Clinicians considering prescribing opioids for chronic-pain management need to carefully weigh the risks and benefits in the wake of rising rates of opioid addiction and overdose.
John Renner, M.D., associate chief of psychiatry at the VA Boston Healthcare System, and Roger Chou, M.D., an assistant professor of medicine at Oregon Health and Sciences University, urged caution in the use of opioids to treat chronic pain at a workshop on pain treatment and addiction risk at APA’s 2013 annual meeting in San Francisco in May.
Both clinicians emphasized that while opioids can be extremely effective for severe chronic pain, their diversion and misuse are significant public-health problems. Renner presented data showing the recent rapid increases in deaths related to opioid overuse and in treatment rates for opioid addiction, while Chou outlined guidelines for prescribing opioids developed by the American Pain Society and the American Academy of Pain Medicine.
Renner also discussed efforts by the Food and Drug Administration (FDA) and Substance Abuse and Mental Health Services Administration (SAMHSA) to respond to what is considered a public-health rather than a criminal-justice problem. He also discussed emerging trends in the treatment of opiate addiction—especially the use of buprenorphine, naltrexone, and naloxone.
Renner also remarked on the emergence of a new and especially troubling phenomenon—combat veterans with a combination of chronic pain, substance abuse, posttraumatic stress disorder, and traumatic brain injury. “That’s the constellation of really problematic patients we are going to be seeing in the VA,” he said.
The trends in addiction and overdose related to prescription opioids are ominous. Renner showed data indicating that in 2010 more than 1.9 million people reported dependence on or abuse of opiate pharmaceuticals. Moreover, he said that by 2011 there were more than 400,000 emergency department visits related to abuse of opiate pharmaceuticals, surpassing the number related to heroin.
More individuals are now dying “because of the use of illegal and legal drugs than [from] motor-vehicle accidents,” he said. “This is being primarily driven by opiate painkillers.”
A number of initiatives are addressing the problem. In 2010 the FDA approved a version of OxyContin that when crushed becomes too slurry to inject; earlier this year the FDA said that all generic versions of the drug also had to be the same abuse-resistant formulation.
However, Renner noted a troubling undercurrent showing the stubborn nature of addiction—data from SAMHSA for 2012 showed a bump in heroin use that he said could be related to the introduction of these abuse-resistant formulations. “As people are no longer easily using some of the opiate pharmaceuticals, the problem hasn’t simply gone away,” Renner said. “They may be switching back to heroin as their drug of choice.”
In addition, he noted that an FDA advisory panel this year recommended changing hydrocodone (Vicodin) from Schedule 3 to Schedule 2—a change that if implemented would restrict refills and prohibit fax or telephone scripts and prescribing by nurse practitioners or physician assistants. Only written prescriptions from a doctor would be allowed, and distributors would be required to store the drugs in special vaults.
(At the recent AMA House of Delegates meeting, physicians debated whether to lend AMA support for the rescheduling; see http://psychnews.psychiatryonline.org/newsArticle.aspx?doi=10.1176/appi.pn.2013.7b41.)
Other federal initiatives include the FDA’s Risk Evaluation Mitigation Strategy (REMS) Program in which pharmaceutical manufacturers of opiates contribute to a fund for continuing education of physicians on prescribing opiates and managing patients with chronic pain and/or addiction.
SAMHSA has instituted the Physician Clinical Support System–Buprenorphine and the Physician Clinical Support System for Opioid Therapy, both of which are Web-based training modules to guide clinicians in use of these drugs.
Finally, Renner said, State Prescription Drug Monitoring Programs, which are electronic databases designed to identify abuse and diversion of prescription drugs and facilitate treatment for those addicted to prescription drugs, show only variable and qualified success. Requirements for participation vary from state to state, and physician participation has been low; moreover, there are concerns about privacy and confidentiality, he said.
He urged clinicians to participate in such programs. “A goal would be for this program to be tied into an electronic medical record system, so that when prescribing, you would be able to check in real time the data on the prescription monitoring system,” he said.
Chou presented guidelines developed by the American Pain Society and the American Academy of Pain Medicine for prescribing opioids for noncancer chronic pain. He emphasized the need for clinicians to do a careful risk assessment of addiction history and drug-seeking behavior.
The guidelines’ 22 recommendations include the following:
Before initiating chronic opioid therapy (COT), clinicians should conduct a history, physical examination, and testing, including assessment of risk of substance abuse, misuse, or addiction.
Clinicians may consider a trial of COT as an option if chronic noncancer pain is moderate or severe, is having an adverse impact on function or quality of life, and potential therapeutic benefits outweigh or are likely to outweigh potential harm.
A benefit-to-harm evaluation, including a history, physical examination, and diagnostic testing, should be performed and documented before and on an ongoing basis during COT.
Chou also cautioned against continually upping the dosages of opioids when patients complain that pain is not ameliorated and urged clinicians to have a strategy for weaning patients off opioids. “Patients should have an exit strategy when starting an opioid,” he said. “We want people to go in [to treatment] with a plan” to get off opioids.
Chou noted that use of opioids for pain may lower pain scores by a point or two, without necessarily improving real-world functioning. “This raises the question of what the goal of therapy is,” he said.
He said treatment of patients with chronic pain should be a multidisciplinary endeavor and urged incorporation of nonopioid and nonpharmacologic therapies, including graded exercise and cognitive-behavioral therapy. “The data show that long-term benefits of opioid therapy are sparse, and we are not sure if they are improving functional outcome and may actually make it worse in some patients,” he noted. “We don’t have lots of evidence on how effective or safe they are in higher-risk patients, which includes a lot of patients with chronic pain.”
“We want people to start on a low dose,” he explained. “No opioid is safe, and we need to be cautious about how we use these drugs. The benefits of opioids for pain are finely balanced with the harms, and I am hoping the trend is [away from] jumping to use of opioids so quickly and toward use of nonopioid and other adjunctive therapies first.” ■