Redefining opioid stewardship

The 2022 release of the U.S. Centers for Disease Control and Prevention (CDC) Clinical Practice Guideline for Prescribing Opioids for Pain should represent a turning point in our nation's response to the ongoing crisis of opioid-related overdose deaths. The first iteration of this guideline—issued in 2016—accelerated the pendulum swing away from prescribing opioids that began in 2010.1, 2 Many pharmacists practicing in inpatient, outpatient, community, and managed care settings joined clinical colleagues, organization administrators, and policymakers in a reactionary approach that focused on policing patients and achieving lower daily dosages of opioid analgesics. Our profession must now reckon with the unintended consequences of this strategy and lead the effort to redefine opioid stewardship with an emphasis on shared decision-making that prioritizes individualized care and allows licensed health professionals to exercise professional judgment in the treatment of people with chronic pain maintained on long-term opioid therapy (LTOT). Although some laws, regulations, and policies that appear to support recommendations in the 2016 CDC Opioid Prescribing Guideline might have had positive results for some patients, they are inconsistent with a central tenet of the guideline: that the recommendations are voluntary and intended to be flexible to support, not supplant, individualized, patient-centered care. Of particular concern, some policies purportedly drawn from the 2016 CDC Opioid Prescribing Guideline have been notably inconsistent with it and have gone well beyond its clinical recommendations. Such misapplication includes extension to patient populations not covered in the 2016 CDC Opioid Prescribing Guideline (e.g., cancer and palliative care patients), rapid opioid tapers and abrupt discontinuation without collaboration with patients, rigid application of opioid dosage thresholds, application of the guideline's recommendations for opioid use for pain to medications for opioid use disorder treatment (previously referred to as medication assisted treatment), duration limits by insurers and pharmacies, and patient dismissal and abandonment. These actions are not consistent with the 2016 CDC Opioid Prescribing Guideline and have contributed to patient harm, including untreated and undertreated pain, serious withdrawal symptoms, worsening pain outcomes, psychological distress, overdose, and suicidal ideation and behavior. The urgency conveyed by the 2022 Guideline reflects the severity of harms related to inappropriate tapering and discontinuation of LTOT. An analysis of Medicaid beneficiaries in Vermont from 2013 to 2017 found the median length of a taper for a patient maintained on ≥120 mg morphine equivalents for ≥90 days was 1 day, that 86% were tapered in less than the recommended minimum of 21 days, and that half of these patients experienced an opioid-related hospitalization or emergency department visit.5 An analysis of Veterans Health Administration data from 2013 to 2014 found that stopping opioid therapy was associated with increased risk of death from overdose or suicide, and an analysis of patients enrolled in commercial insurance or Medicare Advantage from 2007 to 2019 found that tapering opioid dosage by ≥15% was associated with increased risk for overdose and mental health crisis.6, 7 Based in part on these findings, experts have cautioned that it is unethical and unjustified for clinical institutions and external organizations to mandate opioid dose reductions.8 Instead, health professionals involved in the care of patients on LTOT must retain the ability to exercise their professional judgment in developing and adjusting treatment plans. While the 2022 Guideline emphasizes that clinicians should, “regularly reevaluate benefits and risks of continued opioid therapy,” a revised framework that weighs the harms of continuing LTOT against the harms of discontinuation is critical.9 This framework should be extended to new patients seeking to establish care with a clinician, given research demonstrating that even an older adult maintained on a very low daily dose of opioids will struggle to find a new prescriber who will not immediately discontinue LTOT.10 Pharmacists in team-based care environments can support rational and ethical practices by educating prescribers about the potential harms of non-consensual dose reductions and discontinuation of LTOT, and they can lead the development and implementation of policies that prioritize optimizing health outcomes rather than simply measuring milligram morphine equivalents. Pharmacists can also collaborate with state boards of pharmacy and medicine, as well as state and local health departments, to support the CDC Opioid Rapid Response Program. This program facilitates emergency planning to mitigate overdose risks for patients who lose access to prescribers of opioids or other controlled substances.11 Pharmacists in a variety of settings have faced pressure to reduce opioid prescribing, but community pharmacists have been placed in a particularly precarious position. Civil litigation related to opioid dispensing has focused on pharmacists' “corresponding responsibility” to confirm the validity of controlled substance prescriptions, and pharmacists have been characterized as the “last line of defense” in preventing opioid misuse and diversion. Vague and inconsistent lists of “red flags” for misuse and diversion of controlled substances have been issued by the U.S. Drug Enforcement Administration, by the National Association of Boards of Pharmacy, and in civil opioid litigation.12, 13 Community pharmacists typically lack access to patients' health records, and this severely impedes their ability to scrutinize opioid prescriptions to determine whether they are clinically appropriate. This leads community pharmacists to rely on prescription monitoring program data—including embedded “risk scores” based on proprietary algorithms that have not been transparently described or rigorously evaluated—which may perpetuate bias and negative impacts on poor, immigrant, and stigmatized communities.14, 15 Community pharmacists are now practicing in an environment of fear and avoidance in which many focus on policing patients and err on the side of refusing to dispense opioids when potential “red flags” are present.16 Similarly to prescribers, community pharmacists must be empowered to exercise their professional judgment in weighing the harms of continuing and discontinuing LTOT, and their employers and state boards should proactively express and regularly reiterate their support for patient-centered, shared decision-making. Preliminary data from CDC indicate drug overdose deaths decreased significantly from September 2023 to June 2024, but racial disparities have become starker over time with American Indian, Alaska Native, and Black populations experiencing higher age-adjusted rates of drug overdose death than other groups.17, 18 Considered together, these data indicate recent efforts to increase access to effective medications for OUD and harm reduction supplies have been effective but are not reaching priority populations. Pharmacists can facilitate access to buprenorphine for OUD treatment by addressing gaps in stocking and willingness to order in community pharmacies and by playing a more active role in OUD treatment initiation and monitoring—particularly in states where pharmacists can obtain DEA licenses to prescribe controlled substances.19-21 Embracing telehealth treatment for OUD by advocating for permanent approval of this modality by DEA, participating in team-based care models, and accepting telehealth prescriptions in community pharmacies are also important areas of contribution for pharmacists. Pharmacists should continue to facilitate access to naloxone for opioid overdose reversal for patients on LTOT, medications for OUD, and most importantly, for people who use drugs, given they are at greatest risk of experiencing or witnessing an opioid-related overdose. This can be achieved through stocking, recommending, and prescribing both prescription and over-the-counter formulations, and by referring patients to free state resources for this life-saving medication.22, 23 While higher-dose naloxone products and more potent, longer-acting opioid antagonists have recently been approved and marketed for overdose reversal, pharmacists should prioritize the conventional dose formulations that are preferred by people who use drugs and the harm reduction organizations that serve them in the absence of compelling evidence that these formulations are ineffective.24, 25 Pharmacists should contribute to broader harm reduction efforts by selling non-prescription syringes and prescribing or directly distributing syringes to people who inject drugs.26-28 People who use drugs can also be referred to local harm reduction organizations for access to a variety of safer use supplies, including safer smoking supplies and drug checking services.29 Opioid stewardship can no longer be defined by a narrow focus on reducing opioid prescribing for acute and chronic pain syndromes. Instead, it must be defined by a comprehensive approach to caring for populations that use opioids with the primary goal of minimizing harm. Lucas G Hill is a member of the JACCP Editorial Board.