The Unintended Impact of Opioid Prescribing Guidelines: Part 1

Two years ago, the United States reached a grim milestone of more than 106,699 drug overdose deaths recorded in 2021. This milestone followed 2 decades of increases in overdose deaths, fueled in part by the introduction of synthetic opioids such as fentanyl into the drug supply, according to Virginia Ghafoor, PharmD, MBA, pharmacy specialist, pain management at the University of Minnesota Medical Center.

Ghafoor has worked in a diverse range of pain management settings across her career, ranging from clinics to hospitals to palliative care settings. During a presentation¹ at the American Society of Health-System Pharmacists 2023 Midyear Clinical Meeting and Exhibition, she highlighted some of the ways that state and federal government interventions impacted the opioid crisis and drug overdose deaths.

In 2010, changes were underway at the government level to address the narrative around opioids and their marketing. In 2010, deaths due to opioids had begun to plateau, Ghafoor noted. By 2016, data began to paint a different picture, highlighting the intersection between deaths due to prescription opioids and deaths due to illicit fentanyl use.

“This talk isn’t about illicit fentanyl deaths,” she noted, “but certainly what happened in 2016 is going to impact that.”

The First Opioid Prescribing Guidelines

By 2016, headway had been made around the opioid marketing narrative. However, clinical guidelines around opioid prescribing were lacking. That year, the CDC released those guidelines to clarify the grey areas that existed.²

“By the end of 2016…10 states had laws on opioid prescribing,” Ghafoor said. By 2019, not much had changed in terms of the number of prescription opioid deaths, “but now we have 29 states that have opioid prescribing limits. More than half of the country has been inspired in some way by the CDC guidelines to move forward with legislation to address the issue.”

As with many other areas of pharmacy that rely on state-level guidance, state-level opioid legislation was variable. Most, Ghafoor noted, pertained to first-time opioid prescriptions to treat acute pain, while others addressed the treatment of both acute and chronic pain patients; regulations around allowed days’ supply and morphine milligram equivalents (MME) also varied widely.

The 2016 CDC guidelines also led to the implementation of opioid tapering laws, defined as either statues—laws enacted by a legislative body—or regulations, laws enacted by government agencies or departments to execute laws made by legislative bodies. By the end of 2019, 27 states and the District of Columbia had enacted 61 laws around controlled substance tapering for chronic pain management in primary care settings.

Laws Increase Patient Burden

Despite the intentions of these laws, however, there was “very little impact,” Ghafoor explained, with a change of less than 1 in day’s supply of opioid prescriptions and less than 4 in average monthly MME per day per patient.

What did change, though, was the burden placed on patients: “For some of these patients, that burden…was significant, because sometimes that pain provider was the only medical provider the patient was seeing for all of their healthcare,” Ghafoor said. “When opioid tapering laws were enacted, [some] providers were leaving their practice, or getting rid of treating pain altogether, which was having a burden on other aspects of the patient’s health and well-being.”

In 2021, a retrospective cohort study published in JAMA³ looked at 113,000 adult patients on chronic opioid therapy between 2008 and 2019, taking a range of 50 MME to more than 300 MME per day for a period of 12 months. Researchers uncovered a grim statistic: post-tapering periods were associated with an adjusted incidence rate of 6.3 overdose events and 7.4 mental health crisis events per 100 person-years, compared with 4.9 overdose events and 4.3 mental health crisis events per 100 person-years during non-tapered periods.

In 2022, Minnesota took steps to prevent abrupt opioid tapering: A law enacted on August 1, 2022, as an amendment to the state’s Intractable Pain Statue expanded the definition of conditions associated with intractable pain beyond cancer and codified 2 key pieces of law. The first piece states that health care providers treating intractable pain with a controlled substance cannot taper the dose “solely to meet a predetermined [MME] equivalent dosage recommendation” if the patient is stable, not experiencing harm from the level of medication being prescribed, and compliant with both the treatment plan and patient-provder agreement. The second part of the law dictates that pharmacists, health insurance providers, and pharmacy benefit managers cannot refuse to fill a legitimate opioid prescription “solely based on the prescription exceeding a predetermined [MME] equivalent dosage recommendation or threshold.”

Ghafoor, who practices in Minnesota, added that her practice is still working through the process of how to interpret the law most broadly. But since it was enacted, it has served as a “reset button on the use of guidelines,” she said. “Many providers told patients that the whole reason they were being tapered was to meet CDC guidelines. Now, the patients are going to see a whole new version of this, and it makes you have to step back and think about how you engage in these conversations with patients again.”

References

1. Ghafoor V, Wulz J, Benedetti A. Opioid guidelines, regulations, legislation, oh my! Unintended consequences of good intentions. Presented at: American Society of Health-System Pharmacists 2023 Midyear Clinical Meeting & Exhibition; December 3-7, 2023; Anaheim, CA.

2. Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R. CDC clinical practice guideline for prescribing opioids for pain—United States, 2022. MMWR Recomm Rep. 2022;71(3):1-95. doi:10.15585/mmwr.rr7103a1

3. Agnoli A, Xing G, Tancredi DJ, Magnan E, Jerant A, Fenton JJ. Association of dose tapering with overdose or mental health crisis among patients prescribed long-term opioids. JAMA. 2021;326(5):411-419. doi:10.1001/jama/2021.11013