REMS Doesn't Have to Be a ‘Four-letter Word'

Steven Wright, MD

Risk management with patients on opioid therapy offers the opportunity to improve communication and strengthen the physician-patient relationship.

In 2007 the FDA Amendments Act section 909 authorized the FDA to develop legally enforceable Risk Evaluation and Mitigation Strategies (REMS) for pharmaceutical companies to ensure safe medication use (http://1.usa.gov/HSGcp0). Physicians, in turn, also face downstream obligations when it comes to medication safety and responsible prescribing, especially when it comes to opioids and chronic pain.

When “the hot fires and cold frost [that] have particles fanged in different ways” (Lucretius, first century B.C.E. Rome) are unresponsive to treating pain generators for more than three months, the diagnosis is chronic pain, reflecting an inability to heal, and likely to continue indefinitely. Guidelines support the use of chronic opioid therapy for these patients (http://bit.ly/lWFtTQ). Some clinicians glorify opioids; Sir William Osler, the grandfather of modern medicine, called them “God’s own medicine.” Others vilify them, driven by concerns over abuse and addiction: “you’ll taste a devil or two before you’re through” (patient, David M).

While aberrant opioid use is common among those prescribed opioids for valid medical reasons, addiction is not, according to Fishbain et al. in a meta-analysis of 67 adjudicated studies (http://bit.ly/mZj71G), the authors reported that the data showed an overall addiction rate of 3.27% among patients treated with opioids. For those with no personal or family history of abuse and/or addiction, the rate was 0.19%. When present, however, addiction is ruinous and potentially lethal. Physicians, therefore, are obliged to screen patients for risk before initiating opioids and then to monitor for safe use thereafter.

A variety of risk factors and screening instruments have the potential for predicting problem opioid use. However, Turk et al. in the Clinical Journal of Pain found that no single tool or factor, nor combination of several elements, had high reliability (http://bit.ly/ HQvi15). In a literature review done at the Oregon Health and Science University, two high-quality studies found the Screener and Opioid Assessment for Patients with Pain (SOAPP; http://bit.ly/HYcRZD) to be weakly predictive, and one low-quality study found the Opioid Risk Tool (ORT; http://bit.ly/fo5Cns) to be strongly predictive of misuse risk before opioids are prescribed (http://bit.ly/HPTHZb). With respect to assessing risk in patients who are already on opioids, the literature review found that the Current Opioid Misuse Measure (COMM; http://bit.ly/I2dmDQ) was only weakly predictive.

Consent, monitoring, and risk management

As with any medication, informed consent should be obtained from patients prior to the initiation of treatment with opioids; clinicians should explain the risks, benefits, alternatives, and goals of opioid therapy. Unlike informed consent, Controlled Substance Agreements lay out the rules (patients agree to use only one prescriber and one pharmacy, pill counts and lock boxes, safe disposal protocol, etc) and list prohibitions (no alcohol, illicit substances, injecting, snorting, overusing, sharing, selling, diverting, forging, kiting, etc). Although such agreements (not “contracts,” which are inflexible) do not influence behavior, they remind patients of their responsibilities and outline termination criteria should that become necessary (http://bit.ly/I4x3qF).

Keep it simple.

Use monthly follow-up visits to address the “5 A’s”: analgesia, adverse events, activities of daily living (function), affect, and aberrancies (including nonallowed substances). The numerical pain scale is subjective but useful; guide the patient as to what the numbers mean, (eg, 10 is like being burned alive, 5 stops you from what you are doing). This simultaneously establishes the goal for treatment (eg, “get it under 5”). The physical exam can help you determine the patient’s degree of impairment and whether the patient’s pain report rings true.

Keep it simple.

Urine drug testing with confirmation, routine and random, helps determine if patients are taking the medications prescribed and only those substances of potential addiction. Information from pharmacies and Prescription Drug Monitoring Programs helps determine if other clinicians are also prescribing opioids to a patient. Behavioral aberrancies ranging from unauthorized overuse to claims of pet ingestion (ie, “my dog ate them”) to frank forgery require measured responses. Note whether your patients are focused on only opioids or are willing to do anything that could limit their pain. Generally, if addiction is identified, it is not necessary to dismiss the patient from your practice. Instead, you should assist the patient in obtaining the necessary treatment, just as for any new diagnosis.

Keep it simple.

Physicians can provide thorough pain care and still see more than one patient a day. REMS surveillance and smart risk management can keep patients safe with opioids. Not too bad for a four-letter word.

Steven Wright, MD, practices primary care, addiction medicine, and medical pain management in Denver, Colorado.