Safety of epidural catheterization in interventional pain management.
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Biomedical subjects
Publications and source records attributed to Laxmaiah Manchikanti.
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BACKGROUND: Opioid abuse has increased at an alarming rate. However, available evidence suggests a wide variance in the use of opioids, as documented by different medical specialties, medical boards, advocacy groups, and the Drug Enforcement Administration (DEA). OBJECTIVES: The objective of these opioid guidelines by the American Society of Interventional Pain Physicians (ASIPP) is to provide guidance for the use of opioids for the treatment of chronic non-cancer pain, to bring consistency in opioid philosophy among the many diverse groups involved, to improve the treatment of chronic non-cancer pain, and to reduce the incidence of drug diversion. DESIGN: A policy committee evaluated a systematic review of the available literature regarding opioid use in managing chronic non-cancer pain. This resulted in the formulation of the essentials of guidelines, a series of potential evidence linkages representing conclusions, followed by statements regarding relationships between clinical interventions and outcomes. METHODS: Consistent with the Agency for Healthcare Research and Quality (AHRQ) hierarchical and comprehensive standards, the elements of the guideline preparation process included literature searches, literature synthesis, systematic review, consensus evaluation, open forum presentations, formal endorsement by the Board of Directors of the American Society of Interventional Pain Physicians (ASIPP), and blinded peer review. Evidence was designated based on scientific merit as Level I (conclusive), Level II (strong), Level III (moderate), Level IV (limited), or Level V (indeterminate). RESULTS: After an extensive review and analysis of the literature, the authors utilized two systematic reviews, two narrative reviews, 32 studies included in prior systematic reviews, and 10 additional studies in the synthesis of evidence. The evidence was limited. CONCLUSION: These guidelines evaluated the evidence for the use of opioids in the management of chronic non-cancer pain and recommendations for management. These guidelines are based on the best available scientific evidence and do not constitute inflexible treatment recommendations. Because of the changing body of evidence, this document is not intended to be a "standard of care."
BACKGROUND: Zygapophysial or facet joint pain in patients suffering with chronic spinal pain without disc herniation or radiculopathy may be diagnosed with certainty by the use of controlled diagnostic blocks. But, in patients suffering with either lumbar or cervical facet joint pain, even this diagnostic approach may be confounded by false-positives when using a single diagnostic block. It may also be confounded by the administration of anxiolytics and narcotics prior to, or during, the controlled diagnostic facet joint blocks. The effect of sedation on the validity and potential differential results in patients suffering with combined cervical and lumbar facet joint pain has not been evaluated. OBJECTIVE: To assess the effects of midazolam and fentanyl on the diagnostic validity of facet joint blocks in patients suffering with both cervical and lumbar facet joint pain. STUDY DESIGN: Randomized, double-blind, placebo-controlled study. METHODS: The design consisted of a placebo group receiving a sodium chloride solution and two experimental groups receiving either midazolam or fentanyl. Patients included in the study had been diagnosed with facet joint pain using controlled comparative local anesthetic blocks of the medial branches and L5 dorsal rami. They had been treated with lumbar and cervical facet joint nerve blocks and experienced good pain relief; and were presenting for repeat treatment after a period of symptom relief. The study was performed in an interventional pain management practice in the United States; a total of 60 patients participated with 20 patients randomly allocated into each group. Outcome measures included numeric pain scores, proportion of pain relief, and ability to perform prior painful movements. OUTCOME MEASURES: Outcomes were assessed at baseline and after the administration of 1 of the 3 solutions (Group I, sodium chloride solution; Group II, midazolam; or Group III, fentanyl). RESULTS: Overall, 50% of the patients were relaxed or sedated in the placebo group, while 100% of the patients in the midazolam and fentanyl groups were relaxed or sedated. As many as 10% of the patients reported significant relief (>= 80%) with the ability to perform prior painful movements. CONCLUSIONS: Perioperative administration of sodium chloride, midazolam, or fentanyl can confound results in the diagnosis of combined cervical and lumbar facet joint pain. False-positive results with placebo or sedation may be seen in a small proportion of patients.
BACKGROUND: Opioids are used extensively for chronic pain management in the United States. The frequency of opioid use prior to presenting to interventional pain management settings and in interventional pain management settings has been shown to be above 90%. Given that controlled substance abuse and illicit drug use are prevalent phenomena, adherence monitoring of patients that are prescribed opioids is becoming common. Adherence monitoring is carried out by an appropriate history, periodic evaluation of appropriate intake of drugs, random drug testing, and pill counts. Crucial to adherence monitoring is an initial controlled substance agreement and repeated review of the terms of this agreement with on-going education. However, the effect of adherence monitoring on drug abuse is unclear. OBJECTIVE: To identify controlled substance abuse through implementation of the terms of a controlled substance agreement, including periodic review and monitoring outside the organization. STUDY DESIGN: Prospective evaluation with historical controls. METHODS: Five hundred consecutive patients receiving prescription controlled substances were followed in a prospective manner. The evaluation consisted of a chart review to monitor controlled substance intake, with special attention to drugs obtained from outside the organization. Data collection for this purpose included information from records, pharmacies, referring physicians, and all the physicians involved in the treatment of the patient. RESULTS: Results from 500 consecutive patients were evaluated. Controlled substance abuse was seen in 9% of patients; overall, 5% of patients were obtaining controlled substances from other physicians, and 4% from illegal sources. CONCLUSION: Adherence monitoring, including controlled substance agreements and various periodic measures of compliance was associated with a 50% reduction in opioid abuse.
BACKGROUND: The prevalence of persistent upper back and mid back pain due to involvement of thoracic facet joints has been described in controlled studies as varying from 43% to 48% based on IASP criteria. Therapeutic intraventions utilized in managing chronic neck pain and low back pain of facet joint origin include intraarticular injections, medial branch nerve blocks, and neurolysis of medial branch nerves by means of radiofrequency. These interventions have not been evaluated in managing chronic thoracic pain of facet joint origin. OBJECTIVE: To determine the clinical effectiveness of therapeutic thoracic medial branch blocks in managing chronic upper back and mid back pain of facet joint origin. DESIGN: A prospective outcome study. SETTING: Interventional pain management setting in the United States. METHODS: Fifty-five consecutive patients meeting the diagnostic criteria of thoracic facet joint pain by means of comparative, controlled diagnostic blocks were included in this evaluation. All medial branch blocks were performed in a sterile operating room under fluoroscopic visualization with mild sedation with midazolam and/or fentanyl. Statistical methods incorporated intent-to-treat analysis. OUTCOME MEASURES: Numeric pain scores, significant pain relief > or = 50%), Oswestry Disability Index, work status and Pain Patient Profile (P-3). Significant pain relief was defined as an average 50% or greater reduction of numeric pain rating scores. RESULTS: The results showed significant differences in numeric pain scores and significant pain relief (50% or greater) in 71% of the patients at three months and six months, 76% at 12 months, 71% at 24 months, and 69% at 36 months, compared to baseline measurements. Functional improvement was demonstrated at one year, two years, and three years from baseline. There was significant improvement with increase in employment among the patients eligible for employment (employed and unemployed) from baseline to one year, two years, and three years (61% vs 96% to 100%) and improved psychological functioning. CONCLUSION: Therapeutic thoracic medial branch blocks were an effective modality of treatment in managing chronic thoracic pain secondary to facet joint involvement confirmed by controlled, comparative local anesthetic blocks.
BACKGROUND: Prescription drug abuse and illicit drug use are common in chronic pain patients. Adherence monitoring with screening tests, and urine drug testing, periodic monitoring with prescription monitoring programs, has become a common practice in recent years. Random drug testing for appropriate use of opioids and use of illicit drugs is often used in pain management practices. Thus, it is expected that random urine drug testing will deter use of illicit drugs, and also improve compliance. OBJECTIVES: To study the prevalence of illicit drug use in patients receiving opioids for chronic pain management and to compare the results of illicit drug use with the results from a previous study. DESIGN: A prospective, consecutive study. SETTING: Interventional pain management practice setting in the United States. METHODS: A total of 500 consecutive patients on opioids, considered to be receiving stable doses of opioids supplemental to their interventional techniques, were studied by random drug testing. Testing was performed by rapid drug screen. Results were considered positive if one or more of the monitored illicit drugs including cocaine, marijuana (THC), methamphetamine or amphetamines were present. RESULTS: Illicit drug use was evident in 80 patients, or 16%, with marijuana in 11%, cocaine in 5%, and methamphetamine and/or amphetamines in 2%. When compared with previous data, the overall illicit drug use was significantly less. Illicit drug use in elderly patients was absent. CONCLUSION: The prevalence of illicit drug abuse in patients with chronic pain receiving opioids continues to be a common occurence. This study showed significant reductions in overall illicit drug use with adherence monitoring combined with random urine drug testing.
Recent years have been quite eventful for interventional pain physicians with numerous changes in the Medicare payment system with a view for the future and what it holds for interventional pain management for 2006 and beyond. On February 8, 2006, President Bush signed the Deficit Reduction Act of 2005, which cuts the federal budget by 39 billion dollars and Medicare and Medicaid by almost 11 billion dollars over five years. The Act contains a number of important provisions that effect physicians in general and interventional pain physicians in particular. This Act provides one year, 0% conversion factor update in payments for physicians services in 2006. Medicare has four programs or parts, namely Medicare Parts A, B, C, and D, and two funds to pay providers for serving beneficiaries in each of these program. Part B helps pay for physician, outpatient hospital, home health, and other services for the aged and disabled who have voluntarily enrolled. Before 1922, the fees that Medicare paid for those services were largely based on physician's historical charges. Despite Congress's actions of freezing or limiting the fee increases, spending continued to rise because of increases in the volume and intensity of physician services. Medicare spending per beneficiary for physician services grew at an average annual rate of 11.6% from 1980 through 1991. Consequently Congress was forced to reform the way that Medicare sets physician fees, due to ineffectiveness of the fee controls and reductions. The sustained growth rate (SGR) system was established because of the concern that the fee schedule itself would not adequately constrain increases in spending for physicians' services. The law specifies a formula for calculating the SGR, based on changes in four factors: (1) estimated changes in fees; (2) estimated change in the average number of Part B enrollees (excluding Medicare Advantage beneficiaries); (3) estimated projected growth in real gross domestic product (GDP) growth per capita; and (4) estimated change in expenditures due to changes in law or regulation. Overall, the frequency of utilization of interventional procedures has increased substantially since 1998. In 2006 and beyond, interventionalists will face a number of evolving economic and policy-related issues, including reimbursement discrepancies, issues related to CPT coding, issues related to utilization, fraud, and abuse.
BACKGROUND: Opioids are used extensively for chronic pain management in the United States. The frequency of opioid use prior to presenting to interventional pain management settings and in interventional pain management settings has been shown to be above 90%. Opioid abuse has been demonstrated in 9% to 41% of patients receiving chronic pain management. Illicit drug use has been reported in 14% to 34% of patients in chronic pain management settings. OBJECTIVES: To evaluate and correlate multiple variables with opioid abuse and illicit drug use. DESIGN: A prospective, consecutive study. SETTING: Interventional pain management practice setting in the United States. METHODS: A total of 500 consecutive patients prescribed opioids, considered to be receiving stable doses of opioids supplemental to their interventional techniques were evaluated for opioid abuse and for illicit drug use. Abuse was defined as a patient receiving controlled substances from any source other than the prescribing physician at our center with the exception of controlled substances for acute injuries unrelated to the problem being treated, or for emergencies. Urine drug testing for illicit drugs was performed by urine rapid drug screen (Instant Technologies, iCup Norfolk, VA). Results were considered positive if one or more of the monitored illicit drugs including cocaine, marijuana (THC), phencycledane methamphetamine or amphetamines were detected. RESULTS: Opioid abuse was seen in 9% of patients, with illicit drug use in 16% of patients. Significant differences were noted in the prevalence of opioid abuse in patients who developed chronic pain following motor vehicle accident(s) and in patients presenting with pain in three regions of the body. Illicit drug use (marijuana) was more common in females. Illicit drug use was also more common in patients younger than 45, after motor vehicle injury, and in patients with involvement of three regions of the body. CONCLUSION: Opioid abuse and illicit drug use were common in chronic pain patients with a prevalence of 9% and 16%, respectively. Age, pain after motor vehicle accident, involvement of multiple regions and past history of illicit drug use were identified as risk factors.
This comprehensive health policy review of the prescription drug abuse epidemic is based on the written and oral testimony of witnesses at a July 26, 2006 Congressional Hearing, including that of Laxmaiah Manchikanti, MD, the chief executive officer of the American Society of Interventional Pain Physicians and additions from review of the literature. Honorable Mark E. Souder, chairman of the Subcommittee on Criminal Justice, Drug Policy, and Human Resources, introduced the issue as follows: "Prescription drug abuse today is second only to marijuana abuse. In the most recent household survey, initiates to drug abuse started with prescription drugs (especially pain medications) more often than with marijuana. The abuse of prescription drugs is facilitated by easy access (via physicians, the Internet, and the medicine cabinet) and a perception of safety (since the drugs are FDA approved). In addition to the personal toll of drug abuse using prescription drugs, indirect costs associated with prescription drug abuse and diversion include product theft, commission of other crimes to support addiction, law enforcement costs, and encouraging the practice of defensive medicine." The Administration witnesses, Bertha Madras, Nora D. Volkow, MD, Sandra Kweder, MD, and Joe Rannazzisi reviewed the problem of drug abuse and discussed what is being done at the present time as well as future strategies to combat drug abuse, including prescription drug monitoring programs, reducing malprescriptions, public education, eliminating Internet drug pharmacies, and the development of future drugs which are not only tamper-resistant but also non-addictive. The second panel, consisting of consumers and advocates, included Misty Fetco, Linda Surks, and Barbara van Rooyan, all of whom lost their children to drugs, presented their stories and strategies to prevent drug abuse, focusing on education at all levels, development of resistant drugs, and non-opioid treatment of chronic pain. Mathea Falco, JD, and Stephen E. Johnson presented issues related to drug abuse and measures to curb drug abuse by various means. Stephen J. Pasierb presented startling statistics on teen drug abuse and various educational programs to deter abuse. Laxmaiah Manchikanti, MD presented an overview of prescription drug abuse, strategies to prevent drug abuse, including immediate funding and rapid implementation of NASPER, education at all levels and improving relations with the DEA and the provider community.
BACKGROUND: Based on the criteria established by the International Association for the Study of Pain, the prevalence of persistent neck pain, secondary to involvement of cervical facet or zygapophysial joints has been described in controlled studies as varying from 54% to 67%. Intraarticular injections, medial branch nerve blocks and neurolysis of medial branch nerves have been described in managing chronic neck pain of facet joint origin. OBJECTIVES: To determine the clinical effectiveness of therapeutic cervical medial branch blocks in managing chronic neck pain of facet joint origin and to evaluate the effectiveness of the addition of Sarapin and steroids to local anesthetics. DESIGN: A double-blind, randomized, controlled trial. SETTING: An interventional pain management setting in the United States. METHODS: In this preliminary analysis, data from a total of 60 patients were included, with 15 patients in each of the 4 groups. Thirty patients were in a non-steroid group (combined Group I and II); and 30 patients were in a steroid group (combined Group III and IV). All of the patients met the diagnostic criteria of cervical facet joint pain by means of comparative, controlled diagnostic blocks. Four types of interventions were included. Group I served as control, receiving medial branch blocks using bupivacaine. Group II consisted of cervical medial branch blocks with bupivacaine and Sarapin. Group III consisted of cervical medial branch blocks with bupivacaine and betamethasone. Group IV consisted of cervical medial branch blocks with bupivacaine, Sarapin and betamethasone. OUTCOME MEASURES: Numeric pain scores, Neck Pain Disability Index, opioid intake, and work status were evaluated at baseline, 3 months, 6 months and 12 months. RESULTS: Significant pain relief (> or =50%), and functional status improvement was observed at 3 months, 6 months and 12 months. The average number of treatments for 1 year was 3.8 +/- 0.7 in the non-steroid group and 3.4 +/- 1.0 in the steroid group with no significant difference among the groups. Duration of average pain relief with each procedure was 13.4 +/- 3.5 weeks in the nonsteroid group, and it was 15.9 +/- 8.0 weeks in the steroid group with no significant difference among the groups. CONCLUSION: Therapeutic cervical medial branch nerve blocks, with or without Sarapin or steroids, may provide effective management for chronic neck pain of facet joint origin.
BACKGROUND: Postoperative epidural fibrosis may contribute to between 5% to 60% of the poor surgical outcomes following decompressive surgery. Correlations have been reported between epidural scarring and radicular pain, poor surgical outcomes, and a lack of any form of surgical treatment. The use of spinal endoscopic adhesiolysis in recent years in the management of chronic refractory low back and lower extremity pain has been described. METHODS: A prospective, randomized, double-blind trial was conducted to determine the outcome of spinal endoscopic adhesiolysis to reduce pain and improve function and psychological status in patients with chronic refractory low back and lower extremity pain. A total of 83 patients were evaluated, with 33 patients in Group I and 50 patients in Group II. Group I served as the control, with endoscopy into the sacral level without adhesiolysis, followed by injection of local anesthetic and steroid. Group II received spinal endoscopic adhesiolysis, followed by injection of local anesthetic and steroid. RESULTS: Among the 50 patients in the treatment group receiving spinal endoscopic adhesiolysis, significant improvement without adverse effects was shown in 80% at 3 months, 56% at 6 months, and 48% at 12 months. The control group showed improvement in 33% of the patients at one month and none thereafter. Based on the definition that less than 6 months of relief is considered short-term and longer than 6 months of relief is considered long-term, a significant number of patients obtained long-term relief with improvement in pain, functional status, and psychological status. CONCLUSION: Spinal endoscopic adhesiolysis with targeted delivery of local anesthetic and steroid is an effective treatment in a significant number of patients with chronic low back and lower extremity pain without major adverse effects.
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The abuse of prescription-controlled substances is a common phenomenon, associated with illicit drug use, in patients suffering with chronic pain and receiving controlled substances for the management of pain. Prescription drug abuse in Kentucky has led to an increase in Medicare and Medicaid fraud, as well as physician indictments for unscrupulous practices and increased vigilance and prosecution by the authorities. This study was undertaken to evaluate 400 consecutive patients receiving controlled substances in an interventional pain management practice in Western Kentucky to evaluate the prevalence of illicit drug use and opioid abuse and noncompliance with opioid therapy. Results indicated that patients covered by third-party insurance showed 17% (95% CI, 10%-24%) prevalence of illicit drug use, with patients on Medicare, with or without third-party insurance, showing 10% (95% CI, 4%-6%) prevalence, compared to patients on Medicare and Medicaid with 24% (95% CI, 16%-32%) prevalence, and patients with only Medicaid with 39% (95% CI, 29%-49%) prevalence of illicit drug use. In addition, combined use of illicit drugs and misuse of prescription drugs was also seen in a substantially greater proportion of patients in Groups III and IV, with the highest (60%) in Group IV with Medicaid only, followed by Group III with Medicaid supplementation of Medicare insurance in 40% of the patients. Overall illicit drug use, opioid abuse, and noncompliance of opioids is significant in patients in Western Kentucky receiving Medicaid as a primary insurance or as a supplemental insurance to Medicare, despite extensive monitoring, written agreement, and education.
BACKGROUND: The lifetime prevalence of spinal pain has been reported as 54% to 80%, with as many as 60% of patients continuing to have chronic pain five years or longer after the initial episode. Spinal pain is associated with significant economic, societal, and health impact. Available evidence documents a wide degree of variance in the definition and the practice of interventional pain management. OBJECTIVE: To develop evidence-based clinical practice guidelines for interventional techniques in the management of chronic spinal pain, with utilization of all types of evidence, applying an evidence-based approach, with broad representation of specialists from academic and clinical practices. DESIGN: A systematic review of diagnostic and therapeutic interventions applied in managing chronic spinal pain by a policy committee. Design consisted of formulation of essentials of guidelines and a series of potential evidence linkages representing conclusions, and statements about relationships between clinical interventions and outcomes. METHODS: The elements of the guideline preparation process included literature searches, literature synthesis, systematic review, consensus evaluation, open forum presentation, formal endorsement by the Board of Directors of the American Society of Interventional Pain Physicians (ASIPP), and blinded peer review. Methodologic quality evaluation criteria utilized included AHRQ criteria, QUADAS criteria, and Cochrane review criteria. The designation of levels of evidence was from Level I (conclusive), Level II (strong), Level III (moderate), Level IV (limited), to Level V (indeterminate). RESULTS: The accuracy of facet joint nerve blocks was strong in the diagnosis of lumbar and cervical facet joint pain, whereas, it was moderate in the diagnosis of thoracic facet joint pain. The evidence was strong for lumbar discography, whereas, the evidence was limited for cervical and thoracic discography. The evidence was moderate for transforaminal epidural injections or selective nerve root blocks in the preoperative evaluation of patients with negative or inconclusive imaging studies. The evidence was moderate for sacroiliac joint injections in the diagnosis of sacroiliac joint pain. The evidence for therapeutic lumbar intraarticular facet injections of local anesthetics and steroids was moderate for short-term improvement and limited for long-term improvement, whereas, it was negative for cervical facet joint injections. The evidence for lumbar and cervical medial branch blocks was moderate. The evidence for medial branch neurotomy was moderate to strong for relief of chronic low back and neck pain. The evidence for caudal epidural steroid injections was strong for short-term relief and moderate for long-term relief in managing chronic low back and radicular pain, and limited in managing pain of postlumbar laminectomy syndrome. The evidence for interlaminar epidural steroid injections was strong for short-term relief and limited for long-term relief in managing lumbar radiculopathy, whereas, for cervical radiculopathy the evidence was moderate. The evidence for transforaminal epidural steroid injections was strong for short-term and moderate for long-term improvement in managing lumbar nerve root pain, whereas, it was moderate for cervical nerve root pain and limited for lumbar post laminectomy syndrome and spinal stenosis. The evidence for percutaneous epidural adhesiolysis was strong. For spinal endoscopic adhesiolysis, the evidence was strong for short-term relief and moderate for long-term relief. For sacroiliac intraarticular injections, the evidence was moderate for short-term relief and limited for long-term relief. The evidence for radiofrequency neurotomy for sacroiliac joint pain was indeterminate. The evidence for intradiscal electrothermal therapy was strong for short-term relief and moderate for long-term relief in managing chronic discogenic low back pain, whereas, for nucleoplasty, the evidence was limited. The evidence for spinal cord stimulation in failed back surgery syndrome and complex regional pain syndrome was strong for short-term relief and moderate for long-term relief. The evidence for implantable intrathecal infusion systems was moderate to strong. CONCLUSION: These guidelines included the evaluation of evidence for diagnostic and therapeutic procedures in managing chronic spinal pain and recommendations for managing spinal pain. However, these guidelines do not constitute inflexible treatment recommendations. These guidelines do not represent "a standard of care".
BACKGROUND: The past decade has been marked by unprecedented interest in evidence-based medicine and various types of avenues that can provide valid and reliable information about healthcare, including clinical practice guidelines. Thus, healthcare decisions are purportedly and increasingly being made on research-based evidence rather than on expert opinion or clinical experience alone. The methods describing evidence synthesis or development of guidelines in interventional pain management are scarce. OBJECTIVE: To describe the methods of evidence synthesis and development of guidelines in interventional pain management in practical terms. DESCRIPTION: This review sought to provide an understanding of evidence-based medicine, the importance and synthesis of clinical practice guidelines, and the variety of issues related to rating the quality of individual articles, understanding narrative and systematic reviews, grading the strength of the body of evidence, searching for evidence, and finally, the analytical preparation of guidelines, with a focus on interventional pain management. CONCLUSION: Evidence synthesis and development of guidelines in interventional pain management is a complex and difficult task. It is emphasized that practice guidelines are not intended as standards or absolute requirements. Consequently, practice guidelines may be adapted, modified, or rejected, according to the clinical needs and constraints of each practitioner and patient.
In the United States, physicians are faced with two opposing dilemmas in the treatment of pain - the potential for drug abuse and diversion, and the possible undertreatment of pain. While controlled prescription drugs such as narcotic analgesics, anxiolytics, antidepressants, stimulants, and sedative-hypnotics, play a legitimate role in managing chronic pain and other conditions, the illicit use of prescribed medicines is increasing at epidemic proportions. Diversion and abuse of prescription drugs is costly in terms of addiction, overdose, death, and related criminal activities, but chronic pain carries significant economic, social, and health impact as well. The American Society of Interventional Pain Physicians (ASIPP), as the introducing organization, was joined by several physician and nurse practitioner organizations in support of the National All Schedules Prescription Electronic Reporting (NASPER) Act of 2005, legislation that not only will give physicians an information tool to aid in prescribing controlled substances but also will help identify illicit use and abuse. NASPER is the law that provides for the establishment of a controlled substances monitoring program in each state. The concept for NASPER originated with ASIPP and was modeled after the highly successful Kentucky All Schedules Prescription Electronic Reporting Program (KASPER). Legislation was introduced in the United States House of Representatives during three different Congresses, the 107th, 108th, and 109th, by Reps. Edward Whitfield (R-KY) and Frank Pallone (D-NJ). It was first introduced in the United States Senate in the 107th Congress by Sen. Tim Hutchinson (R-AK), and in the 108th and 109th by Sens. Jeff Sessions (R-AL) and Dick Durbin (D-IL), with multiple cosponsors in both chambers. NASPER passed the House on July 27, 2005, by voice vote and passed the Senate by unanimous consent on July 29, 2005. President George W. Bush signed NASPER on August 11, 2005, and it became Public Law 109-60. Implementation of NASPER will improve patient care and reduce abuse and diversion of prescription controlled substances.
BACKGROUND: The role of nonspecific treatment effects in the outcomes of patients receiving interventions for pain has been the subject of controversy and interest. While the administration of placebo and its effects have been widely studied, the role of placebo and nocebo effects of active agents administered prior to or during interventional techniques has not been explored. OBJECTIVES: The evaluation of placebo and nocebo effects of sodium chloride solution and active agents (midazolam and fentanyl) administered during interventional techniques. STUDY DESIGN: Randomized, placebo-controlled, evaluation. METHODS: A total of 360 patients were divided into three groups, with Group I receiving placebo, Group II receiving midazolam, and Group III receiving fentanyl. At 3 months, information was obtained with regards to their impressions or the experience of the study, compared to their previous experiences with the treatment and sedation. They were asked to rate their experience as better, worse, or no change compared to their previous experience. RESULTS: Between 13% to 30% of patients across all three groups of the study, rated their pain relief following injection as better than their previous experience. A smaller proportion, 3% to 8%, of patients in all three groups rated their experience following injection as worse than their previous experience. The majority of patients, 67% to 79%, regardless of group, described no significant differences as compared to their previous experiences with sedation and treatment for cervical or lumbar facet joint pain. CONCLUSION: In patients undergoing interventional procedures, sodium chloride solution, midazolam, and fentanyl produced placebo effects in 13% to 15%, 15% to 20%, and 18% to 30% of the patients respectively. Similarly, a nocebo effect was seen in 5% to 8% of the patients in the sodium chloride group, 8% of the patients in the midazolam group, and 3% to 8% of the patients in the fentanyl group. It is concluded that positive and negative effects may be seen either with placebo or active agents in 13% to 30% of the patients.
BACKGROUND: Multiple studies have documented the incidence of illicit drug use and abuse of opioids. Over the years, several hypotheses have been proposed. Short-acting opioids such as hydrocodone are generally considered to predispose patients to poor pain management, dependency, misuse, or abuse; whereas long-acting opioids such as methadone are thought to provide sustained pain management without dependency or abuse. OBJECTIVES: To evaluate and identify the prevalence of illicit drug use and prescription drug abuse or misuse in patients receiving hydrocodone or methadone. STUDY DESIGN: A prospective, comparative evaluation. METHODS: A total of 200 patients from an interventional pain management setting, divided into two groups of 100 consecutive patients receiving either hydrocodone (Group I) or methadone (Group II) were evaluated with urine testing for illicit drug use, and/or misuse or abuse of opioids. Drug testing was carried out by Rapid Drug Screen(R). RESULTS: Results of this study showed that 22% (95% CI, 13% - 30%) of Group I patients receiving hydrocodone used illicit drugs as compared with 24% (95% CI, 15% - 32%) of those in Group II who were receiving methadone. The misuse or abuse of a prescription opioid was seen in 3% (95% CI, 0% - 6%) of the patients in Group I and 12% (95% CI, 5% - 18%) in Group II. In a significant proportion of patients in both groups, the drug prescribed for them was not detected on testing. The combined use of illicit drugs and misuse of prescription drugs was noted in 24% (95% CI, 15% - 32%) in Group I and 33% (95% CI, 23% - 42%) in Group II. CONCLUSIONS: There were no significant differences as to illicit drug use and/or misuse of opioids in patients treated with hydrocodone or methadone. These findings suggest that the use of a long acting opioid formulation by patients with chronic pain does not reduce the risk of drug abuse or improve compliance with medical therapy.