Prescription Drug Diversion and Pain History, Policy, and

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1
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Library of Congress Cataloging-in-Publication Data

Names: Peppin, John F., editor. | Coleman, John J., Ph. D., editor. | Dineen, Kelly K., editor. | Ruggles, Adam J., editor.
Title: Prescription drug diversion and pain: history, policy, and treatment /
edited by John F. Peppin, John J. Coleman, Kelly K. Dineen, Adam J. Ruggles.
Description: New York, NY : Oxford University Press, [2018] | Includes bibliographical references.
Identifiers: LCCN 2018000838 | ISBN 9780199981830 (pbk.)
Subjects: | MESH: Analgesics, Opioid | Chronic Pain—therapy | Drug and Narcotic Control |
Prescription Drug Diversion—prevention & control | Opioid-Related Disorders—prevention & control | United States
Classification: LCC RC568.O45 | NLM QV 89 | DDC 615.7/822—dc23
LC record available at https://lccn.loc.gov/2018000838

This material is not intended to be, and should not be considered, a substitute for medical or other professional advice.
Treatment for the conditions described in this material is highly dependent on the individual circumstances. And, while this
material is designed to offer accurate information with respect to the subject matter covered and to be current as of the time it
was written, research and knowledge about medical and health issues is constantly evolving and dose schedules for medications
are being revised continually, with new side effects recognized and accounted for regularly. Readers must therefore always
check the product information and clinical procedures with the most up-​to-​date published product information and data sheets
provided by the manufacturers and the most recent codes of conduct and safety regulation. The publisher and the authors make
no representations or warranties to readers, express or implied, as to the accuracy or completeness of this material. Without
limiting the foregoing, the publisher and the authors make no representations or warranties as to the accuracy or efficacy of the
drug dosages mentioned in the material. The authors and the publisher do not accept, and expressly disclaim, any responsibility
for any liability, loss or risk that may be claimed or incurred as a consequence of the use and/​or application of any of the
contents of this material.

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Printed by WebCom, Inc., Canada
v

We dedicate this volume to the memory of two wonderful

health professionals and human beings. This project has been
plagued by sadness for most of the editors. Soon after starting
this project, Dr. Howard Smith passed away suddenly. Howard
was a wonderful man, dedicated to advancing the science and
treatment of pain. He was gracious and was always willing to help
others build their careers. He will be sorely missed. Dr. Kenneth
L. Kirsh was a dear friend who spent his professional life trying
to improve the lives of chronic pain patients. Soon after starting
work on this volume, Ken was diagnosed with advanced cancer
and was not able to continue with this project. He passed away in
March 2017. He too was a wonderful person who will be missed by
his friends, colleagues, family, and patients.
vi
vii

CONTENTS

Contributors ix
Disclosures xi
Preface xiii
John F. Peppin, John J. Coleman, and Kelly K. Dineen

1. Opioid Medications: Old Wine in New Bottles 1

Timothy Atkinson, John J. Coleman, and Jeffrey Fudin

2. Legal Regulation of Prescription Opioids and Prescribers 17

Kelly K. Dineen and Adam J. Ruggles

3. Monitoring Prescriptions, Third-​Party Healthcare Payers, Prescription Benefit

Managers, and Private-Sector Policy Options 39
John J. Coleman

4. Whatever Happened to the Decade of Pain Control and Research? 78

John J. Coleman

5. Evaluation and Treatment of the Chronic Pain Patient: Practice and

Complexity 110
John F. Peppin, Pravardhan Birthi, Bill H. McCarberg, and Yvonne D’Arcy
vii

6. An Overview of the Abuse Potential of Nonopioids: Sedatives, Hypnotics,

and Stimulants 136
Christopher M. Herndon and Kelly N. Gable

7. Psychiatry and Chronic Pain: An Associative Connection 152

Hani Raoul Khouzam

8. Managing Pain in Patients with a History of a Substance Use Disorder: Challenges

and Opportunities 176
Martin D. Cheatle

9. Opioid Prescribing in Stigmatized and Special Populations 190

Kelly K. Dineen

10. The Demise of Interdisciplinary Chronic Pain Management and Its Relationship to
the Scourge of Prescription Opioid Diversion and Abuse 205
Michael E. Schatman

11. Pain Management Assessment Beyond the Physician Encounter: Urine Drug
Monitoring and Patient Agreements 219
Anand C. Thakur

Epilogue 239
John F. Peppin, John J. Coleman, and Kelly K. Dineen
Index 245

viii • Contents
ix

CONTRIBUTORS

Timothy Atkinson, PharmD, BCPS, CPE Jeffrey Fudin, BS, PharmD, DAIPM
Clinical Pharmacy Specialist, Pain FCCP, FASHP, FFSMB
Management Chief Executive Officer and Chief Medical
Veterans Affairs Tennessee Valley Officer, Remitigate LLC
Healthcare System Delmar, NY
Murfreesboro, TN Clinical Pharmacy Specialist and
Director, PGY2 Pharmacy Pain
Pravardhan Birthi, MD
Residency (WOC)
Interventional Pain and PM&R Physician
Stratton VA Medical Center
CHI Health Saint Francis Pain and Physical
Adjunct Associate Professor of Pharmacy
Medicine Clinic
Practice
Grand Island, NE
Albany College of Pharmacy & Health
Martin D. Cheatle, PhD Sciences
Associate Professor Albany, NY
Center for Studies of Addiction Adjunct Assistant Professor of Pharmacy
Perelman School of Medicine Practice
University of Pennsylvania Western New England University College
Philadelphia, PA of Pharmacy
Yvonne D’Arcy, MS, ARNP-​C, Springfield, MA
CNS, FAANP Kelly N. Gable, PharmD, BCPP
Pain Management and Palliative Care Associate Professor
Nurse Practitioner Southern Illinois University Edwardsville
Ponte Vedra, FL School of Pharmacy
Edwardsville, IL
x

Christopher M. Herndon, PharmD, Michael E. Schatman, PhD

BCPS, CPE, FASHP Department of Public Health and
Associate Professor Community Medicine
Southern Illinois University Edwardsville Tufts University School of Medicine
School of Pharmacy Boston, MA
Edwardsville, IL
Anand C. Thakur, MD
Hani Raoul Khouzam, MD, MPH, FAPA CEO/​Medical Director
Staff Psychiatrist ANA Pain Management
Chief of Salinas Outpatient Adult Services Clinical Assistant Professor
Natividad Medical Center Department of Anesthesiology
Salinas, CA Wayne State University
Detroit, MI
Bill H. McCarberg, MD, FABPM
Neighborhood Healthcare (FQHC)
Elizabeth Hospice
San Diego, CA

x • Contributors
xi

DISCLOSURES

Pravardhan Birthi, Martin D. Cheatle, John J. Coleman, Kelly N. Gable, Christopher

M. Herndon, Hani Raoul Khouzam, Michael E. Schatman: Potential conflicts of
interest.
Timothy Atkinson: Axial Healthcare Inc. (Consultant); Daichii Sankyo (Advisory Board);
Purdue Pharma (Epidemiology Advisory Board)
Yvonne D’Arcy: Purdue (Ad board, Speakers Bureau—​non-​branded materials), Ortho-​
McNeil (Speaking—​non-​branded), Egalet (Ad board), Practicing Clinicians Exchange
(Speaking—​Chronic Pain)
Kelly K. Dineen: My spouse is a full-​time employee of Medtronic, Inc., which manufactures
medical devices, including implantable devices for the treatment of chronic pain. I did not
write about the use of devices for pain.
Jeffrey Fudin: Astra Zeneca (Speakers Bureau); Collegium (Consultant, Films);
Daiichi Sankyo (Advisory Board); DepoMed (Advisory Board, Speakers Bureau); Endo
(Consultant, Speakers Bureau); Iroko Pharmaceuticals (Speakers Bureau); Kashiv Pharma
(Advisory Board); KemPharm (Consultant); Pernix Therapeutics (Speaker); Remitigate,
LCC (Owner)
Bill H. McCarberg: Advisor: Pfizer, Collegium, DepoMed, Daiichi Sankyo, Pernix, Eaglet;
Stock holdings: Johnson and Johnson, Biospecifics Technologies, Nektar Therapeutics,
Galena, Collegium; Speaker’s Bureau: Collegium
John F. Peppin: Janssen (Consultant); Ferring Pharmaceuticals (Consultant, Speaker);
OneSource Regulatory (Consultant); YourEncore (Consultant)
Anand C. Thakur: DepoMed Pharmaceuticals (Speaker); Purdue Pharmaceuticals
(Speaker); Kaleo Pharmaceuticals (Speaker); BDSI Pharmaceuticals (Speaker); Daiichi-​
Sankyo Pharmaceuticals (Speaker)
xii
i

PRESCRIPTION DRUG
DIVERSION AND PAIN
xii

PREFACE

Chronic pain and the use of prescription opioids: There are very few topics today that can
raise more emotional response than this combination, which just happens to be the central
theme of this book. In today’s world, opioids, like some of the people who use them and
some who prescribe them, are being vilified because of what experts are calling an epidemic
of opioid abuse. Described as “painkillers” and “narcotics” by the media, there is a growing
sense that physicians who routinely prescribe these drugs for nonmalignant chronic pain
are compromising professional norms, including that of the sacred Hippocratic Oath
directive to first do no harm.
Chronic pain patients, many of whom are already beset by their medical problems, are
further troubled and confused by the back-​and-​forth public debates over the safety and
soundness of their treatment protocols. The topic of opioids is more divisive today than
ever before.1 Ideology rather than physiology becomes all too often the prevailing sen-
timent not only for practitioners, but also for pain patients, policymakers, public health
and safety officials, and even members of the public. Views are often expressed in divisive
pronouncements rather than arrived at through civil discourse.
Opioids indeed are controversial, but the complete story of their benefits and burdens
remains untold. From time to time, data may be selected and interpreted to buttress a claim
that, in turn, may be untrue or only partially true. There has been so much written in the
medical literature for so many years on this topic that one should have no problem finding
an authoritative source or two to reference a pet theory. Although concern for the long term
use of opioids has existed for millennia, the wave of current fear gripping the nation no
doubt has come about because of the increasing morbidity and mortality associated with
their use in treating nonmalignant chronic pain.
Over just the last several years, a major shift has occurred in the literature over the long
term use of opioids to treat chronic pain. The effect of this shift has been felt by patients
who suddenly find their healthcare providers reluctant to continue chronic opioid therapy.
xvi

In the absence of suitable alternatives, many patients will likely bear the personal burden of
this changing environment. Some will become dispirited and confused by the stereotypical
accounts of opioid addiction that abound in the popular media.2
As we show in this book, essential data about opioid abuse, morbidity, and mortality
are lacking and what little data we have are derived from flawed and obsolete government
databases. Yet, these sources are relied upon for public policy development, resource al-
location, and lawmaking. In the absence of sound data, ingrained cultural feelings about
addiction can become a powerful driver of attitudes, even among pain specialists who,
despite their professional training and experience, may be influenced by such bias in their
prescribing practices.
Most would agree that the modern era of chronic pain treatment began in earnest the mid-​
1990s with the introduction of an extended-​release form of oxycodone called OxyContin®.
It was aggressively marketed as the answer to millions of untreated or undertreated chronic
pain patients. OxyContin offered benefits that shorter acting immediate-​release opioids
lacked. Professional medical groups and organizations representing the interests of pain
patients heralded the new drug. With their support, in 2000, congress enacted a statute
declaring the decade beginning in 2001 as the “Decade of Pain Control and Research.”
Lurking beneath the growing euphoria at the time was a growing concern by state and
federal officials over increasing reports of overdoses and deaths attributed to the misuse of
OxyContin, particularly in places like Maine, Ohio, and parts of Appalachia. By the end of
the Decade of Pain Control and Research, the government was geared up and ready to tran-
sition to a decade of drug control. In this book, we explain in detail when, how, and why this
happened.
A basic aim of this book is to inform healthcare professionals and others about some of
the essential aspects of chronic pain treatment, particularly in an time of changing attitudes
about the long term use of opioid therapy. Opioids are not, and never have been, a panacea
for treating pain; they are just one of several tools available for use in specific instances
and with specific patients. Much has changed in the pain field since this book was first
envisioned, and much is expected to change over the coming years.
It is the hope of the authors and publisher that readers employed in the fields of law en-
forcement, medicine, regulatory policy and enforcement, pharmacy, drug treatment, and
academia, as well as interested members of the general public, will benefit from the exper-
tise and candor of the authors. This volume cannot begin to cover all of the important issues
surrounding prescription opioids and chronic pain; rather, it is meant to be a starting point,
a roadmap of sorts for professionals and non-​professionals interested in the modern era of
pain treatment and how we arrived at where we are today.
As mentioned in the dedication page, the editors would like to offer their sincere
condolences to the families of Drs. Kenneth L. Kirsh and Howard Smith, two dedicated
and skilled individuals with whom we began this project and who untiringly worked for the
betterment of pain patients.
John F. Peppin, John J. Coleman, and Kelly K. Dineen

xiv • Preface
xv

REFERENCES
1. http://​health.usnews.com/​health-​news/​blogs/​eat-​r un/​2015/​04/​08/​the-​problem-​w ith-​opioids-​for-​
chronic-​pain. Accessed May 10, 2017.
2. Peppin JF. Marginalization of patients with chronic pain on chronic opioid therapy. Pain Physician.
2009;12:493–​498.

Preface • xv
xvi
xvi

PRESCRIPTION DRUG
DIVERSION AND PAIN
xvi