Opioid Settlement Funds: Do Not Neglect Patients With Pain

The opioid crisis has escalated in the setting of the COVID-19 pandemic to new extremes and has claimed more than half a million lives in the US since 2000. Lawsuits to address the civil and criminal liability of drug companies and other groups have originated from federal, state, local, and tribal jurisdictions. When successful, there will likely be billions of dollars and significant discretion as to how these funds are spent. Several groups have produced reports with principles to address the toll of addiction using settlement funds. However, they lack actionable strategies to address the needs of patients with pain, including patients with chronic pain who are receiving long-term opioid therapy. Persons with pain should not be neglected and deserve better treatment

Epidural steroid injections compared with gabapentin for lumbosacral radicular pain: multicenter randomized double blind comparative efficacy study

Objective To evaluate whether an epidural steroid injection or gabapentin is a better treatment for lumbosacral radiculopathy. Design A multicenter randomized study conducted between 2011 and 2014. Computer generated randomization was stratified by site. Patients and evaluating physicians were blinded to treatment outcomes. Settings Eight military, Veterans Administration, and civilian hospitals. Participants 145 people with lumbosacral radicular pain secondary to herniated disc or spinal stenosis for less than four years in duration and in whom leg pain is as severe or more severe than back pain. Interventions Participants received either epidural steroid injection plus placebo pills or sham injection plus gabapentin. Main outcome measures Average leg pain one and three months after the injection on a 0-10 numerical rating scale. A positive outcome was defined as a ≥2 point decrease in leg pain coupled with a positive global perceived effect. All patients had one month follow-up visits; patients whose condition improved remained blinded for their three month visit. Results There were no significant differences for the primary outcome measure at one month (mean pain score 3.3 (SD 2.6) and mean change from baseline −2.2 (SD 2.4) in epidural steroid injection group versus 3.7 (SD 2.6) and −1.7 (SD 2.6) in gabapentin group; adjusted difference 0.4, 95% confidence interval −0.3 to 1.2; P=0.25) and three months (mean pain score 3.4 (SD 2.7) and mean change from baseline −2.0 (SD 2.6) versus 3.7 (SD 2.8) and −1.6 (SD 2.7), respectively; adjusted difference 0.3, −0.5 to 1.2; P=0.43). Among secondary outcomes, one month after treatment those who received epidural steroid injection had greater reductions in worst leg pain (−3.0, SD 2.8) than those treated with gabapentin (−2.0, SD 2.9; P=0.04) and were more likely to experience a positive successful outcome (66% v 46%; number needed to treat=5.0, 95% confidence interval 2.8 to 27.0; P=0.02). At three months, there were no significant differences between treatments. Conclusions Although epidural steroid injection might provide greater benefit than gabapentin for some outcome measures, the differences are modest and are transient for most people. Trial registration ClinicalTrials.gov Identifier: NCT01495923

Improving Access to Primary and Pain Care for Patients Taking Opioids for Chronic Pain in Michigan: Recommendations from an Expert Panel

This multidisciplinary expert panel was convened to generate recommendations to address the limited access to care that patients experience when taking opioids for chronic pain. Recent policies and guidelines instituted to reduce inappropriate opioid prescribing have had unintended consequences for the 5-8 million patients taking long-term opioid therapy for chronic pain in the U.S. As providers discontinue prescribing and turn away patients dependent on opioids, this population faces limited access to both primary and pain-related care. The root causes of this access issue can be attributed to several overarching barriers, including new opioid-related policies, payment models, a lack of care coordination, stigma, and racial biases. Over multiple rounds of deliberation, the panel brainstormed possible solutions, considering feasibility, impact, and importance, and ultimately ranked their final recommendations in order of implementation priority. The final list included 11 recommendations, from which three overarching themes emerged: 1. Improving care models to better support patients with chronic pain Three recommendations involved improving care models, including the top two: increasing reimbursement for the time needed to treat complex chronic pain and establishing coordinated care models that bundle payments for multimodal pain treatment. 2. Enhancing provider education and training Four recommendations involving provider education efforts received slightly lower rankings and included training on biopsychosocial factors of pain care and clarifying the continuum between physical dependency and opioid use disorder. 3. Implementing practices to reduce racial biases and inequities The remaining four recommendations address racial biases and inequities, ranging from standardizing pain management protocols to reduce bias to increasing recruitment and retention of providers from underrepresented racial minorities. Throughout the process, panelists emphasized the interconnectedness of their proposed solutions, and indicated that multiple approaches are likely needed to meaningfully improve access to care for this patient population. Importantly, though this panel was convened in Michigan, and its expertise grounded in Michigan’s healthcare ecosystem, there are millions of patients taking opioids for chronic pain across the country, and reports of limited access to care are not unique to Michigan. Consequently, there may also be opportunity to apply these recommendations more broadly, in other states and at multiple levels of the United States healthcare system.This research was funded by the Michigan Health Endowment Fund (grant # R-1808-143371).http://deepblue.lib.umich.edu/bitstream/2027.42/168420/1/Lagisetty - Improving Access to Care for Patients Taking Opioids - 2021.pdfDescription of Lagisetty - Improving Access to Care for Patients Taking Opioids - 2021.pdf : White PaperSEL

Opioid Overprescribing After Surgery: Current Practices, Patient Outcomes, and Persistent New Use

More than 700,000 persons died of drug overdose from 1999-2017, with more than half of these deaths involving an opioid. Millions of Americans receive opioid prescriptions as they return home after surgery. While these medicines greatly benefit some patients, many others experience adverse events, convert to persistent opioid use, or have unused pills that provide a reservoir for potential non-medical use. Our aim was to better understand opioid prescribing and use after surgery through conceptual, cohort, and claims-based investigations. We generated an evidence-based conceptual framework on optimizing post-surgical opioid prescribing, quantified prescription opioid oversupply after surgery through a systematic literature review, prospectively measured post-surgical prescription opioid use in a cohort of 140 patients, and determined the incidence of new persistent opioid use after different types of procedures and various surgical subspecialties in a pharmacoepidemiological study of 912,882 opioid-naïve individuals. A framework for opioid prescribing after discharge from surgery involves the interacting perspectives of patients, perioperative teams, and pharmacists, while systems-based factors—ranging from the organizational environment to health-care system and macro-level trends—shape these interactions and influence opioid-related safety outcomes. In the systematic review, most patients (67% to 92%) reported unused prescription opioids after surgery. In the prospective cohort study, 73% of patients who stopped opioid therapy reported unused pills at 1 month, only 6% received maximal nonopioid therapy, and >90% failed to safely store or properly dispose of opioids. In the pharmacoepidemiological study, new persistent opioid use after procedures ranged from 6.6% to 13.6%, with higher odds among procedures not performed in the operating room and particular subspecialty groups. These studies provide multiple, complementary perspectives on how opioid prescribing for surgical patients contributes to the opioid epidemic. Together, these different analyses yield consistent findings on surgical opioid overprescribing that underscore the urgent need for interventions to improve opioid prescribing and use after surgery in the United States. Future studies based on these findings have the potential to improve patient-focused safety and quality outcomes, reduce risk from opioids, and help curb the post-surgical oversupply of opioids that contributes to the most pressing public health crisis of our time

Opioid Overprescribing After Surgery: Current Practices, Patient Outcomes, and Persistent New Use

More than 700,000 persons died of drug overdose from 1999-2017, with more than half of these deaths involving an opioid. Millions of Americans receive opioid prescriptions as they return home after surgery. While these medicines greatly benefit some patients, many others experience adverse events, convert to persistent opioid use, or have unused pills that provide a reservoir for potential non-medical use. Our aim was to better understand opioid prescribing and use after surgery through conceptual, cohort, and claims-based investigations. We generated an evidence-based conceptual framework on optimizing post-surgical opioid prescribing, quantified prescription opioid oversupply after surgery through a systematic literature review, prospectively measured post-surgical prescription opioid use in a cohort of 140 patients, and determined the incidence of new persistent opioid use after different types of procedures and various surgical subspecialties in a pharmacoepidemiological study of 912,882 opioid-naïve individuals. A framework for opioid prescribing after discharge from surgery involves the interacting perspectives of patients, perioperative teams, and pharmacists, while systems-based factors—ranging from the organizational environment to health-care system and macro-level trends—shape these interactions and influence opioid-related safety outcomes. In the systematic review, most patients (67% to 92%) reported unused prescription opioids after surgery. In the prospective cohort study, 73% of patients who stopped opioid therapy reported unused pills at 1 month, only 6% received maximal nonopioid therapy, and >90% failed to safely store or properly dispose of opioids. In the pharmacoepidemiological study, new persistent opioid use after procedures ranged from 6.6% to 13.6%, with higher odds among procedures not performed in the operating room and particular subspecialty groups. These studies provide multiple, complementary perspectives on how opioid prescribing for surgical patients contributes to the opioid epidemic. Together, these different analyses yield consistent findings on surgical opioid overprescribing that underscore the urgent need for interventions to improve opioid prescribing and use after surgery in the United States. Future studies based on these findings have the potential to improve patient-focused safety and quality outcomes, reduce risk from opioids, and help curb the post-surgical oversupply of opioids that contributes to the most pressing public health crisis of our time

Demographics and living arrangements of the minority elderly in the United States

Using data from the U.S. Census Bureau, this study assesses the demographics and living arrangements of the minority elderly population of the United States. Rapid growth in both the number and the proportion of all elderly minority populations are expected. By 2050, one-third of the elderly population will be other than a non-Hispanic White. While existing literature primarily focuses on the demographics and living arrangements of the White elderly population, this study attempts to show the diversity and differences in economic and cultural patterns among the minority elderly population and the implications of such diversity on the living arrangements of the elderly. The data show variations in elderly living arrangements in minority population groups by gender, and across and within the groups themselves. Such differences in living arrangements have important policy implications on both macro and micro level

Opioid Settlement Funds: Do Not Neglect Patients With Pain

The opioid crisis has escalated in the setting of the COVID-19 pandemic to new extremes and has claimed more than half a million lives in the US since 2000. Lawsuits to address the civil and criminal liability of drug companies and other groups have originated from federal, state, local, and tribal jurisdictions. When successful, there will likely be billions of dollars and significant discretion as to how these funds are spent. Several groups have produced reports with principles to address the toll of addiction using settlement funds. However, they lack actionable strategies to address the needs of patients with pain, including patients with chronic pain who are receiving long-term opioid therapy. Persons with pain should not be neglected and deserve better treatment

Prospective preference assessment for the Comparison of Analgesic Regimen Effectiveness and Safety in Surgery (CARES) trial

Abstract Background Clinical trials face major barriers such as under-enrollment and selective enrollment, which threaten study completion and undermine validity and generalizability. Thus, we conducted a prospective preference assessment (PPA) prior to commencing the Comparison of Analgesic Regimen Effectiveness and Safety in Surgery (CARES) trial—a randomized controlled study comparing the outcomes of managing acute postoperative pain between opioid-sparing and opioid-based therapies. This PPA aimed to (1) determine the patients’ willingness to participate in the CARES trial, (2) identify the areas for improvement, and (3) assess the differences between willing and unwilling patients. Methods Patients undergoing elective laparoscopic cholecystectomy were recruited between August 2019 and February 2020 from two academic hospitals. A survey was administered to each patient consisting of (1) a vignette describing the trial, (2) an assessment of the patients’ understanding of the trial, (3) open-ended questions assessing the attitudes towards the trial, and (4) patient-completed questionnaires. Data were analyzed qualitatively with thematic analysis and quantitatively with the Wilcoxon signed-rank and chi-square tests. Results Forty-two patients were enrolled and grouped based on the 6-point Likert scale into willing (4–6, 71%) and not willing (1–3, 29%) to participate in the CARES trial. There were no significant differences with respect to all variables: age, education, sex, visible minority status, previous research, previous surgery, regular use of pain medications, surgical concerns, previous discussions on pain management, significant pain within the past 3 months, and significant use of pain medication within the past month. Factors that motivated participation were contributing to scientific research (45%), altruism (29%), and improving personal pain (24%). Common discouraging factors were negative perceptions of opioids (29%), side effects (21%), being blinded to the study medication (21%), and poor pain management (19%). Conclusions This PPA revealed that two key discouraging factors for patients were being blinded to the type of pain medication being taken and the potential for poor pain management as a consequence of participation. Modifications to improve patient acceptance of the CARES trial include ensuring sufficient rescue medicine and follow-up visits consistent with current standards of care for all patients, as well as patient education surrounding safe administration and side effects of the study medications.http://deepblue.lib.umich.edu/bitstream/2027.42/173825/1/13063_2022_Article_6123.pd

Protocol: mixed-methods study to evaluate implementation, enforcement, and outcomes of U.S. state laws intended to curb high-risk opioid prescribing

Abstract Background The U.S. opioid epidemic has been driven by the high volume of opioids prescribed by healthcare providers. U.S. states have recently enacted four types of laws designed to curb high-risk prescribing practices, such as high-dose and long-term opioid prescribing, associated with opioid-related mortality: (1) mandatory Prescription Drug Monitoring Program (PDMP) enrollment laws, which require prescribers to enroll in their state’s PDMP, an electronic database of patients’ controlled substance prescriptions, (2) mandatory PDMP query laws, which require prescribers to query the PDMP prior to prescribing an opioid, (3) opioid prescribing cap laws, which limit the dose and/or duration of opioid prescriptions, and (4) pill mill laws, which strictly regulate pain clinics to prevent nonmedical opioid prescribing. Some pain experts have expressed concern that these laws could negatively affect pain management among patients with chronic non-cancer pain. This paper describes the protocol for a mixed-methods study analyzing the independent effects of these four types of laws on opioid prescribing patterns and chronic non-cancer pain treatment, accounting for variation in implementation and enforcement of laws across states. Methods Many states have enacted multiple opioid prescribing laws at or around the same time. To overcome this issue, our study focuses on 18 treatment states that each enacted a single law of interest, and no other potentially confounding laws, over a 4-year period (2 years pre-/post-law). Qualitative interviews with key leaders in each of the 18 treatment states will characterize the timing, scope, and strength of each state law’s implementation and enforcement. This information will inform the design and interpretation of synthetic control models analyzing the effects of each of the two types of laws on two sets of outcomes: measures of (1) high-risk opioid prescribing and (2) non-opioid treatments for chronic non-cancer pain. Discussion Study of mandatory PDMP enrollment, mandatory PDMP query, opioid prescribing cap, and pill mill laws is timely given a dynamic policy environment in which numerous states pass, revise, implement, and enforce varied laws to address opioid prescribing each year. Findings will inform enactment, implementation, and enforcement of these laws in additional states

Association of opioid exposure before surgery with opioid consumption after surgery

OBJECTIVE: To determine the effect of prescription opioid use in the year before surgery on opioid consumption after surgery. BACKGROUND: Recently developed postoperative opioid prescribing guidelines rely on data from opioid-naïve patients. However, opioid use in the USA is common, and the impact of prior opioid exposure on the consumption of opioids after surgery is unclear. METHODS: Population-based cohort study of 26,001 adults 18 years of age and older who underwent one of nine elective general or gynecologic surgical procedures between January 1, 2017 and October 31, 2019, with prospectively collected patient-reported data from the Michigan Surgical Quality Collaborative (MSQC) linked to state prescription drug monitoring program at 70 MSQC-participating hospitals on 30-day patient-reported opioid consumption in oral morphine equivalents (OME) (primary outcome). RESULTS: Compared with opioid-naïve participants, opioid-exposed participants (26% of sample) consumed more prescription opioids after surgery (adjusted OME difference 12, 95% CI 10 to 14). Greater opioid exposure was associated with higher postoperative consumption in a dose-dependent manner, with chronic users reporting the greatest consumption (additional OMEs 32, 95% CI 21 to 42). However, for eight of nine procedures, 90% of opioid-exposed participants consumed ≤150 OMEs. Among those receiving perioperative prescriptions, opioid-exposed participants had higher likelihood of refill (adjusted OR 4.7, 95% CI 4.4 to 5.1), number of refills (adjusted incidence rate ratio 4.0, 95% CI 3.7 to 4.3), and average refill amount (adjusted OME difference 333, 95% CI 292 to 374)). CONCLUSIONS: Preoperative opioid use is associated with small increases in patient-reported opioid consumption after surgery for most patients, though greater differences exist for patients with chronic use. For most patients with preoperative opioid exposure, existing guidelines may meet their postoperative needs. However, guidelines may need tailoring for patients with chronic use, and providers should anticipate a higher likelihood of postoperative refills for all opioid-exposed patients