Complex regulatory policies intended to safeguard opioid utilization may be posing unintentional barriers for palliative care patients seeking pain and symptom relief, according to recent research from the Mount Sinai Health System.
Palliative care clinicians at the New York City-based health system have seen mounting challenges when prescribing opioids to seriously ill patients to relieve and manage pain. This trend led Mount Sinai researchers to examine the root causes in a study recently published in the journal NEJM Catalyst Innovations in Care Delivery.
The research uncovered leading barriers related to opioid access impacting quality, health care costs and patient and provider satisfaction. The findings illustrate how measures to curb the opioid overdose epidemic may have inadvertently diminished outcomes among seriously ill patients, according to study co-author Dr. Rebecca Rodin. Rodin is assistant professor in the Brookdale Department of Geriatrics and Palliative Medicine at the Icahn School of Medicine at Mount Sinai.
“What we saw is really dual crises that have emerged of opioid excess — misuse for some and growing inaccessibility for others who are in need,” Rodin told Palliative Care News. “We found that the problems of accessing essential opioids for our seriously ill patients has become widespread and is also causing harm to patients. We’ve found that it’s increasingly difficult to get patients reliable access, and we’re seeing some of the downstream consequences of that and wanted to look more into the potential causes.”
Exploring multiple barriers
Mount Sinai Health System’s footprint includes roughly 9,000 primary and specialty care clinicians and 11 joint-venture centers across the five boroughs of New York City, Westchester and Long Island. The health system provides hospice, behavioral health, emergency services and primary, palliative and home-based care, among other services.
The research spanned a needs assessments survey among 52 clinicians across Mount Sinai Health System’s Brookdale Department of Geriatrics and Palliative Medicine. A large portion, 88%, of the clinicians reported opioid access issues as “occurring often.” Nearly one-third (31%) of these clinicians stated that the access issues frequently led to suboptimal pain control among seriously ill patients.
The surveyed clinicians often reported that barriers to opioid access resulted in patients experiencing higher pain levels, poorer quality of life and increased rates of hospitalizations, which drove up overall health care costs.
Accessibility issues led Mount Sinai’s palliative clinicians to shift treatment plans. About 80% of the surveyed clinicians indicated that they changed opioid prescribing practices across nearly half of their patient census due to limited availability of these medications.
Regulatory restrictions and cost-related challenges around opioid prescribing disrupted the balance of clinical capacity and negatively impacted staff satisfaction, the study found. Mount Sinai palliative clinicians cited spending more than one hour daily fielding phone calls with insurance companies and pharmacies regarding patient opioid access. The surveyed clinicians reported decreased job satisfaction as a result.
“The key issues we identified were mostly systemic barriers at the levels of pharmacies, insurance companies and providers,” Rodin said. “It’s primarily related to widespread shortages of opioid medications at pharmacies, barriers due to the need for prior insurance authorization and high costs of opioids, as well as providers not being familiar with these issues and how to navigate them in outpatient settings. These issues have serious consequences on patient care.”
The regulatory mix around opioids
Cost issues related to opioid prescribing may be impacted by recent federal regulatory actions. The White House in April released an executive order eliminating “duty-free de minimis treatment” of internationally imported goods from China including synthetic opioids. Effective May 2, the executive order stipulated that products valued under $800 are subject to all “applicable duties” including new taxes, among other regulatory requirements. Among the factors was a drive to “target deceptive shipping practices” among illicit drug manufacturers, the Trump administration stated in the order.
Opioid supply issues tie back to standards set by the U.S. Drug Enforcement Administration (DEA), which sets annual restrictions for manufacturing quantities of these drugs. The allowable manufactured amounts have consistently been reduced each year since 2017, despite growing shortages of opioids that have been annually reported by the U.S. Food and Drug Administration (FDA), according to Rodin.
Opioid concerns have mounted over the past decade. The federal government in 2017 designated the opioid crisis as a public health emergency through the Public Health Service Act, which the U.S. Department Health and Human Services (HHS) reiterated in June 2024.
Opioid-involved deaths have increased “substantially” across the country since 1999, reported the U.S. Centers for Disease Control and Prevention (CDC). Three “distinct waves” of increased opioid overdose deaths have occurred over the last 25 years, fueled by different variances of these drugs. An average of 224 individuals died each day from opioid-related overdose in 2022, according to a CDC report. Opioids were indicated in nearly half (43%) of all drug-related deaths that year, the CDC report found.
Growing substance abuse concerns have spurred regulatory overhaul around opioid prescribing including guidelines and policies aimed at mitigating misuse. Among these came the Mainstreaming Addiction Treatment Act, which included recommended standards of practice when prescribing opioids that can deter drug misuse. Statutes and regulations related to opioid prescribing requirements also vary at the state level.
These regulations have helped to move the needle forward around safe and effective prescribing, according to Rodin. They have also complicated the ability for palliative patients to access opioids that can help provide pain relief.
A large goal of examining opioid access issues is to build a foundation of data that supports the development of a stronger conceptual framework for improved and effective utilization, Rodin indicated.
Better regulatory safeguards and oversight are needed to mitigate the negative patient impacts and ease clinicians’ administrative burdens, she said. The opioid disparities may be disproportionately impacting underserved populations, she added.
“Finding a better balance is really what’s needed, that doesn’t make people with serious illnesses innocent victims of the war on drugs,” Rodin told Palliative Care News. “Unfortunately, these access issues tend to disproportionately affect the most vulnerable populations, patients with low incomes, those with limited mobility and [individuals] from historically marginalized communities. Having an understanding of where the main issues are can help people bridge some of the barriers and systemic issues. We’ve learned a lot from the opioid epidemic, and we really need to be using real-time data and evidence to guide our current reforms and policies to address what’s happening now.”
