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Opioid Risk Management
Besides the potential for opioid analgesia adverse effects, which often can be controlled by safe prescribing practices, the risks of greatest concern have been opioid diversion, misuse, abuse, and addiction. Documents in this section offer guidance for better opioid risk management, including: patient risk assessment, risk minimization, and compliance monitoring.
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Monitoring Opioid Adherence in Chronic Pain Patients: Tools, Techniques, and Utility
By: Laxmaiah Manchikanti, MD, et al. Pain Physician. 2008(March);11:S155-S180 (26pp).
PDF available at: http://www.painphysicianjournal.com/2008/april/2008;11;S155-S180.pdf
The prevalence of opioid misuse, abuse, and addiction has fostered considerable concern among physicians, who may subsequently hesitate to prescribe these medications. This paper provides a comprehensive overview of the numerous monitoring approaches that have been described in the literature – including screening instruments and urine drug testing – and it addresses the benefits and limitations of these techniques and tools.
The complex nature of drug misuse and abuse problems are discussed and, while no single monitoring technique can fully address these difficult issues, the authors describe how multiple approaches to adherence monitoring may be employed to sustain the prudent use of opioids for the treatment of chronic pain. Numerous charts and tables provide helpful summary information.
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Urine Drug Screening: Practical Guide for Clinicians
By: Karen E. Moeller, PharmD, BCPP, et al. Mayo Clinic Proceedings. 2008;83(1):66-76.
PDF available at: http://www.mayoclinicproceedings.com/pdf%2F8301%2F8301r1.pdf
Drug testing, commonly used in health care, workplace, and criminal settings, has become widespread during the past decade. Urine drug screens have been the most common method for analysis because of ease of sampling. The simplicity of use and access to rapid results have increased demand for and use of immunoassays; however, these assays are not perfect. False-positive results of immunoassays can lead to serious medical or social consequences if results are not confirmed by secondary analysis, such as gas chromatography–mass spectrometry (GCMS). The Department of Health and Human Services’ guidelines for the workplace require testing for the following 5 substances: amphetamines, cannabinoids, cocaine, opiates, and phencyclidine. This article discusses potential false-positive results and false-negative results that occur with immunoassays of these substances and with alcohol, benzodiazepines, and tricyclic antidepressants. Other pitfalls, such as adulteration, substitution, and dilution of urine samples, are discussed. The practical concepts summarized in this article should minimize the potential risks of misinterpreting urine drug screens. Access checked 2/9/08.
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Commonsense Opioid-Risk Management in Chronic Noncancer Pain: A Clinician’s Perspective
By: James D. Toombs, MD; from Pain Treatment Topics, August 2007.
PDF available here for download: http://www.pain-topics.org/pdf/OpioidRiskMgmt.pdf (145 KB, 13 pages)
Opioids have a legitimate and important role in treating chronic noncancer pain (CNP). Although there are risks, these medications should be available to patients who gain benefit from them and can use them safely. In this guidance paper, James Toombs, MD, applies the Model Policy for the Use of Controlled Substances for the Treatment of Pain from the Federation of State Medical Boards to provide a practical clinical framework helping to minimize risks when prescribing opioids. This allows standardizing the process of opioid management but does not dictate or constrain individualized approaches to therapy.
Recognizing potential risks of opioids, treatment decisions regarding their use should be made only after a comprehensive evaluation of patients. Due consideration should be given to the complete medical history, including past or potential substance misuse. Taking all factors into account, opioid selection, doses, and treatment monitoring can be effectively tailored for patient needs and prudent clinical practice. Access checked 2/9/08.
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Avoiding Opioid Abuse While Managing Pain: A Guide for Practitioners (Book)
By: Lynn R. Webster, MD, FACPM, FASAM, and Beth Dove; June 2007.
See review and ordering information at:
http://pain-topics.org/education_CME_locator/indexbkrv.php#Webster
This book presents a balanced perspective in advocating effective pain control via opioid analgesics, when appropriate, yet cautioning the reader about the many associated risks and pitfalls. The authors point out that primary care physicians, nurse practitioners, and other first-contact clinicians are uniquely positioned to make a difference at the beginning of medical treatment. Patients with chronic pain or a substance-use disorder are more likely to seek treatment from a general practitioner than from a specialist. So front-line healthcare providers can maximize the chances for success when patients begin opioid therapy. The authors include step-by-step protocols for assessing patients’ risks of opioid abuse as well as for legally protecting the opioid prescriber. An emphasis is on acknowledging and addressing drug-related behaviors that sometimes compromise effective pain treatment with opioids. Access checked 2/9/08.
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Patient Level Opioid Risk Management
By: Nathaniel P. Katz, MD, MS; from PainEDU.org, Inflexxion, Inc., 2007.
PDF available for download at: http://www.painedu.com/manual.asp (1 MB, 39 pp; free registration required)
Opioids, like all medications, are associated with risks, and the prevalence of negative consequences of opioid use has risen concomitantly with their increased use. Risks include: abuse and addiction, overdose, side effects [eg, nausea, vomiting, itching, dizziness, sedation, cognitive dysfunction, mood disturbance, sweating, constipation], and endocrine disturbance. The risks of greatest concern have been abuse and addiction. While some clinicians have been comforted by a mythology that addiction does not occur in “legitimate” pain patients, the reality is that there is significant overlap between patients with pain and those with addictive disorders. In this document, the author discusses various myths and realities of long-term opioid therapy and offers guidance for risk minimization. Topics include patient risk assessment, management, and monitoring. Access checked 8/14/08.
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Assessing Obstructive Sleep Apnea Potential, Which May Affect Opioid Risk (Snore Score)
From: American Sleep Apnea Association. 2007.
HTML available at: http://www.sleepapnea.org/resources/pubs/snorescore.html
Patients with untreated obstructive sleep apnea (OSA) stop breathing repeatedly during sleep, sometimes hundreds of times during the night and often for a minute or longer. Besides other concerns with this disorder, persons with OSA who are prescribed opioid analgesics may be at particular risk of respiratory depression and fatal asphyxia. This quick, 6-item questionnaire – the Snore Score -- can help detect patients who have or are at risk for OSA, and thereby help guide better informed opioid-prescribing decisions. Accessed 2/9/08.
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Opioids for Pain: Risk Management (Module 6)
By: Steven Richeimer, MD; from California Society of Anesthesiologists; 2006.
HTML article at: http://www.csahq.org/cme2/course.module.php?course=3&module=12&terms=show
Pain management has become a medical-legal minefield. This brief CME program presents 8 preventative measures that can help reduce healthcare providers' risks of incurring a medical-legal action while providing effective pain relief for patients in need: 1) prescribe only to your patients; 2) assess pain thoroughly; 3) educate and provide informed consent; 4) document; 5) don’t hesitate to get help; 6) know how to manage addiction risk in patients with pain; 7) have a reliable emergency call system; and 8) don’t fail to treat pain. Access checked 2/9/08.
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Rapid-Onset Opioids: Recognizing and Preventing Abuse, Addiction, and Diversion
By: Lara K. Dhingra, PhD, and Steven D. Passik, PhD; from Medscape; 2006.
HTML article available online at: http://www.medscape.com/viewprogram/5471
Pain management requires a multidimensional approach to ensure safety as well as efficacy. Considering the potential growth of rapid-onset opioids in pain management, this brief CME course offers techniques for the recognition of addiction as well as aberrant drug-taking behavior. Various strategies and guidance are presented regarding therapeutic dosing and the use of rapid-onset opioids for breakthrough pain. Two important practices are discussed: 1) thorough prescreening of patients, and 2) the clinician’s responsibility to monitor treatment compliance. Access checked 2/9/08.
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Urine Drug Testing in Clinical Practice: Dispelling the Myths & Designing Strategies
By: Douglas L. Gourlay, MD, FRCPC, FASAM; Howard A. Heit, MD, FACP, FASAM; Yale H. Caplan, PhD, D-ABFT; from California Academy of Family Physicians. 2006 (Edition 3).
PDF available for download at: http://www.familydocs.org/assets/171_UDT 2006.pdf (28 pp)
Urine drug testing (UDT) in clinical practice should be a consensual diagnostic test, which is done for the benefit of the patient with pain. This CME course helps healthcare providers (1) understand the purpose of UDT and identify a clear testing strategy, (2) distinguish between UDT for detection of illicit drug use and for monitoring adherence to an analgesic treatment regimen, (3) appreciate drug-testing methodology, instrumentation, and sensitivity/specificity of results, (4) identify strategies to improve analysis and interpretation of results, and (5) understand the limitations of UDT. Access checked 2/9/08.
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Universal Precautions in Pain Medicine:
The Treatment of Chronic Pain With or Without the Disease of Addiction
By: Douglas L. Gourlay, MD and Howard A. Heit, MD, in Medscape Neurology & Neurosurgery, 7(1), 2005.
Similarly published in Pain Medicine, 6(2), 2005.
HTML article available online at: http://www.medscape.com/viewarticle/503596
It is impossible to determine before hand, with any certainty, who will become problematic users of prescription opioid medications. With this in mind, the authors stress the need to carefully assess all patients regarding past and present aberrant behaviors when they exist, and to apply reasonably set limits in the clinician-patient relationship. Along with this, it is possible to triage chronic pain patients into one of three categories according to risk.
By adopting a "universal precautions approach" to the management of all chronic pain patients, regardless of pharmacologic status, stigma is reduced, patient care is improved, and overall risk is contained. Careful application of this approach will greatly assist in the identification and interpretation of aberrant behaviors and, where they exist, the diagnosis of underlying addictive disorders. Treatment plans can then be adjusted on an individual basis, as described in this article. Access checked 2/9/08.
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Treating Pain and Preventing Abuse and Diversion
By: Brian Goldman, MD, MCFP, FACEP, from LearnSomething.com, 2005.
Go to online course...> (Click on "Click here to begin registration"; free registration is required.)
Both the under-treatment of pain and opioid drug abuse are serious problems in our society. The Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) have recommended that the makers of scheduled opioid analgesics develop Risk Management Programs (RMPs) that address abuse and diversion. One of the key parts of the RMP is an educational program "assuring the safe prescribing of the product by physicians."
The aim of this continuing medical educational (CME) course is to minimize and prevent prescription drug diversion by helping physicians recognize the principles of good pain management and, at the same time, to recognize patients at risk of abuse, addiction, and diversion of opioid analgesics. Included discussions will help readers identify the “street” market for opioid analgesics, understand methods used by criminal drug diverters, and design strategies to minimize drug diversion without harming legitimate patients. Access checked 2/9/08.
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Opioid Risk Management - THCI Conference Presentations
From: Tufts Health Care Institute, 2005.
Go to website at: http://www.thci.org/opioid/
In March 2005, leading experts from industry, academia, and regulatory agencies gathered in Boston to discuss current thinking and future directions in opioid risk management. The conference, chaired by Nathaniel Katz, MD, MS, of Tufts University School of Medicine, addressed issues surrounding the abuse of prescription opioid analgesics.
It was recognized that abuse of Rx opioids has become a major problem in the U.S.-- ahead of cocaine, heroin, and stimulants -- and the pharmaceutical industry is subject to increasing pressures by the FDA, DEA, Congress, and the general public to minimize the risks associated with their opioid products. The one-day, invitation-only Opioid Risk Management conference featured 15 presentations of the latest information on these challenging issues, which are available for download and viewing at the Tufts Health Care Institute website. Access checked 2/9/08.
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Rights and Responsibilities of Healthcare Professionals in the Use of Opioids for the Treatment of Pain
Consensus from: the American Academy of Pain Medicine, the American Pain Society, and the American Society of Addiction Medicine; 2004.
HTML article available online at: http://www.ampainsoc.org/advocacy/rights.htm
Healthcare professional concerns regarding the potential for harm to patients -- as well as possible legal, regulatory, licensing, or other third party sanctions related to the prescription of opioids -- contribute significantly to the mistreatment of pain. Though many types of pain are best addressed by non-opioid interventions, opioids are often indicated as a component of effective pain treatment.
Addiction to opioids may occur despite appropriate opioid therapy for pain. Persistent failure to recognize and provide appropriate medical treatment for the disease of addiction is poor medical practice and may become grounds for practice concern. Similarly, persistent failure to use opioids effectively when they are indicated as part of the treatment of pain, including in persons with active or recovering addiction, is poor medical practice and also may be a concern. This consensus document provides 8 recommendations for dealing with these and other vital issues. Access checked 2/9/08.
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Definitions Related to the Use of Opioids for the Treatment of Pain (Clarifications of "Addiction")
Consensus from: The American Academy of Pain Medicine, the American Pain Society, and the American Society of Addiction Medicine. 2001.
PDF available for download at: http://www.painmed.org/pdf/definition.pdf (568 KB; 4 pp)
Scientists, clinicians, regulators, and the lay public use disparate definitions of terms related to pain and addiction. These disparities contribute to a misunderstanding of the nature of addiction and the risk of addiction, especially in situations in which opioids are used, or are being considered for use, to manage pain. Confusion regarding the treatment of pain results in unnecessary suffering, economic burdens to society, and inappropriate adverse actions against patients and professionals.
The definitions offered in this brief document do not constitute formal diagnostic criteria, but it is hoped that they may serve as a basis for the future development of more specific, universally accepted diagnostic guidelines. The definitions and concepts presented were developed through a consensus process of the American Academy of Pain Medicine, the American Pain Society, and the American Society of Addiction Medicine. Access checked 2/9/08.
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Also See: Pain-Topics.org "Addiction & Pain Treatment" Section
This special section focuses on the clarification, identification, prevention, and treatment of addictive disorders within the context of pain and, conversely, on pain management in persons with a history of addiction. Patients in pain may misuse a variety of substances to palliate their conditions, including prescribed and illicit opioids. Continued misuse can become harmful abuse, which may lead to physiological and psychological dependence (addiction). The interface of pain and addiction is a common and vexing problem in clinical practice.
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Pain Treatment Topics and its associates do not endorse any medications, products, services, or treatments described, mentioned, or discussed in any of the resources in this section. Nor are any representations made concerning efficacy, appropriateness, or suitability of any such medications, products, services, or treatments for particular patients.
In view of the possibility of human error or advances in medical knowledge, Pain Treatment Topics and its associates do not warrant the information contained in the above contents is in every respect accurate or complete, and they are not responsible nor liable for any errors or omissions made by the original sources or for results obtained from the use of this information. |
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