Adolescent Nonmedical Use of Prescription Pain Relievers, Stimulants, and Depressants, and Suicide Risk.

BACKGROUND: Although the link between drug abuse and suicide risk is established, few studies have examined the relationship between the nonmedical use of prescription drugs (NMUPD) and suicide risk, particularly among adolescents. OBJECTIVES: To explore the relationship between NMUPD and suicide risk among 4,148 adolescents in grades 9-12 enrolled in five public high schools. METHODS: Logistic regression models were constructed for the nonmedical use of prescription pain relievers, depressants, stimulants, and a composite measure for any NMUPD. Models were estimated before and after controlling for key covariates. RESULTS: About 21% of respondents reported lifetime NMUPD. After covariate adjustment, students who had reported any NMUPD were between 1.7 and 2.3 times more likely to report suicidal ideation, but not a suicide attempt (p < .0001). When stratified by sex and drug, nonmedical use of pain relievers, stimulants, and depressants were significantly associated with greater odds of suicidal ideation and behavior for both males and females (p < .05). However, NMUPD of pain relievers were not associated with greater odds of suicide attempts for males or females or among males who reported nonmedical use of stimulants. Nonmedical use of depressants was associated with greater odds of suicide attempts for both males and females (OR = 1.61 and 2.25, respectively) and among females who reported nonmedical use of stimulants (OR = 2.06, p < .01). CONCLUSIONS/IMPORTANCE: Results suggest that some adolescents may be inappropriately self-medicating psychological distress with prescription medications or NMUPD may promote suicide risk, especially for males and females who use depressants and females who use stimulants.

System dynamics modeling as a potentially useful tool in analyzing mitigation strategies to reduce overdose deaths associated with pharmaceutical opioid treatment of chronic pain.

OBJECTIVE: To illustrate a system-level, simulation-based approach for evaluating mitigation strategies to address the dramatic rise in abuse, addiction, and overdose deaths associated with the use of pharmaceutical opioid analgesics to treat chronic pain. SIMULATED INTERVENTIONS: Making available drug formulations with increased tamper-resistance, prescriber education programs, and programs that reduce rates of medical user-related abuse and addiction. SIMULATED OUTCOME MEASURE: Number of overdose deaths of medical users of pharmaceutical opioid analgesics, including those who abuse or have become addicted. METHODS: A demonstration system dynamics model is developed, tested, and used to evaluate the impact of candidate mitigation strategies on the outcome measures. RESULTS: Tamper-resistant drug products will likely reduce overdose death rates but may not reduce overall deaths if there is increased prescribing. Prescriber education would likely reduce deaths through a reduction in patient access to pharmaceutical opioid analgesics. CONCLUSIONS: The system dynamics approach may have potential for opioid-related policy evaluation. However, metrics must be carefully selected, and trade-offs may be involved. For example, it may be difficult to limit negative outcomes associated with pharmaceutical opioids without adversely affecting chronic pain patients' access to pharmaceutical treatment. Ultimately, a combination of metrics and value judgments will be needed to properly evaluate mitigation strategies.

Position paper: appropriate use of pharmacotherapeutic agents by the orofacial pain dentist.

Orofacial Pain Dentistry is concerned with the prevention, evaluation, diagnosis, treatment, and management of persistent and recurrent orofacial pain disorders. The American Dental Association, through the Commission on Dental Accreditation (CODA), now recognizes Orofacial Pain as an area of advanced education in Dentistry. It is mandated by CODA that postgraduate orofacial pain programs be designed to provide advanced knowledge and skills beyond those of the standard curriculum leading to the DDS or DMD degrees. Postgraduate programs in orofacial pain must include specific curricular content to comply with CODA standards. The intent of CODA standards is to assure that training programs develop specific educational goals and objectives that describe the student/resident's expected knowledge and skills upon successful completion of the program. A standardized core curriculum, required for accreditation of dental orofacial pain training programs, has now been adopted.Among the various topics mandated in the curriculum are pharmacology and, specifically, pharmacotherapeutics. The American Academy of Orofacial Pain (AAOP) recommends, and the American Board of Orofacial Pain (ABOP) requires, that the minimally competent orofacial pain dentist* be knowledgeable in the management of orofacial pain conditions using medications when indicated. Basic knowledge of the appropriate use of pharmacotherapeutics is essential for the orofacial pain dentist and, therefore, constitutes part of the examination specifications of the ABOP. The minimally competent orofacial pain clinician must demonstrate knowledge, diagnostic skills, and treatment expertise in many areas, such as musculoskeletal, neurovascular, and neuropathic pain syndromes; sleep disorders related to orofacial pain; orofacial dystonias; and intraoral, intracranial, extracranial, and systemic disorders that cause orofacial pain or dysfunction. The orofacial pain dentist has the responsibility to diagnose and treat patients in pain that is often chronic, multifactorial, and complex. Failure to understand pain mechanisms can lead to inaccurate diagnoses and ineffective, delayed, or harmful treatment. It is the responsibility of the orofacial pain dentist to accurately diagnose the cause(s) of the pain and decide if treatment should be dentally, medically, or psychologically oriented, or if optimal management requires a combination of all three treatment approaches. Management may consist of a number of interdisciplinary modalities including, eg, physical medicine, behavioral medicine, and pharmacology or, in rare instances, surgical interventions. Among the essential armamentarium is the knowledge and proper use of pharmacologic agents.

RxPATROL: a Web-based tool for combating pharmacy theft.

OBJECTIVE: To report the incidence of pharmacy-related burglaries and robberies and characteristics of pharmacies where such crimes have occurred using recent data from Rx Pattern Analysis Tracking Robberies & Other Losses (RxPATROL), a national Web-based information clearinghouse on pharmacy-related theft of prescription medications and over-the-counter products. DESIGN: Descriptive, nonexperimental study. SETTING: United States between 2005 and 2006. PARTICIPANTS: Not applicable. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Number of pharmacy theft reports received; incident type, date, and location; point of entry; and pharmacy security features. RESULTS: Between 2005 and 2006, 202 pharmacy burglary and 299 pharmacy robbery reports from 45 different states were filed with RxPATROL. More than 70% of pharmacies reporting such crimes lacked a security camera. Among those reporting a burglary, 60% lacked dead bolt locks, a solid exterior door, a motion detector device, or a safe or vault for storage of controlled substances. Burglars most often obtained access to the pharmacy via the front door. CONCLUSION: RxPATROL is a Web-based tool that can assist pharmacies and law enforcement in collaborating more effectively to combat and prevent pharmacy-related crimes.

Detecting signals of opioid analgesic abuse: application of a spatial mixed effect poisson regression model using data from a network of poison control centers.

PURPOSE: The recent rise in the non-medical use of opioid analgesics in the US has underscored the importance of comprehensive post-marketing surveillance of these products. To assist pharmacovigilance efforts, we developed a methodology for detecting geo-specific "signals" of potential outbreaks of prescription drug abuse by 3-digit ZIP (3DZ) code. METHODS: The number of intentional exposure calls involving nine specific opioid analgesics were obtained from eight regional poison control centers between first quarter 2003 and fourth quarter 2004. The unit of analysis was a combination of drug-quarter/year-3DZ. We fitted an empirical Bayes mixed effects Poisson-Gamma regression model that adjusted for differences across 3DZs in opioid analgesic exposure. A relative report rate (RR) >or=3 at a probability of >0.95 was the signal threshold criterion. RESULTS: A total of 15,769 valid drug-time-3DZ combinations were identified. Of these, 1.9% (n = 294) met the signal threshold criterion. The number of signals generated per drug-quarter/year-3DZ combination ranged from 0 to 13. The largest number of signals were those involving methadone (n = 71), hydrocodone (n = 57), and branded oxycodone extended-release (n = 45). Signals for methadone and branded oxycodone extended-release were predominantly clustered in Appalachia. Hydrocodone-related signals showed less geographic clustering with approximately 26% reported from California, and the remainder from other regions in the US. CONCLUSIONS: Our results show marked regional differences in reported abuse of specific opioid analgesics. Additional research is needed to determine the sensitivity and specificity of signals obtained using this spatial mixed effect Poisson regression model.

Pharmacy-related theft of controlled substances: RxPATROL® findings.

OBJECTIVE: To characterize pharmacy-related theft data reported to the Rx Pattern Analysis Tracking Robberies and Other Losses (RxPATROL®) database during the time periods before (2007-2010) and after (2011-2016) the August 2010 switch to reformulated OxyContin® (oxycodone hydrochloride) extended-release tablets (Purdue Pharma L.P.). METHODS: The RxPATROL® database was queried to identify characteristics associated with theft of drug products. Variables analyzed included incident counts, drugs involved (OxyContin or other oxycodone products), pharmacy-security features, and other incident-related information. The data captured from 2007 to 2010, defined as the original formulation period, were compared with those captured from 2011 to 2016, defined as the post-reformulation period. RESULTS: A total of 6,905 incidents were reported from 2007 to 2016, with robbery (51.8 percent) and burglary (26.4 percent) being the most commonly reported incidents. The number of total robbery incidents reported peaked in 2010 and remained steady. Incidents reported as robberies that involved OxyContin initially increased from 2007 to 2010 and then steadily decreased from 296 in 2010 to 13 in 2016. Total burglary reports decreased from 2009 to 2015 and slightly increased from 2015 to 2016. Total burglary reports that involved OxyContin decreased after 2009. Total burglary reports that involved oxycodone remained steady from 2009 to 2014, decreased from 2014 to 2015, and remained steady from 2015 to 2016. The majority of reported incidents occurred on weekdays and involved suspects who entered and exited through the front door at pharmacies without security features such as alarms, dead bolts, and cameras. CONCLUSION: Following replacement of the original formulation of OxyContin with a new formulation that has abuse-deterrent properties in 2010, pharmacy thefts of OxyContin reported to the RxPATROL® database decreased. The decreases were not fully explained by concurrent trends in total robbery or burglary incidents reported to the RxPATROL® database over the same time period.

Prescription opioid abuse among enrollees into methadone maintenance treatment.

A multi-state survey of 5663 opioid dependent persons enrolling in 72 methadone maintenance treatment programs (MMTPs) was conducted to determine the prevalence of prescription opioid (PO) abuse, factors associated with PO abuse and sources for POs. Regions where PO abuse was believed to be prevalent were oversampled; primary opioid was defined as the drug used the most before coming to the MMTP. Among primary heroin abusers, 69% reported abusing POs. Opioid abuse frequencies among primary PO abusers were oxycodone (79%), hydrocodone (67%), methadone (40%), morphine (29%), heroin (13%), hydromorphone (16%), fentanyl (9%) and buprenorphine (1%). Correlates (p < or = .01) of PO abuse, using general estimating equations, were: low urbanicity (MMTPs located in comparatively low population density counties), white ethnicity, no history of injecting primary drug, no previous methadone treatment, younger age, chronic pain, and pain as a reason for enrollment. The most frequent sources of POs were dealer, friend or relative, and doctor's prescription; least frequent were Internet and forged prescription. One-third of PO abusers reported a history of injecting their primary drug. PO abuse is highly prevalent among MMTP patients. Future studies should describe HIV/HCV needle injection practices, characteristics that predict treatment outcomes, and factors that contribute to higher prevalence of persistent pain among PO abusers.

Quantifying morbidity associated with the abuse and misuse of opioid analgesics: a comparison of two approaches.

BACKGROUND: Due to the rising nonmedical use of opioid analgesics, methods are needed to quantify the associated health-related consequences. METHODS: Using opioid analgesic intentional exposure reports from poison control centers from January 2003-June 2004, we calculated quarterly rates for 7 opioids at the 3-digit ZIP code level using population- and patient-based denominators. RESULTS: Hydrocodone was the most widely prescribed opioid (maximum: 5,321,390 patients per quarter), with the largest intentional exposure caseload (range: 498-1,290), and the highest aggregate population-based rate (maximum of 13.61 cases per 1,000,000 individuals). Methadone had the highest aggregate patient-based rate (maximum 2.03 cases per 1,000 patients). CONCLUSION: Population- and patient-based rates are complementary tools that address different public health questions. Population-based rates describe the health-related burden of nonmedical opioid analgesic use on the community as a whole, while patient-based rates show this burden ("risk") in relation to the level of corresponding medicinal use ("benefit") within a given area.

Correlates of nonmedical use of hydromorphone and hydrocodone:results from a national household survey.

Over the past decade, the misuse and abuse of opioid medications in the United States has risen dramatically. Although data show a substantial variation in the nonmedical use of individual opioids, relatively little is known about risk factors for the nonmedical use of specific opioid products. This study compared the prevalence and correlates of the nonmedical use of oral immediate-release hydromorphone (marketed under the brand name of Dilaudid), versus that of hydrocodone combination products using a nationally representative sample of the civilian noninstitutionalized United States population aged 12 years or older. Data were from the 2003 National Survey on Drug Use and Health. An estimated 31.3 million individuals reported lifetime nonmedical use of an opioid analgesic. Of these, 2.9 percent reported lifetime nonmedical use of Dilaudid, and 51.9 percent reported lifetime nonmedical use of hydrocodone combination products exclusive of nonmedical Dilaudid use. Nonmedical Dilaudid users were likely to be older, Caucasian, and to have reported a higher lifetime prevalence of heroin, cocaine and injection drug use, as well as nonmedical use of other opioids. Nonmedical Dilaudid users were at higher risk for engaging in more serious substance abuse-related behaviors than those who reported lifetime nonmedical use of hydrocodone combination products.

Opioids with abuse-deterrent properties: A regulatory and technological overview.

Three concurrent public health problems coexist in the United States: endemic nonmedical use/misuse of opioid analgesics, epidemic overdose fatalities involving opioid analgesics, and endemic chronic pain in adults. These intertwined issues comprise an opioid crisis that has spurred the development of formulations of opioids with abuse-deterrent properties and label claims (OADP). To reduce abuse and misuse of prescription opioids, the federal Food and Drug Administration (FDA) has issued a formal Guidance to drug developers that delineates four categories of testing to generate data sufficient for a description of a product's abuse-deterrent properties, along with associated claims, in its Full Prescribing Information (FPI). This article reviews the epidemiology of the crisis as background for the development of OADP, summarizes the FDA Guidance for Industry regarding abuse-deterrent technologies, and provides an overview of some technologies that are currently employed or are under study for incorporation into OADP. Such technologies include physical and chemical barriers to abuse, combined formulations of opioid agonists and antagonists, inclusion of aversive agents, use of delivery systems that deter abuse, development of new molecular entities and prodrugs, and formulation of products that include some combination of these approaches. Opioids employing these novel technologies are one part of a comprehensive intervention strategy that can deter abuse of prescription opioid analgesics without creating barriers to the safe use of prescription opioids. The maximal public health contribution of OADP will probably occur only when all opioids have FDA-recognized abuse-deterrent properties and label claims.

Secular trends in opioid prescribing in the USA.

Opioid abuse and misuse in the USA is a public health crisis. The use of prescription opioid analgesics increased substantially from 2002 through 2010, then plateaued and began to decrease in 2011. This study examined prescriptions of branded and generic immediate- and extended-release opioid analgesics from 1992 to 2016. This was juxtaposed against state and federal policies designed to decrease overutilization and abuse, as well as the launch of new opioid products, including opioids with abuse-deterrent properties (OADPs). The data indicate that these health policies, including the utilization and reimbursement of OADPs, have coincided with decreased opioid utilization. The hypothesis that OADPs will paradoxically increase opioid prescribing is not supported.

The association between nonmedical use of prescription drugs and extreme weight control behavior among adolescents.

Although extreme weight control behavior (EWCB) is associated with substance use, no research has examined the association between the nonmedical use of prescription drugs (NMUPD) and EWCB. Self-report data were collected from a sample of 4,148 students in Grades 9-12 enrolled in 5 high schools across the United States. Logistic regression models were constructed to examine the nonmedical use of prescription pain relievers, depressants, stimulants, and a composite measure for any NMUPD, and the EWCB of fasting, use of diet pills, powders, or liquids, and vomiting or laxative use. Models were estimated before and after controlling for key covariates for males and females. Approximately 16% of respondents reported any EWCB during the past 30 days, while 11% reported any NMUPD during the past 30 days. After covariate adjustment, any NMUPD was associated with any EWCB in both males and females (p < .05), and all EWCB remained significant in females who reported prescription pain reliever use (p < .01), with 2 out of 3 remaining significant for prescription stimulant and depressant use (p < .01). The only significant association detected for males was between prescription pain reliever use and using diet pills, powders, or liquids (OR = 2.2, p < .01). Results suggest significant associations between NMUPD and EWCB, with variations by sex. These findings provide directions for additional research and point to several potential identification and intervention efforts. (PsycINFO Database Record

Measures That Identify Prescription Medication Misuse, Abuse, and Related Events in Clinical Trials: ACTTION Critique and Recommended Considerations.

Accurate assessment of inappropriate medication use events (ie, misuse, abuse, and related events) occurring in clinical trials is an important component in evaluating a medication's abuse potential. A meeting was convened to review all instruments measuring such events in clinical trials according to previously published standardized terminology and definitions. Only 2 approaches have been reported that are specifically designed to identify and classify misuse, abuse, and related events occurring in clinical trials, rather than to measure an individual's risk of using a medication inappropriately: the Self-Reported Misuse, Abuse, and Diversion (SR-MAD) instrument and the Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS). The conceptual basis, strengths, and limitations of these methods are discussed. To our knowledge, MADDERS is the only system available to comprehensively evaluate inappropriate medication use events prospectively to determine the underlying intent. MADDERS can also be applied retrospectively to completed trial data. SR-MAD can be used prospectively; additional development may be required to standardize its implementation and fully appraise the intent of inappropriate use events. Additional research is needed to further demonstrate the validity and utility of MADDERS as well as SR-MAD. PERSPECTIVE: Identifying a medication's abuse potential requires assessing inappropriate medication use events in clinical trials on the basis of a standardized event classification system. The strengths and limitations of the 2 published methods designed to evaluate inappropriate medication use events are reviewed, with recommended considerations for further development and current implementation.

Risk identification, risk assessment, and risk management of abusable drug formulations.

There is a demand for pharmaceutical products with reduced abuse liability. These products must meet three tests to be successful. They must be safe for patients, be less likely to injure the abuser, and be less desirable for abuse by established drug abusers relative to existing products on a dose for dose (milligram-equivalent) basis. There is a need for standardization of the evaluation of abusable pharmaceuticals in the various stages of drug development from preclinical animal studies to postmarketing surveillance. Formulations with reduced abuse liability must: (1) be tested using standard animal, benchtop, and human pharmacokinetic methods that allow interpretation, (2) sufficiently reduce the recovery of abusable drug substance, or contain another ingredient to deter abuse, (3) not alter drug activity for patients in an undesirable or risky way, and (4) have an accurate pre-approval estimation of their reduced abuse liability, which is validated by adequate epidemiologic post-approval surveillance.

Association between non-medical and prescriptive usage of opioids.

Understanding and managing prescription opioid abuse is one of the major challenges in pain management worldwide. The relationships between prescriptive usage of opioids and reported morbidity at the national level, using data from the Drug Abuse Warning Network (DAWN), were examined. When the major prescription opioids were evaluated, the association between prescriptive medical use in kilograms and reported morbidity, as measured by a ratio between the two, was similar for the intermediate-potency opioids (hydrocodone, methadone, oxycodone, and morphine). This rate was much lower for low-potency opioids (codeine, meperidine, pentazocine, and propoxyphene) and much greater for high-potency opioids (hydromorphone and fentanyl). When the drugs were adjusted by potency (relative to morphine), the rates of reported morbidity per kilogram of morphine equivalent opioid in prescriptive usage were similar among the opioids. Using the potency-adjusted total kilograms of opioid in prescriptive use for all the opioids evaluated, there was a statistically significant association (r(2)=0.9791) with the reported morbidity for prescription analgesics as a class, as measured in the DAWN system. These data suggest that non-medical use of opioids is predictable based on potency and extent of prescriptive use.

Caveat emptor: Erroneous safety information about opioids in online drug-information compendia.

BACKGROUND: Healthcare professionals and consumers refer to online drug-information compendia (eg, Epocrates and WebMD) to learn about prescription medications, including opioid analgesics. With the significant risks associated with opioids, including abuse, misuse, and addiction, any of which can result in life-threatening overdose, it is important for those seeking information from online compendia to have access to current, accurate, and complete drug information to help support clinical treatment decisions. Although compendia are informative, readily available, and user friendly, studies have shown that they may contain errors. OBJECTIVE: To review and identify misinformation in drug summaries of online drug-information compendia for selected opioid analgesic products and submit content corrections to the respective editors. METHODS: Between 2011 and 2013, drug summaries for Purdue's prescription opioid analgesic products from seven leading online drug-information compendia were systematically reviewed, and the requests for corrections were retrospectively categorized and classified. At least 2 months following requests, the same compendia were then reexamined to assess the degree of error resolution. RESULTS: A total of 859 errors were identified, with the greatest percentage in Safety and Patient Education categories. Across the seven compendia, the complete or partial resolution of errors was 34 percent; therefore, nearly two thirds of the identified errors remain. CONCLUSION: The results of this analysis, consistent with past studies, demonstrate that online drug-information compendia may contain inaccurate information. Healthcare professionals and consumers must be informed of potential misinformation so they may consider using multiple resources to obtain accurate and current drug information, thereby helping to ensure safer use of prescription medications, such as opioids.

Assessment of physical function and participation in chronic pain clinical trials: IMMPACT/OMERACT recommendations.

Although pain reduction is commonly the primary outcome in chronic pain clinical trials, physical functioning is also important. A challenge in designing chronic pain trials to determine efficacy and effectiveness of therapies is obtaining appropriate information about the impact of an intervention on physical function. The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) and Outcome Measures in Rheumatology (OMERACT) convened a meeting to consider assessment of physical functioning and participation in research on chronic pain. The primary purpose of this article is to synthesize evidence on the scope of physical functioning to inform work on refining physical function outcome measurement. We address issues in assessing this broad construct and provide examples of frequently used measures of relevant concepts. Investigators can assess physical functioning using patient-reported outcome (PRO), performance-based, and objective measures of activity. This article aims to provide support for the use of these measures, covering broad aspects of functioning, including work participation, social participation, and caregiver burden, which researchers should consider when designing chronic pain clinical trials. Investigators should consider the inclusion of both PROs and performance-based measures as they provide different but also important complementary information. The development and use of reliable and valid PROs and performance-based measures of physical functioning may expedite development of treatments, and standardization of these measures has the potential to facilitate comparison across studies. We provide recommendations regarding important domains to stimulate research to develop tools that are more robust, address consistency and standardization, and engage patients early in tool development.

Key Data Gaps Regarding the Public Health Issues Associated with Opioid Analgesics.

Most pharmaceutical opioids are used to treat pain, and they have been demonstrated to be effective medications for many. Their abuse and misuse pose significant public health concerns in the USA. Research has provided much insight into the prevalence, scope, and drivers of opioid abuse, but a holistic understanding is limited by a lack of available data regarding key aspects of this public health problem. Twelve data gaps were revealed during the creation of a systems-level computer model of medical use, diversion, nonmedical use, and the adverse outcomes associated with opioid analgesics in the USA. Data specific to these gaps would enhance the validity and real-world applications of systems-level models of this public health problem and would increase understanding of the complex system in which use and abuse occur. This paper provides an overview of these gaps, argues for the importance of closing them, and provides specific recommendations for future data collection efforts.

Implementing a Process to Review Product-Specific Misinformation in Online Drug Information Compendia.

Health care professionals and consumers often use online drug information compendia, which are intended to be user-friendly, readily available, accurate, and up-to-date. While these resources can be valuable, it has been shown that some compendia contain inaccuracies and outdated information, motivating the Medical Services (medical information) Department at Purdue Pharma LP to implement a periodic, standardized review of select online drug information compendia. Monographs within compendia for up to 9 Purdue products were reviewed and compared to their current Full Prescribing Information, with a focus on identifying safety-related misinformation. Content correction requests for nearly 1000 errors were submitted to 7 compendia clinical editors. This surprisingly large number of errors highlights the need for compendia to better maintain accurate product monographs, as well as for pharmaceutical companies to proactively and periodically review them for misinformation. Based on these findings, an overview on how the pharmaceutical industry may implement a drug information compendia review process is provided.

Pain management, controlled substances, and state medical board policy: a decade of change.

Physicians' concerns about regulatory scrutiny and the possibility of unwarranted investigation by regulatory agencies negatively affect their prescribing of opioid analgesics to treat pain. Indeed, some state medical boards have rejected prescribing practices that are considered acceptable by today's standards. This article describes a ten-year program of research, education, and policy development implemented by the Pain & Policy Studies Group aimed at updating and clarifying state medical board policies on the use of opioid analgesics to treat pain, including cancer and chronic noncancer pain. Following surveys of medical board members and educational workshops, state medical board policies began an initial period of change, drawing on guidelines from other states, particularly in California. The next phase of policy development was marked by the introduction of Model Guidelines by the Federation of State Medical Boards of the U.S. The Model Guidelines address professional standards for the appropriate prescribing of opioid analgesics for pain management, as well as physicians' fears of regulatory scrutiny. Although most state medical boards have adopted regulations, guidelines, or policy statements relating to controlled substances and pain management, to date ten boards have adopted the Model Guidelines, while ten more have adopted the Model Guidelines in part. Further actions are recommended so that state medical boards can address inadequate pain management and physician concerns about regulatory scrutiny.