In an effort to curb the nation's opioid crisis, state legislators have recently pursued a spate of laws to limit prescribing, resulting in pushback from some doctors worried about the clinical implications.
State officials promote the laws, which usually aim to restrict duration or total dosage, as a way to prevent overly generous prescribing that might lead to an opioid or heroin addiction. One target has been first-time opioid prescribing amid worries that writing a script following outpatient surgery or a fracture can risk longer-term problems.
At issue, as these laws are hammered out, is to what extent should clinical practice be circumscribed? Among the concerns are that some patients may suffer from inadequate pain relief or that onerous rules might encourage doctors to avoid opioids entirely because of the hassles involved.
Some physicians are already backing off from treating chronic pain patients in Massachusetts, where a new law became effective in March, said George Abraham, MD, MPH, FACP, Governor for ACP's Massachusetts Chapter and professor of medicine at the University of Massachusetts Medical School in Worcester. “There is a lot of extra work now involved,” he said. “The average primary care physician says this is an added burden which they don't want to undertake.”
Nearly 2 million Americans ages 12 and older have a substance use disorder involving prescription opioids, according to federal data. The medications also can provide a gateway to heroin, according to the National Institute on Drug Abuse, which has reported that nearly half of young heroin users state that they had misused prescription opioids first.
Federal legislators have also taken steps to tackle the opioid epidemic, this summer passing the Comprehensive Addiction and Recovery Act, which focuses on expanded treatment and prevention efforts. Earlier this year, the CDC released guidelines for treating chronic pain, with a focus on primary care physicians, the latest in a series of efforts to provide clinical guidance.
The passage of these state laws, though, indicate that educational initiatives alone haven't been sufficient, said ACP Member Yngvild Olsen, MD, MPH, who serves on the board of the American Society of Addiction Medicine. “Voluntary efforts and CME efforts to really try and change those prescribing patterns haven't resulted in necessarily the kind of impact that I think addiction treatment groups as well as others would have liked to have seen.”
Still, Dr. Olsen worries that the increasing number of state laws will leave some patients stranded without adequate relief. “We know that there is a significant issue related to chronic pain and chronic pain management in the U.S.,” she said.
Prescribing limits are usually part of more comprehensive state opioid laws, which incorporate other clinical and public health strategies. The Massachusetts law, whose provisions go into effect in stages, has numerous other components, including a requirement that the patient and the prescriber enter into a written pain management treatment agreement for extended-release long-acting opioids.
First-time prescriptions for Massachusetts patients being treated on an outpatient basis are limited to 7 days. To date, the state laws have frequently settled on 7 days for initial prescribing, although the duration proposed at first by state officials can be somewhat shorter, said Karmen Hanson, a health policy analyst at the National Conference of State Legislatures. Other states that have passed laws with prescribing limits within the last year include Connecticut, Maine, New York, Rhode Island, and Vermont.
Generally there are exclusions involving cancer patients or those in palliative care, such as with the law ultimately passed in Massachusetts. Along with setting a 7-day limit for initial prescribing for adults, that law also restricted any opioid for a minor to 7 days. Patients are additionally provided the option to only partially fill a prescription; the unused balance is declared void.
But the initial version of the law proposed by Gov. Charlie Baker was “fairly draconian,” with a 72-hour limit on first-time use, Dr. Abraham said. It was a classic scenario “of someone who is not in touch with the reality of patient care trying to make a proposal,” he said.
The final law, which was supported by the Massachusetts Medical Society along with ACP's state chapter, according to Dr. Abraham, did contain some flexibility. It provided exceptions beyond 7 days for both adults and minors if “in the professional medical judgment of a practitioner” a longer supply was needed for an acute medical condition or for chronic pain management. But on a practical level, doctors will likely apply that flexibility to chronic pain scenarios rather than for acute pain, Dr. Abraham noted.
Doctors and legislators in several other states have similarly wrestled with the balancing act between public health and clinical autonomy. Vermont's legislation, signed into law in June, initially restricted opioids for minor procedures to 10 pills, according to the Vermont Medical Society. The final law steered away from any specific numbers, instead authorizing the state's health commissioner to work with an advisory council—composed of a cross-section of public health officials and prescriber representatives—to determine any limits.
In Maine, the original limit proposed by Gov. Paul R. LePage in March also was shorter—3 days for acute pain and 15 days for chronic pain—than that which was ultimately passed. After pushback by Maine doctors for more flexibility, led by the Maine Medical Association, the finalized law set an outside limit of 7 days for acute pain and 30 days for chronic pain, beginning in January 2017.
For some acute pain situations, such as fractured ribs or a compression fracture, a 3-day limit wasn't reasonable both in terms of effective pain relief and the logistics of bringing patients back to the office so quickly, said John Erickson, MD, FACP, who practices in Portland and is Governor for ACP's Maine Chapter. Doctors would fill up appointment slots with refill-related visits, making it more difficult to care for other patients, he said.
One element, which the Maine Medical Association testified against, remained in the final version—to set the maximum daily dose at 100 morphine milligram equivalents (MMEs) for new patients. The law does provide exemptions for cancer patients and those in palliative care, as well as a transition period for chronic pain patients already on higher doses.
Those chronic pain patients can continue taking daily amounts as high as 300 MME but should be phased out by July 2017. In testimony to the state legislature, the medical association argued that the limit was too restrictive and harmful to patients, stating that thousands of Maine patients took dosages above 100 MME and more than 1,200 patients exceeded 300 MME as of late 2015.
Dr. Erickson described such state rules as a “blunt tool” and worries about those chronic pain patients, including some of his own, whose bodies have become tolerant to all but the highest doses.
“I think many of the nonopioid approaches are very limited,” he said. “We are going to have a hole in our ability to manage pain in a certain proportion of people, there's no question in my mind about that. But I think it's a small proportion of people. And I think if we save even 50 lives a year by doing this, it's probably a good thing.”
The 7-day limit aligns with the recent CDC guidelines for primary care practitioners. While the guidelines focus on chronic pain primarily, the authors noted that long-term use can begin with an initial prescription for acute pain. Thus, they recommend that the “lowest effective dose” should be prescribed, with 3 days or less often being sufficient. More than 7 days “will rarely be needed,” they wrote in the March 15 Morbidity and Mortality Weekly Report.
For chronic pain, intermediate-release opioids should be started instead of extended-release, the guidelines advised. Clinicians should exercise caution, weighing risks and benefits, when increasing dosages over time. Greater than 90 MME daily should be avoided, or physicians should “carefully justify a decision to titrate dosage to ≥90 MME/day.” (ACP offered feedback on a draft version of the CDC guidelines and issued a statement of support after the final version was released.)
Along with establishing prescribing limits, state legislators also have expanded the role of requirements related to prescription drug monitoring programs (PDMPs), which have become nearly universal. By June, nearly all states operated a monitoring program and at least half of the states had some requirements related to prescribers checking the databases, although they varied in specifics, according to the National Conference of State Legislatures.
In Maryland, a law was passed this year requiring all prescribers to register by mid-2017 at the latest and start querying the database by mid-2018 for most initial opioid prescriptions and at least every 90 days for longer-term use. When the database was set up, it was designed to be voluntary, said Dr. Olsen, who practices in Baltimore. But, she said, “It's become really clear that not only voluntary use of the PDMP but voluntary registration has been very lackluster.”
But how well do these state-based prescribing initiatives work? One analysis of PDMPs published in July in Health Affairs found that a state's decision to implement a program translated into a reduction in 1.12 opioid-related overdose deaths per 100,000 people the following year. If all states took proactive measures, such as updating their data weekly, more than 600 lives would be saved annually, the authors found.
Meanwhile, another recent analysis looking at opioid use and overdose among disabled individuals on Medicare painted a less optimistic picture. The research, published on July 7 by the New England Journal of Medicine, looked at patterns of potential overuse as well as overdose during 2006-2012, when states implemented 81 controlled-substances laws. Researchers didn't find any significant reductions in adverse outcomes, including hazardous use and overdose, when looking at 8 different types of opioid-related laws, including prescribing limits.
Studying ripple effects
Recent data from IMS Health open up the possibility that opioid prescribing has peaked, with a 6.8% reduction nationally between 2014 and 2015. The largest reduction in prescriptions—greater than 10%—was identified in Rhode Island; Washington, D.C.; Texas; and West Virginia.
As state laws multiply, though, it's important that researchers track not just any changes in prescribing and adverse effects, such as addiction, but also patient feedback regarding pain relief, Dr. Olsen said. “In states where these laws have been put in place,” she said, “there have been reports of physicians who have perhaps as a result changed their prescribing behavior. In many cases, that has been appropriate but in other situations, the pendulum may have gone too far in the other direction.”
In Portland, Dr. Erickson has already been working with his small cadre of chronic pain patients who have been exceeding the 100 MME cap to gradually reduce their dose. “They're not happy about it,” he said. “There are definitely some that have been on substantial doses for a while, and this is going to be hard for them.”
One risk that should be monitored in Maine and other states is whether patients desperate for relief turn to heroin as their only option, Dr. Erickson said. But the Portland internist is primarily optimistic about the new state thresholds, acknowledging the need to set some guideposts on what to date has been “open-ended” prescribing.
“Although every physician would like to think that we're very able and capable at prescribing the safest and most effective way, and only when needed, I think frankly none of us are perfect,” he said.
He also said that the limits might provide doctors a ready explanation when they encounter a patient who is pushing the opioid envelope. Potentially, state limits “will make it easier for doctors to prescribe,” he said. “I think open-ended prescribing was seen as a no-win scenario that probably drove more people [doctors] away from prescribing.”‘