Drug and Alcohol Dependence 173 (2017) S1–S3
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Editorial
Prescription opioids: New perspectives and research on their role in chronic pain management and addiction夽
The papers in this supplement issue were inspired by a conference held in Baltimore, Maryland in March of 2016. The day-long conference, sponsored by the Mid Atlantic Node of the National Institute on Drug Abuse’s (NIDA’s) National Drug Abuse Treatment Clinical Trials Network and the Central East Addiction Technology Transfer Center, was titled “Providing answers: Treatment and prevention in the opioid prescription epidemic”. Following opening remarks by Geetha Subramaniam, MD, from the NIDA Center for the Clinical Trials Network, thirteen speakers made presentations on topics that provided a comprehensive overview of the origins of the prescription opioid epidemic as well as its unforeseen and unwanted consequences that have included a dramatic rise in overdose deaths and a growing rate of opioid dependence. Current public health approaches to overdose reduction were discussed, and the treatment of prescription opioid use disorders within new models of integrated medical care was highlighted. The present supplement to Drug and Alcohol Dependence similarly tells a story of the prescription opioid epidemic: the role of opioids in pain management, the advent of adverse consequences as opioid prescribing increased and the initiatives that are being implemented to staunch the flow of prescription opioids and address public health consequences. First authors of the supplement papers include both contributors who participated in the original conference (Cicero, Dunn, Knudsen, Tompkins, Weiss) and new contributors invited because of their expertise in important related topic areas including prescription drug monitoring programs (Kreiner), physician guidelines and training (Barth) and behavioral interventions for chronic pain treatment (Garland). The reader is referred to excellent recently published review papers for an overview of the topics surrounding the prescription opioid epidemic (Brady et al., 2016; Volkow and McLellan, 2016). This journal supplement adds to the growing literature on these inter-related topics and expands on some key areas with papers that provide insights and new data. It is notable that the NIDA National Drug Abuse Treatment Clinical Trials Network (CTN) plays a strong role in this endeavor. The guest editors are all faculty in the Mid Atlantic Node of the CTN. Several of the first authors, including Barth, Dunn, Ling, Tompkins and Weiss, are currently or previously affiliated with various nodes of
夽 This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
the CTN. The CTN is gratefully acknowledged for providing funding for the special issue via the Mid Atlantic Node. The story of the prescription opioid epidemic begins with an understanding of who is using these medications and why use has escalated nationwide. The paper by Cicero et al. compares the onset and progression of opioid use disorder in individuals who began their use via licit prescription with the intent of pain control versus illicitly with the intent of experimentation and pleasure-seeking. The trajectories of these two groups were remarkably similar, with self-medication for psychiatric symptoms and stress frequently cited as the original reason for use, and escape from withdrawal symptoms coming to dominate as use continued and dependence developed. The observation that the initial source of drugs is largely irrelevant to progression of an opioid use disorder (OUD) is one of many important findings from study of the prescription opioid epidemic. The paper by Tompkins et al. addresses another critical dimension of the epidemic, which is the escalation of opioid prescribing among physicians for the treatment of pain. The paper sets the stage by providing an overview of the psychophysiology of pain and the history of chronic pain management in this country. Reasons are explored for the rise of opioid-focused pain clinics that replaced earlier multi-disciplinary clinics. The advent of a campaign for pain as the “fifth vital sign” is thought to underpin the dramatic rise in use of opioids for pain management and the unintended consequences that have followed. The paper also begins a discussion of alternative approaches to pain management including non-opioid medications, physical procedures and psychotherapy approaches, a theme that is taken up again in a later paper (see Garland et al. in this issue). The Tompkins paper acknowledges that there are “no easy answers” to the physicians’ dilemma, but outlines some critical areas where more research is needed. As health care providers constitute the main source of prescription opioids, the paper by Barth et al. describes initiatives aimed at enhancing guidelines and provider trainings on safe and effective prescribing practices. The paper focuses on evaluation of clinical guidelines and trainings for practitioners and touches as well on initiatives aimed at improved prescribing safety such as the FDAinitiated Risk Evaluation and Mitigation Strategies (REMS), and state level Prescription Drug Monitoring Programs (PDMPs). The paper highlights the need for continued and enhanced training of clinicians in both acute post-operative and chronic pain management and in recognition and treatment of opioid use disorder in
http://dx.doi.org/10.1016/j.drugalcdep.2016.11.018 0376-8716/© 2017 Published by Elsevier Ireland Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
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Editorial / Drug and Alcohol Dependence 173 (2017) S1–S3
their patients. The authors point to the current paucity of good data and outline research needs on conditions under which providers adopt guideline recommendations and/or utilize prescribing safety systems such as PDMPs and the impact this has on treatment access and patient outcomes. Finally, they point to an urgent need for access to effective non-opioid pain management alternatives if guidelines are to have an impact in reducing rates of opioid prescribing. Picking up on one of the topics discussed by Barth et al., the paper by Kreiner et al. focuses in on the Prescription Drug Monitoring Programs that have been developed in nearly every state to capture and track prescribing behavior of individual health care providers. The paper describes a set of prescriber risk indicators that have been developed from the rich database available through the Prescription Behavior Surveillance System (PBSS), a longitudinal, multi-state database of de-identified PDMP data, developed to serve as both a public health surveillance and a policy evaluation tool. The paper then describes a study that uses data from the state of Maine to validate these risk indicators by examining their association with independent licensing board actions. The paper provides insights into the types of behaviors that comprise risk indicators along with evidence that the risk indicators are valid. These indicators should be useful for broader application to understand characteristics of clinicians with high rates of opioid prescribing and to examine changes in risky prescribing behaviors as a function of other system level initiatives that may be undertaken in the future. The sharp rise in opioid overdose deaths associated with the prescription opioid epidemic has captured national attention and been the driving force for vigorous public health initiatives in education and prevention. The paper by Dunn et al. provides empirical data from the study of a computerized education intervention designed to impart knowledge of potentially life-saving steps that can be taken in response to an opioid overdose incident. These are simple but effective intervention steps that can be implemented by anyone anytime in the absence of the specific naloxone antidote for overdose reversal. Thus, the education program both complements and supplements naloxone distribution programs and has the potential for wide-spread public health benefits. Parallel with the rise in overdose deaths is a growing cohort of prescription opioid users who have become dependent on their medications and begun to exhibit the behaviors associated with addiction, including escalation of drug-seeking and substitution or switching to less costly but more risky alternatives, primarily heroin. Effective treatments for opioid dependence including methadone, buprenorphine and naltrexone have long been available. However, information is needed on the best treatment approaches for the new cohort of prescription opioid users. The paper by Weiss et al. describes results of the first large-scale study of buprenorphine as a treatment for individuals with prescription opioid user disorder. Conducted under auspices of the National Drug Abuse Treatment Clinical Trials Network and using an adaptive design, the study first evaluated a brief buprenorphine taper followed by a longer maintenance treatment episode implemented in volunteers from the large proportion of participants (94%) who failed the brief taper by continuing or returning to drug use. The paper highlights the importance of longer rather than short-term interventions, provides insights into the role of adjunctive counseling as part of medical management by physicians and examines post-treatment outcomes at 3.5 years after treatment ended. Overall, the paper provides supportive evidence for the effectiveness of buprenorphine treatment in prescription OUD and encouraging data on continued improvement in outcomes over a long-term follow-up. Access to effective treatments is a critical issue for substance use disorders, including prescription opioid use disorders. Buprenor-
phine has been identified as an effective treatment (see Weiss paper above) and is unique in that the treatment can be delivered by physicians in office- or clinic-based practice. The paper by Knudsen et al. takes up the question of provider availability for delivering this effective treatment. Specifically, it examines national data sets to ask whether the rate of growth in number of buprenorphine prescribers has been related to rates of opioid overdose deaths in nearby locales. The study documents overall growth in the number of physician buprenorphine prescribers with higher growth rates in areas where overdose has been a greater problem. Although more research is needed on the factors that prompt physicians and other health care providers to engage in the treatment of substance users, the study suggests that at least some physicians may be appropriately responding to local opioid-related mortality conditions and modifying their clinical practice behavior accordingly to support improved treatment access. Several papers allude to the important role that non-opioid therapies may play in treatment of chronic pain. There are many options available (see Tompkins et al., this issue), with cognitivebehavioral therapies having received the most substantial support to date for efficacy. The paper by Garland et al. introduces the reader to previous evaluation research on non-opioid treatments and then describes a novel behavioral approach called Mindfulness-Oriented Recovery Enhancement (MORE). This variation on cognitive-behavioral treatment seeks to enhance positive affect in chronic pain patients in order to counter hypothesized reward processing deficits. Using electronic ecological momentary assessment data from a clinical trial, the paper provides evidence that MORE, compared to a support group control, reduced momentary pain, increased momentary positive affect, enhanced positive affect regulation and reduced risk of post-treatment opioid misuse. Thus, MORE, with its novel conceptual grounding, holds promise as an addition to the much-needed panoply of non-pharmacologic behavioral interventions that are useful for treatment of chronic pain patients, especially those at risk for opioid misuse. Walter Ling, a well-known substance abuse researcher and formerly principal investigator of the Pacific Node of the National Drug Abuse Treatment Clinical Trials Network, contributes his wisdom in our final paper. The paper first expands on the history of pain treatment and how it has led to the current epidemic of over-prescribing. It then goes straight to the heart of the matter by considering the etiology of the typical chronic pain patient and pointing out that it is the suffering associated with pain more so than the physical sensation of pain per se, that is the central issue for chronic pain patients and the thing they seek to remediate. Ling points out that the therapeutic role of opioids in chronic pain is quite uncertain and that at the end of the day, what is needed are interventions that can relieve the suffering caused by chronic pain rather than the physical sensation of pain itself. This final paper does an excellent job of re-capping some of the major themes of the supplement issue and provides a vision for the future where opioids used in moderation will be one of several intervention approaches that may be useful in treating the chronic pain patient. The current supplement issue makes a substantive contribution to a complex area of critical public health importance. We trust that readers will gain new knowledge and perspectives from the papers assembled herein and that these papers will contribute to the advance of both research and public health agendas.
Conflict of interest Drs. Stitzer and Bigelow have nothing to declare. Dr. Schwartz did a one-time consultation for Reckitt-Benckiser with all payment made to Friends Research Institute.
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References Brady, K.T., McCauley, J.L., Back, S.E., 2016. Prescription opioid misuse, abuse and treatment in the United States: an update. Am. J. Psychiatry 173, 18–26. Volkow, N.D., McLellan, A.T., 2016. Opioid abuse in chronic pain—misconceptions and mitigation strategies. N. Engl. J. Med. 374, 1253–1263.
Maxine L. Stitzer ∗ Behavioral Pharmacology Research Unit, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, United States Robert P. Schwartz Friends Research Institute, Baltimore, MD, United States George E. Bigelow Behavioral Pharmacology Research Unit, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, United States
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∗ Corresponding author at: Department of Psychiatry, BPRU, Hopkins Bayview Medical Center, 5510 Nathan Shock Drive, Baltimore, MD, 21224, United States. E-mail address:
[email protected] (M.L. Stitzer)
19 November 2016 20 November 2016