Aaron M. Gilson

Opioid Pharmacotherapy for Chronic Non-Cancer Pain in the United States: A Research Guideline for Developing an Evidence-Base

UNLABELLED This document reports the consensus of an interdisciplinary panel of research and clinical experts charged with reviewing the use of opioids for chronic noncancer pain (CNCP) and formulating guidelines for future research. Prescribing opioids for chronic noncancer pain has recently escalated in the United States. Contrasting with increasing opioid use are: 1) The lack of evidence supporting long-term effectiveness; 2) Escalating misuse of prescription opioids including abuse and diversion; and 3) Uncertainty about the incidence and clinical salience of multiple, poorly characterized adverse drug events (ADEs) including endocrine dysfunction, immunosuppression and infectious disease, opioid-induced hyperalgesia and xerostomia, overdose, falls and fractures, and psychosocial complications. Chief among the limitations of current evidence are: 1) Sparse evidence on long-term opioid effectiveness in chronic pain patients due to the short-term time frame of clinical trials; 2) Insufficiently comprehensive outcome assessment; and 3) Incomplete identification and quantification of ADEs. The panel called for a strategic interdisciplinary approach to the problem domain in which basic scientists and clinicians cooperate to resolve urgent issues and generate a comprehensive evidence base. It offered 4 recommendations in 3 areas: 1) A research strategy for studying the effectiveness of long-term opioid pharmacotherapy; 2) Improvements in evidence-generation methodology; and 3) Potential research topics for generating new evidence. PERSPECTIVE Prescribing opioids for CNCP has outpaced the growth of scientific evidence bearing on the benefits and harms of these interventions. The need for a strong evidence base is urgent. This guideline offers a strategic approach to creating a comprehensive evidence base to guide safe and effective management of CNCP.

The burden of the nonmedical use of prescription opioid analgesics.

An increase in the prescribing of opioids over the past several years often has been perceived as the primary reason for the increase in the nonmedical use of prescription opioids. Determining the prevalence of this illicit use has been difficult, because of varied methodologies and terminologies that are used to estimate the number of people directly contributing to or affected by this burden. Despite these discrepancies, the findings from several nationally recognized surveys have demonstrated that the prevalence of nonmedical prescription opioid use is indeed significant and has been increasing in recent years. The considerable burden on society imposed by misuse and abuse of these drugs is largely due to the monetary costs associated with nonmedical use (e.g., strategies implemented to prevent or deter abuse, treatment programs for misusers, etc.), decreased economic productivity, and the indirect effect on access to appropriate health care. However, using various nonpharmacologic and pharmacologic approaches to treat patients who use prescription opioids illicitly can decrease its overall prevalence and associated impact, with the development of novel opioid formulations designed to reduce nonmedical use providing valuable clinical tools as part of an overall risk management program. In addition, prescription monitoring programs are a prevalent drug control system designed to identify and address abuse and diversion of prescription medications, including opioids. Such resources, along with an accurate understanding of the problem, extend greater hope that the public health challenge of nonmedical prescription opioid use can be effectively mitigated.

Pain Management and Prescription Monitoring

Preventing diversion and abuse of prescription controlled substances while ensuring their availability for legitimate medical use is an important public health goal in the United States. In one approach to preventing and identifying drug diversion, 17 states have implemented prescription monitoring programs (PMPs) to monitor the prescribing of certain controlled substances. While PMPs are not intended to interfere with legitimate prescribing, some in the pain management community feel that they negatively affect prescribing for pain management. This article describes a collaborative project initiated by the Pain & Policy Studies Group that brought together regulatory and pain management representatives twice in 1998 to share perspectives and reconcile differing views on the effects of PMPs. The ultimate goals of this project are to provide accurate information to healthcare clinicians about PMPs, better define the balance between preventing drug diversion and providing pain management, and promote continued dialog and cooperation among the groups.

Profiling multiple provider prescribing of opioids, benzodiazepines, stimulants, and anorectics

BACKGROUND The main objective of this study was to determine the prevalence of multiple providers for different controlled substances using the largest electronic prescription monitoring program (PMP) in the United States. A secondary objective was to explore patient and medication variables associated with prescriptions involving multiple providers. PMPs monitor the final allocation of controlled substances from pharmacist to patient. The primary purpose of this scrutiny is to diminish the utilization of multiple providers for controlled substances. METHODS This is a secondary data analysis of the California PMP, the Controlled Substance Utilization Review and Evaluation System (CURES). The prevalence of multiple provider episodes was determined using data collected during 2007. A series of binomial logistic regressions was used to predict the odds ratio (OR) of multiple prescriber episodes for each generic type of controlled substance (i.e., opioid, benzodiazepine, stimulant, or diet pill (anorectic) using demographic and prescription variables. RESULTS Opioid prescriptions (12.8%) were most frequently involved in multiple provider episodes followed by benzodiazepines (4.2%), stimulants (1.4%), and anorectics (0.9%), respectively. The greatest associations with multiple provider episodes were simultaneously receiving prescriptions for different controlled substances. CONCLUSIONS Opioids were involved in multiple provider prescribing more frequently than other controlled substances. The likelihood of using multiple providers to obtain one class of medications was substantially elevated as patients received additional categories of controlled substances from the same provider or from multiple practitioners. Polypharmacy represents a signal that requires additional vigilance to detect the potential presence of doctor shopping.

Improving access to opioid analgesics for palliative care in India.

Approximately one million people in India experience cancer pain every year. 1 As in many developing countries, it is typical that cancer is diagnosed in the late stages, when pain is prevalent and often severe. 2 Severe pain destroys a person’s quality of life and dignity. Severe pain also affects families, neighbors, and the community: a painful death leaves an indelible mark, especially in India, where the person with cancer is often cared for in the community and at home. 1,3

Regulatory barriers to pain management.

OBJECTIVES To provide an overview of relevant federal and state policies, as well as recommendations for identifying and addressing barriers to the treatment of cancer and non-cancer pain. DATA SOURCES Review of federal and state statutes and medical board guidelines. CONCLUSIONS There has been an increase in pain-related policies since the mid 1980s, with recent years showing a significant amount of policy development and adoption. However, a variety of laws and policies contain provisions that have the potential to discourage the use of opioid analgesics for the relief of pain. IMPLICATIONS FOR NURSING PRACTICE The evaluation and treatment of patients with cancer and non-cancer pain can be enhanced by a knowledge of the specific restrictions of controlled substances statutes and practice guidelines. In this way, there will be less chance for nurses to practice outside established legal parameters.

Improving State Pain Policies: Recent Progress and Continuing Opportunities

The National Institutes of Health reports that 100 million Americans suffer from chronic pain, including pain associated with the disease of cancer. Painful conditions can strike anyone, including cancer patients and cancer survivors. Unrelieved severe pain can limit a persons functioning and sometimes even destroy the will to live. When the quality of pain relief provided is inadequate, it is usually the result of failures to apply existing knowledge about pain and its treatment, including the appropriate use of opioids. But pain relief also can be affected by the regulatory environment and fear of being investigated for excessive prescribing. The importance of evaluating and improving policies governing pain management has been recognized by national and international authorities, including the Institute of Medicine and the World Health Organization. A pilot examination of state laws and regulatory policies demonstrated that they contained a number of outdated medical concepts and prescribing restrictions and did not contain key elements of law that can make pain management a priority for licensed medical practitioners. The Pain & Policy Studies Group developed a research program to evaluate US federal and state policy governing the medical use of pain medication. This article describes 3 national policy evaluations and how the results are being used to document improvements in state pain policies. An emerging role for clinicians and their professional organizations to improve their states pain policies is discussed.

An analysis of the number of multiple prescribers for opioids utilizing data from the California Prescription Monitoring Program.

Prescription monitoring programs scrutinize the prescribing of controlled substances to diminish the utilization of multiple prescribers (aka. “doctor shopping”). The use of multiple prescribers is not a problem per se and can be legitimate, as when the patients regular physician is not available or a concurrent painful condition is being cared for by a different practitioner.

An examination of global and regional opioid consumption trends 1980-2011.

ABSTRACT Despite expert recognition that strong opioid analgesics are the cornerstone of treatment for moderate to severe pain, most of the worlds population lacks adequate availability of opioids. Moreover, great disparities in availability of opioids continue to exist between higher- and lower-to-middle-income countries. This study examined more than 30 years of consumption data reported to the International Narcotics Control Board, from 1980 to 2011, for five opioids that are indicated for the treatment of moderate to severe pain: fentanyl, hydromorphone, morphine, oxycodone, and pethidine. As such, this study offers a regional and global perspective on opioid consumption, providing an indication of preparedness for treating moderate to severe pain. Countries are categorized according to the World Health Organizations six geographical regions. Morphine equivalence (ME) statistics were calculated for each study drug, allowing for equianalgesic comparisons between consumption of the study opioids and well as the ability to aggregate all study opioids (Total ME). The ME statistic is adjusted for country population, which allows for uniform global-, regional-, and country-level equianalgesic comparisons of consumption of morphine with other opioids. Although overall trend lines revealed general increases by region, profound inequities in opioid consumption continue to abound globally.

Time Series Analysis of California’s Prescription Monitoring Program: Impact on Prescribing and Multiple Provider Episodes

UNLABELLED Prescription monitoring programs (PMPs) are designed to reduce medication diversion by identifying individuals obtaining the same medication from multiple providers (termed multiple provider episodes [MPEs]). This study determined whether recent changes to Californias PMP influenced: 1) the extent that practitioners issue prescriptions for a variety of Schedule II opioids; and 2) the incidence of MPEs involving these opioids. Intervention time series of Californias PMP data was used to determine the effect of requiring practitioners to transition from using triplicate prescription forms for Schedule II medications to security forms for all controlled substances. Outcome measures included changes in number of prescriptions issued for Schedule II long-acting or short-acting (SA) opioids and the MPEs involving these medications. Requiring a security form was associated with a sustained prescribing increase for SA hydromorphone, meperidine, and SA oxycodone; no prescribing changes were found for SA fentanyl, methadone, and SA morphine, or for any long-acting opioids. The same policy change, however, increased MPEs involving all opioids. Further effort is required to determine how Californias PMP can continue to ensure availability of prescription opioids for medical use while better mitigating their diversion. PERSPECTIVE Statistical model-building was used to evaluate the influence of changes to Californias prescription monitoring program. The extent that practitioners prescribe Schedule II opioids and the incidence of people receiving prescriptions from multiple providers were measured. Such research illustrates the viability of evaluating drug control program impact on prescribing practice and potential diversion behaviors.