Update on Risk Evaluation and Mitigation Strategies (REMS) Associated with Long-Acting Opioids

By Fudin, Jeffrey | Drug Topics, October 2011 | Go to article overview

Update on Risk Evaluation and Mitigation Strategies (REMS) Associated with Long-Acting Opioids


Fudin, Jeffrey, Drug Topics


AN ONGOING CE PROGRAM OFTHE UNIVERSITY OF CONNECTICUT COLLEGE OF PHARMACY AND DRUG TOPICS

Abstract

The Risk Evaluation and Mitigation Strategies (REMS) program was instituted by FDA partly in an attempt to reduce the risk and prevalence of opioid abuse in the treatment of pain. REMS programs are now underway and have been largely integrated for all long-acting/extended-release and rapid-onset opioids used in the treatment of chronic pain and acute pain, respectively. The pharmacist plays a multidimensional role in this effort, which includes educating patients, prescribers, and the community at large, being vigilant to signs of overprescribing or abuse, and recognizing the biopsychosocial factors that put pain patients at risk for substance abuse. Designing opioid regimens for chronic pain, identifying risk fadors for variable age groups from adolescents to elderly patients, and selecting opioids because of the risk associated with alternative pain medications all present unique challenges to the healthcare provider. The principles and tools of the REMS program are designed to reduce societal and patient risks, but the pharmacist has the clear legal and ethical obligation to act when abuse is suspected. Such actions must be informed, measured, and appropriate to the specific circumstances. Significant reductions in the risk of opioid abuse have been achieved with trilateral agreements and other tools of collaborative practice, as well as by the often stringent REMS requirements now in place for monitoring the behavior of patients, prescribers, and dispensers in the medical treatment of chronic pain.

Opioids are a class of medications uniquely associated with a wide spectrum of prescribing and dispensing attitudes on the part of healthcare providers. Although some providers may prescribe opioids too freely, other practitioners fear opioids so much that they may refuse to prescribe them even for the terminally ill (Figure I),1 A continuum of variable nonadherence occurs with chronically prescribed opioids, the spectrum of which varies among pain patients versus recreational users (Figure 2).2 The Risk Evaluation and Mitigation Strategies (REMS) program was instituted by FDA in part as an attempt to confront the growing risk of opioid abuse in the United States and the growing numbers of deaths caused each year by negligent opioid prescribing, opioid abuse, and misuse. Most opioids can be used as a safe and effective treatment for pain, as long as the risks - especially the risks of addiction and abuse - are identified, stratified, minimized, and effectively mitigated.

Psychosocial factors in the risk of addiction

In general, patients with behavioral health disorders, including general anxiety disorder, post-traumatic stress disorder, familymember abuse, and sexual abuse have a higher risk of addiction than does the general population. Family history of drug abuse, youth (preteen to young adult), and iniquitous social influences all contribute to greatest risk. These biopsychosoáal issues can often be identified within particular family structures,3

In assessing risk, patient history should include any instances of substance abuse, including alcoholism on the part of the patient or close family member. Cigarette smoking is an important risk factor, both because of the habitual action of bringing the hand to the mouth and also because nicotine itself is a highly addictive drug. Although not all smokers are at risk for opioid addiction, a higher percentage of patients with addiction disorders are smokers compared to that for the general population,4

The concept of stratifying the risk of abenant behavior was proposed by Gourlay, who evaluated patients with "universal precautions," designating them as low risk, moderate risk, and high risk in several distinct risk areas,5 For example, a patient who never had substance abuse is at low risk for this disorder, a patient with a past history of abuse is at moderate risk, and a patient with a current pattern of substance abuse is at high risk. …

The rest of this article is only available to active members of Questia

Already a member? Log in now.

Notes for this article

Add a new note
If you are trying to select text to create highlights or citations, remember that you must now click or tap on the first word, and then click or tap on the last word.
One moment ...
Default project is now your active project.
Project items

Items saved from this article

This article has been saved
Highlights (0)
Some of your highlights are legacy items.

Highlights saved before July 30, 2012 will not be displayed on their respective source pages.

You can easily re-create the highlights by opening the book page or article, selecting the text, and clicking “Highlight.”

Citations (0)
Some of your citations are legacy items.

Any citation created before July 30, 2012 will labeled as a “Cited page.” New citations will be saved as cited passages, pages or articles.

We also added the ability to view new citations from your projects or the book or article where you created them.

Notes (0)
Bookmarks (0)

You have no saved items from this article

Project items include:
  • Saved book/article
  • Highlights
  • Quotes/citations
  • Notes
  • Bookmarks
Notes
Cite this article

Cited article

Style
Citations are available only to our active members.
Buy instant access to cite pages or passages in MLA, APA and Chicago citation styles.

(Einhorn, 1992, p. 25)

(Einhorn 25)

1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

Cited article

Update on Risk Evaluation and Mitigation Strategies (REMS) Associated with Long-Acting Opioids
Settings

Settings

Typeface
Text size Smaller Larger Reset View mode
Search within

Search within this article

Look up

Look up a word

  • Dictionary
  • Thesaurus
Please submit a word or phrase above.
Print this page

Print this page

Why can't I print more than one page at a time?

Help
Full screen

matching results for page

    Questia reader help

    How to highlight and cite specific passages

    1. Click or tap the first word you want to select.
    2. Click or tap the last word you want to select, and you’ll see everything in between get selected.
    3. You’ll then get a menu of options like creating a highlight or a citation from that passage of text.

    OK, got it!

    Cited passage

    Style
    Citations are available only to our active members.
    Buy instant access to cite pages or passages in MLA, APA and Chicago citation styles.

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn, 1992, p. 25).

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn 25)

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences."1

    1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

    Cited passage

    Thanks for trying Questia!

    Please continue trying out our research tools, but please note, full functionality is available only to our active members.

    Your work will be lost once you leave this Web page.

    Buy instant access to save your work.

    Already a member? Log in now.

    Author Advanced search

    Oops!

    An unknown error has occurred. Please click the button below to reload the page. If the problem persists, please try again in a little while.