Medical Examiner

Pill Limits Are Not a Smart Way to Fight the Opioid Crisis

How much to prescribe, and to whom, is a complicated medical question.

A pharmacist counting pills.
Photo illustration by Slate. Photo by Jupiterimages/Stockbyte.

Last week, President Trump traveled to Manchester, New Hampshire—a designated ground zero of the opioid epidemic—and announced a number of national initiatives to combat the crisis. One proposal was a call to cut by one-third the number of opioid prescriptions over the next three years.

Details were fuzzy. But such a plan demands clarity, lest the policies designed to achieve it end up doing more harm than good. In particular, it seems worth asking what problem the “one-third by three years” plan is trying to fix, and whether or not reducing prescriptions by a set amount will achieve this goal.

Addiction is one target, but it’s not entirely clear that limiting the number of pills prescribed will meaningfully affect addiction rates. People who are given a few days of opioid-pain reliever such as Percocet or Vicodin rarely develop addiction. Yes, a subset is at risk; it includes people with past or current histories of addiction and those struggling with psychiatric conditions, and caution is particularly important with young adults. It’s wise to discuss if opioids are really needed (as they often aren’t), to prescribe as few pills as possible, and to enlist a family member to manage them for a young adult.

Addiction in chronic pain patients is a somewhat different story. Estimates for new onset addiction resulting from opioids prescribed to manage chronic pain run the gamut, but the CDC guideline on prescribing opioids cites a range of 0.7 percent at low dose to 6.1 percent at higher doses from one study, though lower and higher estimates can be found.

The president’s call is likely aimed at curtailing overdoses as well. The undeniable reality is that prescription pills (often mixed with other drugs) do produce fatalities, sometimes in patients who receive them as part of medical care. Nonetheless, about three-quarters of the roughly 42,000 opioid-related overdose deaths in 2016 were caused by heroin and illicit fentanyl. Deaths associated with commonly prescribed opioids (in cases where there is no heroin and fentanyl present) have fallen only slightly since 2011 (from 10,346 to 9,688 in 2016, a figure that includes typical pain medications but not methadone), despite a 48 percent reduction in high-dose opioid prescriptions since that time. These realities challenge the assumption that prescription control will have a big impact on the overall toll of opioid deaths. Meanwhile, anyone with a conscience has to ask what will happen to patients whose medications for pain are reduced in order to meet a presidential mandate of one-third by three years.

This brings us to a worrisome plan proposed this February by the Centers for Medicaid and Medicare Services as part of its annual policy-update process. That agency will decide in early April if Medicare will continue to pay for an opioid prescription if a patient’s total dose is at 90 morphine milligram equivalents (MME) per day or higher. (A 10-milligram tablet of oxycodone is equivalent to about 15 mg of morphine or 15 MME.) The overwhelming majority of people who receive opioids never take the equivalent of 90 MME. However, the CMS asserts that 1.6 million Medicare patients received such a dose for at least one day in 2016. Another report found half a million received more than 120 MME for at least 3 months. (An estimate for 90 MME was not offered.)

The CMS plan would upend the lives of people like Anne Fuqua, a 37-year-old nurse from Birmingham, Alabama. Anne worked in hospice care but has not been able to take care of patients for the past 14 years, she told us. In her late teens, she was diagnosed with primary generalized dystonia, a neurological disorder marked by involuntary movements and painful muscle spasms.

In Anne’s case, the spasms pulled her body to the side, making it difficult to sit up straight, and her fingers were clenched so tightly that she could not use utensils to cut food. Unable to tolerate the usual medications prescribed for dystonia, Anne and her doctor found that opioids dramatically reduced the rigidity.

Fuqua is among millions suffering from afflictions such as rheumatoid arthritis, neurological illness, and inflammatory conditions, who receive opioids, sometimes at high doses. Without these drugs, many of them can’t get out of bed or hold a job. That doesn’t mean that all such patients should have been treated with high-dose opioids (surely some decisions to initiate the medication by their doctors were ill-advised), but what happens to these patients after the fact should not be based on cookie-cutter logic.

Fuqua, who has Medicare Advantage, receives more than 1000 MME daily. Her regimen includes oxycodone and fentanyl, and it allowed her to shop for a bridesmaid dress with her goddaughter on spring break two weeks ago. She is scared for herself. “I’m not sure how I would manage to continue paying for my opioids if I were forced to pay out of pocket.” Anne told us. And she worries about others, “Patients with limited means will forego heat, air conditioning, and possibly food just to get relief if doing so will allow them to save sufficient funds to pay for their medication.”

To be fair, the CMS asserts that a doctor’s attestation that the higher dose is “medically necessary” should suffice, provided the doctor submits proper notification, either by phone, computer, and even hard-copy forms. But private market insurers, which frequently manage medication plans for Medicare Part D, have often shown themselves unwilling to accept such attestations, at least not without a fight. In any case, it is not likely that physicians will voluntarily assume so much unpaid bureaucratic labor on behalf of several hundred thousand Medicare beneficiaries at or above 90 MME per day over the long term.

The CMS proposal will likely accelerate a nationwide pattern of nonconsensual opioid dose reductions. The CDC’s own 2016 Guideline on Prescribing Opioids for Chronic Pain avoids calling for these reductions but instead urges that dose decisions be based on careful appraisal of harms and benefits. But that wise counsel has been set aside by many health regulators, as they devise quality metrics, payment policies, and even thresholds for criminal investigation based heavily if not exclusively on dose.

While a strong case can be made for carefully reducing doses in voluntary patients, no data support nonconsensual or forcible dose reductions or curtailment in otherwise stable patients. There is also anecdotal evidence of harm (emotional trauma, medical or psychiatric deterioration, and suicide).

Another troubling issue, separate from the harm that the CMS proposal is likely to cause, is it relies on a simplistic inference about prescription doses that is increasingly at odds with scientific data. Analyses of data from the Veterans Health Administration found that at least half the deaths from opioids occurred when the prescribed dose was less than 60 MME. Parallel VHA analyses suggest that characteristics such as mental illness, addiction, and major medical problems are more powerful predictors of risk than opioid dosage. Researchers from Kaiser Permanente and the Denver Health Medical Center in Colorado found that prescription dose didn’t predict overdose risk at all, once mental health and other factors were considered.

These data do not exclude the possibility that there remains a dose-related risk. But they hint at something more plausible: that “overdose” with prescriptions involves a collision of several factors. The opioids doctors prescribe are part of a chaotic situation including other sedatives, alcohol, and emotional distress. If this is the case, then forced dose reduction may not stop the chaos.

For some, the implementation of dose reduction will actually worsen their health. As we have heard from patients across the country, forcible dose reductions often result in rupture of the care relationships as pain patients find themselves without anyone who can continue medicines that they rely on. These patients now have an official title: “opioid refugees.” Experts willing to care for them are few and far between. Media reports, online suicide tabulations, and a burgeoning academic literature chart their despair and, sometimes, their demise.

The less troubling aspect of the CMS proposal is its second prong, an imposition of a seven-day limit on opioid prescribing for acute pain from, for example, when a patient breaks a bone or has an operation. If the agency goes through with this element of the plan, it will basically be joining half of all states that restrict duration of opioid analgesia to somewhere from three to 10 days, depending upon the state. Some pharmacy benefit managers, the pharmaceutical industry, some insurers, and the American Dental Association have enacted or demanded prescribing limits as well.

Duration limits, we caution, are not proven to prevent addiction. However, restricting pain relievers to a few days or to a week will generally suffice. (Often, no opioids are needed.) And, critically, handing out smaller prescriptions for short-term pain instead of a 30-day supply—a bad dispensing habit that many doctors have not yet broken—would help keep unused pills from falling into the wrong hands. It is possible to reduce the number of opioids prescribed for Americans in a responsible manner. As a matter of reflex, doctors need to pause and consider whether to prescribe opioid pain relievers in the first place, and if they deem it necessary, they should limit the number of “extra” pills authorized. But prudent limits are a far cry from a blanket attempt to lower pill numbers. Too many health care providers have started to see their fierce commitment to dose reductions as a badge of good citizenship, without any effort to measure the human outcomes of their own policies.

We hope that when the president called for reducing prescribing, he did not have something like the CMS proposal in mind. Data already show that reducing pills is not the same as saving lives. The agency should reconsider its plan and let this proposal die a painless death.

Disclaimer: Stefan Kertesz’s views are his own and do not represent positions of the Department of Veterans Affairs. He reports past ownership of stock in Merck and Abbott, amounting to less than 3 percent of assets and sold in December 2017, but no other involvement or interest in the pharmaceutical industry.

Sally Satel is a psychiatrist and resident scholar at the American Enterprise Institute and a lecturer at the Yale School of Medicine.

Stefan Kertesz is a physician at the Birmingham VA Medical Center and the University of Alabama at Birmingham.