Fourth Wave of Opioid (Illicit Drug) Overdose Deaths and Diminishing Access to Prescription Opioids and Interventional Techniques: Cause and Effect.

BACKGROUND: In the midst of the COVID-19 pandemic, data has shown that age-adjusted overdose death rates involving synthetic opioids, psychostimulants, cocaine, and heroin have been increasing, including prescription opioid deaths, which were declining, but, recently, reversing the trends. Contrary to widely held perceptions, the problem of misuse, abuse, and diversion of prescription opioids has been the least of all the factors in recent years. Consequently, it is important to properly distinguish between the role of illicit and prescription opioids in the current opioid crisis. Multiple efforts have been based on consensus on administrative policies for certain harm reduction strategies for individuals actively using illicit drugs and reducing opioid prescriptions leading to curbing of medically needed opioids, which have been ineffective. While there is no denial that prescription opioids can be misused, abused, and diverted, the policies have oversimplified the issue by curbing prescription opioids and the pendulum has swung too far in the direction of severely limiting prescription opioids, without acknowledgement that opioids have legitimate uses for persons suffering from chronic pain. Similar to the opioid crisis, interventional pain management procedures have been affected by various policies being applied to reduce overuse, abuse, and finally utilization. Medical policies have been becoming more restrictive with reduction of access to certain procedures, with the pendulum swinging too far in the direction of limiting interventional techniques. Recent utilization assessments have shown a consistent decline for most interventional techniques, with a 18.7% decrease from 2019 to 2020. The causes for these dynamic changes are multifactorial likely including the misapplication of the 2016 Centers for Disease Control and Prevention (CDC) guidelines for prescribing opioids for chronic pain, the relative ease of access to illicit synthetic opioids and more recently issues related to the COVID-19 pandemic. In addition, recent publications have shown association of dose tapering with overdose or mental health crisis among patients prescribed long-term opioids. These findings are leading to the hypothesis that federal guidelines may inadvertently be contributing to an increase in overall opioid deaths and diminished access to interventional techniques. Together, these have resulted in a fourth wave of the opioid epidemic. METHODS: A narrative review. RESULTS: The fourth wave results from a confluence of multiple factors, including misapplication of CDC guidelines, the increased availability of illicit drugs, the COVID-19 pandemic, and policies reducing access to interventional procedures. The CDC guidelines and subsequent regulatory atmosphere have led to aggressive tapering up to and including, at times, the overall reduction or stoppage of opioid prescriptions. Forced tapering has been linked to an increase of 69% for overdoses and 130% for mental health crisis. The data thus suggests that the diminution in access to opioid prescriptions may be occurring simultaneously with an increase in illicit narcotic use.Combined with CDC guidelines, the curbing of opioid prescriptions to medically needed individuals, among non-opioid treatments, interventional techniques have been affected with declining utilization rates and medical policies reducing access to such modalities. CONCLUSION: The opioid overdose waves over the past three decades have resulted from different etiologies. Wave one was associated with prescription opioid overdose deaths and wave two with the rise in heroin and overdose deaths from 1999 to 2013. Wave three was associated with a rise in synthetic opioid overdose deaths. Sadly, wave four continues to escalate with increasing number of deaths as a confluence of factors including the CDC guidelines, the COVID pandemic, increased availability of illicit synthetic opioids and the reduction of access to interventional techniques, which leads patients to seek remedies on their own.

Methodology for Evidence Synthesis and Development of Comprehensive Evidence-Based Guidelines for Interventional Techniques in Chronic Spinal Pain.

BACKGROUND: The re-engineered definition of clinical guidelines in 2011 from the IOM (Institute of Medicine) states, "clinical practice guidelines are statements that include recommendations intended to optimize patient care that is informed by a systematic review of evidence and an assessment of the benefit and harms of alternative care options." The revised definition distinguishes between the term "clinical practice guideline" and other forms of clinical guidance derived from widely disparate development processes, such as consensus statements, expert advice, and appropriate use criteria. OBJECTIVE: To assess the literature and develop methodology for evidence synthesis and development of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. METHODS: A systematic review of the literature including methodology of guideline development encompassing GRADE approach for guidance on evidence synthesis with recommendations. RESULTS: Some of the many factors described in 2011 continue as of 2020 and impede the development of clinical practice guidelines. These impediments include biases due to a variety of conflicts and confluence of interest, inappropriate and poor methodological quality, poor writing and ambiguous presentation, projecting a view that these are not applicable to individual patients or too restrictive with the elimination of clinician autonomy, and overzealous and inappropriate recommendations, either positive, negative, or non-committal. Thus, ideally, a knowledgeable, multidisciplinary panel of experts with true lack of bias and confluence of interest must develop guidelines based on a systematic review of the existing evidence. This manuscript describes evidence synthesis from observational studies, various types of randomized controlled trials (RCTs), and, finally, methodological and reporting quality of systematic reviews. The manuscript also describes various methods utilized in the assessment of the quality of observational studies, diagnostic accuracy studies, RCTs, and systematic reviews. LIMITATIONS: Paucity of publications with appropriate evidence synthesis methodology in reference to interventional techniques. CONCLUSION: This review described comprehensive evidence synthesis derived from systematic reviews, including methodologic quality and bias measurement. The manuscript described various methods utilized in the assessment of the quality of the systematic reviews, RCTs, diagnostic accuracy studies, and observational studies.

Lessons for Better Pain Management in the Future: Learning from the Past.

The treatment of noncancer pain in the United States and globally is met with significant challenges, resulting in profound physical, emotional, and societal costs. Based on this need, numerous modalities have been proposed to manage chronic pain, including opioid and nonopioid interventions as well as surgical approaches. Thus, the future of pain management continues to be mired in evolving concepts and constant debates. Consequently, it is crucial to understand the past as we move towards the future. The evolution of lessons for better pain management at present and for the future starting from the 1990s to the present date are reviewed and emphasized with a focus on learning from the past for the future. This review summarizes the evolution of multiple modalities of treatments, including multidisciplinary programs, multimodal therapy, interventional techniques, opioid therapy, other conservative modalities, and surgical interventions. This review emphasizes the individual, patient-centered development of an effective pain treatment plan after proper evaluation to establish a diagnosis. It includes measurable outcomes that focus on improvements in the quality of life and activities of daily living, as well as improvement in pain and function and, most importantly, return to productive citizenship. It is crucial that the knowledge of best practices be advanced, along with emphasis on lessons learned in the past to provide best practices for better pain management.

An Updated Analysis of Utilization of Epidural Procedures in Managing Chronic Pain in the Medicare Population from 2000 to 2018.

BACKGROUND: With increasing costs of health care in the United States, attention is focused on expensive conditions. Musculoskeletal disorders with low back and neck pain account for the third highest amount of various disease categories. Minimally invasive interventional techniques for managing spinal pain, including epidural injections, have been considered to be growing rapidly. However, recent analyses of utilization of interventional techniques from 2000 to 2018 has shown a decline of 2.6% and a decline of 21% from 2009 to 2018 for epidural and adhesiolysis procedures. OBJECTIVES: The objectives of this analysis of epidural procedures from 2000 to 2018 are to provide an update on utilization of epidural injections in managing chronic pain in the fee-for-service (FFS) Medicare population, with a comparative analysis of 2000 to 2009 and 2009 to 2018. STUDY DESIGN: Utilization patterns and variables of epidural injections in managing chronic spinal pain from 2000 to 2009 and from 2009 to 2018 in the FFS Medicare population in the United States. METHODS: This analysis was performed by utilizing master data from CMS, physician/supplier procedure summary from 2000 to 2018. The analysis was performed by the assessment of utilization patterns using guidance from Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). RESULTS: Overall, epidural procedures declined at a rate of 20.7% per 100,000 Medicare enrollees in FFS Medicare in the United States from 2009 to 2018, with an annual decline of 2.5%. However, from 2000 to 2009, there was an increase of 89.2%, with an annual increase of 7.3%. This analysis showed a decline in all categories, with an annual decrease of 4.7% for lumbar interlaminar and caudal epidural injections, 4.7% decline for cervical/thoracic transforaminal epidural injections, 1.1% decline for lumbar/sacral transforaminal epidural injections, and finally 0.4% decline for cervical/thoracic interlaminar epidural injections. Overall declines from 2009 to 2018 were highest for cervical and thoracic transforaminal injections with 35.1%, followed by lumbar interlaminar and caudal epidural injections of 34.9%, followed by 9.4% for lumbar/sacral transforaminal epidurals, and 3.5% for cervical and thoracic interlaminar epidurals. LIMITATIONS: This analysis was limited by noninclusion of Medicare Advantage plans, which constitutes almost 30% of the Medicare population. In addition, utilization data for individual states continues to be sparse and may not be accurate or representative of the population. CONCLUSIONS: The declining utilization of epidural injections in all categories with an annual of 2.5% and overall decrease of 20.7% from 2009 to 2018 compared with annual increases of 7.3% and overall increase of 89.2% from 2000 to 2009 shows a slow decline of utilization of all epidural injections. KEY WORDS: Chronic spinal pain, interlaminar epidural injections, caudal epidural injections, transforaminal epidural injections, utilization patterns.