Julie Hemker has lived with chronic pain for all of her 37 years. She's had 47 operations for sacral agenesis, a congenital disorder of the spine, and as a teen in Indianapolis she learned self-hypnosis, distraction, and biofeedback. Such pain-management techniques allowed her to attend college and find fulfilling work. But recent complications, including an abnormal bone growth near her spine and a cerebrospinal fluid leak, have caused debilitating pain.
Figure. Julie Hemker...Image Tools
“There's a stigma associated with taking a narcotic,” she said recently. “I very much want to believe I can keep the pain from getting the best of me. It took a lot of years, well into my adulthood, before I would say, ‘I'm in pain.’”
Hemker's story points up a central quandary of managing chronic noncancer pain. She has successfully, even triumphantly, used nondrug methods most of her life—she calls herself “empowered”—but when those haven't sufficed and she has needed medication, not all of her clinicians have responded adequately. One physician told her he “didn't believe in” opioids, even though she's allergic to the antiseizure drugs and antidepressants often given for neuropathic pain. And when she is finally given an opioid, even she isn't sure it's worth the risks.
It's impossible to know how many Americans suffer from chronic undertreated pain; a 2011 Institute of Medicine report, Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research, estimated 100 million, though that number has recently been questioned. In the past decade, the treatment of chronic noncancer pain has been complicated by rising rates of prescription opioid misuse and deaths. As part of a federal effort to combat the “public health crisis,” in April of last year the Food and Drug Administration (FDA) proposed its Risk Evaluation and Mitigation Strategy (REMS) for long-acting and extended-release opioids. Approved this past July, the REMS requires the more than 20 makers of these drugs to offer free or low-cost continuing education for prescribers (physicians, NPs, and physician assistants) addressing risks and safe use. The companies will also have to make consumer-friendly medication guides available and submit to audits to determine the companies' compliance with FDA requirements and whether the REMS is inhibiting patients' access to pain medication (see http://1.usa.gov/PH4rNL to read the FDA announcement of the REMS).
It's a bold step. But when it comes to managing chronic noncancer pain, several questions remain unanswered. Are opioids appropriate? And if so, will the REMS prevent their misuse or just make it more difficult for patients in pain to get effective medication?
CHRONIC PAIN AND OPIOIDS: A COMPLEX HISTORY
On May 30 and 31, the FDA hosted a two-day meeting to address the “national dilemma” of opioid use. Amid panel discussions on the epidemiology of chronic pain and the genetics of drug response, patients and family members also testified to “the two sides” of opioids: the drugs' strong analgesic properties and their equally powerful dangers.
One researcher said that the randomized trials on opioids for chronic noncancer pain are “too small, too brief, and not adequately designed to evaluate the safety of long-term use of opioid medications for chronic noncancer pain for the less common but still important adverse outcomes” (see http://1.usa.gov/Nuix21 for more on the meeting). Further research into long-term use of the drugs will be crucial.
The meeting was well timed. The previous several months had seen some extraordinary developments:
December 23, 2011. The nonprofit news organization ProPublica reported that the American Pain Foundation, a major nonprofit advocacy and lobbying group, received 90% of its 2010 budget from the pharmaceutical industry—primarily Purdue Pharma, maker of OxyContin—“and closely mirrors its positions.”
March 2012. A report in the Journal of Palliative Medicine revealed that more than half of hospice and palliative care physicians surveyed said that their routine end-of-life care, including giving opioids, had been characterized as murder or euthanasia.
May 8, 2012. Senators Max Baucus (D-MT) and Chuck Grassley (R-IA) of the Senate Finance Committee investigated the financial ties between several drug manufacturers and the medical groups that advocate the use of opioids for chronic pain. Citing a 400% increase in opioid overdoses between 1999 and 2008, the senators question whether the drug misuse is “driven by misinformation and dubious marketing practices.”
May 8, 2012. The American Pain Foundation announced that, “due to irreparable economic circumstances,” it would shut down immediately.
May 29, 2012. A joint Milwaukee Journal Sentinel–MedPage Today investigation found that in the last five years opioid prescriptions to older adults increased by 32%, despite inconclusive evidence of their effectiveness and safety in this population. It also revealed financial ties between drugmakers and the American Geriatrics Society panel that recommended opioids over other analgesics for chronic pain in older patients.
July 3, 2012. The Centers for Disease Control and Prevention reported that in 2009 methadone accounted for 30% of U.S. deaths caused by prescription painkillers. Methadone has been increasingly used to treat pain because it's a generic drug that's 12 times cheaper than OxyContin; most of the 4 million methadone prescriptions that year were written by practitioners without pain-management training.
CONFLICT OF INTEREST AND OPIOID MISUSE: IS THERE A LINK?
Senators Grassley and Baucus implied that financial ties between drugmakers and groups like the American Geriatrics Society lead to irresponsible prescribing and unreliable guidelines. But does a tie always constitute a conflict? It depends on whom you ask.
“When you're on the payroll for an industry, it's very clear that it's very hard to bite the hands that feed you,” said Jeanne Lenzer, an independent journalist who has written about conflicts of interest and drug marketing and is a practicing physician assistant. She cited a study by Stelfox and colleagues, published in the January 8, 1998, issue of the New England Journal of Medicine, showing that researchers with financial ties to a pharmaceutical company wrote significantly more positive reviews on the safety of calcium channel antagonists—drugs linked to possibly severe cardiac and gastrointestinal effects—than those who did not. Since then, Lenzer said, several studies have supported that finding.
But Carol Curtiss, MSN, RN-BC, a private consultant on pain and an instructor at Tufts University School of Medicine in Boston, views the ties among clinicians, researchers, and the pharmaceutical industry as largely positive (although she acknowledges that that isn't always the case). “If we didn't have support from industry,” she said, “we would have little to no drug development and a lot less supported education.” She currently has ties to two drugmakers; one of them, Archimedes Pharma, manufactures a fentanyl nasal spray for the treatment of breakthrough cancer pain, a product she once wrote about favorably.
When asked why that doesn't constitute a conflict, she said she wrote the commentary before she had the relationship with Archimedes. Writing such an article while having a financial tie to a manufacturer “would clearly be a conflict,” she said, something she wouldn't do. She sees her role as that of an educator presenting balanced information. “If it's not balanced, I wouldn't say it. For no amount of money am I willing to ruin my credibility and integrity,” she said.
THE MISUSE PROBLEM AND NURSING'S SOLUTIONS
For Curtiss, it's education, of both patients and providers, that holds the keys to the problem of opioid “diversion”—the misuse of prescribed drugs. She put it bluntly: “Prohibition has never worked. If you severely restrict pain medication, it will not solve the problem of addiction.” Lenzer might concur. As a physician assistant, she said, she has seen addiction-screening protocols fail patients in severe pain.
In Washington, which ranks among the top 10 states in terms of deaths from opioid misuse, a 2010 law caps the dose of an opioid permitted without review by a pain specialist. Ardith Doorenbos, PhD, RN, FAAN, associate professor at the University of Washington's School of Nursing in Seattle, said the law was a necessary step but complicates the treatment of chronic pain in rural residents, especially Native Americans. There are only 20 or so board-certified pain specialists in the state, she said, most of them practicing in cities.
However, before the law was enacted, Doorenbos obtained funding for an initiative she calls Telepain, which now helps rural practitioners meet the state's requirements. Telepain involves an interprofessional team—a physician, an anesthesiologist, a psychiatrist, specialists in addiction and in rehabilitation, and a nurse. Together they review cases faxed from clinics around the state and fax back their recommendations. It's too early to assess patient outcomes, but Doorenbos sees great potential in the interprofessional approach to pain control—one that requires greater involvement from nurses. “If we want to avoid those deaths, we've got to have nursing at the table,” she said. “Telepain is all about training the practitioner in the community. What we need are pain champions.”
Also, the University of Washington's school of health professions has been designated one of 12 Centers of Excellence in Pain Education by the National Institutes of Health Pain Consortium. The university's center will provide resources for the schools of medicine, dentistry, pharmacy, and nursing in an interprofessional model of pain-management education, Doorenbos said.
The interprofessional model could prove crucial. As Douglas Throckmorton of the Center for Drug Evaluation and Research said in his closing remarks at the FDA meeting in May, the FDA “can't solve this alone. Academics can't solve this alone. Patient groups can't solve this alone.”—Joy Jacobson
RESOURCES FOR PREVENTING OPIOID DIVERSION
Prescription drug monitoring programs. Most states maintain a database of all controlled substances prescribed in the state (see http://1.usa.gov/N46OUP). These programs exist to support the “legitimate” use of these drugs, so that “doctor shoppers” and “pill mills” can be detected and the diversion of drugs prevented. Preliminary evidence suggests that the databases are helping to improve rates of appropriate prescribing, according to the Prescription Monitoring Program Center of Excellence (see http://bit.ly/NtM5ue).
OpioidRisk.com. Funded by the National Institute on Drug Abuse, the site offers online information, training, and other resources for clinicians treating patients in pain who also may present a risk of opioid addiction.
The Opioid Risk Tool is one of several available for screening patients for a risk of misusing an opioid. One version is available at http://bit.ly/MaPYVh.
© 2012 Lippincott Williams & Wilkins, Inc.