https://www.healthaffairs.org/action/showDoPubSecure?doi=10.1377%2Fhblog20180117.832392&format=full&

 

As a way to stem the harms associated with prescription opioids, many health care entities and state governments have imposed restrictions on opioid prescribing for acute and chronic pain, creating new problems that require both monitoring and remediation. Last fall, for example, PhRMA, the drug industry trade association, declared support for “limiting the supply of opioids to seven days for acute pain treatment.” Two pharmacy benefits chains, CVS Health and Express Scripts, endorsed similar limits. CVS will also restrict doses to less than 90 morphine milligram equivalents (MME), absent exemption. By mid-2017, 23 states had enacted legislation with a limit, guidance or requirement related to opioid prescriptions, according to a review by the National Conference of State Legislatures. Most of these 23 states restrict prescription length based on the contested proposition that mandatory limits will prevent opioid addiction.

The number of opioid prescriptions written by health care providers has fallen since 2011, and the number of high dose prescriptions (>90 MME) fell 41.4 percent from 2010 to 2015. The new restrictions will almost surely accelerate this trend. But the move to encourage (and enforce) more conservative prescribing has produced unintended consequences.

Chronic pain patients, who are stable and arguably benefiting from long-term opioids, are now facing draconian and often rapid dose reductions. Sometimes, alternatives to opioids for chronic pain are not offered, not covered by healthcare insurers, or not readily accessible or available to patients. Consequently, patients have endured not only unnecessary suffering, but some have turned to suicide, 23 of which are publicly documented by a physician. We worry that these tragedies, too, will escalate as opioids are restricted.

Take the case of Jay Lawrence, 58, of Hendersonville, Tennessee. We interviewed his wife and reviewed his records. Since age 50, he had taken opioids for injuries sustained in a car crash in the 1990s. He had undergone three spinal surgeries due to loss of mobility and constant pain, and ended up on continuous spinal infusions of morphine and clonidine. Few physicians could regard his situation as a straightforward success. His wife, Meredith, described a life where the good days included taking his dogs out and a joint trip to a big box store. On the bad days, which were many, the pain was overwhelming. But external pressures changed the course of his care and interrupted what fragile stability the couple managed to achieve.

Mr. Lawrence’s doctors advised him in February 2017 that state and federal guidelines required reducing his dose of oral morphine. That dose was reduced from 120 to 90 mg on a single day, with plans to lower it to 60 mg the next month and to 45 mg thereafter. Meredith says one doctor told her, “My patient’s quality of life is not worth losing my practice.” On March 2, 2017, Jay shot himself through the chest with a Ruger pistol, with Meredith holding his hand.

There are other examples of abrupt opioid prescribing changes. In the summer of 2017, one of us (Satel) heard from a 66-year old orthopedic surgeon, “Dr. R.,” in Northern California, who told us a story we originally described elsewhere. Dr. R suffered from interstitial cystitis since her early 30s. “I felt like I had a lit match in my bladder and urethra,” she said. Soon after being diagnosed, her physician placed her on 20 mg of methadone and she was able to practice. Then, “suddenly my doctor did not want to treat me anymore,” Dr. R reported. The physician announced “she didn’t want to see me anymore,” and left the room. “She didn’t give me a last prescription, and didn’t wait until I found another pain doctor who would help me.” Eventually, Dr. R, who was stretching her final allotment of pills, found a pain physician to resume the prescription, though she reported that suicide was an option for her had she not been able to find another prescriber.

In situations like that of Dr. R, physicians often declare that involuntary prescribing changes are due to federal guidelines. Yet the Centers for Disease Control and Prevention (CDC) issued no mandate that physicians make abrupt or dramatic changes to care in its 2016 Guideline on Prescribing Opioids for Chronic Pain. For patients already on opioids, the Guideline suggests that physicians and patients consider the potential harms and benefits of continuing opioids. It makes no claims about the benefits of nonconsensual dose reduction, a practice for which supporting data do not exist.

The irony is that these developments are hurting people who are reasonably unlikely to misuse opioids, although opioids do present important safety concerns, including risk of overdose. As federal and private survey data indicate, pain patients are not at highest risk for misuse of prescription opioids. Instead, most misuse reflects diversion.

Despite these realities, in today’s administrative climate all incentives point toward nonconsensual dose reductions, with little consideration for patient wellbeing. Consider the endorsements this year by the Pharmacy Quality Alliance, the National Quality Forum, and the National Committee for Quality Assurance of an opioid quality metric that counts the number of patients receiving over 120 MME against the performance rating for a physician or other care provider. None of these metrics honor the CDC Guideline’s distinction between new opioid starts and follow-up care of patients already stable on a given dose. And none take into account whether patients live or die as a result of the care they receive. Similarly, Prescription Drug Monitoring Databases, mandated in over 35 states, invite fear of prosecution. Most states do not require a warrant for law enforcement to search the data and recent Circuit Court rulings have overruled two that did.

As a result of these policies, clinicians feel caught between the demands of regulators and patients. In a recent Medscape survey, half the doctors expressed fear of violent reactions from patients seeking prescriptions. To alleviate the risk opioid discontinuations that lead to tragedy, we believe three things are necessary:

First, a more comprehensive system should monitor adverse outcomes associated with ending opioid treatment. We consider the fate of Mr. Lawrence to be a sentinel event. We consider the immense distress, the abandonment by her physician, and potential disaster of suicide that befell Dr. R when her methadone was discontinued to fall uncomfortably close to a sentinel event. The Joint Commission defines a sentinel event to be a patient safety event that results in death, permanent harm or severe temporary harm. It mandates these events be analyzed, recorded, reported to the patient or family, and subject to corrective action.

Another post-hoc monitoring approach would enlist the investigative capacity of the CDC, which already dispatches trained investigators to assess outbreaks of diarrhea and poisonings. Suicide rates are rising in the United States, and the CDC should investigate cases of suicide that ensue when stable patients in good standing (i.e., those who have not threatened staff, forged prescriptions, etc.) are non-consensually taken off opioid medication.

Second, contemporaneous data could help prevent harm and track risk to patients in real time. Suicidal ideation and reports of its completion following opioid discontinuation increasingly find their way to Facebook, Twitter, and news article comments sections. Concerned laypersons already use social media to assist pain patients at risk of suicide. A cadre of trained outreach workers could do more. At the same time, authorities should take advantage of social media to identify communities at risk the way the pharmaceutical leaders have begun to use techniques of social listening to monitor for adverse drug effects.

In addition, investigators associated with integrated health systems and large insurers can and should use analytic techniques to capture both the frequency and risk factors for adverse outcomes, including death, following opioid discontinuation. Along these lines, health care providers that already monitor opioid prescribing should develop registries to record adverse outcomes such as overdose, hospitalization or death, after prescriptions end.

Finally, physicians require reaffirmation of a professional safe harbor for cautious, patient-centered decision-making where opioids are concerned. A tenet of medical practice dictates that if a patient is stable on a medicine, then any change must be accompanied by a good reason to do so. Whether or not a patient was initially a good candidate for opioids, if they are now stable, then great care must be taken in any transition. For this reason, regulators should re-evaluate policies that incentivize dose reductionswithout reference to patient wellbeing.

Exhibit 1: United States Opioid Overdose Deaths And Total United States Opioid Prescriptions (2010–2016)


Source: Opioid overdose deaths from CDC; Total opioid prescriptions from Pezalla et al. (2017); Graph prepared by Stefan Kertesz, MD.

Editor’s Note

In the first anecdote of this post, the individuals gave permission for their real names to be used. In the second anecdote, Dr. R is a pseudonym.

Authors’ Note

Authors Gordon and Kertesz, who are employees of the Veterans Health Administration, indicate that the views presented here are their own and do not represent positions of the United States Department if Veterans Affairs or any other government entity.

Comment;

Certain things bear repeating;

First, a more comprehensive system should monitor adverse outcomes associated with ending opioid treatment. We consider the fate of Mr. Lawrence to be a sentinel event. We consider the immense distress, the abandonment by her physician, and potential disaster of suicide that befell Dr. R when her methadone was discontinued to fall uncomfortably close to a sentinel event. The Joint Commission defines a sentinel event to be a patient safety event that results in death, permanent harm or severe temporary harm. It mandates these events be analyzed, recorded, reported to the patient or family, and subject to corrective action.

Second, contemporaneous data could help prevent harm and track risk to patients in real time. Suicidal ideation and reports of its completion following opioid discontinuation increasingly find their way to Facebook, Twitter, and news article comments sections. Concerned laypersons already use social media to assist pain patients at risk of suicide. A cadre of trained outreach workers could do more. At the same time, authorities should take advantage of social media to identify communities at risk the way the pharmaceutical leaders have begun to use techniques of social listening to monitor for adverse drug effects.

Finally, physicians require reaffirmation of a professional safe harbor for cautious, patient-centered decision-making where opioids are concerned. A tenet of medical practice dictates that if a patient is stable on a medicine, then any change must be accompanied by a good reason to do so. Whether or not a patient was initially a good candidate for opioids, if they are now stable, then great care must be taken in any transition. For this reason, regulators should re-evaluate policies that incentivize dose reductionswithout reference to patient wellbeing.

Dr. Raymond Oenbrink
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