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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 California's 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 California's 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 California's 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 California's 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. [ABSTRACT FROM AUTHOR]

Three national surveys were conducted in 1991, 1997, and 2004 to evaluate state medical board members' knowledge and attitudes about prescribing opioid analgesics for pain management. Topics addressed include perceived legality of prolonged opioid prescribing, characteristics of addiction, prevalence of medication abuse and diversion, and perceived importance and influence of medical board policy. Questions were added in 2004 to determine board members' views about law enforcement involvement in physician investigations and prosecutions. This study assesses medical regulators' current beliefs and compares the 2004 responses with previous responses to determine how knowledge and attitudes about prescribing opioids have changed in recent years. Survey results show that board members have a greater understanding of pain management issues, particularly regarding characteristics of addiction and the legality of prolonged opioid prescribing for chronic noncancer pain. During the last 15 years, there has been substantial regulatory policy development, with medical boards adopting regulations, guidelines, or policy statements to provide guidance to licensees about using opioids to treat pain. However, many board members believe that federal and state law enforcement agencies have increased criminal investigations and prosecutions of physicians. We discuss appropriate regulatory and law enforcement responses to opioid prescribing violations, and suggest crucial next steps. PERSPECTIVE: The authors examine the evolution of state medical board members' knowledge and attitudes about prescribing opioid analgesics to treat chronic pain, demonstrate that medical regulators believe that there have been increased criminal investigations and prosecutions of physicians for their prescribing practices, and suggest ways to avoid unwarranted criminal prosecutions. [ABSTRACT FROM AUTHOR]

State laws and regulatory policies govern healthcare practice, including the prescribing, dispensing, and administering of opioid analgesics to treat pain. A number of national healthcare and law enforcement organizations have identified drug regulatory policy as a potential barrier to pain relief and palliative care, and have called for evaluation and removal. This article summarizes and discusses the results of an innovative evaluation methodology that was used to produce three policy analysis tools, including one report that graded and ranked states based on the quality of their policies related to pain management and palliative care (called a Progress Report Card [PRC]). The PRC development and implementation was a first-of-a-kind study that compared pain policies in all states over a three year period according to the same evaluation criteria. Results demonstrate significant progress to improve policy in a number of states during the study period, but also showed that most state policies are characterized by a lack 'balance.' In addition to providing examples of policy change in particular states, the relevance of these findings to current policy issues, including the importance of communicating and implementing new policies is discussed. The need for partnerships between the healthcare and law enforcement communities is emphasized to create a more positive regulatory environment for pain relief and palliative care, which ultimately will benefit patient care. [ABSTRACT FROM AUTHOR]

This study updates a previous analysis of trends in medical use and abuse of opioid analgesics, and provides data from 1997 through 2002. Two research questions were evaluated: 1) What are the trends in the medical use and abuse of frequently prescribed opioid analgesics used to treat severe pain, including fentanyl, hydromorphone, meperidine, morphine, and oxycodone? 2) What is the abuse trend for opioid analgesics as a class compared to trends in the abuse of other drug classes? Results demonstrated marked increases in medical use and abuse of four of the five studied opioid analgesics. In 2002, opioid analgesics accounted for 9.85% of all drug abuse, up from 5.75% in 1997. Increase in medical use of opioids is a general indicator of progress in providing pain relief. Increases in abuse of opioids is a growing public health problem and should be addressed by identifying the causes and sources of diversion, without interfering with legitimate medical practice and patient care. Copyright © 2004 by Elsevier Science (USA). [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

In less-developed countries, opioids such as morphine are often not available for pain relief because of excessive regulations imposed to prevent their misuse and diversion. We describe the effect that these draconian measures have had on the availability of drugs for medical use in Kerala, India, and present results of a study, which we did to ascertain whether or not the misuse and diversion of opioids is as prevalent as the government reaction would suggest. We followed 1723 patients in Calicut, India, who were being treated for pain with oral morphine on an outpatient home-care basis. Over 2 years, we did not identify any instances of misuse or diversion. These results suggest that, in the context of India as a less-developed country, oral morphine can be dispensed safely to patients for use at home. We recommend that palliative care programmes talk to concerned governmental authorities, to make them aware of the medical need for opioids, and communicate with local news media to increase awareness of palliative care and the use of these analgesics. Our project has overcome regulatory barriers that had interrupted availability of morphine and its use in pain relief in India. [ABSTRACT FROM AUTHOR]

Misunderstandings regarding the nature and occurrence of addiction have historically been barriers to the appropriate treatment of pain and have stigmatized the medical use of opioids. This article reviews the evolution of nomenclature related to addiction, presents current scientific understanding of addiction that may help shape universally acceptable terminology, and discusses an integrated effort of pain and addiction professionals to reach consensus on addiction-related terms. The article suggests key principles that may clarify terminology including: clear differentiation of the concepts of addiction and physical dependence, conceptualization of addiction as a multidimensional disease, and use of a label for the phenomenon of addiction that does not include the ambiguous term "dependence." More universal agreement on terminology related to addiction is expected to improve the treatment of both pain and addictive disorders; improve communication between health care providers, regulators, and enforcement agencies; and reduce health care and other societal costs. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: A recent National Institute on Drug Addiction Call to Action focused on expanding methadone treatment access for individuals with opioid use disorder (OUD). One research priority identified was optimal educational and support structures, including training to provide methadone across multiple healthcare settings (e.g., primary care, opioid treatment programs [OTPs], pharmacies) and healthcare workers (HCWs) (e.g., providers, pharmacists). This scoping review sought to better understand HCWs' knowledge, attitudes, and stigma as it relates to methadone provision., Methods: Four databases (PubMed, PsycInfo, CINAHL, Web of Science) were searched for publications between 2010 and 2022 using keywords-methadone, HCW, outpatient setting, knowledge, attitudes, and stigma, focusing on HCWs in general and pharmacists specifically., Results: A total of 2,747 articles were identified and 14 met inclusion criteria for review. Settings included OTPs (n = 4), specialty addiction treatment clinics (n = 3), community pharmacies (n = 2), and multiple settings (n = 5). All articles (n = 14) examined methadone-related attitudes. Despite approval of methadone in 1972 to treat OUD, four articles illustrated continued methadone-related stigma held by HCWs. In response to COVID-19-related policy changes allowing methadone take-home flexibility, OTP clinicians expressed a range of attitudes concerning patient risk and potential program liability around diversion and misuse. One article assessing knowledge suggested that, even when most pharmacists correctly answered knowledge questions, a significant minority had misunderstandings that could undermine effective treatment., Conclusions: Given the current imbalance between methadone treatment demand and availability, there is a critical need to expand outpatient methadone services. Pharmacists partnering with OTPs represent a logical but underutilized access point. We identified key areas to improve HCWs methadone-related knowledge, attitudes, and stigma. Future research should explore the impact of outpatient pharmacy-OTP and other expansion services, and systematic training, education, and evaluation of methadone-related understanding, including assessment tools to measure knowledge, attitudes, and stigma., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Objectives: Older adults' (ages ≥65) inappropriate over-the-counter medications (OTC) use is prevalent, comprising Drug-Age, Drug-Drug, Drug-Disease, and Drug-Label types. Given that pharmacies sell many OTCs, structurally redesigning pharmacy aisles for improving patient safety (Senior Safe) was conceived to mitigate older adult OTC misuse, using Stop Signs and Behind-the-Counter Signs for high-risk OTCs. This study determined whether Senior Safe reduced high-risk OTCs misuse, while secondarily evaluating misuse changes for all OTCs., Methods: A randomized controlled trial design matched and randomly allocated 20 health system community pharmacies to control or intervention groups. All 288 study participants completed an OTC choice task in which they chose a hypothetical symptom scenario (pain, sleep, cough/cold/allergy), selected an OTC, and described how they would use it at symptom onset and if symptoms persisted or worsened. Reported OTC use was evaluated for each misuse type. Intervention and control sites were compared for each misuse type using multivariate modeling., Results: For high-risk OTCs, Drug-Age and Drug-Drug misuse were more likely in control sites (OR = 2.752, P = 0.004; OR = 6.199, P = 0.003, respectively), whereas Drug-Disease and Drug-Label misuse had too few occurrences in intervention sites for statistical comparisons. For all OTCs, only Drug-Age misuse was more likely for control sites (OR = 5.120, P = 0.001). Adults aged 85+ years had the greatest likelihood of all misuse types., Conclusions: Results demonstrated that older adults frequently reported multiple misuse types, highlighting safety concerns. Senior Safe reduced high-risk OTC misuse, especially for older adults younger than 85 years. Cumulatively, these findings provide insights into practice recommendations supported through regulatory guidance., Competing Interests: The authors disclose no conflict of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Background and Objectives: Older adults (≥65 years) are the largest consumers of over-the-counter (OTC) medications and exceptionally vulnerable to the risks of these medications, including adverse drug events (ADEs). However, little is known about how older adults select and use OTCs. This is the first multisite study designed to prospectively quantify the type and intended use of OTCs selected by older adults in community pharmacies where products are purchased., Research Design and Methods: Older adults ( n = 144) were recruited from 10 community pharmacies from a Midwestern health system. Participants were given hypothetical symptoms and asked to select one or more OTCs for self-treatment. They were asked to report how they would use the products at symptom onset and when symptoms persisted or worsened. They also reported their current medication list and health conditions. Participants' OTC selections were evaluated for 4 types of misuse: drug-age, drug-drug, drug-disease, and drug-label., Results: Of the 144 participants, 114 (79%) demonstrated at least one type of misuse when describing how they would use their OTC selections at symptom onset. Drug-drug and drug-label misuse had the highest prevalence. Overall, 26 (18%) and 28 (19%) participants showed only drug-drug or drug-label misuse, respectively. Notably, 55 (38%) of participants demonstrated misuse in 2 or more misuse categories. Misuse potential was exacerbated when participants described treating persistent or worsening symptoms., Discussion and Implications: The results highlight the high prevalence and complexity of OTC misuse in older adults and the need for additional work to improve OTC safety., Competing Interests: None., (© The Author(s) 2024. Published by Oxford University Press on behalf of The Gerontological Society of America.)

Introduction: Community pharmacies, as unique and accessible healthcare venues, are ideal locations to implement interventions aiming to improve patient care. However, these interventions may increase workload or disrupt workflow for community pharmacists, technicians, and other staff members, threatening long-term sustainment. There are growing calls from the field of implementation science to design for intervention sustainment and maintenance by maximizing innovation fit. Senior Safe™, an intervention to facilitate safer over-the-counter (OTC) product selection by older adults, serves as a case study to examine the congruence between Innovation Factors and community pharmacy Inner Context constructs and their implications for workload and sustainment., Methods: Using the Exploration, Preparation, Implementation, Sustainment (EPIS) framework, this qualitative study identified factors surrounding Senior Safe implementation. Semi-structured interviews were conducted with staff from pharmacies where Senior Safe was implemented. Two coders independently analyzed interview transcripts using deductive analysis based on EPIS constructs. Thematic analysis was used to generate three themes that encapsulated innovation fit., Results: Nineteen pharmacy staff members participated, with the majority reporting no significant change in their workload or workflow due to Senior Safe. Interview feedback supported a pre-existing culture of the healthcare system to engage patients, of leadership commitment to patient safety initiatives, and of an amplified role of pharmacy technicians., Discussion and Conclusion: Pharmacy staff interviews revealed congruence between Innovation Factors and Inner Context that likely yielded intervention workload neutrality. This study highlighted the importance for researchers to consider maintenance and sustainability when designing and implementing an intervention and the critical influence of culture and leadership support during this process., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2024 The Authors.)

Background: Community pharmacies are an ideal location to address challenges of over-the-counter medication safety, yet many successful interventions are only tested in a few pharmacies without expansion, creating unrealized opportunities to improve patient care on a larger scale. Scaling up to numerous pharmacies can be challenging because each community pharmacy has unique needs and layouts and requires individualized adaptation., Objectives: This paper reports techniques for (a) adapting a community pharmacy intervention to fit the unique physical layout and patient needs of health system pharmacy sites without increasing staff workload, (b) identifying strategies to gather feedback on adaptations from stakeholders, and (c) developing materials to share with pharmacy champions for them to independently implement and sustain the intervention in their organization., Practice Description: The study team collaborated with Aurora Pharmacy, Inc to develop an intervention designed to increase awareness of safe over-the-counter medication use for older adults., Practice Innovation: Senior Safe, a community pharmacy-based intervention, was designed, implemented, and tested using the Exploration, Preparation, Implementation, and Sustainment implementation framework., Evaluation Methods: Senior Safe was adapted through pilot testing and a randomized control trial. Feedback was collected from key stakeholders, including pharmacy staff, older adults, and a research advisory group., Results: A finalized version of Senior Safe, as well as an implementation package, was provided to Aurora Pharmacy to integrate into all 63 sites., Conclusion: This multiphase study illustrated that refining an intervention is possible and welcomed by pharmacy staff, but it requires time, resources, and funds to create an impactful, sustainable community pharmacy intervention., Competing Interests: Disclosure The authors declare no relevant conflicts of interest or financial relationships., (Copyright © 2023 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

Background: US Veterans are four times more likely to be diagnosed with chronic obstructive pulmonary disease (COPD) compared to the civilian population with no care model that consistently improves Veteran outcomes when scaled. COPD Coordinated Access to Reduce Exacerbations (CARE) is a care bundle intended to improve the delivery of evidence-based practices to Veterans. To address challenges to scaling this program in the Veterans' Health Administration (VA), the COPD CARE Academy (Academy), an implementation facilitation package comprised of five implementation strategies was designed and implemented., Methods: This evaluation utilized a mixed-methods approach to assess the impact of the Academy's implementation strategies on the RE-AIM framework implementation outcomes and the extent to which they were effective at increasing clinicians' perceived capability to implement COPD CARE. A survey was administered one week after Academy participation and a semi-structured interview conducted 8 to 12 months later. Descriptive statistics were calculated for quantitative items and thematic analysis was used to analyze open-ended items., Results: Thirty-six clinicians from 13 VA medical centers (VAMCs) participated in the Academy in 2020 and 2021 and 264 front-line clinicians completed COPD CARE training. Adoption of the Academy was indicated by high rates of Academy session attendance (90%) and high utilization of Academy resources. Clinicians reported the Academy to be acceptable and appropriate as an implementation package and clinicians from 92% of VAMCs reported long-term utilization of Academy resources. Effectiveness of the Academy was represented by clinicians' significant increases (p < 0.05) in their capability to complete ten implementation tasks after Academy participation., Conclusions: This evaluation found that the use of implementation facilitation paired with additional strategies enhanced the capacity of clinicians to implement COPD CARE. Future assessments are needed to explore post-academy resources that would help VAMCs to strategize localized approaches to overcome barriers., (© 2023. The Author(s).)

Background: Although opioid prescribing has recently trended downward, opioid-related overdoses and deaths have drastically increased. Community pharmacists are accessible health care providers who are well positioned to disseminate information on opioid safety and to educate and counsel on medication use, managing adverse events, and proper medication disposal. Patient callbacks facilitate appropriate medication usage. We developed an opioid callback program that provides a framework for pharmacists to follow up with patients with an opioid prescription., Objectives: This study aimed to (1) describe the development of the opioid callback initiative and (2) report results from a pilot test in 2 community pharmacies., Methods: The opioid callback process and data collection forms were collaboratively developed with community pharmacists at each site. Data recorded on the opioid callback forms were descriptively analyzed and chi-square test of independence explored differences by pain durations related to opioid disposal, security, and safety. Participating pharmacy staff were interviewed to identify facilitators and barriers to implementation, as well as opportunities for improvement., Results: Forty-one opioid callbacks were attempted and 36 were completed (87.8%). Pharmacists were statistically significantly more likely to discuss naloxone with patients with chronic pain (89.5%) than those with acute pain (46.2%). Pharmacists reported that the program successfully raised awareness of opioid disposal opportunities and safe opioid practices, including storage and naloxone ownership. They expressed patients' willingness to answer questions and appreciation for the extra attention and care., Conclusion: Community pharmacists are well positioned to address the opioid crisis as access points for medication questions, opioid safety education, opioid disposal, naloxone, and medications for people with an opioid use disorder. This study presents a proof of concept for a pharmacist-led opioid callback program. Expansion could help inform patients about how to use opioids safely, how to treat an opioid overdose, and where to dispose of unused medications., (Copyright © 2023 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

Introduction: The Senior Section is a continuation of a previous intervention that aims to address a gap in medication safety, specifically related to older adult selection and use of over-the-counter medications. The purpose of this paper is to describe the protocol of this study., Methods: This study will occur in three phases: an adaptation phase, an effectiveness phase using a randomized controlled trial, and a sustainment phase. This study will take place in conjunction with administrative leadership and pharmacy sites of a regional Midwest integrated health system. Eye tracking technology will inform the adaptation of the intervention and demonstrate effectiveness in the randomized controlled trial. Following the randomized controlled trial, the health system will implement the intervention without research team support. Fidelity and long-term effectiveness outcomes will be collected to demonstrate sustainment., Discussion: The potential implications of this study are a complete and sustained redesign of the pharmacy setting to include educational and directional materials on medication safety, leading to a decrease in over-the-counter medication misuse in older adults. This project could provide a road map for pharmacy organizations to tailor and adopt the Senior Section, to ultimately reduce inappropriate over-the-counter medication use in older adults., Competing Interests: Declaration of competing interest None., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Medications for opioid use disorder (MOUD), including injectable naltrexone (IN), are part of evidence-based OUD treatments. MOUD access often is limited, especially in rural communities. When authorized to administer non-vaccination injections, pharmacists can increase IN accessibility. However, inadequate reimbursement for pharmacist-administered IN can hinder widespread adoption., Objectives: To pilot test a process to obtain a preliminary estimate of the total costs and time associated with community-pharmacist administered IN., Methods: A purposively-selected sample of key informants at community pharmacies administering IN were surveyed about time and cost for best practice IN activities. Respondents estimated the time to perform activities and average pharmacist/pharmacy technician hourly salary, which were used to calculate administration costs., Results: The approach to estimate time and costs was feasible. Administrative costs (mean = $93, range: $48-$164) and time (mean = 123 min., range: 63-220 min.) to administer IN varied widely. Pharmacists'/pharmacy technicians' roles varied by pharmacy., Conclusions: Pharmacists allocate significant time and resources to administer IN. Insufficient reimbursement may disincentivize pharmacy-involved OUD treatment and ultimately slow needed expansion of MOUD services. Increasing IN services requires engaging pharmacies to expand their practice through educational campaigns, along with a commitment to reimburse the cost of medications and related administration activities., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Introduction: When patients are seen in an ambulatory outpatient clinic, such as their primary care provider's office, the prescriber often stops or discontinues medications. Although medication discontinuations are documented in the clinic's health record, this information may not be communicated to the pharmacy. Within the last decade, CancelRx has attempted to address this issue by sending a message from the clinic to the pharmacy when a medication has been discontinued or changed., Objectives: This project studied pharmacy medication discontinuation workflows and pharmacists' perspectives at 3 UW Health outpatient pharmacies before and after implementation of CancelRx., Methods: CancelRx was implemented at UW Health in October 2017. Pharmacists from 3 outpatient pharmacies were observed at 3 distinct time points. The research team conducted 9 observations 3-months before CancelRx implementation (July 2017). Additionally, 9 observations were completed at 3-months after CancelRx implementation (January 2018) and at 9-months after CancelRx implementation (July 2018). Collective case study and comparative workflow modeling were used in this study. Observation field notes were deductively coded and aggregated to determine task frequency, occurrence, and patterns using an interpretivist theoretical approach., Results: During the study, 106 medication discontinuation instances (referred to as cases) were observed; 28 cases 3-months prior to CancelRx, 59 cases 3-months after CancelRx, and 16 cases 9-months after CancelRx. Medication discontinuation tasks aligned with the predetermined workflow: receiving and investigating the discontinuation messages, matching the message to the medication in the patient's profile and discontinuing it, documenting and communicating the message to others as necessary. After implementing CancelRx, the workflow changed as most pharmacists eliminated the investigating and documenting tasks., Conclusions: This study provided insight into the medication discontinuation workflow in community pharmacies, especially after implementing CancelRx. Organizations are recommended to proactively consider the implications for novel health information technology before implementation to anticipate workflow and pharmacy practice changes and improve acceptance and effectiveness., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2022 The Authors. Published by Elsevier Inc.)

Background: The Grasha-Riechmann teaching styles, which includes three didactic and two prescriptive styles, have been shown to help enhance learning within educational settings. Although an adaption of the Grasha-Riechmann style classification has enabled coaching styles to be identified for use as part of quality improvement (QI) initiatives, research has not examined the styles actually utilized by coaches within a QI initiative or how the styles change overtime when the coach is guiding an organization through change implementation. Interactions between coaches and HIV service organization (HSO) staff participating in a large implementation research experiment called the Substance Abuse Treatment to HIV care (SAT2HIV) Project were evaluated to begin building an evidence base to address this gap in implementation research., Methods: Implementation & Sustainment Facilitation (ISF) Strategy meetings (n = 137) between coaches and HSO staff were recorded and professionally transcribed. Thematic coding classifications were developed from the Grasha-Riechmann framework and applied to a purposively selected sample of transcripts (n = 66). Four coders independently coded transcripts using NVivo to facilitate text identification, organization, and retrieval for analysis. Coaching style use and changes across the three ISF phases were explored., Results: Facilitator and formal authority were the two coaching styles predominately used. Facilitator sub-themes shifted from asking questions and providing support to supporting independent action over time. Coaches' use of formal authority sub-styles shifted notably across time from setting expectations or ensuring preparation to offering affirmation or feedback about changes that the HSO's were implementing. The use of the delegator or personal model coaching styles occurred infrequently., Conclusions: The current research extends implementation research's understanding of coaching. More specifically, findings indicate it is feasible to use the Grasha-Riechmann framework to qualitatively identify coaching styles utilized in a facilitation-based implementation strategy. More importantly, results provide insights into how different coaching styles were utilized to implement an evidence-based practice. Further research is needed to examine how coaching styles differ by organization, impact implementation fidelity, and influence both implementation outcomes and client outcomes., Trial Registration: ClinicalTrials.gov NCT02495402 . Registered on July 6, 2015., (© 2021. The Author(s).)

Background: No interventions have attempted to decrease misuse of over-the-counter (OTC) medications for adults aged 65 years or older (older adults) by addressing system barriers. An innovative structural pharmacy redesign (the Senior Section) was conceptualized to increase awareness of higher-risk OTC medications. The Senior Section contains a curated selection of OTC medications and is close to the prescription department to facilitate pharmacy staff-patient engagement to reduce misuse., Objective: This pilot study examined the Senior Section's effectiveness at influencing OTC medication misuse in older adults., Methods: A pretest-post-test nonequivalent groups design was used to recruit 87 older adults from 3 pharmacies. Using a hypothetical scenario, the participants selected an OTC medication that was compared with their medication list and health conditions, and their reported use was compared with the product labeling. Misuse outcomes comprised drug-drug, drug-disease, drug-age, and drug-label, with 5 subtypes. Patient characteristics were compiled into a propensity score matching logistic regression model to estimate their effects on the Senior Section's association with misuse at pre- or postimplementation., Results: Patient characteristics were uniform between pre- and postimplementation, and, once entered into a propensity score matching model, drug-label misuse (exceeds daily dosage) statistically significantly lessened over time (z = -2.42, P = 0.015). In addition, the Senior Section reduced drug-label misuse (exceeds single dosage) for both the raw score model (z = -6.38, P = 0.011) and the model in which the patient characteristics propensity score was added (z = -5.82, P = 0.011). Despite these limited statistical effects, misuse was found to decrease after implementation for 7 of 11 comparisons., Conclusion: These nascent outcomes begin providing an evidence base to support a well-conceived, pharmacy-based OTC medication-aisle redesign for reducing older adult OTC medication misuse. The Senior Section, when broadly implemented, creates permanent structures and processes to assist older adults to access risk information when selecting safer OTC medications., (Copyright © 2021 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

Background: Opioid use disorder (OUD) is a major public health issue in the United States. Medications for OUD (MOUD), which combines the use of approved medications with counseling and behavioral therapies, represents an evidence-based approach to treat individuals living with an OUD. However, MOUD has not kept up with increased demand and new treatment approaches are needed. One approach is injectable naltrexone, an approved and effective MOUD treatment, provided by pharmacists, who are more geographically accessible and have legal authority to administer it in some states., Objectives: To explore how different community pharmacists provide injectable naltrexone treatment and identify best practices., Methods: An exploratory sequential mixed-methods design was used to investigate pharmacy-based naltrexone injection practices, involving a pharmacist questionnaire and interviews with pharmacists, prescribers, and community stakeholders. An inductive/iterative content analysis approach, guided by an initial straw model, was used to identify and explore conceptual categories for the interviews., Results: The final sample included 68 pharmacy surveys and 14 total interviews with pharmacists (n = 9), prescribers (n = 3), and community stakeholders (n = 2). Pharmacies providing naltrexone injections reported administering over 700 injections in the past year. Interviews revealed benefits and barriers to pharmacist-provided injections and the importance of the prescriber-pharmacist relationship in OUD treatment. Three pharmacy treatment delivery models were identified, compared to the initial straw model, and informed development of a best practices checklist for community pharmacies interested in establishing or expanding a naltrexone injection service., Conclusions: The study demonstrates how community pharmacies developed and implemented a naltrexone injection service. Pharmacists' and prescribers' feedback clearly suggests an untapped interest, as well as resources, in realizing pharmacists' roles as providers of injectable naltrexone treatment. Implementation research could inform the development and evaluation of an intervention based on these best practices to further explore the utility of community pharmacy-based naltrexone injection services., (Copyright © 2020. Published by Elsevier Inc.)

Background: For older adults, health risks from inappropriate use of over-the-counter (OTC) medications represent a prevalent clinical and public health challenge. Focus groups with pharmacists led to the identification of a number of systems barriers to pharmacists supporting the safe selection and use of OTC medications by this population. Such feedback informed the development of the Senior Section™, a physical redesign that located a curated inventory of lower-risk OTC medications proximal to the prescription department., Objectives: To determine whether implementation of the Senior Section resulted in improvements to the ability of pharmacy staff to engage with older adult patients to support OTC medication safety issues., Methods: A qualitative approach, in which pharmacy staff from 4 pharmacies within a single chain participated in a semi-structured interview, was used to evaluate the implementation of the Senior Section in their pharmacies. Interview transcripts underwent a deductive and iterative content analysis., Results: Eight pharmacists and 5 technicians were interviewed. They viewed the Senior Section as contributing to notable improvements in proximity, medication safety, convenience, and patient selection behaviors. The Senior Section's safer OTC inventory and its sectional layout, its relationship to the prescription department, and its signage served to enhance its usefulness as an OTC safety improvement intervention. Moreover, it functioned beneficially while streamlining the coordination of services with between pharmacists and technicians, and did not interfere with existing pharmacy workflows., Conclusions: Pharmacy staff believed that the Senior Section facilitated their ability to engage with older adults to support safe OTC selection and use and thus to reduce OTC-related harms., (Copyright © 2020 Elsevier Inc. All rights reserved.)

The potential risks of over-the-counter (OTC) medications are often aggravated in vulnerable populations, such as older adults. The elevated patterns of older-adult OTC medication use do not necessarily translate into a greater understanding of these medications or their safety implications. The objective of this study was to assess how older adults' knowledge, beliefs, and attitudes inform their decision-making regarding OTC use. Situational interviews were conducted in three community pharmacies with 87 older-adult participants to capture how they intended to use an OTC medication. The interviews were transcribed and qualitatively analyzed, generating seven key themes: (1) medication use concerns; (2) following label instructions; (3) wait time until medication effect; (4) responses to medication not working; (5) decision to stop medication; (6) sources of information; and (7) safety implications. This study shows substantial variations in older-adult OTC medication use while providing insight on factors that influence older adults' appropriate OTC medication use and, in some cases, the potential for harmful effects.

Background and Objectives: Over-the-counter (OTC) medication use has increased safety risks for adults older than 65. Most older adults purchase OTC medications from community pharmacies, where the considerable distance or visual obstructions between the prescription area and OTC aisles undermine pharmacists' ability to assist patients with OTC medication decisions. An innovative redesign of an abbreviated medication section specifically for older adults (called the Senior Section TM ) can facilitate pharmacy staff/patient interaction, potentially improving safe medication selection and use. This study evaluated the impact of the Senior Section on the frequency and content of OTC encounters between pharmacy staff and patients., Research Design and Methods: An intervention mixed-methods design generated data from patient OTC encounters, and interviews with two pharmacists and two technicians, throughout the study. NVivo was used to code interview transcripts, and frequencies and chi-square analyses demonstrated pre/post-intervention comparisons for the OTC encounter variables., Results: After Senior Section implementation, pharmacy staff were more likely to initiate (and be involved in) patient encounters, address more topics or problem/symptoms, provide details about OTC products, discuss appropriateness of OTC use, and discuss medication classes highlighted in the Senior Section. Pharmacy staff were less likely to need to leave the prescription department for extended periods; they also had fewer prolonged encounters or encounters about product location. Importantly, the Senior Section did not impede pharmacy workflow., Discussion and Implications: The Senior Section prompted more frequent, effective, and efficient engagements between pharmacy staff and patients, which may substantially reduce OTC-related harms among older adults., Competing Interests: Conflicts of interest: None, (© Individual authors.)

Purpose: The purpose of this study is to determine the types of content and to what extent that individual State Boards of Nursing (SBON) in the U.S. are providing information and education for nurses to mitigate prescription opioid misuse and diversion by patients and the public., Design: A descriptive, cross-sectional, survey research design was selected., Methods: A survey of the SBON by two investigators, who independently reviewed each SBON website, was completed over a four-week time-period. The websites were explored for resources related to opioids. Links and descriptions were reviewed, then compared for accuracy., Results: All but two SBON had at least some information on the mitigation of prescription opioid misuse and diversion. Minimal information was available regarding the mitigation of opioid misuse and diversion in 18 of the 50 states and DC (35%)., Conclusions: SBON have a responsibility to educate licensees to enable them to assist in the mitigation of opioid misuse and diversion. States have resources like PDMPs, opioid tool-kits, newsletters, announcements, and prescriber guidelines that need to be more numerous, of higher quality, and easier to access. SBON should be commended for the resources that they currently provide, but more can be done for nurses to aid in this endeavor. SBON are positioned to provide education and information for nurses to reduce opioid misuse, and diversion. The SBON websites need to have a link to their PDMP, opioid toolkit, OD treatment, and opioid prescribing guidelines readily accessible by nurses and especially APRNs., (Copyright © 2020 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.)

Purpose: A key challenge regarding the current opioid epidemic is understanding how concerns regarding opioid-related harms affect access to pain management, an essential element of cancer care. In certain regions of the United States where disproportionately high cancer mortality and opioid fatality rates coexist (such as southwest Virginia in central Appalachia), this dilemma is particularly pronounced., Methods: This longitudinal, exploratory, secondary analysis used the Commonwealth of Virginia All Payer Claims Database to describe prescription opioid medication (POM) prescribing patterns and potential harms for adult patients with cancer living in rural southwest Virginia between 2011 and 2015. Descriptive and inferential statistical analyses were conducted at the patient, prescriber, and prescription levels to identify patterns and predictors of POM prescribing and potential harms. To explore geographic patterns, choropleth and heat maps were created., Results: Of the total sample of patients with cancer (n = 4,324), less than 25% were prescribed a Controlled Substance Schedule II POM at least three times in any study year. More than 60% of patients never received a Controlled Substance Schedule II POM prescription. Six hundred fifty-two patients (15.1%) experienced 1,599 hospitalizations for any reason; 10 or fewer patients were admitted for 11 opioid use disorder-related hospitalizations. The main findings suggest potential undertreatment of cancer-related pain; no difference in risk for opioid-related hospitalization on the basis of frequency of POM prescriptions; and geographic disparities where opioid overdoses are occurring versus where POM prescription use is highest., Conclusion: These findings have significant opioid policy and practice implications related to the need for cancer-specific prescribing guidelines, how to optimally allocate health delivery services, and the urgent need to improve data interoperability and access related to POMs.

Objective: This study used an innovative information-gathering approach to provide insight into the nature and structure of pharmacy staff encounters with patients seeking over-the-counter (OTC) medications and revealed specific activities of pharmacy staff around these encounters., Methods: A multistep process was used to develop and standardize an 8-item OTC Encounter Form to document the characteristics of pharmacy staff-patient encounters. The OTC Form contained several domains, including topics discussed and the problems or symptoms identified during the encounter, staff functions during the encounter, and approximate time spent with the patient. Nine pharmacists and 8 technicians used the OTC Form to document patient encounters over 7 consecutive days. Frequency distributions for each OTC Form item are reported., Results: One hundred eleven OTC Forms were completed. Adults aged 65 years or older were involved in 46% of all encounters. Pharmacists provided the only assistance in 41% of encounters and worked in partnership with other pharmacy staff for another 25% of encounters. Many encounters required the pharmacy staff to leave the prescription department, involved discussions about a variety of problems or symptoms, and lasted less than 3 minutes. Although the most prevalent encounter topic was locations of a particular product, about one-third of encounters involved either recommendations about a product or providing information about a product, and 41% involved communications about 2 or more topics. Finally, 11% of encounters generated a nondrug recommendation, and 8% resulted in a referral to a physician., Conclusion: Pharmacists play a key role in ensuring that the benefits of OTC medications outweigh the risks, thereby providing an important resource for patient engagement about safe medication selection and use. Examining the features of OTC encounters creates an evidence base to promote best practices for OTC encounters, increasing pharmacists' ability to help people, especially older adults, navigate the intricacies of OTC medication use, without significantly increasing pharmacy staff workload., (Copyright © 2019 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

Background: Advanced practice registered nurses (APRNs) are essential partners in the management of pain, both in primary care and in pain specialty practices. One of the more controversial treatment practices surrounds the use of opioid analgesic medication for the relief of pain in persons with chronic pain. Although several guidelines have been developed, the extent and impact of APRN knowledge, attitudes, and values about pain management and opioid prescribing practices are not known. In addition, regulatory mandates may encumber APRN scope of pain management practice., Aims: This manuscript describes the development and pilot testing of the Achieving Effective & Safe Opioid Prescribing-APRN (AESOP-APRN) Survey conceptualized to address these topics., Design: Instrument development., Participants/subjects: Advanced practice registered nurses., Methods: Phase I addressed development, content validity determination, and survey refinement. APRN-focused discussion groups, expert review, and analysis of content were conducted. In phase II, pilot testing was conducted to determine reliability., Results: APRNs are aware of regulatory restrictions to practice and potential implications on patient outcomes. The Initial Content Validity Index suggested refinement of survey questions. After content revision, final ratings were acceptable. A sample of APRNs (N = 23) completed the survey. Cronbach's α range (.65-.91) suggests acceptable internal consistency for a new survey., Conclusions: Even at this initial phase, the newly developed AESOP-APRN Survey accurately represents the underlying thematic concepts of interest; however further psychometric analyses are required, and instrument refinement is possible. Additional study should include analysis of members from a variety of health care disciplines, as was the intention of the development of the Core Competencies for Pain Management from which many items were derived., (Copyright © 2019 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.)

Background: A staggering number of Americans are dying from overdoses attributed to prescription opioid medications (POMs). In response, states are creating policies related to POM harm reduction strategies, overdose prevention, and alternative therapies for pain management, such as cannabis (medical marijuana). However, little is known about how the use of cannabis for pain management may be associated with POM use., Purpose: The purpose of this article is to examine state medical cannabis (MC) use laws and policies and their potential association with POM use and related harms., Methods: A systematic literature review was conducted to explore United States policies related to MC use and the association with POM use and related harms. Medline, PubMed, CINAHL, and Cochrane databases were searched to identify peer-reviewed articles published between 2010 and 2017. Using the search criteria, 11,513 records were identified, with 789 abstracts reviewed, and then 134 full-text articles screened for eligibility., Findings: Of 134 articles, 10 articles met inclusion criteria. Four articles were cross-sectional online survey studies of MC substitution for POM, six were secondary data analyses exploring state-level POM overdose fatalities, hospitalizations related to MC or POM harms, opioid use disorder admissions, motor vehicle fatalities, and Medicare and Medicaid prescription cost analyses. The literature suggests MC laws could be associated with decreased POM use, fewer POM-related hospitalizations, lower rates of opioid overdose, and reduced national health care expenditures related to POM overdose and misuse. However, available literature on the topic is sparse and has notable limitations., Conclusions: Review of the current literature suggests states that implement MC policies could reduce POM-associated mortality, improve pain management, and significantly reduce health care costs. However, MC research is constrained by federal policy restrictions, and more research related to MC as a potential alternative to POM for pain management, MC harms, and its impact on POM-related harms and health care costs should be a priority of public health, medical, and nursing research., (Copyright © 2017 Elsevier Inc. All rights reserved.)

In the Republic of Georgia, the incidence and prevalence of cancer are increasing, signifying a growing need for palliative care and pain relief, including with controlled opioid medicines. As a signatory to the Single Convention, the Georgian government has a responsibility to ensure the adequate availability of controlled medicines for medical purposes; however, the consumption of morphine is very low, suggesting a high occurrence of unrelieved pain. In Georgia, palliative care development began in the 2000s including the adoption of a policy document in 2005, the creation of the National Palliative Care Coordinator in 2006, and important changes in Georgian legislation in 2007 and 2008, which served to lay a foundation for improving opioid availability. In 2008, a neurologist from the Sarajishvili Institute of Neurology and Neurosurgery in Tbilisi, and member of the Georgia National Association for Palliative Care, was selected to be an International Pain Policy Fellow to focus on improving opioid availability. Working with colleagues, government officials, and international experts, the Fellow contributed to several improvements to opioid availability, such as 1) positive changes to opioid prescribing legislation, 2) clarification of legislative terminology regarding dependence syndrome, 3) initiating the importation of both sustained-release and immediate-release oral morphine, and 4) improvements in the availability of sustained-release morphine. Despite these varied achievements, morphine consumption remains low in Georgia relative to the estimated amounts needed. The Fellow is continuing to study and understand the barriers that are impeding physician's prescription of opioids and patient's acceptance of them., (Copyright © 2017 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Background: Controlled substance prescription (CSP) use and abuse in the United States has become a public health epidemic. One common and dangerous indicator of abuse involves obtaining CSPs concurrently., Objective: The objective of this study was to identify the prevalence and factors associated with individuals receiving potentially inappropriate concurrent CSPs., Methods: This was a retrospective, cohort analysis using data from the 2013-2014 Texas prescription drug monitoring program (PDMP). Descriptive statistics and a multiple logistic regression analysis were conducted to examine the individual-level and prescription utilization factors associated with individuals obtaining concurrent CSPs., Results: Among Texas residents, 1,640,015 individuals (6.10% of all Texas residents and 15.99% of all CSP utilizers) were identified with at least one concurrent CSP combination. Concurrent opioid prescriptions were found to be the most prevalent concurrent use combination (n = 1,574,572). Having prescriptions for opioids, being ≥18 years of age, utilizing CSPs for >30 days, utilizing greater than one CSP, having a multiple provider episode, and traveling >25 miles to obtain CSPs were all statistically significant predictors of utilizing concurrent CSPs., Conclusion: The study findings indicate a high prevalence of individuals utilizing concurrent CSPs. This practice is concerning when considering that many overdose deaths result from the concurrent use of CSPs. Prescribers should utilize PDMPs to ensure that aberrant prescription drug behaviors, such as the use of concurrent opioids and benzodiazepines do not readily occur.

Objective: Prescription drug abuse has reached epidemic levels, leading to overdose-related morbidity and mortality. Patient and regional-level factors are believed to contribute to higher rates of prescription drug abuse. The objective of this study was to determine the prevalence and factors associated with multiple provider episodes (MPEs) in Texas., Methods: This was a retrospective cohort analysis of data from the Texas Prescription Drug Monitoring Program (PDMP) database, linked with Texas county census data. Descriptive statistics and a multilevel model regression analysis were employed to estimate the prevalence of MPEs and examine the association between individual controlled substance prescription (CSP) utilization and county factors associated with MPEs., Results: Among the 10,381,532 Texas residents utilizing CSPs in 2013, prescription opioids were the most frequently dispensed CSP (38.64%). The prevalence of MPEs was 71.30 per population of 100,000. Of those with MPEs, 76.98% received CSPs for more than 150 days and 11.48% had an average daily morphine equivalent dose (MED) 100 mg/day or higher. Residing in metropolitan areas, traveling more than 100 miles to obtain and fill prescriptions, chronic use of CSPs, younger age, and high MED were all significantly associated with increased risk of MPEs., Conclusions: This study revealed that previous estimates of prescription drug abuse may be drastically underestimated. Prescription drug abuse is a major public health problem in Texas, especially in metropolitan areas. Therefore, prevention efforts need to be addressed at the individual level and through public health and policy legislation., (© 2016 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com)

In response to increased awareness of prescription opioid misuse, abuse, addiction, diversion, and overdose, states have promulgated a large number of public policies intended to regulate the practice of pain medicine. Nearly every state now has at least 1 type of policy; others only provide recommendations to physicians. This article reviews the existing policies and extracts specific provisions within each of them. Although there are many similarities across policies, unique features are found in some and are specifically reviewed. This review can serve as a quick reference for policymakers and as a guide for researchers interested in the impacts of such policies., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Prescription opioid abuse is at epidemic levels. Opioids diverted from friends and family members who have legitimate prescriptions are a major source of abused prescription opioids. Nurses are vital to any effort to combat this public health crisis because they have the opportunity to provide essential anticipatory guidance every time a patient receives prescription medication. The purpose of this article is to inform nurses of the magnitude of opioid diversion, the nonmedical use of opioids, and opioids' inappropriate disposal. The authors propose three potential interventions in which nurses can play a critical role: teaching patients about the risks of opioid diversion, providing patients with information on the safekeeping and proper disposal of opioids, and tracking patients' analgesic use to improve our knowledge of prescription analgesic requirements for pain management. Nurses are in an ideal position to help reverse the occurrence and potentially fatal consequences of prescription opioid diversion.

Lindsey Wahowiak's late-2014 article discussing the status of pain management in the United States references findings from the University of Wisconsin Pain & Policy Studies Group's (PPSG) policy evaluation reports as supporting her conclusions. This commentary clarifies that the PPSG reports do not gauge the extent of pain care in each state, but rather how they relate to the quality of policies governing such treatment. This commentary also further supports Ms. Wahowiak's emphasis that influencing clinical pain outcomes is multifaceted and requires a multifaceted response. Importantly, policy change, along with its broad and continued communication and implementation, should be considered as only one of many crucial elements in providing quality pain management.

Prescription opioids have increasingly been involved in overdose deaths and treatment admissions. Disposal programs may play an important role in curbing this trend. The objectives of this study were to: (1) quantify the prescription opioids returned for disposal to a local take-back program, and (2) explore selected drug characteristics that may predict the quantity of unused opioids. Leftover prescription opioid medications returned for disposal to a community drug take-back event were quantified and analyzed according to controlled substances schedule, formulation, number of active ingredients, and directions for use. Days' supply of medication remaining, calculated using the number of dosage units remaining divided by the maximum number of dosage units per day allowed by the prescriber, was the primary outcome variable. Opioid prescriptions returned for disposal had greater than 60 % of the amount dispensed remaining unused. Short-acting C-II and C-III combination opioids accounted for greater than 80 % of the prescriptions returned. Day supply dispensed was the strongest predictor of day supply remaining, regardless of other drug characteristics. These findings indicate that disposal programs are effective at removing unused medication from patient homes. To reduce leftover medication, prescriber education programs should address the amount to be prescribed. Continual monitoring of quantities prescribed and returned for disposal may be useful in evaluating the effects of these programs on leftover medication. Further research on drug characteristics may inform prescribing practices and reduce leftover medication.

Despite expert recognition that strong opioid analgesics are the cornerstone of treatment for moderate to severe pain, most of the world's 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 Organization's 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.

This commentary relates to the recently published essay in PLOS Medicine, entitled "Untreated Pain, Narcotics Regulation, and Global Health Ideologies." That essay describes regulatory and other systemic barriers preventing the accessibility of opioid analgesics and contributing to patients not receiving adequate pain relief. Four main points highlighted in the essay are discussed in this commentary: (1) the role of international treaties in medication availability; (2) the role of the International Narcotics Control Board in medication availability; (3) the role of regulatory policy in treating pain; and (4) the role of opioid analgesics in treating pain. Recent authoritative statements and activities suggest a strengthened infrastructure within which governments currently can work to improve the availability of controlled medicines to enhance patient pain and palliative care services.

Context: Morphine has been considered the gold standard for treating moderate-to-severe pain, although many new opioid products and formulations have been marketed in the last two decades and should be considered when examining opioid consumption. Understanding opioid consumption is improved by using an equianalgesic measure that controls for the strengths of all examined opioids., Objectives: The research objective was to use a morphine equivalence (ME) metric to determine the extent that morphine consumption relates to the total consumption of all other study opioids., Methods: An ME metric was created for morphine and the aggregate consumption of each study opioid (Total ME), adjusted for country population to allow for uniform equianalgesic comparisons. Graphical and statistical evaluations of morphine use and Total ME consumption trends (between 1980 and 2009) were made for the global and geographic regional levels and selected developed and developing countries., Results: Global morphine consumption rose dramatically in the early 1980s but has been significantly outpaced by Total ME since 1996. As expected, the extent of morphine and Total ME consumption varied notably among regions, with the Americas, Europe, and Oceania regions accounting for the highest morphine use and Total ME in 2009. Developing and least developed countries, compared with developed countries, demonstrated lower overall Total ME consumption., Conclusion: Generally, worldwide morphine use has not increased at the rate of Total ME, especially in recent years. Examining a country's ability to effectively manage moderate-to-severe pain should extend beyond morphine to account for all available potent opioids., (Copyright © 2013 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.)

Background: Many international governmental and nongovernmental organizations regard unrelieved cancer pain as a significant global public health problem. Although opioids such as morphine are considered essential medicines in the provision of palliative care and for treating cancer pain, especially when the pain is severe, low- and middle-income countries often lack such medications., Aim: The primary aim of this study was to examine countries' government and health-care system influences on opioid availability for cancer pain and palliative care, as a means to identify implications for improving appropriate access to prescription opioids., Design: A multivariate regression of 177 countries' consumption of opioids (in milligrams/death from cancer and AIDS) contained country-level predictor variables related to public health, including Human Development Index, palliative care infrastructure, and health system resources and expenditures., Results: Results were highly explanatory (adjusted R(2) = 82%) and Human Development Index was the most predictive variable when controlling for all other factors in the statistical model (B = 11.875, confidence interval = 10.216, 13.534, p < 0.0001)., Conclusions: Study findings demonstrate that a limited number of predictor variables characterizing a country's government and health-care system infrastructure can explain its opioid consumption level, with the greatest influence being very high Human Development Index. However, Human Development Index is not the most policy-relevant factor, and this finding should be reconciled against the reality that many countries with low or medium Human Development Index have succeeded in creating and sustaining a health-care system to strengthen cancer pain care and palliative care, including through the appropriate use of essential prescription opioids.

Background: 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 patient's regular physician is not available or a concurrent painful condition is being cared for by a different practitioner., Purpose: The primary objective of this study was to determine if those patients who used a few prescribers (two to five) in a 1-year period were distinguishable from those who used only one prescriber., Methods: We performed a secondary data analysis of the California Prescription Monitoring Program, the Controlled Substance Utilization Review and Evaluation System, by using data collected during 1999-2007., Results: The group who used a few providers (two to five) differed substantially from those who visited one provider over a 1-year period. However, the dissimilarity did not suggest that these patients were more prone to the abuse of opioids., Conclusions: The decision not to investigate patients who visit a low number of multiple prescribers (two to five) appears to be justifiable. If the number of providers in a given period of time is used to determine if a patient should be challenged as being a "doctor shopper," cutoffs with high specificity (low false-positive rates) should be chosen. Further epidemiologic research is needed to determine the association of the number of prescribers and misuse and/or abuse of opioids., (Copyright © 2011 John Wiley & Sons, Ltd.)

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., (Wiley Periodicals, Inc.)

In 2011, the World Health Organization (WHO) published a series of 21 guidelines to assist governments in improving their national drug control laws, regulations, and administrative procedures to promote the availability of controlled medicines for pain relief and for a variety of acute and chronic diseases and conditions. These guidelines ultimately are designed to encourage the development of policies designed to fulfill a country's dual obligation concerning these medicines: to prevent their abuse, diversion and trafficking while ensuring access for medical and scientific purposes. This article summarizes each guideline and outlines the constituents who can actively participate in making controlled medicines available to the patients who need them. It is hoped that representatives of governments and medical institutions, as well as health care professionals, will commonly and effectively use the revised WHO guidelines as a policy change tool.

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., (Published by Elsevier Ireland Ltd.)

Context: In the United States, physicians' practice is regulated at the state level, with medical board members distinguishing legitimate medical practice from unprofessional conduct. For this process to be effective, regulators should have knowledge and beliefs that conform to current standards of practice and medical understanding. Past research has demonstrated that some board members continue to view the prolonged prescribing of opioid analgesics to treat noncancer pain as being unlawful or unacceptable medical practice, especially when the patient with pain has a history of substance abuse., Objectives: This study was designed to determine whether relevant clinical or policy issues can adequately explain regulators' attitudes about the legality of opioid prescribing for patients with noncancer pain., Methods: A total of 277 questionnaires were obtained from a national sample of medical board members. Using binomial logistic regression procedures, the predictive significance of 12 factors related to four variable domains was explored: 1) beliefs about opioid addiction and diversion, 2) beliefs and knowledge about federal and state policy, 3) clinical beliefs about opioid prescribing, and 4) demographic characteristics., Results: Separate logistic regression models were computed to determine the extent that knowledge and beliefs contribute to attitudes about the legality of chronic opioid therapy for noncancer pain and for noncancer pain with a history of substance abuse. Three variables demonstrated statistical significance in both regression models: 1) characterizing addiction in terms of physiological phenomena, 2) believing regulatory policy is useful to improve pain relief, and 3) incorrectly believing that federal law limits the amount of Schedule II medication that can be prescribed at one time. When considering the legality of prescribing opioids for patients with noncancer pain, the following additional factors had a notable influence: viewing addiction as common when treating pain with opioids (P=0.030), considering it very important for a board to have a regulatory policy about pain treatment (P=0.038), doubting the legitimacy of more than one opioid prescription for a single patient (P<0.0001), and being younger (P=0.038). Alternatively, for patients with noncancer pain and a history of abuse, only one other factor was significant: reporting the adequacy of their training in pain management as "poor" (P=0.012)., Conclusion: Study results showed that the parsimonious regression models used in this study reasonably explained such attitudes. Suggestions were offered for achieving more comprehensive insight about the factors that can shape regulators' attitudes about prescribing legality., (Copyright © 2010 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.)

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., (Copyright 2010 American Pain Society. All rights reserved.)

Objective: Opioid analgesics are the drugs of choice for the treatment of moderate to severe acute and cancer pain. Although their role in the management of chronic pain not related to cancer is controversial, there is increasing evidence for their benefit in certain patient populations., Design: A 32-item survey to assess Wisconsin physicians' knowledge, beliefs, and attitudes toward opioid analgesic use was mailed to 600 randomly selected licensed physicians, resulting in a 36% response rate., Results: Half of the respondents considered diversion a moderate or severe problem in Wisconsin. A majority considered addiction to be a combination of physiological and behavioral characteristics, rather than defining it solely as a behavioral syndrome. Most physicians felt it lawful and acceptable medical practice to prescribe opioids for chronic cancer pain, but only half held this view if the pain was not related to cancer. Fewer physicians considered such prescribing as lawful and generally accepted medical practice if the patient had a history of substance abuse. About two-thirds of physicians were not concerned about being investigated for their opioid prescribing practices, but some admitted that fear of investigation led them to lower the dose prescribed, limit the number of refills, or prescribe a Schedule III or IV rather than a Schedule II opioid., Conclusion: Wisconsin physicians who responded to this survey held many misconceptions about the prescribing of opioids. Such views, coupled with a lack of knowledge about laws and regulations governing the prescribing of controlled substances, may result in inadequate prescribing of opioids with resultant inadequate management of pain.