions

Carefully consider the appropriateness of starting or continuing an

opioid

Monitor pain ratings, and more importantly, functional status

Begin any pain management regimen with the end in mind (develop an

exit strategy).

Page 71: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

EQUIANALGESIC OPIOID DOSING

Equianalgesic Doses (mg)

Drug Parenteral Oral

Morphine 10 30

Buprenorphine 0.3 0.4 (sl)

Codeine 100 200

Fentanyl 0.2-0.3 NA

Hydrocodone NA 30

Hydromorphone 1.5 7.5

Meperidine 100 300

Oxycodone 10* 20

Oxymorphone 1 10

Tramadol 100* 120*Not available in the USAdapted from: McPherson ML. Demystifying Opioid Conversion Calculations: A Guide For Effective Dosing. Amer Soc of Health-Systems Pharm, Bethesda, MD, 2010. Copyright ASHP, 2010. Used with permission.NOTE: Learner is STRONGLY encouraged to access original work to review all caveats and explanations pertaining to this chart.

Page 72: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

5-STEP OCC PROCESS

1. Globally assess pain complaint (PQRSTU)

2. Determine TDD current opioid (LA and SA)

3. Decide which opioid analgesic will be used for the new

agent and consult established conversion tables to

determine new dose

4. Individualize dosage based on assessment information

gathered in Step 1

5. Patient follow-up and continual reassessment (7-14 days)

Gammaitoni AR, et al. Clinical J Pain 2003;19:286-297

Page 73: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

USE A SIMPLE CONVERSION TO FIGURE OUT MATH

12 inches = 1 foot Problem- How many inches in 2 feet?

“x” inches = equivalents 12 inches

2 feet equivalents 1 foot

(x)(1) = (2)(12)

1X = 24

X= 24 = 24

1

Page 74: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

NEED TO SWITCH DRUGS DUE TO S/E

Patient it currently taking 135 mg oral morphine daily. He is experiencing increasing pruritis and undesirable drowsiness.

The decision is made between the patient and the provider to switch to oxycodone.

How many mg of oxycodone should be prescribed?

Page 75: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

SETTING UP THE CONVERSION EQUATION

“x” mg new opioid = equivalent mg new opioid

mg of current opioid equivalent mg current opioid

“x” mg oral oxycodone = 20 mg oral oxycodone

135 mg oral morphine 30 mg oral morphine

(x)(30) = (20)(135)

30X = 2700

X= 2700 = 90 mg oxycodone (reduce by 25-50% for safety)= 45-70 mg

30

Dose based on available dosage strengths and dosing frequency (SA or LA)

Page 76: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

RESOURCES

Chronic Pain Initiative Toolkit: Primary Care Providers. (2012)

http://www.p4communitycare.org/media/related-downloads/cpi-toolkit-pcps.pdf

http://www.p4communitycare.org/media/related-downloads/cpi-toolkit-pcps.pdf

Institute for Clinical Systems Improvement. Health Care Guideline: Assessment and Management of Chronic Pain. Updated 2013.

https://www.icsi.org/_asset/bw798b/ChronicPain.pdf

https://www.icsi.org/_asset/bw798b/ChronicPain.pdf

An Annotated Bibliography of Patient and Provdier Resources

Included in PCNP meeting handouts

Page 77: Safe and Effective Prescribing of Analgesics · 2018-03-31 · May 2016 October 2016 June 2016 July 2016 August 2016 September 2016 May 17, 2016 National Association Board of Pharmacy

Questions