scholarly journals Infection Control Practices (Safe Injection and Medication Vial Utilization) for Interventional Techniques: Are They Based on Relative Risk Management or Evidence?

2011 ◽  
Vol 5;14 (5;9) ◽  
pp. 434-434
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Single Dose ◽  
Relative Risk ◽  
Pain Management ◽  
Infection Control ◽  
Case Reports ◽  
Interventional Techniques ◽  
Interventional Pain Management ◽  
Safe Injection ◽  
Multiple Patients ◽  
Injection Practices

Background: Recently, multiple regulations and recommendations for safe infection control practices and safe injection and medication vial utilization have been implemented. These include single dose and multi-dose vials for a single patient and regulations. It is a well known fact that transmission of bloodborne pathogens during health care procedures continues to occur because of the use of unsafe and improper injection, infusion, and medication administration. Multiple case reports have been published illustrating the occurrence of infections in interventional pain management and other minor techniques because of lack of safe injection practices, and noncompliance with other precautions. However, there are no studies or case reports illustrating the transmission of infection due to the use of single dose vials in multiple patients when appropriate precautions are observed. Similarly, the preparation standards for simple procedures such as medial branch blocks or transforaminal epidurals have not been proven to be essential. Further, the effectiveness or necessity of surgical face masks and hats, etc., for interventional techniques has not been proven. Objective: To assess the rates of infection in patients undergoing interventional techniques. Study Design: A prospective, non-randomized study of patients undergoing interventional techniques from May 2008 to December 2009. Study Setting: An interventional pain management practice, a specialty referral center, a private practice setting in the United States. Methods: All patients presenting for interventional techniques from May 2008 to December 2009 are included with documentation of various complications related to interventional techniques including infection. Results: May 2008 to December 2009 a total of 3,179 patients underwent 12,000 encounters with 18,472 procedures. A total of 12 patients reported suspicion of infection. All of them were evaluated by a physician and only one of them was a superficial infection due to the patient’s poor hygienic practices which required no antibiotic therapy. Limitations: Limitations include the nonrandomized observational nature of the study. Conclusion: There were no infections of any significance noted in approximately 3,200 patients with over 18,000 procedures performed during a 20 month period in an ambulatory surgery center utilizing simple precautions for clean procedures with the use of single dose vials for multiple patients and using safe injection practices. Clinical Trial Registrion: NCT00625248 Key words: Interventional pain management, interventional techniques, complications, infection, safe injection practices, single dose vials, multi-dose vials, surgical face masks, relative risk.

scholarly journals Assessment of Infection Control Practices for Interventional Techniques: A Best Evidence Synthesis of Safe Injection Practices and Use of Single-Dose Medication Vials

2012 ◽  
Vol 5;15 (5;9) ◽  
pp. E573-E614 ◽  
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Single Dose ◽  
Pain Management ◽  
Infection Control ◽  
Case Reports ◽  
Evidence Synthesis ◽  
Interventional Techniques ◽  
Management Procedures ◽  
Best Evidence Synthesis ◽  
Interventional Pain Management ◽  
Multiple Patients

Background: It is universally accepted that transmission of bloodborne pathogens during health care procedures continues to occur because of the use of unsafe and improper injection, infusion, and medication administration practices by health care professionals in various clinical settings. This resulted in development of multiple guidelines based on case reports; however, these case reports are confounded by multiple factors without causal relationship to a single factor. Even then, singledose vials used for multiple patients have been singled out and became the focus of infection control policies resulting in inordinate expenses for practices without improving patient safety. The cost of implementation of single dose vial policy in Interventional Pain Management for drugs alone may cost $750 million, whereas with single use radional gloves may exceed $1 billion per year. Study Design: Best evidence synthesis. Objective: To critically appraise and synthesize the literature on infection control practices for interventional techniques, including safe injection and medication vial utilization. Methods: The available literature on infection control practices was reviewed. Due to the nature of the studies involved, with the majority being case reports, and a few prospective evaluations, quality assessment and clinical relevance criteria were not applied. Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 through June 2012, literature from the Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), and manual searches of the bibliographies of known primary and review articles. Outcome Measures: The primary outcome measure was correlating infection to a breach of standards in infection control practices. The secondary objective was to assess the contribution of single-dose vials independently for infection. Results: A total of 60 reports met inclusion criteria, with 16 reports related to pain management and other procedures, of which 9 reports were attributed to issues related to interventional techniques. Based on an estimated 37 infections occurring during 200 million interventional techniques from 1997 through 2011, the rate of infection is speculated to be one infection for every 5 million interventional pain management procedures. However, if 10 times more infections are estimated, the infection rate appears to be one infection for every 500,000 interventional pain management procedures. The evidence is good for infection related to a breach of infection control practices. There is good evidence that contamination of multi-dose or single-dose vials can contribute to infection. There was poor evidence that the use of single-dose vials on multiple patients with appropriate infection control practices cause infection in interventional pain management. Limitations: The limitations of this comprehensive best evidence synthesis include the paucity of literature and dependence of governmental agencies on their literature without applying Institute of Medicine (IOM) criteria for guideline synthesis

scholarly journals Reassessment of Evidence Synthesis of Occupational Medicine Practice Guidelines for Interventional Pain Management

2008 ◽  
Vol 4;11 (8;4) ◽  
pp. 393-482
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Chronic Pain ◽  
Pain Management ◽  
Strong Evidence ◽  
Guideline Development ◽  
Medial Branch ◽  
Low Back ◽  
Quality Of Evidence ◽  
Interventional Techniques ◽  
Interventional Pain Management

Background: Appropriately developed practice guidelines present statements of best practice based on a thorough evaluation of the evidence from published studies on the outcomes of treatments, which include the application of multiple methods for collecting and evaluating evidence for a wide range of clinical interventions and disciplines. However, the guidelines are neither infallible, nor a substitute for clinical judgment. While the guideline development process is a complex phenomenon, conflict of interest in guideline development and inappropriate methodologies must be avoided. It has been alleged that the guidelines by the American College of Occupational and Environmental Medicine (ACOEM) prevent injured workers from receiving the majority of medically necessary and appropriate interventional pain management services. An independent critical appraisal of both chapters of the ACOEM guidelines showed startling findings with a conclusion that these guidelines may not be applied in patient care as they scored below 30% in the majority of evaluations utilizing multiple standardized criteria. Objective: To reassess the evidence synthesis for the ACOEM guidelines for the low back pain and chronic pain chapters utilizing an expanded methodology, which includes the criteria included in the ACOEM guidelines with the addition of omitted literature and application of appropriate criteria. Methods: For reassessment, randomized trials were utilized as it was in the preparation of the guidelines. In this process, quality of evidence was assessed and recommendations were made based on grading recommendations of Guyatt et al. The level of evidence was determined utilizing the quality of evidence criteria developed by the U.S. Preventive Services Task Force (USPSTF), as well as the outdated quality of evidence criteria utilized by ACOEM in the guideline preparation. Methodologic quality of each individual article was assessed utilizing the Agency for Healthcare Research and Quality (AHRQ) methodologic assessment criteria for diagnostic interventions and Cochrane methodologic quality assessment criteria for therapeutic interventions. Results: The results of reassessment are vastly different from the conclusions derived by the ACOEM guidelines. The differences in strength of rating for the diagnosis of discogenic pain by provocation discography and facet joint pain by diagnostic facet joint nerve blocks is established with strong evidence. Therapeutic cervical and lumbar medial branch blocks and radiofrequency neurolysis, therapeutic thoracic medial branch blocks, cervical interlaminar epidural steroid injections, caudal epidural steroid injections, lumbar transforaminal epidural injections, percutaneous and endoscopic adhesiolysis, and spinal cord stimulation qualified for moderate to strong evidence. Additional insight is also provided for evidence rating for intradiscal electrothermal therapy (IDET), automated percutaneous disc decompression, and intrathecal implantables. Conclusion: The reassessment and reevaluation of the low back and chronic pain chapters of the ACOEM guidelines present results that are vastly different from the published and proposed guidelines. Contrary to ACOEM’s conclusions of insufficient evidence for most interventional techniques, the results illustrate moderate to strong evidence for most diagnostic and therapeutic interventional techniques. Key words: Guidelines, evidence-based medicine, systematic reviews, ACOEM, interventional pain management, interventional techniques, guideline development, workers’ compensation, chronic pain guidelines, low back pain guidelines

Case Reports On The Multimodal Management of Refractory Chronic Oncological Pain of The Chest Wall: The Use of The Spinal Erector Plane Neurolysis

2021 ◽  
Author(s):  
John Cardenas ◽  
Juan Felipe Vargas-Silva ◽  
Alejandro Ramirez
Keyword(s):  
Pain Management ◽  
Chest Wall ◽  
Case Reports ◽  
Management Strategies ◽  
Erector Spinae ◽  
Opioid Rotation ◽  
Interventional Pain Management ◽  
Multimodal Management ◽  
Advanced Stage Cancer

Abstract Chronic pain of oncological origin is one of the most frequent complications and is difficult to control, that results in a decrease in the quality of life and disability among patients suffering from this pathology. Primary or metastatic tumors originating from lung, colonic, or breast neoplasms can invade the chest wall, causing progressive respiratory pain and symptoms that require multiple interventions to achieve adequate control. Many of these cases presenting with advanced-stage cancer are often incurable; thus, pain management and palliative care are primary objectives. Multimodal management is the strategy of choice in these cases through the participation of a multidisciplinary team. Analgesic therapy covers the use of potent opioids, opioid rotation, adjuvant analgesics, and interventional pain management strategies. We report two cases of chronic oncological pain of the chest wall refractory to pharmacological analgesic management. The optimization of multimodal management and the performance of neurolysis by phenolization of the erector spinae plane achieved an adequate response.

scholarly journals Triaging Interventional Pain Procedures During COVID-19 or Related Elective Surgery Restrictions: Evidence-Informed Guidance from the American Society of Interventional Pain Physicians (ASIPP)

2020 ◽  
Vol 4S;23 (8;4S) ◽  
pp. E183-S204
Author(s):  
Christopher Gharibo
Keyword(s):  
Chronic Pain ◽  
Pain Management ◽  
Surgical Procedures ◽  
Task Force ◽  
Elective Surgery ◽  
Interventional Techniques ◽  
Elective Surgical Procedures ◽  
Chronic Pain Patients ◽  
Interventional Pain Management ◽  
Pain Patients

Background: The COVID-19 pandemic has worsened the pain and suffering of chronic pain patients due to stoppage of “elective” interventional pain management and office visits across the United States. The reopening of America and restarting of interventional techniques and elective surgical procedures has started. Unfortunately, with resurgence in some states, restrictions are once again being imposed. In addition, even during the Phase II and III of reopening, chronic pain patients and interventional pain physicians have faced difficulties because of the priority selection of elective surgical procedures. Chronic pain patients require high intensity care, specifically during a pandemic such as COVID-19. Consequently, it has become necessary to provide guidance for triaging interventional pain procedures, or related elective surgery restrictions during a pandemic. Objectives: The aim of these guidelines is to provide education and guidance for physicians, healthcare administrators, the public and patients during the COVID-19 pandemic. Our goal is to restore the opportunity to receive appropriate care for our patients who may benefit from interventional techniques. Methods: The American Society of Interventional Pain Physicians (ASIPP) has created the COVID-19 Task Force in order to provide guidance for triaging interventional pain procedures or related elective surgery restrictions to provide appropriate access to interventional pain management (IPM) procedures in par with other elective surgical procedures. In developing the guidance, trustworthy standards and appropriate disclosures of conflicts of interest were applied with a section of a panel of experts from various regions, specialties, types of practices (private practice, community hospital and academic institutes) and groups. The literature pertaining to all aspects of COVID-19, specifically related to epidemiology, risk factors, complications, morbidity and mortality, and literature related to risk mitigation and stratification was reviewed. The evidence -- informed with the incorporation of the best available research and practice knowledge was utilized, instead of a simplified evidence-based approach. Consequently, these guidelines are considered evidence-informed with the incorporation of the best available research and practice knowledge. Results: The Task Force defined the medical urgency of a case and developed an IPM acuity scale for elective IPM procedures with 3 tiers. These included emergent, urgent, and elective procedures. Examples of emergent and urgent procedures included new onset or exacerbation of complex regional pain syndrome (CRPS), acute trauma or acute exacerbation of degenerative or neurological disease resulting in impaired mobility and inability to perform activities of daily living. Examples include painful rib fractures affecting oxygenation and post-dural puncture headaches limiting the ability to sit upright, stand and walk. In addition, urgent procedures include procedures to treat any severe or debilitating disease that prevents the patient from carrying out activities of daily living. Elective procedures were considered as any condition that is stable and can be safely managed with alternatives. Limitations: COVID-19 continues to be an ongoing pandemic. When these recommendations were developed, different stages of reopening based on geographical regulations were in process. The pandemic continues to be dynamic creating every changing evidence-based guidance. Consequently, we provided evidence-informed guidance. Conclusion: The COVID-19 pandemic has created unprecedented challenges in IPM creating needless suffering for pain patients. Many IPM procedures cannot be indefinitely postponed without adverse consequences. Chronic pain exacerbations are associated with marked functional declines and risks with alternative treatment modalities. They must be treated with the concern that they deserve. Clinicians must assess patients, local healthcare resources, and weigh the risks and benefits of a procedure against the risks of suffering from disabling pain and exposure to the COVID-19 virus. Key words: Coronavirus, COVID-19, interventional pain management, COVID risk factors, elective surgeries, interventional techniques, chronic pain, immunosuppression

scholarly journals Ambulatory Surgery Centers and Interventional Techniques: A Look at Long-Term Survival

2011 ◽  
Vol 3;14 (2;3) ◽  
pp. E177-E212 ◽  
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Health Care ◽  
Pain Management ◽  
Ambulatory Surgery ◽  
Health Care Expenditures ◽  
The United States ◽  
Payment System ◽  
Ambulatory Surgery Centers ◽  
Interventional Techniques ◽  
Outpatient Procedures ◽  
Interventional Pain Management

With health care expenditures skyrocketing, coupled with pervasive quality deficits, pressures to provide better and more proficient care continue to shape the landscape of the U.S. health care system. Payers, both federal and private, have laid out several initiatives designed to curtail costs, including value-based reimbursement programs, cost-shifting expenses to the consumer, reducing reimbursements for physicians, steering health care to more efficient settings, and finally affordable health care reform. Consequently, one of the major aspects in the expansion of health care for improving quality and reducing costs is surgical services. Nearly 57 million outpatient procedures are performed annually in the United States, 14 million of which occur in elderly patients. Increasing use of these minor, yet common, procedures contributes to rising health care expenditures. Once exclusive within hospitals, more and more outpatient procedures are being performed in freestanding ambulatory surgery centers (ASCs), physician offices, visits to which have increased over 300% during the past decade. Concurrent with this growing demand, the number of ASCs has more than doubled since the 1990s, with more than 5,000 facilities currently in operation nationwide. Further, total surgical center ASC payments have increased from $1.2 billion in 1999 to $3.2 billion in 2009, a 167% increase. On the same lines, growth and expenditures for hospital outpatient department (HOPD) services and office procedures also have been evident at similar levels. Recent surveys have illustrated on overall annual growth per capita in Medicare allowed ASC services of pain management of 23%, with 27% growth seen in ASCs and 16% of the growth seen in HOPD. Further, the proportion of interventional pain management which was 4% of Medicare ASC spending in 2000 has increased to 10% in 2007. Thus, interventional pain management as an evolving specialty is one of the most commonly performed procedures in ASC settings apart from HOPDs and well-equipped offices. In June 1998, the Health Care Financing Administration (HCFA) proposed an ASC rule in which at least 60% of interventional procedures were eliminated from ASCs, and the remaining 40% faced substantial cuts in payments. Following the publication of this rule, based on public comments and demand, Congress intervened and delayed implementation of the rule for several years. The Centers for Medicare and Medicaid Services (CMS) published its proposed outpatient prospective system for ASCs in 2006, setting ASC payments at 62% of HOPD payments. Following multiple changes, the rule was incorporated with a 4-year transition formula which ended in 2010, with full effect occurring in 2011 with ASCs reimbursed at 57% of HOPD payments. Thus, the landscape of interventional pain management in ambulatory surgery centers has been constantly changing with declining reimbursements, issues of fraud and abuse, and ever-increasing regulations. Key words: Outpatient prospective payment system, ambulatory surgery center payment system, Government Accountability Office, Medicare Modernization and Improvement Act, interventional techniques

scholarly journals Analysis of Growth of Interventional Techniques in Managing Chronic Pain in the Medicare Population: A 10-Year Evaluation from 1997 to 2006

2009 ◽  
Vol 1;12 (1;1) ◽  
pp. 9-34 ◽  
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Chronic Pain ◽  
Pain Management ◽  
Ambulatory Surgery ◽  
Facet Joint ◽  
Medicare Beneficiaries ◽  
Interventional Techniques ◽  
Ambulatory Surgery Center ◽  
Interventional Pain Management ◽  
Joint Injections ◽  
Surgery Center

Background: Recent reports of the United States Government Accountability Office (GAO), the Medicare Payment Advisory Commission (MedPAC), and the Office of Inspector General (OIG) expressed significant concern with overall fiscal sustainability of Medicare and exponential increase in costs for interventional pain management techniques. Interventional pain management (IPM) is an evolving specialty amenable to multiple influences. Evaluation and isolation of appropriate factors for increasing growth patterns have not been performed. Study Design: Analysis of the growth of interventional techniques in managing chronic pain in Medicare beneficiaries from 1997 to 2006. Objective: To evaluate the use of all interventional techniques. Methods: The standard 5% national sample of the CMS carrier claim record data for 1997, 2002, and 2006 was utilized. This data set provides information on Medicare enrollees in the feefor-service Medicare program. Current procedural technology (CPT) codes for 1997, 2002, and 2006 were used to identify the number of procedures performed each year, and trends in expenditures. Results: Interventional techniques increased significantly in Medicare beneficiaries from 1997 to 2006. Overall, there was an increase of 137% in patients utilizing IPM services with an increase of 197% in IPM services, per 100,000 Medicare beneficiaries. The majority of the increases were attributed to exponential growth in the performance of facet joint interventions. There was a 13.9-fold difference in the increase between the state with the lowest rate and the state with the highest rate in utilization patterns of interventional techniques (California 37% vs. Connecticut 514%), with an 11.6-fold difference between Florida and California (431% vs. 37% increase). In 2006, Florida showed a 12.7-fold difference compared to Hawaii with the lowest utilization rate. Hospital outpatient department (HOPD) expenses constituted the highest increase with fewer patients treated either in an ambulatory surgery center (ASC) or in-office setting. Overall HOPD payments constituted 5% of total 2006 Medicare payments, in contrast to 57% of total IPM payments, an 11.4-fold difference. Limitations: The limitations of this study include a lack of inclusion of Medicare participants in Medicare Advantage plans and potential documentation, coding, and billing errors. Conclusion: This study shows an overall increase of IPM services of 197% compared to an increase of 137% in patients utilizing IPM services from 1997 to 2006. Key words: Interventional techniques, interventional pain management, facet joint injections, epidural steroid injections, sacroiliac joint injections, chronic pain, chronic spinal pain, ambulatory surgery center (ASC), hospital outpatient department (HOPD)

scholarly journals Accountable Interventional Pain Management: A Collaboration Among Practitioners, Patients, Payers, and Government

2013 ◽  
Vol 6;16 (6;11) ◽  
pp. E635-E670
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Pain Management ◽  
Sacroiliac Joint ◽  
Facet Joint ◽  
Significant Proportion ◽  
The United States ◽  
Fee For Service ◽  
Interventional Techniques ◽  
Epidural Injections ◽  
Interventional Pain Management ◽  
Facet Joint Interventions

The prevalence, costs, and disability associated with chronic pain continue to escalate. So too, the numerous modalities of treatments applied in managing these patients continue to increase as well. In the period from 2000 to 2011 interventional techniques increased 228%. In addition, analysis of utilization trends and expenditures for spinal interventional techniques alone from 2000 to 2008 illustrated an increase in Medicare fee-for-service expenditures of 240% in terms of dollars spent in the United States. The Office of Inspector General (OIG) of the Department of Health and Human Services showed an increase in facet joint and transforaminal epidural injections, with a significant proportion of these services did not meet the medical necessity criteria. The increasing utilization of interventional techniques is also associated with significant variations among specialty groups and regional variations among states. Overall procedures have increased by 173%, with rate of 130% per 100,000 Medicare beneficiaries for epidural injections; 383%, with a rate of 308% for facet joint interventions; and overall 410%, or a rate of 331% for sacroiliac joint interventions. Certain high volume interventions such as lumbar transforaminal epidural injections and lumbar facet joint neurolysis have actually increased a staggering 806% and 662%. Coverage policies across ambulatory settings and by multiple payers are highly variable. Apart from variability in the development of coverage policies, payments also substantially vary by site of service. In general, amongst the various ambulatory settings the highest payments are made to hospital outpatient departments (HOPDs) the lowest to in-office procedures, and payment to ambulatory surgery centers (ASCs) falling somewhere in the middle. This manuscript describes the many differences that exist between the various settings, and includes suggestions for accountable interventional pain management with coverage for techniques with evidence, addressing excessive use of specific techniques, and equalizing payments across multiple ambulatory settings. Key words: Accountable interventional pain management, Medicare, Medicare Evidence Development & Coverage Advisory Committee, epidural injections, facet joint interventions, sacroiliac joint injections, payment policies

scholarly journals Utilization of Interventional Techniques in Managing Chronic Pain in the Medicare Population: Analysis of Growth Patterns from 2000 to 2011

2012 ◽  
Vol 6;15 (6;12) ◽  
pp. E969-E982 ◽  
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Chronic Pain ◽  
Pain Management ◽  
Sacroiliac Joint ◽  
Facet Joint ◽  
Medicare Beneficiaries ◽  
Interventional Techniques ◽  
Geometric Average ◽  
Interventional Pain Management ◽  
Facet Joint Interventions ◽  
Joint Injections

Background: Reports from the United States Government Accountability Office (GAO), the Institute of Medicine (IOM), the Medicare Payment Advisory Commission (MedPAC), and the Office of Inspector General (OIG) continue to express significant concern with the overall fiscal sustainability of Medicare and the exponential increase in costs for chronic pain management. Study Design: The study is an analysis of the growth of interventional techniques in managing chronic pain in Medicare beneficiaries from 2000 to 2011. Objective: To evaluate the use of all interventional techniques in chronic pain management. Methods: The study was performed utilizing the Centers for Medicare and Medicaid Services (CMS) Physician Supplier Procedure Summary Master Data from 2000 to 2011. Results: Interventional techniques for chronic pain have increased dramatically from 2000 to 2011. Overall, the increase of interventional pain management (IPM) procedures from 2000 to 2011 went up 228%, with 177% per 100,000 Medicare beneficiaries. The increases were highest for facet joint interventions and sacroiliac joint blocks with a total increase of 386% and 310% per 100,000 Medicare beneficiaries, followed by 168% and 127% for epidural and adhesiolysis procedures, 150% and 111% for other types of nerve blocks and finally, 28% and 8% increases for percutaneous disc procedures. The geometric average of annual increases was 9.7% overall with 13.7% for facet joint interventions and sacroiliac joint blocks and 7.7% for epidural and adhesiolysis procedures. Limitations: The limitations of this study included a lack of inclusion of Medicare participants in Medicare Advantage plans, as well as potential documentation, coding, and billing errors. Conclusion: Interventional techniques increased significantly in Medicare beneficiaries from 2000 to 2011. Overall, there was an increase of 177% in the utilization of IPM services per 100,000 Medicare beneficiaries, with an annual geometric average increase of 9.7%. The study also showed an exponential increase in facet joint interventions and sacroiliac joint blocks. Key words: Interventional techniques, interventional pain management, facet joint injections, epidural steroid injections, sacroiliac joint injections, chronic pain, chronic spinal pain

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