Amid rising deaths due to prescription painkillers, doctors are finding alternative ways to help patients manage chronic pain.
Gary LeRoy, MD, dreads the early-morning phone call from the coroner’s office-the one where he learns that a patient who has been taking opioids has died in his sleep.
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LeRoy, a family practitioner in Dayton, Ohio, prescribes opioids carefully. He orders them only in small quantities and for limited periods, and instructs patients in how to use them. But patients don’t always tell him what medications they are getting from other prescribers. Nor can he stop them from getting drugs from friends and family members, or buying them on the street.
The result, if the drugs are used in the wrong combination, is the notification from the coroner. “That kind of call really gnaws at you,” he says.
Experts agree opioid use in the U.S. is out of control-and primary care doctors are writing most of the prescriptions. A study of 2013 Medicare Part D claims found that internists and family practitioners accounted for over half of the 54.5 million prescriptions written for Schedule II opioids that year.
Like LeRoy, most primary care doctors take their prescribing responsibilities seriously. Indeed, 84% say they are “very” or “moderately” concerned about the possibility of opioid addiction among their patients, and 80% about the possibility of death, according to a 2015 survey.
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Yet as the main providers of healthcare to most Americans, primary care doctors are who patients turn to first when seeking relief from pain. The question now is, how do primary care providers become part of the solution? How do they minimize the number of opioids they dispense and reduce the number of people dependent on them, while still helping to ease the chronic pain millions of Americans experience?
The magnitude of the problem is difficult to overstate. According to the CDC:
more than 165,000 Americans died from overdoses related to prescription opioids between 1999 and 2014, with 14,000 of those deaths occurring in 2014 alone.
Per-capita opioid prescriptions grew by 7.3% between 2007 and 2012, with prescribing rates among internists and family practitioners rising faster than other specialties,
In 2014 about two million people abused or were dependent on prescription opioids.
More than one thousand people per day are treated in emergency departments for misusing prescription opioids
Opioid dependence among primary care patients receiving prescriptions for treating pain not related to cancer may be as high as 26%.
Amid the sobering statistics, however, are signs that opioid use may be levelling off. A state-by-state survey of opioid use by IMS Health, a healthcare data company, found a 6.8% decline in the number of opioid prescriptions filled in the U.S. between 2014 and 2015.
Even so, the 2015 total-nearly 228 million, or an average of 0.7 per person-remains startlingly large.
Apart from the damage that opioids can inflict on their own, they correlate strongly with increased heroin use and addiction. This is because heroin is often cheaper and easier to acquire than opioids in many places around the country. A 2013 study from the Center for Behavioral Health Statistics and Quality found “a strong association between prior nonmedical use of pain relievers [opioids] and the subsequent past year initiation of heroin use.”
The rapid increases in opioid use and addiction have drawn the attention of the president, Congress and policymakers. In February President Obama proposed adding $1.1 billion to address prescription opioid abuse. Meanwhile, by mid-May both houses of Congress had passed legislation designed to slow the spread of opioid and heroin addiction, and Washington insiders expected a unified bill to go to the president for his signature shortly thereafter.
Perhaps most significantly for physicians, in March the Centers for Disease Control and Prevention (CDC) issued a guideline for prescribing opioids. Intended mostly for primary care providers, it consists of 12 specific recommendations for when, how and to whom physicians should prescribe opioids other than for cancer treatment, and palliative and end-of-life care.
“The guideline communicates that we shouldn’t be treating common conditions with opioids on a routine basis. And this is the first time the medical community is getting that message from the federal government,” says Andrew Kolodny, MD, executive director of Physicians for Responsible Opioid Prescribing (PROP).
Even so, some physicians remain too quick to prescribe these powerful medications, even if it’s for the right reasons, says Thomas Tape, MD, FACP, professor of internal medicine at the University of Nebraska-Lincoln, chair of the American College of Physicians Board of Regents, and the American College of Physician’s liaison to the CDC committee that wrote the guideline.
“I think there hasn’t been enough attention paid to how easy it is to become dependent on opioids,” he says. “As a physician you naturally want to alleviate pain, so if you’re not sure exactly how long that patient will require severe analgesic control you’re going to err on the side of being a little more generous.”
Balancing the desire to alleviate pain against the dangers opioids pose is but one of the thorny issues PCPs must confront when considering whether to prescribe opioids, and why some providers are reluctant to treat patients who have been prescribed them previously. Challenges include finding effective alternative therapies for patients experiencing chronic pain, monitoring patients who take opioids and finding successful tapering strategies for the users.
Like most physicians, Tape distinguishes between acute and chronic pain when thinking about opioid prescribing. The former, he says, generally is associated with severe tissue damage resulting from trauma, an accident or surgery and doesn’t require prolonged opioid use.
However, when pain is chronic-a condition that the CDC defines as lasting three months or more-the calculus changes. This type of pain is more likely to stem from a central nervous system issue, Tape says, and in such cases opioids are not as effective as they are in treating acute pain.
In Tape’s clinical practice, the vast majority of patients requesting opioids began getting them from previous providers for conditions such as chronic headaches, fibromyalgia, and back pain. If they have been using them for years, he says, it’s often very difficult to taper them off the medications.
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That difficulty is why “the non-medicinal approach to pain should always be in the forefront of a doctor’s thinking,” says Jeffry Lindenbaum, DO, a family physician who has practiced addiction medicine in Yardley, Pennsylvania for 39 years. “You want to try all the other modalities first before you possibly sentence someone to a lifetime of opioid therapy.”
Time and money constraints also can play a role in the decision of whether to prescribe opioids. “In the primary care environment, if you’ve got a patient who spends more than 15 minutes in the room it starts to cost you a lot of money,” says Robert Twillman, PhD, FAMP, executive director of the American Academy of Pain Management (AAPM). “The fastest way to get them out of the room is to write a prescription. I’m not saying that’s a conscious decision, but I think it plays a role.”
PROP, along with others who have studied the problem, believes that patient satisfaction surveys also have played a role in the opioid epidemic. The organization wrote recently to Andy Slavitt, acting administrator of the Centers for Medicare & Medicaid Services, asking to have questions regarding pain management removed from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey.
Noting that hospitals are “financially incentivized” to score highly on the HCAHPS surveys, the letter-which was signed by 57 other organizations--says that questions regarding pain treatment “have had the unintended consequence of encouraging aggressive opioid use in hospitalized patients and upon discharge.” It cites a 2014 study in the Journal of Hospital Medicine that found that doctors prescribe opioids in more than half of 1.14 million nonsurgical admissions.
Sometimes PCPs will refer patients experiencing chronic pain to pain management specialists. But doing so can be frustrating, notes Wanda Filer, MD, FAAFP, president of the American Academy of Family Physicians. Iff the specialist can’t perform an epidural or some other procedure, or the procedure doesn’t work they send them back to the primary care doctor.
Filer’s assessment is “absolutely correct,” says David Craig, PharmD, a former board member of the American Pain Society. The problem for his members, he says, is financial. Many pain specialists are highly-paid anesthesiologists. “They go for training in this specialty in order to make more money. But writing scripts or talking to patients for an hour doesn’t pay a lot. So if you want to maintain that $400,000 salary you need to do something that’s procedure-based.”
Even more than with most patients, treating those who use opioids requires getting a comprehensive medical picture of the patient, and especially all the medications he or she is using. That’s because patients experiencing chronic pain frequently also suffer from other conditions such as insomnia, depression and diabetes, notes Tape.
Often these patients are taking numerous medications prescribed by multiple providers-not to mention those the patients acquire on their own. The wrong combination, such as opioids and benzodiazepine, can be lethal, says Leroy, because both act to suppress the body’s breathing reflex-hence the many opioid-related deaths that occur during sleep. The effect is strengthened by alcohol use, he adds.
That danger makes it essential to review patient medications regularly, says Lindenbaum. “Every time a patient comes in, the first thing my medical assistant does is get a good history of what they are taking,” he says. “That includes over-the-counter medications and the ones they ‘borrowed’ from their best friend and the drugs they stole from someone’s medicine cabinet.”
Most physicians who prescribe opioids require patients to sign a contract, or user agreement, spelling out the patient’s responsibilities, such as undergoing random urine testing or getting their prescriptions filled at designated pharmacies, as well as the consequences of violating the agreement.
Patients in Tape’s clinical practice are required as part of their agreement to attend a monthly class taught by a behavioral medicine specialist and a pharmacist. The former focuses on techniques for managing chronic pain, such as exercises and behavioral therapy, that don’t involve medications. The latter educates patients on the addictive properties of opioids and the effect of mixing them with other medications.
The consequences of violating a user agreement vary among practices. In some cases repeated violations may lead a physician to dismiss the patient from his or her practice. But that is nearly always a last resort. More typical is the response of Filer, who practices in a federally qualified health center in York, Pennsylvania. If a urine test on one of her patients comes back positive for drugs that shouldn’t be present (or negative for drugs that should be there), she’ll stop prescribing the medication.
“The goal [of the user agreement] is for them to understand their role and my role,” she says. “And when we say we’re done [prescribing] there’s a reason for it. We’re trying to keep them safe and give them the best care while also protecting the health of the community.”
In recent years states have been helping to reduce deaths from opioid combinations, as well as “doctor shopping,” by creating electronic databases of controlled substances called prescription drug monitoring programs (PDMPs.) PDMPs enable doctors to get a picture of all the prescription drugs a patient is taking before writing (or refilling) an opioid prescription, says Cynthia Reilly, director of the prescription drug abuse project of the Pew Charitable Trust.
Reilly says that consulting the PDMP before prescribing opioids to a patient is one of the most effective steps a PCP can take to protect the patient’s health. Still, she notes, even an up-to-date and comprehensive PDMP database will show only the medications the patient has acquired legally, and only from that state. Moreover, time-pressed physicians don’t always remember to check PDMPs before writing a prescription.
To help address the latter problem, Reilly says, a majority of states now allow practices to delegate a non-physician to check the PDMP. “They [the non-physician] can run a report so it’s ready for the prescriber to use when the patient is there in the examining room,” she says.
The ultimate goal, of course, is to get patients who are taking opioids for chronic pain off of them entirely. Accomplishing that requires a two-part strategy, experts say. The first is to find an effective tapering strategy, and the second is to find an alternative method for managing the patient’s pain.
Complicating the tapering challenge is the fact that long-term opioid use can induce opioid-induced hyperalgesia (OIH), in which the brain becomes more sensitive to pain. Consequently, Tape explains, “when you try to taper them down, they perceive their pain as actually getting worse because the opioids have made them more sensitive to pain in the first place. It’s kind of like a drug withdrawal situation.”
Physicians in Tape’s clinical practice try to prepare patients for what they will likely experience when they begin reducing opioid use, including the possibility of OIH.
Physicians who treat opioid-dependent patients say there are no widely-accepted \tapering protocols. Each physician and patient have to develop a strategy geared to the patient’s circumstances. “Everyone has their own history as to how they got on it, why they got on it, what dose they take, and so on,” says Sameer V. Awsare, MD, FACP, associate executive director of the Oakland, California-based Permanente Medical Group and head of its opioid initiative.
Awsare says that as part of its opioid initiative, Permanente regularly brings together a variety of specialists, including pharmacists, neurologists, psychiatrists and physical therapists, to help primary care providers navigate the complex process of weaning long-time opioid users off the medications and find other ways of managing the patient’s pain.
LeRoy sometimes uses celebrity deaths, notably that of Michael Jackson, to drive home the dangers of opioid use with his patients. “It becomes very real for patients when they see it happen to a high-profile person,” he says.
The highly individualized nature of opioid dependence or addiction also means that alternative pain management techniques must be tailored to the patient’s individual circumstances. “Every person has their own genetic makeup and psychological baggage,” notes Lindenbaum. “You can’t just say, ‘let’s follow this cookbook,’ because not every person is like that.”
Over his four decades of treating people with chronic pain, Lindenbaum has developed a “toolbox” of alternatives to opioids. Among the approaches are physical therapy, massage therapy, acupuncture, water therapy, osteopathic manipulation and, for low back pain, the McKenzie Method.
Medications he tries with his patients include nonsteroidal anti-inflammatory drugs, anti-depressants, and anti-seizure drugs such as Lyrica (Pregablin), which has been approved for treating the diffused pain caused by fibromyalgia. It can also be effective sometimes in treating migraines.
But physicians looking for non-medicinal alternatives to pain management frequently bump up against other obstacles, namely, a lack of availability and/or insurance coverage for such services.
For example, in 2010 a joint task force of the departments of defense and veterans affairs issued a study that identified five nonpharmacological therapies for chronic pain: chiropractic and osteopathic manipulation, massage therapy, acupuncture, biofeedback and yoga. But the APM’s Twillman points out that chiropractic/osteopathic manipulation is the only one covered by Medicare. Commercial payers are only slightly better in their coverage, he says.
As for the availability of such therapies, he notes that while in clinical practice in Kansas he saw patients who had come from hundreds of miles away for treatment, because none was available where they lived. “So even for a well-informed physician who understands that using these methods can reduce the need for opioids, actually getting a patient access to these services and afford it is a real challenge.”
The ultimate solution, he believes, lies in developing multi-disciplinary pain clinics that can address all the issues facing patients who use opioids for chronic pain: physical, emotional, social and psychological. “But again, it becomes a question of where the reimbursement comes from, and can you keep the doors open and the lights on with that sort of model?”