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Context There are concerns that policies aimed to prevent opioid misuse may unintentionally reduce access to opioids for patients at end-of-life. Objective We assessed trends in opioid prescribing among patients on discharge from the hospital to hospice care. Methods This was a retrospective cohort study among adult (age ≥18 years) patients discharged from a 544-576 bed, academic medical center to hospice care between January 1, 2010 to December 31, 2018. Study data were collected from a repository of patients’ electronic health record data. Our primary outcome was the frequency of opioid prescribing on discharge to hospice care. Our primary exposure was the calendar year of discharge. We also investigated non-opioid analgesic prescribing and stratified opioid prescribing trends by patient characteristics (e.g., demographics, cancer diagnosis, and location of hospice care). Results Among 2,648 discharges to hospice care, mean (standard deviation) age was 65.8 (16.0) years, 46.3% were female, and 58.7% had a cancer diagnosis. Opioid prescribing on discharge to hospice care decreased significantly from 91.2% (95% confidence interval (CI) = 87.1%–94.1%) in 2010 to 79.3% (95% CI = 74.3%–83.5%) in 2018 adjusting for age, sex, cancer diagnosis, and location of hospice care. Prescribing of non-opioid analgesic medications increased over the same time period. Conclusions We observed a statistically significant decreasing trend in opioid prescribing on discharge to hospice care. Further research should aim to confirm these findings and to identify opportunities to ensure optimal pain management among patients transitioning to hospice care.

Background The role pharmacies play in addressing the opioid crisis and drug-related risks such as injection drug use is evolving. Estimating the prevalence of injection drug use at the community level is challenging because of the stigma of drug use. Many community pharmacies sell nonprescription sterile syringes; thus, pharmacy-level sales of injection equipment may be an indicator of drug-related harms and unmet needs of high-risk populations. Objectives To describe, compare, and assess the convergent validity of staff-reported nonprescription syringe (NPS) sales volume and NPS administrative sales data from community pharmacies in Massachusetts (MA) and Rhode Island (RI). Methods This study employed both prospective cross-sectional survey data collection and utilization of administrative pharmacy sales data. Between November 2017 and January 2018, we administered a telephone-based survey to estimate average weekly NPS type and volume for 191 chain pharmacies (CVS Health) located in communities experiencing fatal opioid overdoses above the state’s 2015 annual median rate. For the same time period, we obtained NPS sales data from surveyed pharmacies and all CVS Health pharmacies in the 2 states. We calculated Spearman correlations to assess convergence of average weekly volume between pharmacy staff reports and sales data. Results All pharmacies responded to the survey. Most (98.4%) pharmacies surveyed sold NPS, but 42.0% reported running out of stock monthly or more frequently. Pharmacy staff tended to under-report syringe sales. Staff-reported weekly NPS sales volume was 67,922 versus 70,962 syringes from administrative pharmacy sales data. Spearman correlation between reported and actual NPS sales was 0.40 (95% CI 0.27–0.51). Conclusion The counts of administrative pharmacy syringe sales data in MA and RI indicate high need, substantial volume, and notable access at community pharmacies. Future research should use NPS sales data rather than self-report data to track emerging trends and tailor local responses.

Objective Describe patient attitudes toward opioid treatment agreements (OTAs) and characterize perceptions of their impact on patient care, behavior, communication with prescribers, and engagement with the health care system. Design Qualitative descriptive study. Setting Federally qualified health center with six clinic locations serving a rural population. Subjects Patients were prescribed long-term opioid therapy and were required to sign an OTA through an in-person office visit with a clinical pharmacist. Methods Patients who signed an OTA were recruited to participate in semistructured, in-person, one-on-one interviews. Data were analyzed using immersion-crystallization methods. Results Among the 20 patients recruited, 50% were men; 70% were insured by the state’s Medicaid program; and 85% were using opioids for hip, back, and/or neck pain. Four major themes arose from the interviews. First, individuals who use long-term opioids experience a wide variety of opioid-related fears and stigmas. Second, individuals articulated real or potential benefits from implementing OTAs. Third, opinions differed on whether OTAs affected behavior and reduced opioid misuse and diversion. Finally, individuals provided feedback on the health care system’s OTA implementation process. Conclusions Patients experienced a wide variety of opioid-related fears and stigmas, including how OTA requirements can perpetuate these issues. Despite these feelings, participants articulated real or potential positive outcomes from the use of OTAs, although they were mixed on whether these agreements translated to any behavior changes. If OTAs are to become standard practice, future research is needed to describe the diversity of patient perspectives and experiences with OTAs and to evaluate their effect on patient outcomes.

BACKGROUND: A large proportion of individuals who use heroin report initiating opioid use with prescription opioids. However, patterns of prescription opioid use preceding heroin-related overdose have not been described. OBJECTIVE: To describe prescription opioid use in the year preceding heroin overdose. DESIGN: Case-control study comparing prescription opioid use with a heroin-involved overdose, non-heroin-involved opioid overdose, and non-overdose controls from 2015 to 2017. PARTICIPANTS: Oregon Medicaid beneficiaries with linked administrative claims, vital statistics, and prescription drug monitoring program data. MAIN MEASURES: Opioid, benzodiazepine, and other central nervous system depressant prescriptions preceding overdose; among individuals with one or more opioid prescription, we assessed morphine milligram equivalents per day, overlapping prescriptions, prescriptions from multiple prescribers, long-term use, and discontinuation of long-term use. KEY RESULTS: We identified 1458 heroin-involved overdoses (191 fatal) and 2050 non-heroin-involved opioid overdoses (266 fatal). In the 365 days prior to their overdose, 45% of individuals with a heroin-involved overdose received at least one prescribed opioid compared with 78% of individuals who experienced a non-heroin-involved opioid overdose (p

CE Information Activity Available Online: To access the article and evaluation online, go to https://www.highmarksce.com/mscare. Target Audience: The target audience for this activity is physicians, advanced practice clinicians, nursing professionals, pharmacists, and other health care providers involved in the management of patients with multiple sclerosis (MS). Learning Objectives: Recognize the frequency of utilization of non-DMT medications by MS patients and integrate questions about their use into patient history. Characterize and be mindful of the out-of-pocket cost burden of DMT and non-DMT medication use in patients with MS. Accreditation Statement: In support of improving patient care, this activity has been planned and implemented by The Consortium of Multiple Sclerosis Centers (CMSC) and Intellisphere, LLC. CMSC is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the health care team. This activity was planned by and for the health care team, and learners will receive 0.5 Interprofessional Continuing Education (IPCE) credit for learning and change. For Physicians: The Consortium of Multiple Sclerosis Centers designates this journal-based activity for a maximum of 0.5 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. For Nurses: This activity is awarded 0.5 contact hours of nursing continuing professional development (NCPD) (0.5 of these credits are in the area of pharmacology). For Pharmacists: This knowledge-based activity (UAN JA4008165-9999-22-020-H01-P) qualifies for 0.5 contact hours (0.05 CEUs) of continuing pharmacy education credit. For Physician Assistants: The Consortium of Multiple Sclerosis Centers has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. This activity is designated for 0.5 AAPA Category 1 CME credits. Approval is valid until April 1, 2023. PAs should only claim credit commensurate with the extent of their participation. It is the policy of the Consortium of Multiple Sclerosis Centers to mitigate all relevant financial disclosures from planners, faculty, and other persons that can affect the content of this CE activity. For this activity, all relevant disclosures have been mitigated. Disclosures: Francois Bethoux, MD, editor in chief of the International Journal of MS Care (IJMSC), has served as Physician Planner for this activity. He has disclosed no relevant financial relationships. Alissa Mary Willis, MD, Associate Editor of IJMSC, has disclosed no relevant financial relationships. Daniel Hartung, PharmD, MPH, consults for the National Multiple Sclerosis Society and Sandoz Pharmaceuticals. Leorah Freeman, MD, PhD, has served as a consultant for Genentech, Celgene/Bristol Myers Squibb, EMD Serono, TG Therapeutics, and Novartis; and has received grant/program support from EMD Serono and Genentech. The staff at IJMSC, CMSC, and Intellisphere, LLC who are in a position to influence content have disclosed no relevant financial relationships. Laurie Scudder, DNP, NP, Continuing Education Director CMSC, has served as a planner and reviewer for this activity. She has disclosed no relevant financial relationships. Method of Participation: Release Date: April 1, 2022; Valid for Credit through: April 1, 2023 In order to receive CE credit, participants must: (1) Review the continuing education information, including learning objectives and author disclosures.(2) Study the educational content.(3) Complete the evaluation, which is available at https://www.highmarksce.com/mscare. Statements of Credit are awarded upon successful completion of the evaluation. There is no fee to participate in this activity. Disclosure of Unlabeled Use: This educational activity may contain discussion of published and/or investigational uses of agents that are not approved by the FDA. The CMSC and Intellisphere, LLC do not recommend the use of any agent outside of the labeled indications. The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the CMSC or Intellisphere, LLC. Disclaimer: Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any medications, diagnostic procedures, or treatments discussed in this publication should not be used by clinicians or other health care professionals without first evaluating their patients’ conditions, considering possible contraindications or risks, reviewing any applicable manufacturer’s product information, and comparing any therapeutic approach with the recommendations of other authorities.

Background: In 2017, the United States Comprehensive Addiction and Recovery Act (CARA) expanded authorization to prescribe buprenorphine for opioid use disorder to nurse practitioners (NPs). In contrast to physicians, NPs were required to complete 16 additional hours of training on controlled substance prescribing before a buprenorphine waiver application. As this differential additional education mandate was seen as a potential barrier, we sought to evaluate the impact of this requirement on both waiver acquisition and prescribing of controlled substances, comparing NPs who obtained waivers to those who had not.Methods: Through 2016-2018 Oregon Prescription Drug Monitoring Program and linked NP licensure data, we identify factors associated with waiver acquisition at baseline (2016), and evaluated changes in controlled substance prescribing before (2016) and after waiver acquisition (2018). Using chi-square and Mann-Whitny U testing, we calculated and described controlled substance prescribing types, rates, and patient level quantities including co-prescribing of benzodiazepines and opioids by NPs. Multivariable linear regression compared prescribing by waivered and non-waivered NPs for significant changes in non-buprenorphine controlled substance prescribing.Results: Waivered NPs were more likely to have a psychiatric certification, have prior disciplinary action, and have generally higher levels of non-buprenorphine controlled substance prescribing than their non-waivered counterparts.. While there was a significant increase in opioid prescriptions per patient among waivered NPs, following CARA implementation, co-prescribing of benzodiazepines and opioids significantly declined among waivered NPs relative to non-waivered NPsConclusions: Although educational requirements were rescinded in 2021 for most applicants, enhanced opioid prescribing training should be incorporated into professional educational offerings regardless of regulatory mandate. We recommended continued focus on education regarding avoidance of high risk prescribing such as co-prescribing of opioids and benzodiazepines. NPs who acquire waivers may take on higher risk patients who are already using opioids and these findings may represent transitions in practice and patient setting.

Background Residential treatment is a common approach for treating opioid use disorder (OUD), however, few studies have directly compared it to outpatient treatment. The objective of this study was to compare OUD outcomes among individuals receiving residential and outpatient treatment. Methods A retrospective cohort study used linked data from a state Medicaid program, vital statistics, and the Substance Abuse and Mental Health Services Administration (SAMHSA) Treatment Episodes Dataset (TEDS) to compare OUD-related health outcomes among individuals treated in a residential or outpatient setting between 2014 and 2017. Multivariable Cox proportional hazards and logistic regression models examined the association between treatment setting and outcomes (i.e., opioid overdose, non-overdose opioid-related and all-cause emergency department (ED) visits, hospital admissions, and treatment retention) controlling for patient characteristics, co-morbidities, and use of medications for opioid use disorders (MOUD). Interaction models evaluated how MOUD use modified associations between treatment setting and outcomes. Results Of 3293 individuals treated for OUD, 957 (29%) received treatment in a residential facility. MOUD use was higher among those treated as an outpatient (43%) compared to residential (19%). The risk of opioid overdose (aHR 1.39; 95% CI 0.73–2.64) or an opioid-related emergency department encounter or admission (aHR 1.02; 95% CI 0.80–1.29) did not differ between treatment settings. Independent of setting, MOUD use was associated with a significant reduction in overdose risk (aHR 0.45; 95% CI 0.23–0.89). Residential care was associated with greater odds of retention at 6-months (aOR 1.71; 95% CI 1.32–2.21) but not 1-year. Residential treatment was only associated with improved retention for individuals not receiving MOUD (6-month aOR 2.05; 95% CI 1.56–2.71) with no benefit observed in those who received MOUD (aOR 0.75; 95% CI 0.46–1.29; interaction p = 0.001). Conclusions Relative to outpatient treatment, residential treatment was not associated with reductions in opioid overdose or opioid-related ED encounters/hospitalizations. Regardless of setting, MOUD use was associated with a significant reduction in opioid overdose risk.

Objective To estimate unintended pregnancies averted and the cost effectiveness of pharmacist prescription of hormonal contraception. Methods A decision-analytic model was developed to determine the cost effectiveness of expanding the scope of pharmacists to prescribe hormonal contraception compared with the standard of care and contraceptive access in clinics. Our perspective was that of the payor, Oregon Medicaid. Our primary outcome was unintended pregnancies averted. Secondary outcomes included: costs and quality-adjusted life years (QALYs). Model inputs were obtained from an analysis of Medicaid claims for the first 24 months after policy implementation in Oregon, and the literature. Univariate and bivariate sensitivity analyses, as well as a Monte Carlo simulation, were performed. Results Among Oregon's Medicaid population at risk for unintended pregnancy, the policy expanding the scope of pharmacists to prescribe hormonal contraception averted an estimated 51 unintended pregnancies and saved $1.6 million dollars. Quality of life was also improved, with 158 QALYs gained per 198,000 women. Sensitivity analysis demonstrated that the model was most sensitive to the effect on contraceptive continuation rates. If contraceptive continuation rates among women receiving care from a pharmacist are 10% less than among clinicians, than pharmacist prescription of hormonal contraception will not avert unintended pregnancies. Conclusion Pharmacist prescription of hormonal contraception averts unintended pregnancies and is cost effective. Full implementation of the policy is needed for maximum benefits. Prospective data on the effect of the policy on contraceptive continuation rates are needed.

To describe early utilization of pharmacist prescription of contraception in Oregon's Medicaid program.Using Oregon Medicaid claims data, we conducted a retrospective analysis and quantified overall and monthly trends in pharmacist-prescribed contraceptives from January 1, 2016, to December 31, 2017. Our population was restricted to patients obtaining a new prescription for oral and transdermal methods and who had continuous Medicaid coverage during the study period. We summarized demographic and utilization characteristics, including whether patients were continuing or switching methods or initiating contraception. New prescriptions were those written to patients who did not have one for hormonal contraception in the prior 30 days. To assess program safety, we examined rates of prescriptions to patients with medical contraindications to contraceptive use.Among the 3,614 patients receiving a new prescription for oral or transdermal contraceptives in the Oregon Medicaid program from all health care providers, 367 (10%) received their prescription from a pharmacist. Five months after implementation, pharmacists filled an average of 61 prescriptions per month as the prescriber. Most claims originated from retail chain pharmacies (94%) in urban locations (71%). The majority of patients who were prescribed contraception by pharmacists (73.8%) had no history of contraceptive prescriptions in the preceding 30 days (n=252). Ages ranged from 13 to 49 years, fewer patients lived in a rural location (35.7%), most received a combined hormonal pill (90.5%), and the average day's supply dispensed was 65 (range of 21-364 days). Fewer than 5% (12) of patients had a diagnostic code indicating a possible contraindicating comorbidity.Among Medicaid enrollees, we found that 10% of all new oral and transdermal contraceptive prescriptions were written by pharmacists.

BACKGROUND: Although direct-acting antivirals (DAA) have revolutionized the treatment of chronic hepatitis C virus (HCV), many state Medicaid programs have limited coverage because of their expense. In 2015, the Centers for Medicare & Medicaid Services (CMS) notified states about the legality of Medicaid coverage limitations, particularly within managed care programs. OBJECTIVES: To (1) examine how relaxation and alignment of hepatitis C policies within the Oregon Medicaid program affected DAA utilization and (2) describe changes in DAA coverage policies and patient characteristics of treated individuals over time. METHODS: We manually collected DAA Medicaid drug policies in the state of Oregon before and after the CMS notification was released. After categorizing DAA policies into 2 groups based on baseline prior authorization criteria (restrictive and permissive), we evaluated how changes in these DAA policies affected utilization over 3 time periods (pre-CMS period, post-CMS period, and fibrosis policy alignment). Immediate and gradual changes in trend were assessed using an interrupted time series regression model. Finally, we examined patient characteristics and liver disease complications over time as policy restrictions were removed and aligned with one another. RESULTS: From 2014 to 2018, Oregon's coordinated care organizations and fee-for-service drug policies relaxed liver fibrosis and substance abstinence coverage criteria leading to immediate increases in DAA use in 2016 (0.62 prescriptions per 10,000 enrollees per month; 95% CI = 0.17 to 1.08) and 2018 (1.07 prescriptions per 10,000 enrollees per month; 95% CI = 0.63 to 1.51) among more restrictive coordinated care organizations at baseline. This was followed by a decrease in trend after the 2016 and 2018 impact (-0.05; 95% CI = -0.11 to -0.001 and -0.07; 95% CI = -0.13 to -0.02, respectively). Over the 3 periods, there was a decrease in treated individuals with liver-related complications (P < 0.0001) and an increase in those with a substance use diagnosis (P = 0.0013). CONCLUSIONS: Reducing coverage limitations resulted in treatment of patients with fewer liver-related complications and more substance use disorders. Expanding access to treatment did not result in sustained increases in utilization, and additional interventions may be necessary to meet HCV elimination goals. DISCLOSURES: This study was funded in part by AbbVie Pharmaceuticals, which did not have any role in the study design, collection, analysis and interpretation of data, writing the report, or the decision to submit the report for publication. Hartung received support for his work on this study via a grant from AbbVie Pharmaceuticals. The other authors did not receive any financial support for their contributions to this study. The authors have no other financial disclosures to report. This study was presented at the Academy Health Annual Research Meeting in Washington, DC, on June 3, 2019.

Objective:To determine the association between Medicare Part D Plan disease-modifying therapy (DMT) restrictiveness and adherence and outcomes among people with multiple sclerosis (MS)Methods:We used Medicare claims data from 2010 to 2014 to identify individuals with a full year enrollment (Part A, B, D), an MS diagnosis, and one or more self-administered DMT prescription. Plans were considered restrictive if all available DMTs required a prior authorization or step therapy restriction; otherwise they were considered permissive. We compared DMT adherence, defined as a medication possession ratio (MPR) >=80%, MS-related emergency department (ED) or inpatient admissions, and outpatient visits by Part D plan restrictiveness. We used multivariate regression models to control for patient demographics and comorbidities.Results:There were 37,713 Medicare beneficiaries with MS who were enrolled in either restrictive (n=29,901) or permissive (n=7812) Part D plans during the study period. Patients enrolled in restrictive plans were older (60 versus 58 years; pConclusions:Medicare beneficiaries with MS enrolled in restrictive Part D plans were less adherent to their DMT and had higher rates of MS-related outpatient visits.

This cross-sectional study evaluates opioid prescribing patterns from 2009 to 2018 in a network of community health centers that frequently treat low-income patients in the US., Key Points Question Are there prescribing patterns for opioid medications in safety-net clinics? Findings In this cross-sectional study of 3 227 459 opioid prescriptions abstracted from electronic health records of patients treated at a network of community health centers between January 1, 2009, and December 31, 2018, the number of prescriptions per 100 primary care patients decreased 73.7% from 110.8 in 2009 to 29.1 in 2018. Other metrics of opioid use decreased to a similar degree. Meaning Opioid prescribing in a large network of community health centers decreased from January 1, 2009, to December 31, 2018, which likely reflects a mix of federal, state, and local policies and initiatives directed at reducing harms associated with increased opioid prescribing in the early 2000s., Importance Understanding opioid prescribing patterns in community health centers (CHCs) that disproportionately serve low-income patients may help to guide strategies to reduce opioid-related harms. Objective To assess opioid prescribing patterns between January 1, 2009, and December 31, 2018, in a network of safety-net clinics serving high-risk patients. Design, Setting, and Participants Cross-sectional study of 3 227 459 opioid prescriptions abstracted from the electronic health records of 2 129 097 unique primary care patients treated from 2009 through 2018 at a network of CHCs that included 449 clinic sites in 17 states. All age groups were included in the analysis. Main Outcomes and Measures The following measures were described at the population level for each study year: (1) percentage of patients with at least 1 prescription for an opioid by age and sex, (2) number of opioid prescriptions per 100 patients, (3) number of long-acting opioid prescriptions per 100 patients, (4) mean annual morphine milligram equivalents (MMEs) per patient, (5) mean MME per prescription, (6) number of chronic opioid users, and (7) mean of high-dose opioid users. Results The study population included 2 129 097 patients (1 158 413 women [54.4%]) with a mean (SD) age of 32.2 (21.1) years and a total of 3 227 459 opioid prescriptions. The percentage of patients receiving at least 1 opioid prescription in a calendar year declined 67.4% from 15.9% in 2009 to 5.2% in 2018. Over the 10-year study period, a greater percentage of women received a prescription (13.1%) compared with men (10.9%), and a greater percentage of non-Hispanic White patients (18.1%) received an opioid prescription compared with non-Hispanic Black patients (9.5%), non-Hispanic patients who self-identified as other races (8.0%), and Hispanic patients (6.9%). The number of opioid prescriptions for every 100 patients decreased 73.7% from 110.8 in 2009 to 29.1 in 2018. The number of long-acting opioids for every 100 patients decreased 85.5% during the same period, from 22.0 to 3.2. The MMEs per patient decreased from 1682.7 in 2009 to 243.1 in 2018, a decline of 85.6%. Conclusions and Relevance In this cross-sectional study, the opioid prescribing rate in 2009 in the CHC network was higher than national population estimates but began to decline earlier and more precipitously. This finding likely reflects harm mitigation policies and efforts at federal, state, and clinic levels and strong clinical quality improvement strategies within the CHCs.

RESEARCH OBJECTIVE: The impact of prescribing initiatives that encourage dose reductions is still largely unknown. Our objective was to determine whether the degree of opioid dose reduction among patients with high‐dose chronic opioid treatment (COT) associates with suicide, opioid overdose, other opioid‐related adverse events, or buprenorphine fills. STUDY DESIGN: In this retrospective cohort study, we identified patients with COT in 2014 or 2015 with 12 months of follow‐up to determine opioid dose trajectory and an additional 12 months of follow‐up to identify outcomes. We characterized dose trajectories in 12 months after a period of COT as abrupt discontinuation, dose reduction with discontinuation, dose reduction without discontinuation, and no dose reduction or discontinuation. We also characterized the effect of patient demographics (age, race, gender, rural vs. urban), prescription profile during COT, and diagnoses of alcohol abuse, depression, or any drug abuse. Multivariate logistic regression was used to examine the effect of dose trajectories on suicide (fatal or non‐fatal), opioid overdose (fatal or non‐fatal), other adverse events, and buprenorphine fills in the following year. Other adverse events included a diagnosis of adverse effects, opioid abuse, opioid dependence, or unspecified opioid use diagnosed in outpatient, inpatient (hospital), or emergency department settings. POPULATION STUDIED: We studied 17,990 continuously enrolled Medicaid recipients in Oregon with high‐dose COT. All analyses used the Oregon Medicaid claims data linked with the Oregon Prescription Drug Monitoring Program (PDMP) and vital statistics data sets covering calendar years 2014 to 2017. PRINCIPAL FINDINGS: In the 12 months after the high‐dose COT period, there were 1,328 (7.38%) individuals with an abrupt discontinuation, 2,953 (16.41%) with a dose reduction with discontinuation, 4,282 (23.8%) with a dose reduction without discontinuation, and 9,427 (52.40%) with no dose reduction or discontinuation. Patients who abruptly discontinued had the highest odds of fatal or nonfatal suicide (adjusted odds ratio (aOR) 12.1, 95% confidence interval (CI) 3.5, 41.6), fatal or nonfatal overdose (aOR 2.6, 95% CI 1.4, 4.7), or other adverse events (aOR 2.0, 95% CI 1.4, 2.7). Among those who had an opioid overdose, patients who discontinued opioid use after COT were more likely to overdose on heroin than those who did not discontinue opioid use (P

Access to providers of treatment for opioid use disorder is a critical challenge to confronting the opioid epidemic. In 2017, the Comprehensive Addiction and Recovery Act (CARA) expanded buprenorphine prescribing privileges to nurse practitioners (NP). This research examined the effect of this regulatory change on buprenorphine prescribing in the state of Oregon. We performed an interrupted time‐series (ITS) analysis to examine the effect of CARA implementation (February 2017) on buprenorphine prescribing for medications to treat opioid disorders (MOUD) from January 1, 2016 to December 31, 2018. Specifically, we characterized changes in the trend and patterns of buprenorphine prescribing overall, by prescriber type (NPs vs MD/DO), and geographic designation. Our ITS regression models estimated prepolicy trends, immediate changes after CARA implementation, and changes in trend following implementation. We used Oregon Prescription Drug Monitoring Program data linked to a provider and dispensing characteristic files. Our study sample post‐CARA included 179 NPs with a total of 440 525 buprenorphine prescriptions statewide written by all prescribers. Prior to CARA implementation, the trend in total buprenorphine dispensing was increasing by 149 prescriptions per month (P

Objective\ud \ud To estimate differences in treatment costs and health outcomes between non-myeloablative hematopoietic stem cell transplantation (HSCT) and disease-modifying therapies (DMTs) for the treatment of relapsing-remitting multiple sclerosis (RRMS).\ud \ud \ud Methods\ud \ud We collected data on costs and reimbursements for patients who underwent HSCT for RRMS at Northwestern Memorial Hospital in Chicago (USA) between January 2017 and January 2019. The costs of HSCT were compared against those for DMTs in the United States, obtained from the literature. We also conducted a literature review to interpret the cost comparisons in terms of disease control and patients’ wellbeing defined as no evidence of disease activity (NEDA), neurologic disability by the Expanded Disability Status Scale (EDSS), and quality of life by the short form SF-36, respectively.\ud \ud \ud Results\ud \ud Outside of the data, herein, no other studies on cost of HSCT for RRMS were found in the literature. HSCT mean total costs, based on our own hospital, were $85,184 (range $70,635 to $120,260). Mean revenue collected was $95,268 (range $16,544 to $173,204). In comparison, according to the literature, 2019 DMT costs in the USA ranged from $80,000 to $100,000 per year per patient. Compared to DMTs, studies of HSCT reported greater improvement in no evidence of disease activity, disability, and quality of life.\ud \ud \ud Limitations\ud \ud Costs of HSCT would be expected to vary by conditioning regimen utilized, patient selection, center experience, and regional variation. No cost data on other HSCT regimens or on the three most recently licensed DMTs, alemtuzumab, ocrelizumab, and cladribine, are available. Randomized trials for cost comparisons are missing and variations in HSCT designs, populations, and methodology preclude more precise cost estimates.\ud \ud \ud Conclusion\ud \ud Costs of non-myeloablative HSCT after which DMTs are indefinitely discontinued, are approximately the same cost as those for one year of prescription DMTs. Since DMTs assessed in this analysis are given on an ongoing basis, whilst HSCT is not, HSCT is expected to produce long-term cost-savings. When considered alongside the available clinical evidence, which suggests that HSCT may generate more health gains than DMTs, HSCT is likely to represent a cost-effective use of resources. Model-based health economic analyses are required to substantiate this conclusion.

ObjectiveTo describe recommendations made by an interdisciplinary controlled substance committee and acceptance by primary care providers.DesignRetrospective cohort study.SettingMultisite federally qualified health center using an interdisciplinary committee to provide patient-specific recommendations to prescribers with patients using prescription opioids and other controlled substances.SubjectsPatients prescribed long-term opioids.MethodsWe identified and characterized committee recommendations to prescribers between January 1, 2013, and December 31, 2016. We manually reviewed electronic medical records to determine if recommendations were accepted at eight months. The primary outcome was the overall acceptance rate of recommendations. Secondary outcomes were the acceptance of recommendations to reduce opioid doses and change in opioid dose from baseline.ResultsThe committee made 337 recommendations for 94 patients. Of those, 169 recommendations (50.1%) were accepted within eight months. The most common recommendation was to change opioid prescribing (N = 53, 56.4%), but recommendations varied. For patients with a recommendation to change opioid prescribing, this was accepted in 31 of 53 patients (58.5%). Overall, opioid doses decreased from 60 morphine equivalents per day (interquartile range [IQR] = 27.5–135, range = 5–1,260) at baseline to 40 morphine equivalents per day (IQR = 15–105, range = 0–1,260) at eight months (P ConclusionsAn interdisciplinary committee was well positioned to offer primary care providers with nonopioid options to manage chronic nonmalignant pain and provide support in reducing opioid doses. About half of recommendations were accepted by primary care providers. Future research should focus on strategies to improve the utility of this approach and its impact on clinical outcomes.

PURPOSE: Public and private payers have implemented benefit limitations to reduce high-risk opioid prescriptions. The effect of these policies on the increase of out-pocket payment is unclear. To understand this gap, we compared the discrepancies in trends between opioid prescription fills vs claims among Medicaid beneficiaries. METHODS: Data from the Oregon Prescription Drug Monitoring Program (PDMP) and Oregon Medicaid administrative claims were used to identify Medicaid beneficiaries 18 years and older enrolled at least one full month from 2015 to 2017. Generalized linear models assessed the trends in the monthly rates of opioid PDMP prescription fills and pharmacy claims per 1000 eligible members. Rates by morphine equivalent dose (MED) tier (120 MED) and co-prescribed opioid and benzodiazepine were also assessed. RESULTS: During the study period, an average of 495 355 Medicaid members had 2 797 054 opioid PDMP fills and 2 472 155 opioid Medicaid pharmacy claims. Study participants had 15.4 (95% confidence interval [CI] 13.6 to 17.0; P < .001) more prescriptions per 1000 member per month in the PDMP data (114.1 [SD 7.4]) compared with the Medicaid claims data (98.7 [SD 7.9]). Similarly, there were 1.9 more co-occurring opioid/benzodiazepine prescriptions per 1000 members per month observed in the PDMP data than the Medicaid claims data (95% CI 1.7 to 2.1; P < .001). At each MED tier, the PDMP fills were consistently higher than the claims (P < .001). CONCLUSIONS: Higher rate of fills in the PDMP compared to pharmacy claims suggests that there may be an increasing trend of out-of-pocket payment among Medicaid beneficiaries.

Background Although prescription drug monitoring programs (PDMPs) have been widely implemented to potentially reduce abuse of prescription opioids, there is limited data on variations in PDMP use by prescriber specialty. Such knowledge may guide targeted interventions to improve PDMP use. Methods Using data from Washington state Medicaid program, we performed a retrospective cohort study of opioid prescribers and their PDMP queries between Nov 1, 2013 and Oct 31, 2014. PDMP registration was mandatory for emergency physicians, but not for other providers. The unit of analysis was the prescriber. The primary outcome was any prescriber queries of the PDMP. We used multivariate regression models to identify variations in PDMP queries by prescriber specialty, as well as to explore explanatory pathways for observed variations. Results We studied 17,390 providers who prescribed opioids, including 8718 (50%) who were not registered with PDMP, 4767 (27%) who were registered but had no recorded use of the PDMP, and 3905 (23%) PDMP users (queries/user: median 18, IQR 5–64). Compared to general medicine physicians, PDMP use was higher for emergency physicians (OR 1.4, 95%CI: 1.2–1.7), and lower for surgical specialists (OR 0.1, 95%CI: 0.08–0.1), obstetrician-gynecologists (OR 0.2, 95%CI: 0.1–0.2) and dentists (OR 0.4, 95%CI: 0.4–0.5). Higher use by emergency physicians appeared to be mediated by higher registration rates, rather than by provider level predilection to use the PDMP. Conclusions A minority of opioid prescribers to Medicaid beneficiaries used the PDMP. We identified variations in PDMP use by prescriber specialty. Interventions to increase PDMP queries should target both PDMP registration and PDMP use after registration, as well as specialties with current low use rates.

Background Oregon's Medicaid program is delivered through 16 Coordinated Care Organizations (CCOs) participating in a statewide performance improvement program to reduce high-dose opioid prescribing. CCOs were allowed flexibility to develop their own dose targets and any policies, trainings, guidelines, and/or materials to meet these targets. In this study, we characterize CCO strategies to reduce high-dose opioid prescribing across the 16 CCOs. Methods We reviewed relevant CCO documents and conducted semi-structured interviews with CCO administrators to acquire opioid-related policies, practices, timelines and contextual factors. We applied a systematic coding procedure to develop a comprehensive description of each CCO's strategy. We used administrative data from the state to summarize contextual utilization data for each CCO. Results Most CCOs selected a target daily morphine milligram equivalent (MME) dose of 90 mg. Sixteen issued quantity limits related to dose, eight restricted specific drug formulations (short-acting or long-acting), and 11 allowed for time-limited taper plan periods for patients over threshold. Many CCOs also employed provider trainings, feedback reports, and/or onsite technical assistance. Other innovations included incentive measures, electronic health record alerts, and toolkits with materials on local alternative therapy resources and strategies for patient communication. CCOs leveraging collaborations with regional partners appeared to mount a greater intensity of interventions than independently operating CCOs. Conclusions CCOs developed a diversity of interventions to confront high-risk opioid prescribing within their organization. As healthcare systems mount interventions to reduce risky opioid prescribing, it is critical to carefully describe these activities and examine their impact on process and health outcomes.

Background High dosage opioid use is a risk factor for opioid-related overdose commonly cited in guidelines, recommendations, and policies. In 2012, the Oregon Medicaid program developed a prior authorization policy for opioid prescriptions above 120 mg per day morphine equivalent dose (MED). This study aimed to evaluate the effects of that policy on utilization, prescribing patterns, and health outcomes. Methods Using administrative claims data from Oregon and a control state (Colorado) between 2011 and 2013, we used difference-in-differences analyses to examine changes in utilization, measures of high risk opioid use, and overdose after introduction of the policy. We also evaluated opioid utilization in a cohort of individuals who were high dosage opioid users before the policy. Results Following implementation of Oregon's high dosage policy, the monthly probability of an opioid fill over 120 mg MED declined significantly by 1.7 percentage points (95% confidence interval [CI]; -2.0% to -1.4%), whereas it increased significantly by 1.0 percentage points (95% CI 0.4% to 1.7%) for opioid fills < 61 mg MED. Fills of medications used to treat neuropathic pain also increased by 1.2 percentage points (95% CI 0.7% to 1.8%). The monthly probability of multiple pharmacy use declined by 0.1 percentage points (-0.2% to -0.0) following the prior authorization, but there were no significant changes in ED encounters or hospitalizations for opioid overdose. Among individuals who were using a high dosage opioid before the policy, there was a 20.3 percentage point (95% CI -15.3% to -25.3%) decline in estimated probability of having a high dosage fill after the policy. Conclusions Oregon's prior authorization policy was effective at reducing high dosage opioid prescriptions. While multiple pharmacy use also declined, we found no impact on opioid overdose were observed.

Multiple sclerosis (MS) is a disabling, chronic disease that imposes a significant economic burden on patients and the US healthcare system. The largest cost component for individuals with MS are prescription drugs, specifically disease-modifying therapies (DMTs). Despite an increase in the number and diversity of DMTs over the past 10 years, acquisition costs for all DMTs have escalated dramatically at rates substantially higher than medical inflation. Currently, costs for most DMTs exceed $70,000 a year. Recent cost-effectiveness studies suggest the cost for nearly all DMTs exceeds generally accepted thresholds for what is considered a good value in the USA, even after factoring expected rebates. The high cost of DMTs is symptomatic of systemic dysfunction in the pharmaceutical market. Strategies aimed at reigning in high-cost medications include proposals ranging from increasing pricing transparency to allowing Medicare to negotiate directly with manufacturers. Because the economics of pharmaceuticals are inherently complex, a diversity of approaches will be required.

Objective Washington State mandated seven hospital “best practices” in July 2012, several of which may affect ED opioid prescribing and provide a policy template for addressing the opioid prescription epidemic. We tested the hypothesis that the mandates would reduce opioid dispensing after an ED visit. We further assessed for a selective effect in patients with prior risky or chronic opioid use. Methods We performed a retrospective, observational analysis of ED visits by Medicaid fee-for service beneficiaries in Washington State, between July 1, 2011 to June 30, 2013. We used an interrupted time series design to control for temporal trends and patient characteristics. The primary outcome was any opioid dispensing within 3 days after an ED visit. The secondary outcome was total morphine milligram equivalents (MMEs) dispensed within 3 days. Results We analyzed 266,614 ED visits. Mandates were associated with a small reduction in opioid dispensing after an ED visit (-1.5%, 95%CI: -2.8% to -0.15%). The mandates were associated with decreased opioid dispensing in 42,496 ED visits by patients with prior risky opioid use behavior (-4.7%, 95%CI: -7.1% to -2.3%) and in 20,238 visits by patients with chronic opioid use (-3.6%, 95%CI: -5.6% to -1.7%). Mandates were not associated with reductions in MMEs per dispense in the overall cohort or in either subgroup. Conclusions Washington state “best practice” mandates were associated with small but non-selective reductions in opioid prescribing rates. States should focus on alternative policies to further reduce opioid dispensing in subgroups of high risk and chronic users. This article is protected by copyright. All rights reserved.

Background Out-of-pocket payment for prescription opioids is believed to be an indicator of abuse or diversion, but few studies describe its epidemiology. Prescription drug monitoring programs (PDMPs) collect controlled substance prescription fill data regardless of payment source and thus can be used to study this phenomenon. Objective To estimate the frequency and characteristics of prescription fills for opioids that are likely paid out-of-pocket by individuals in the Oregon Medicaid program. Research Design Cross-sectional analysis using Oregon Medicaid administrative claims and PDMP data (2012 to 2013). Subjects Continuously enrolled nondually eligible Medicaid beneficiaries who could be linked to the PDMP with two opioid fills covered by Oregon Medicaid. Measures Patient characteristics and fill characteristics for opioid fills that lacked a Medicaid pharmacy claim. Fill characteristics included opioid name, type, and association with indicators of high-risk opioid use. Results A total of 33 592 Medicaid beneficiaries filled a total of 555 103 opioid prescriptions. Of these opioid fills, 74 953 (13.5%) could not be matched to a Medicaid claim. Hydromorphone (30%), fentanyl (18%), and methadone (15%) were the most likely to lack a matching claim. The 3 largest predictors for missing claims were opioid fills that overlapped with other opioids (adjusted odds ratio [aOR] 1.37; 95% confidence interval [CI], 1.34-1.4), long-acting opioids (aOR 1.52; 95% CI, 1.47-1.57), and fills at multiple pharmacies (aOR 1.45; 95% CI, 1.39-1.52). Conclusions Prescription opioid fills that were likely paid out-of-pocket were common and associated with several known indicators of high-risk opioid use.

One in three Medicare beneficiaries have diabetes, and 3.1 million require insulin (1). As insulin prices rise (2), one in four people on insulin report reducing use due to cost (3). Insulin price and affordability concerns the 7 in 10 Medicare beneficiaries with Part D drug coverage, which requires significant deductibles and copayments and places no maximum on out-of-pocket costs (4,5). In particular, Medicare Part D has a coverage gap (doughnut hole) whereby beneficiaries pay a percentage of a drug’s price until reaching catastrophic coverage (4). To lower financial burden, the Affordable Care Act incrementally reduced patients’ cost-sharing during the gap from 100% to 25% of drug price (2010 to 2019) (4). Concurrently, manufacturers had to provide greater price discounts during the gap, reaching a 70% discount by 2019 (4). Although patients now pay a lower percentage of a drug’s price, these savings can be counterbalanced by simultaneous price increases. Patients’ cost-sharing during the gap also uses a drug’s full list price and excludes manufacturer rebates that insulate plans from rising prices (2). We examined how patients’ out-of-pocket costs for insulin would have dropped from 2014 to 2019 due to Part D policy changes and whether higher …

ObjectiveTo determine whether closing the Part D coverage gap (donut hole) between 2010 and 2019 lowered patients' out-of-pocket costs for disease-modifying therapies (DMTs) for multiple sclerosis (MS).MethodsUsing nationwide Medicare Formulary and Drug Pricing Files, we analyzed Part D drug benefit design and DMT prices in 2010, 2016, and 2019. We calculated average monthly list prices for DMTs available in each year (4 DMTs in 2010, 11 DMTs in 2016, and 14 DMTs in 2019). We projected patients' annual out-of-pocket cost for each DMT alone under a standard Part D plan in that year. We estimated potential savings attributable to closing the coverage gap between 2010 and 2019 (beneficiaries' cost sharing dropped from 100% to 25%) under 3 scenarios: no increase in price, an inflation-indexed price increase (3% annually), and the observed price increase.ResultsMedian monthly DMT prices rose from $2,804 to $5,987 to $7,009 over the years 2010, 2016, and 2019, respectively. Median projected annual out-of-pocket costs rose from $5,916 to $6,229 to $6,618. With unchanged or inflation-indexed DMT price changes, closing the coverage gap would have reduced annual out-of-pocket costs by $2,260 (38% reduction) and $1,744 (29% reduction), respectively. Despite having the lowest monthly price, generic glatiramer acetate had among the highest out-of-pocket costs ($6,731 to $6,939 a year) in 2019.ConclusionsMedicare Part D beneficiaries can pay thousands of dollars yearly out of pocket for DMTs. Closing the Part D coverage gap did not reduce out-of-pocket costs for patients because of simultaneous increases in DMT prices.

PURPOSE: To identify and systematically categorize opioid dose reductions and discontinuations in large administrative datasets. METHODS: Using a dataset of Oregon Medicaid beneficiaries linked with prescription drug monitoring program (PDMP) data between 2014 and 2017, we identified patients with high-dose chronic opioid therapy (COT), ≥84 consecutive days with an average daily MME of ≥50 on each of those days. We categorized patients into four mutually exclusive groups based on the trajectory of opioid use in the year after COT: abrupt discontinuation, dose reduction and discontinuation, dose reduction without discontinuation, and stable or increasing dose. Finally, we examined prescription patterns in each category. RESULTS: Among individuals with high-dose COT, 7636 (37.1%) had an abrupt discontinuation, 2577 (12.5%) had a dose reduction and discontinuation, 7739 (37.6%) had a dose reduction without discontinuation, and 2623 (12.8%) had a stable or increasing dose in the year following the COT episode. Among those who discontinued opioid use (n = 10 213, 49.6%), three in four (74.8%) did so without evidence of tapering. Patients who discontinued opioid use were younger, had higher daily MME during COT, and were more likely to have filled a benzodiazepine or had a multiple provider or multiple pharmacy episode compared to patients who did not discontinue opioid use. CONCLUSIONS: Dose reductions and discontinuations after a COT episode can be identified in large administrative datasets. Those with a discontinuation were more likely to have riskier prescription profiles during their COT episode.

The global rise in opioid-related harms has impacted the United States severely. Current efforts to manage the opioid crisis have prompted a re-evaluation of many of the existing roles in the healthcare system, in order to maximize their individual effects on reducing opioid-associated morbidity and preventing overdose deaths. As one of the most accessible healthcare professionals in the US, pharmacists are well-positioned to participate in such activities. Historically, US pharmacists have had a limited role in the surveillance and treatment of substance use disorders. This narrative review explores the literature describing novel programs designed to capitalize on the role of the community pharmacist in helping to reduce opioid-related harms, as well as evaluations of existing practices already in place in the US and elsewhere around the world. Specific approaches examined include strategies to facilitate pharmacist monitoring for problematic opioid use, to increase pharmacy-based harm reduction efforts (including naloxone distribution and needle exchange programs), and to involve community pharmacists in the dispensation of opioid agonist therapy (OAT). Each of these activities present a potential means to further engage pharmacists in the identification and treatment of opioid use disorders (OUDs). Through a careful examination of these approaches, we hope that new strategies can be adopted to leverage the unique role of the community pharmacist to help reduce opioid-related harms in the US.

Key Points Question What is the association of industry payments to physicians and prescriptions for repository corticotropin (H. P. Acthar Gel; Mallinckrodt Pharmaceuticals)? Findings In this cross-sectional study of 235 specialist physicians who frequently prescribe corticotropin to Medicare beneficiaries, 207 (88%) received a monetary payment from the drug’s maker, with more than 20% of frequent prescribers receiving more than $10 000. There was a significant association between higher dollar amounts paid to these prescribers and greater Medicare spending on their corticotropin prescriptions. Meaning Financial conflicts of interest among physicians may be driving corticotropin expenditures for the Medicare program., This study uses Medicare Part D and Open Payments data to characterize payments to physicians from the manufacturer of repository corticotropin gel (H. P. Acthar Gel, an ACTH analogue) and associations between those payments and the number of prescriptions and Medicare expenditures for the drug in 2015., Importance Despite great expense and little evidence supporting use over corticosteroids, prescriptions for repository corticotropin (H. P. Acthar Gel; Mallinckrodt Pharmaceuticals) have increased markedly. Aggressive sales tactics and payments from the manufacturer may influence prescribing behavior for this expensive medication. Objective To characterize industry payments to physician specialists who prescribe corticotropin in the Medicare program. Design, Setting, and Participants This study was a cross-sectional analysis of Centers for Medicare & Medicaid Services 2015 Part D prescribing data linked to 2015 Open Payments data. Nephrologists, neurologists, and rheumatologists with more than 10 corticotropin prescriptions (frequent prescribers) in 2015 were included. Exposures Frequency, category, and magnitude of corticotropin-related payments from Mallinckrodt recorded in the Open Payments database. Main Outcomes and Measures Frequency, category, and magnitude of corticotropin-related payments from Mallinckrodt, as well as corticotropin prescriptions and expenditures for Medicare beneficiaries. Results Of the 235 included physicians, 65 were nephrologists; 59, neurologists; and 111, rheumatologists. A majority of frequent corticotropin prescribers (207 [88%]) received corticotropin-related payments from Mallinckrodt. The median (range) total payment for 2015 was $189 ($11-$138 321), with the highest payments ranging from $56 549 to $138 321 across the specialties. More than 20% of frequent prescribers received more than $10 000 and the top quartile of recipients received a median (range) of $33 190 ($9934-$138 321) in total payments per prescriber. Payments for compensation for services other than consulting contributed the most to the total amount. Mallinckrodt payments were positively associated with greater Medicare spending on corticotropin (β = 1.079; 95% CI, 1.044-1.115; P

The US Food and Drug Administration has registered 13 multiple sclerosis (MS) disease-modifying therapies (DMTs). The medications are not interchangeable as they vary in route of administration, efficacy, and safety profile. Selecting the appropriate MS DMT for individual patients requires shared decision-making between patients and neurologists. To reduce costs, insurance companies acting through pharmacy benefit companies restrict access to MS DMTs through tiered coverage and other regulations. We discuss how policies established by insurance companies that limit access to MS DMTs interfere with the process of shared decision-making and harm patients. We present potential actions that neurologists can take to change how insurance companies manage MS DMTs.

Purpose To characterize disease burden and medication usage in rural and urban adults aged ≥85 years. Methods This is a secondary analysis of 5 years of longitudinal data starting in the year 2000 from 3 brain-aging studies. Cohorts consisted of community-dwelling adults: 1 rural cohort, the Klamath Exceptional Aging Project (KEAP), was compared to 2 urban cohorts, the Oregon Brain Aging Study (OBAS) and the Dementia Prevention study (DPS). In this analysis, 121 participants were included from OBAS/DPS and 175 participants were included from KEAP. Eligibility was determined based on age ≥85 years and having at least 2 follow-up visits after the year 2000. Disease burden was measured by the Modified Cumulative Illness Rating Scale (MCIRS), with higher values representing more disease. Medication usage was measured by the estimated mean number of medications used by each cohort. Findings Rural participants had significantly higher disease burden as measured by MCIRS, 23.0 (95% CI: 22.3-23.6), than urban participants, 21.0 (95% CI: 20.2-21.7), at baseline. The rate of disease accumulation was a 0.2 increase in MCIRS per year (95% CI: 0.05-0.34) in the rural population. Rural participants used a higher mean number of medications, 5.5 (95% CI: 4.8-6.1), than urban participants, 3.7 (95% CI: 3.1-4.2), at baseline (P < .0001). Conclusions These data suggest that rural and urban Oregonians aged ≥85 years may differ by disease burden and medication usage. Future research should identify opportunities to improve health care for older adults.

Objective: To examine the pricing trajectories in the United States of disease-modifying therapies (DMT) for multiple sclerosis (MS) over the last 20 years and assess the influences on rising prices. Methods: We estimated the trend in annual drug costs for 9 DMTs using published drug pricing data from 1993 to 2013. We compared changes in DMT costs to general and prescription drug inflation during the same period. We also compared the cost trajectories for first-generation MS DMTs interferon (IFN)–b-1b, IFN-b-1a IM, and glatiramer acetate with contemporaneously approved biologic tumor necrosis factor (TNF) inhibitors. Results: First-generation DMTs, originally costing $8,000 to $11,000, now cost about $60,000 per year. Costs for these agents have increased annually at rates 5 to 7 times higher than prescription drug inflation. Newer DMTs commonly entered the market with a cost 25%–60% higher than existing DMTs. Significant increases in the cost trajectory of the first-generation DMTs occurred following the Food and Drug Administration approvals of IFN-b-1a SC (2002) and natalizumab (reintroduced 2006) and remained high following introduction of fingolimod (2010). Similar changes did not occur withTNF inhibitorbiologics during these time intervals.DMT costs inthe United States currently are 2 to 3 times higher than in other comparable countries. Conclusions: MS DMT costs have accelerated at rates well beyond inflation and substantially above rates observed for drugs in a similar biologic class. There is an urgent need for clinicians, payers, and manufacturers in the United States to confront the soaring costs of DMTs. Neurology® 2015;84:1–8

Objective The pharmacist’s role and responsibilities in addressing the opioid epidemic have yet to be clearly defined, particularly from the patient’s point of view. This qualitative study explores the pharmacist’s role in promoting opioid safety from the perspective of pharmacists and patients. Design Focus groups. Setting Patient groups were held in person, and pharmacist groups were held online. Subjects Oregon pharmacists (N = 19, Mage = 39.0 years, range = 26–57 years, 58% female) and patients (N = 18, Mage = 60.1 years, range = 30–77 years, 71% female) with current experience dispensing or receiving opioid medications. Methods Pharmacists were asked about the challenges and opportunities for opioid safety monitoring and prescription dispensing. Patients were asked about their experiences accessing care, medications, and safety information. Focus group data were analyzed by a multidisciplinary team using an immersion-crystallization approach. Results Pharmacists and patients agreed that pharmacists are responsible for medication safety. Pharmacists expressed discomfort filling potentially high-risk opioid prescriptions and noted barriers such as lack of clinical information and discomfort policing high-risk prescribing. Patients were concerned about pharmacists potentially overstepping their professional responsibilities by interfering with prescribers’ clinical decisions. Conclusions Feedback from both pharmacists and patient participants suggests that there is uncertainty in the degree to which pharmacists can and should confront the prescription opioid epidemic directly. Ambiguities in the pharmacist’s role may be best clarified through structured training promoting enhanced between-party communication.

Study objective We assess whether an automated prescription drug monitoring program intervention in emergency department (ED) settings is associated with reductions in opioid prescribing and quantities. Methods We performed a retrospective cohort study of ED visits by Medicaid beneficiaries. We assessed the staggered implementation (pre-post) of automated prescription drug monitoring program queries at 86 EDs in Washington State from January 1, 2013, to September 30, 2015. The outcomes included any opioid prescribed within 1 day of the index ED visit and total dispensed morphine milligram equivalents. The exposure was the automated prescription drug monitoring program query intervention. We assessed program effects stratified by previous high-risk opioid use. We performed multiple sensitivity analyses, including restriction to pain-related visits, restriction to visits with a confirmed prescription drug monitoring program query, and assessment of 6 specific opioid high-risk indicators. Results The study included 1,187,237 qualifying ED visits (898,162 preintervention; 289,075 postintervention). Compared with the preintervention period, automated prescription drug monitoring program queries were not significantly associated with reductions in the proportion of visits with opioid prescribing (5.8 per 1,000 encounters; 95% confidence interval [CI] –0.11 to 11.8) or the amount of prescribed morphine milligram equivalents (difference 2.66; 95% CI –0.15 to 5.48). There was no evidence of selective reduction in patients with previous high-risk opioid use (1.2 per 1,000 encounters, 95% CI –9.5 to 12.0; morphine milligram equivalents 1.22, 95% CI –3.39 to 5.82). The lack of a selective reduction in high-risk patients was robust to all sensitivity analyses. Conclusion An automated prescription drug monitoring program query intervention was not associated with reductions in ED opioid prescribing or quantities, even in patients with previous high-risk opioid use.

Study objective The link between prescription opioid shopping and overdose events is poorly understood. We test the hypothesis that a history of prescription opioid shopping is associated with increased risk of overdose events. Methods This is a secondary analysis of a linked claims and controlled substance dispense database. We studied adult Medicaid beneficiaries in 2014 with prescription opioid use in the 6 months before an ambulatory care or emergency department visit with a pain-related diagnosis. The primary outcome was a nonfatal overdose event within 6 months of the cohort entry date. The exposure of interest (opioid shopping) was defined as having opioid prescriptions by different prescribers with greater than or equal to 1-day overlap and filled at 3 or more pharmacies in the 6 months before cohort entry. We used a propensity score to match shoppers with nonshoppers in a 1:1 ratio. We calculated the absolute difference in outcome rates between shoppers and nonshoppers. Results We studied 66,328 patients, including 2,571 opioid shoppers (3.9%). There were 290 patients (0.4%) in the overall cohort who experienced a nonfatal overdose. In unadjusted analyses, shoppers had higher event rates than nonshoppers (rate difference of 4.4 events per 1,000; 95% confidence interval 0.8 to 7.9). After propensity score matching, there were no outcome differences between shoppers and nonshoppers (rate difference of 0.4 events per 1,000; 95% confidence interval –4.7 to 5.5). These findings were robust to various definitions of opioid shoppers and look-back periods. Conclusion Prescription opioid shopping is not independently associated with increased risk of overdose events.

Through improved adherence, once-monthly injectable extended-release naltrexone (XR-NTX) may provide an advantage over other oral agents approved for alcohol and opioid dependence treatment. The objective of this study was to evaluate cost and utilization outcomes between XR-NTX and other pharmacotherapies for treatment of alcohol and opioid dependence. Published studies were identified through comprehensive search of two electronic databases. Studies were included if they compared XR-NTX to other approved medicines and reported economic and healthcare utilization outcomes in patients with opioid or alcohol dependence. We identified five observational studies comparing 1,565 patients using XR-NTX to other therapies over six months. Alcohol dependent XR-NTX patients had longer medication refill persistence versus acamprosate and oral naltrexone. Healthcare utilization and costs was generally lower or as low for XR-NTX-treated patients relative to other alcohol dependence agents. Opioid dependent XR-NTX patients had lower inpatient substance abuse-related utilization versus other agents and $8170 lower total cost versus methadone.

Background: Academic medical centers are examining relationships with the pharmaceutical industry and making changes to limit interactions. Most doctors, however, practice outside of academic institutions and see pharmaceutical detailers and accept drug samples and gifts. Little guidance for practicing physicians exists about transforming practices to become pharma-free. Consideration must be given to the impact on practice culture, staff views, and patient needs. Methods: A small private practice, setting out to transform into a pharma-free clinic, used a practice transformation process that examined the industry presence in the clinic, educated the doctors on potential conflicts of interest, and improved practice flow. Staff were given the opportunity to share concerns, and their issues were acknowledged. Educational interventions were developed to help providers keep current. Finally, efforts were made to educate patients about the policy. Results: The clinic recorded the degree to which it was detailed. Loss of gifts, keeping current with new drugs, and managing without samples were noted concerns. Policy change champions developed strategies to address concerns. Discussion: A shift in practice culture to a pharma-free clinic is achievable and maintainable over time. Barriers to success can be identified and overcome with attention given to careful gathering of information, staff input, and stakeholder education. (J Am Board Fam Med 2013;26:332‐338.)

This study examined the distribution of opioid prescribing across providers and patients and the extent to which concentrated distribution predicts opioid misuse.Using 2013 Oregon Medicaid claims and the National Provider Identifier Registry, this study identified patients who filled at least one opioid prescription and providers who prescribed opioids for those patients (N=61,477 Medicaid beneficiaries). This study examined the distribution of opioid prescriptions by provider and patient, the extent to which high-volume opioid use was associated with potential opioid misuse, and how this association changed when patients received opioids from providers in the top decile of morphine-equivalent doses (MEQ) prescribed in 2013. This study used four indicators of opioid misuse: doctor and pharmacy shopping for opioid prescriptions, opioid prescription overlap, and opioid and benzodiazepine prescription overlap.Opioid use and prescriptions were heavily concentrated among the top 10% of opioid users and prescribers. Those high-volume opioid users and prescribers accounted for, respectively, 83.2% and 80.8% in MEQ of entire opioids prescribed. Patients' increasing use of opioids (by MEQ) was associated with most measures of opioid misuse. Patients receiving opioids from high-volume prescribers had a higher probability of opioid prescription overlap and opioid and benzodiazepine prescription overlap compared with other patients, but the difference was significant only among patients who received high doses of opioids, and the size of the difference was modest.Whereas current policies emphasize reducing opioid prescriptions across all patients and providers, study results suggest that focusing policies on high-volume opioid users and prescribers may be more beneficial.

Background: Controversy exists about the safety of substituting generic anti-epileptic drugs (AEDs). Lamotrigine, the prototypical newer AED, is often used for psychiatric and neurological conditions other than epilepsy. The safety of generic substitution of lamotrigine in diverse populations of AED users is unclear. Objective: The objective of this study was to evaluate potential associations between generic substitution of lamotrigine and adverse consequences in a population of diverse users of this drug. Study Design: This study was a retrospective cohort-crossover design using state Medicaid claims data from July 2006 through June 2009. Methods: Subjects were included in the cohort if they converted from brand to generic lamotrigine and had 2 years of lamotrigine use prior to conversion. The frequency of emergency department (ED) visits, hospitalizations and condition-specific ED visits or hospitalizations were recorded in the 60 days immediately following the conversion to generic lamotrigine, then compared with the incidence of the same events during a randomly selected time period indexed to one of the patient’s past refills of branded lamotrigine. Multi-variate conditional logistic regression was used to quantify the association between generic conversion and health services utilization while controlling for changes in lamotrigine dose and concurrent drug use. Results: Of the 616 unique subjects included in this analysis, epilepsy was the most common diagnosis (41%), followed by bipolar disorder (32%), pain (30%) and migraine (18%). Conversion to generic lamotrigine was not associated with a statistically significant increase in the odds of an ED visit (adjusted odds ratio [AOR]=1.35; 95% confidence interval [CI] 0.92, 1.97), hospitalization (AOR=1.21; 95% CI 0.60, 2.50) or condition-specific encounter (AOR 1.75; 95 CI 0.87, 3.51). Conclusions: A statistically significant increase in ED visits, hospitalizations or condition-specific encounters was not observed following the switch from brand to generic lamotrigine, although a type II error cannot be ruled out.

Comparative effectiveness research fundamentally reorients how clinical evidence is generated and used with the goal of providing actionable information to decision-makers. To achieve this, it is vital that decision-makers and the research enterprise are engaged from research inception, to evidence generation and translation. Practice-based research networks are affiliated clinicians in diverse communities with the goal of conducting research to improve care. Practice-based research networks have the potential to advance all phases of the comparative effectiveness research cycle. The aim of this paper is to explore current and potential roles of practice-based research networks in conducting comparative effectiveness research.