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Pharmacy Law: Determining the Legitimacy of Opioid Prescriptions

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Overview

The pharmacists at XYZ Pharmacy are concerned. The pharmacy is in close proximity to a pain management clinic and patients from this clinic regularly present the pharmacists with prescriptions for MS Contin®, oxycodone, methadone, and other opioids in quantities as large as 1,000 tablets for a 1-month supply. Those prescriptions are usually accompanied with prescriptions for fentanyl oral lozenges. A few other physicians in the area also write prescriptions for large quantities of opioids and patients prefer going to XYZ Pharmacy since some of the other pharmacies in town will not fill their prescriptions. The XYZ pharmacists are concerned about the legitimacy of many of these prescriptions, the potential for legal and regulatory scrutiny, and wonder, "What is our responsibility under the law?" The above situation is very general and begs for additional facts with regard to each patient and each physician. Nonetheless, it serves to introduce one of the most perplexing and troublesome issues a pharmacist can face: determining whether an opioid prescription written by a prescriber is legitimately written for the treatment of pain.

Pharmacists’ concerns are exacerbated when several patients present multiple opioid prescriptions for very large quantities and very high dosages from the same prescriber or the same few prescribers. However, large quantities and high dosages are often necessary and legitimate in order to adequately treat severe pain patients. Regulators, law enforcement agencies, and legislatures have clearly articulated that they condone this practice. (See inset, page 2.) Nonetheless, pharmacists may hesitate to dispense these prescriptions fearing the consequences of the legal/regulatory system. In particular, the law imposes a legal duty on pharmacists called the corresponding responsibility doctrine. Simply stated, the corresponding responsibility doctrine places upon the pharmacist an equal legal responsibility with the prescriber to ensure that the prescriptions are written for a legitimate medical purpose.

The treatment of addicts for addiction in the ordinary course of a prescriber’s practice is not a legitimate medical purpose. Except for limited circumstances as described by law, addicts may not be treated for addiction outside of licensed treatment programs. Treating addicts with opioids for pain is a legitimate medical purpose, but sometimes the real purpose of treatment can be hard to determine.

Pharmacists can engage in certain steps and incorporate tools to help them determine if prescriptions are legitimate. They can also help educate pain patients who receive opioids about how to prevent diversion. Diversion and abuse of legitimate prescription drugs, especially among youth, is a significant societal problem.

Details

Publication Date: 03/20/2017
Expiration Date: 03/20/2018
CE Credit: 2.0 (0.20 CEU)
Type of Activity: Knowledge-based

This program was developed by The Rx Consultant and published by Continuing Education Network, Inc. The Rx Consultant accepts no advertising or financial support from the pharmaceutical industry and is funded solely by the purchase of programs. The Rx Consultant is dedicated to providing unbiased, balanced information to health care practitioners.

Programs developed by The Rx Consultant are written by health care providers with expertise in the topic area, peer-reviewed, extensively edited, and fact-checked. This development process was created to insure that every program presents information that is current, accurate, relevant to "real world" health care providers, and written in an easy reading, "plain English" style.

Authors

Richard R. Abood, B.S. Pharm., J.D., Professor of Pharmacy Practice, Thomas J Long School of Pharmacy & Health Sciences, University of the Pacific, Stockton, CA.

Disclosure Statement

Richard R. Abood reports no financial or personal relationship with any commercial interest producing, marketing, reselling, or distributing a product or service that appears in this issue.

Target Audience

This accredited program is targeted to pharmacists and nurses.

Goals & Objectives

At the conclusion of this program, participants will be able to:

    1. Describe the complexities healthcare professionals face with chronic pain management that make it difficult to ensure adequate pain treatment in appropriate patients.
    2. Explain the Corresponding Responsibility Doctrine and how it has been applied to court cases involving pharmacists.
    3. List methods that can assist pharmacists in determining the legitimacy of opioid prescriptions.
    4. Discuss the legally accepted standards for the treatment of pain in an addict.

Accreditation Statements

The Rx Consultant is a publication of Continuing Education Network, Inc.

Continuing Education Network, Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education as a provider of continuing pharmacy education.

Continuing Education Network is approved by the California Board of Registered Nursing, Provider Number CEP 13118. Programs approved by CA BRN are accepted by most State Boards of Nursing.

ACPE Universal Activity Number: 0428-0000-17-004-H03-P


Exam & Credit Statement Procedures

Upon successful completion of this program and the post test (70%), 2.0 hours of continuing education credit will be awarded. To receive credit and your exam score, please complete the exam questions and program evaluation.

Editorial and Review Board

Chief Editor and CE Administrator


Terry M. Baker, PharmD

Managing Editor


Tracy Farnen, PharmD

Associate Editors


James Chan, PharmD, PhD
Pharmacy Quality and Outcomes Coordinator
Kaiser Permanente
Oakland, CA

Associate Clinical Professor
School of Pharmacy
University of California San Francisco
San Francisco, CA

Richard Ron Finley, B.S. Pharm.,R.Ph.
Clinical Pharmacist (volunteer faculty)
University of California, San Francisco (UCSF) Memory and Aging Center
Lecturer (Emeritus) UCSF, Department of Clinical Pharmacy
Health Sciences Clinical Professor, UCSF School of Pharmacy
San Francisco, CA

Consultant Pharmacist
Ray Dolby Brain Health Center, Sutter Health/CPMC
San Francisco, CA

Consult Pharmacist Aging and Adult Health Services
San Francisco Health Department
San Francisco, CA

Julio R. Lopez, PharmD, FCSHP
Chief of Pharmacy Service
VA Northern California Health Care System

Adjunct Clinical Professor
College of Pharmacy
Touro University
Vallejo, CA

Assistant Clinical Professor
School of Pharmacy
University of California, San Francisco
San Francisco, CA Adjunct Professor
Thomas J. Long School of Pharmacy
University of the Pacific
Stockton, CA

Visiting Associate Professor and Lecturer
Nursing School
Samuel Merritt University
Oakland, CA

Pamela Mausner, MD

Helen Berlie, Pharm.D. CDE, BCACP
Clinical Assistant Professor, Pharmacy Practice
Wayne State University
Detroit, MI

Ambulatory Care Specialist - Diabetes
Health Centers Detroit Medical Group
Detroit, MI

Senior Editorial Advisor


Gerard Hatheway, PharmD, PhD

Editorial Advisors


Belinda M. Danielson, RPh
Christopher M. DeSoto, PharmD
Angie S. Graham, PharmD
Cynthia Chan Huang, PharmD, MBA
Fred Plageman, PharmD

Editorial Advisor and Clinical Practice Consultant for Nurse Practitioners


Emily K.
Meuleman, RN, C, MS

About the Rx Consultant

The Rx Consultant is a monthly publication dedicated to providing health care professionals with the information they need to educate patients about drugs and manage drug therapy. The reader is responsible for confirming the information presented here and interpreting it in relation to each patient's specific situation before utilizing the information.

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