PHILADELPHIA—Sales of opioids more than doubled between 2001 and 2012, according to a lecture delivered at the 66th Annual Meeting of the American Academy of Neurology. In response to increases in the abuse of, addiction to, and deaths resulting from opioids, the FDA is seeking to establish tighter control over the prescription of these drugs. The agency is requiring drug manufacturers to make changes to drug safety labels and to perform postmarketing studies of opioids.
The FDA’s statements “are sending shockwaves across a lot of the industry, and also into the medical establishment,” said Christopher H. Gibbons, MD, Assistant Professor of Neurology at the Harvard Medical School in Boston. “This is really going to reverberate in terms of how we practice medicine.” Neurologists need to become more familiar with the literature on opioids and follow certain principles to prescribe the drugs appropriately, he added.
Christopher H. Gibbons, MD
Evidence for Opioids’ Efficacy in Chronic Pain Is Equivocal
Many clinicians are comfortable prescribing opioids for short-lived syndromes such as acute pain, dental pain, traumatic injuries, and postsurgical pain, said Dr. Gibbons. The vast majority of neurologists, however, treat patients with chronic pain, and rapid recovery from chronic pain is unlikely, he added.
For this reason, it is worthwhile for neurologists to review the evidence about opioids’ efficacy in treating chronic pain. The majority of trials examining opioids for noncancer pain were short-term studies, however. Treatment patterns have been extrapolated from these short-term studies, but this approach may not be viable, said Dr. Gibbons.
A systematic review conducted in 2013 identified 15 low- to medium-quality trials supporting the short-term efficacy of opioids in chronic lower back pain. A meta-analysis, however, concluded that opioids were no more effective than placebo for relieving chronic lower back pain. The meta-analysis also found no placebo-controlled, randomized, long-term trials of opioid therapy in chronic lower back pain.
The increasing incidence of diabetes will result in “an enormous number of people with neuropathic pain,” said Dr. Gibbons. A 2013 review of the literature suggested that short-term studies provide equivocal evidence about opioids’ efficacy in reducing neuropathic pain. Intermediate-term studies demonstrate that opioids have significant efficacy, compared with placebo, but the studies were limited by small sample sizes, short durations, and potentially inadequate handling of dropouts. The review also concluded that the long-term analgesic efficacy of opioids in chronic neuropathic pain is uncertain.
“The pressure here is that we need data,” said Dr. Gibbons. “We need good, long-term, randomized controlled trials to really make informed decisions about our patients.”
Patient Selection and Counseling Are Crucial
Careful patient selection is a crucial aspect of opioid treatment. Neurologists should confirm the underlying condition that causes the pain because a poorly defined condition may increase the likelihood of a poor outcome. Also, a patient should have moderate to severe pain for opioids to be an appropriate option. A personal or family history of drug abuse or the presence of psychiatric conditions may be a predictor that a patient will abuse opioid therapy. “You need to review the risks and benefits [of opioids] in every single case,” said Dr. Gibbons. “There is no standard approach here.”
Although evidence about opioids’ efficacy in chronic conditions may be scarce, neurologists can follow certain general recommendations when considering these drugs as a therapeutic option. Neurologists should avoid chronic opioid therapy whenever possible, but this may be difficult to do if a patient has already had pain relief with a short course of opioids prescribed by another clinician, said Dr. Gibbons. Therefore, it is important to educate the referring physicians about the dangers of starting opioids in patients who have chronic noncancer pain, according to Dr. Gibbons.
Documenting the risks and benefits of opioid therapy is a good practice from the medical and legal points of view. Drafting an opioid contract can clarify what the neurologist expects of the patient and vice versa. Opioids should be started at a low dose, and dose increases should occur slowly, Dr. Gibbons advised.
“Methadone can be a particularly useful agent for neuropathic pain, but you have to be comfortable with the complexities of using it and know all of the serious risks,” said Dr. Gibbons. The drug’s half-life ranges between 60 and 120 hours, and it may take 12 days to achieve a steady level of drug in the body. Neurologists should be aware that methadone can prolong QT intervals and cause cardiac arrhythmias.
Starting opioid therapy requires significant time counseling patients about the risks and benefits, and it is appropriate for neurologists to document and bill for this time using time-based billing codes, said Dr. Gibbons. Spending time to educate and counsel a patient before initiating treatment can reduce complications during therapy, he added. “Don’t wait for a problem to occur and then try and chase it afterward.”