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

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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. …