Pharmacy staff-reported adaptations to naloxone provision and over-the-counter (OTC) syringe sales during the COVID-19 pandemic: Experiences across multiple states and 2 pharmacy chains.

BACKGROUND: Access to harm reduction materials was greatly disrupted during coronavirus disease 2019 (COVID-19). Community pharmacies often continued provision of harm reduction materials as part of their usual operations during the pandemic, but little is known about what, if any, adaptations were made and the perceived impact of these actions from the perspective of pharmacy staff. OBJECTIVES: We explored how pharmacy staff across 4 states in 2 major pharmacy chains adapted to the COVID-19 pandemic for ongoing naloxone and over-the-counter (OTC) syringe access and how staff perceived the pandemic affected drug use in the community they served and their pharmacy's volume of syringe sales and naloxone provision. METHODS: We analyzed 134 pharmacy staff responses to a 12-month follow-up assessment for an educational intervention conducted in 2 pharmacy chains in Oregon, Washington, Massachusetts, and New Hampshire. Respondents answered closed- and open-ended questions collected online from July 2020 to February 2022. Questions measured prevalence of adaptations and perceived uptake of naloxone and OTC syringe services. Descriptive statistics summarized adaptations and perceived impact and chi-square tests explored differences by state and pharmacy chain. Open-ended responses were reviewed and analyzed to identify summary points and themes. RESULTS: With few differences by state or pharmacy chain detected, pharmacy staff reported more naloxone mailing, requests by phone, streamlined counseling, and drive-thru provision adaptations to OTC syringe sales and naloxone provision during the pandemic. Most staff perceived adaptations as increasing or maintaining naloxone provision and OTC syringe sales. Respondents described specific aspects of the pharmacy that contributed to successful adaptations, including tailoring to specific product demand, inventory levels, drive-thru access, and a perception of extraordinary public health need at a time of and in places affected by the opioid crisis. CONCLUSIONS: Pharmacy OTC syringe and naloxone access continued during the COVID-19 pandemic through streamlining workflows and innovating no-contact harm reduction services, reinforcing pharmacy's public health role.

Examining the effects of COVID-19 on pharmacy dispensing of naloxone and syringes sales across Massachusetts and New Hampshire.

BACKGROUND: Coronavirus disease 2019 (COVID-19) lockdowns disrupted access to harm reduction supplies and services known to be effective in overdose prevention and contributed to a worsening of the opioid crisis. However, because pharmacies can provide naloxone and sell over-the-counter (OTC) sterile syringes, their continued operation throughout the pandemic potentially reinforced a public health role as a distribution hub for safer use supplies. OBJECTIVES: The objective of this analysis was to examine patterns of naloxone and OTC syringe sale volume at 463 community pharmacies in 2 states with high overdose rates during the COVID-19 pandemic. METHODS: We analyzed weekly pharmacy-level dispensing data from January 5, 2020, to December 31, 2020, from one corporate community pharmacy chain in Massachusetts (n = 415 pharmacies) and New Hampshire (n = 48 pharmacies). Descriptive statistics and visualizations over the analytical period were generated as initial explorations of the outcome. Zero-inflated Poisson and negative binomial models were used to analyze distribution data along with county-level COVID-19 case rates and store-level COVID-19 testing location status during the same time. Interactions tested the effect of COVID-19 case rates on naloxone and OTC syringe sales. RESULTS: Pharmacies that reported selling nonprescription syringes and dispensing naloxone during the study period averaged 210.13 OTC syringes sold and 0.53 naloxone prescriptions per week. Pharmacies in communities that experienced greater COVID-19 case burden also exhibited higher naloxone dispensing and OTC syringe sales during this period. The odds of selling OTC syringes increased over time but naloxone dispensing remained constant over the pandemic year. Pharmacies hosting COVID-19 testing tended to have lower OTC syringe sales and naloxone provision than nontesting sites. CONCLUSION: During the COVID-19 pandemic, pharmacies provided harm reduction services and dispensed lifesaving medications by quickly adapting to fulfill community needs without disrupting co-located services for COVID-19 response.

"Like it was just everyday business": A qualitative study of pharmacy-based naloxone and syringe customer experience.

BACKGROUND: As rates of overdoses involving opioids continue to rise in the United States, community pharmacies are uniquely positioned as a central access point of care for individuals to access harm reduction supplies, such as naloxone and nonprescription syringes (NPS). OBJECTIVES: This study aimed to identify the facilitators and barriers of obtaining naloxone and NPS at community pharmacies that participated in Respond to Prevent (R2P), a multicomponent intervention to increase dispensing rates of naloxone, buprenorphine, and NPS. METHODS: Pharmacy customers were recruited to participate in semistructured qualitative interviews conducted immediately after they obtained, or attempted to obtain, naloxone and NPS (when applicable) from R2P-participating pharmacies. Thematic analysis was conducted on the transcribed interviews, and content coding was applied to ethnographic notes and text messages from participants. RESULTS: Of the 32 participants, most (n = 28, 88%) successfully obtained naloxone and most of those seeking NPS successfully (n = 14, 82%) purchased them as well. Participants reported positive overall experiences at the community pharmacies. Participants described using the intervention advertising materials, as designed, to facilitate the request for naloxone. Many participants shared that they felt respected by pharmacists and that they valued naloxone counseling sessions that were tailored to meet their needs and allowed space for them to ask questions. Barriers included experiences where the intervention did not address structural challenges that prohibited the purchase of naloxone and where certain types of staff lacked knowledge, treated participants poorly, or did not adequately provide expected naloxone counseling. CONCLUSION: Pharmacy customer experiences obtaining naloxone and NPS in R2P-participating pharmacies identify facilitators and barriers to access that may be used to reform implementation and future interventions. Barriers identified can help enhance strategies or inform policies to improve pharmacy-based harm reduction supply distribution not addressed through existing interventions.

Readiness of community pharmacies to implement an opioid safety intervention.

BACKGROUND: We report on efforts to measure readiness to adopt opioid safety initiatives in community pharmacies within 2 large chains. Previous studies identified lack of knowledge, confidence, or enthusiasm in addressing harm reduction efforts. We implemented an intervention that provided training to improve opioid safety. The goal was to increase naloxone prescribing and nonprescription syringe sales, reduce stigma, and decrease opioid overdoses among patients and customers. OBJECTIVES: To assess pharmacy readiness for intervention delivery, by characterizing pharmacy culture around opioid safety; describing current practices and challenges interacting with patients and customers on naloxone, nonprescription syringe sales, and buprenorphine; and determining pharmacy defined goals for implementing the intervention. METHODS: The sample included pharmacy managers and staff pharmacists from 2 large chains who completed a brief phone interview. Interviews consisted of Likert-scale and open-ended, theoretically driven questions. Questions focused on workplace culture, patient engagement, naloxone and buprenorphine prescribing, nonprescription syringe sales, and intervention goals. Coding categories for the open-ended questions were derived using a thematic review of responses. RESULTS: A total of 163 respondents described both workplace culture and how they encourage patient opioid safety as including public health awareness, patient engagement, and naloxone prescribing. Sale of nonprescription syringes exhibited high variability: no sales barriers (53.9%), sales with barriers (21.5%), and no sales (20.9%). Half of pharmacists (50.3%) interacted with buprenorphine prescribers outside of medication fills. Most respondents (68.7%) endorsed being ready to promote the intervention. Pharmacists named goals in adopting the intervention of wanting more knowledge and educational materials, talking points with patients, and best practices for offering naloxone. CONCLUSION: Community pharmacists, before implementation, described awareness of and receptiveness to opioid safety initiatives, with substantial barriers around nonprescription syringe sales. Assessed knowledge level, culture, and identified barriers that emerged in the readiness assessments can be used to tailor future pharmacy-specific programming.

Implementation of an academic detailing intervention to increase naloxone distribution and foster engagement in harm reduction from the community clinician.

BACKGROUND: Respond to Prevent (R2P) is a randomized clinical trial which sought to accelerate distribution of naloxone and other harm reduction materials from community pharmacies. R2P combined an online continuing education course with in-store materials, specifically designed for use in community pharmacies, and then supported implementation through the one-on-one educational technique of academic detailing. OBJECTIVE: The objective of this paper is to describe and synthesize our experiences providing academic detailing as part of the R2P randomized trial. METHODS: Closed-ended items from standardized post detailing questionnaires were analyzed with descriptive statistics. Open-ended items were content analyzed for key themes using immersion-crystallization qualitative methods. RESULTS: A total of 176 pharmacies participated in R2P with 175 receiving their initial academic detailing visit between August 2019 and May 2021. Initial visits were in-person and lasted a median of 35 minutes (interquartile range, 20-45 minutes). The R2P naloxone guide was the most common topic covered (n = 162, 92.6%). Following a fidelity check to assess adequacy of the R2P program implementation, 80 pharmacies (45.7%) required secondary academic detailing. Secondary detailing was more targeted and most frequently focused on the sale of nonprescription syringes (n = 28; 35.2%) or disposal container distribution (n = 30; 37.5%). Analysis of the open-ended items identified factors that the detailers perceived to affect the quality of academic detailing sessions, including the pharmacy environment, participant knowledge of and attitudes toward the subject matter, and ability of the detailer to remain flexible yet consistent. CONCLUSION: R2P provided a standardized process to foster naloxone distribution and engagement in harm reduction with demonstrated implementation in 175 community pharmacies across 4 states. Academic detailing was perceived to be well-received and effective at providing education and promoting distribution of naloxone and nonprescription syringes in community pharmacies. Additional research is needed to confirm these perceptions through evaluation post-intervention behavioral and attitude changes.

Evaluation of a Medicaid performance improvement project to reduce high-dose opioid prescriptions.

BACKGROUND: In 2015, Oregon's Medicaid program implemented a performance improvement project to reduce high-dose opioid prescribing across its 16 coordinated care organizations (CCOs). The objective of this study was to evaluate the effect of that program on prescription opioid use and outcomes. METHODS: Using Medicaid claims data from 2014 to 2017, we conducted interrupted time-series analyses to examine changes in the prescription opioid use and overdose rates before (July 2014 to June 2015) and after (January 2016 to December 2017) implementation of Oregon's high-dose policy initiative (July 2015 to December 2015). Prescribing outcomes were: 1) total opioid prescriptions 2) high-dose [> 90 morphine milligram equivalents per day] opioid prescriptions, and 3) proportion of opioid prescriptions that were high-dose. Opioid overdose outcomes included emergency department visits or hospitalizations that involved an opioid-related poisoning (total, heroin-involved, non-heroin involved). Analyses were performed at the state and CCO level. RESULTS: There was an immediate reduction in high dose opioid prescriptions after the program was implemented (- 1.55 prescription per 1000 enrollee; 95% CI - 2.26 to - 0.84; p < 0.01). Program implementation was also associated with an immediate drop (- 1.29 percentage points; 95% CI - 1.94 to - 0.64 percentage points; p < 0.01) and trend reduction (- 0.23 percentage point per month; 95% CI - 0.33 to - 0.14 percentage points; p < 0.01) in the monthly proportion of high-dose opioid prescriptions. The trend in total, heroin-involved, and non-heroin overdose rates increased significantly following implementation of the program. CONCLUSIONS: Although Oregon's high-dose opioid performance improvement project was associated with declines in high-dose opioid prescriptions, rates of opioid overdose did not decrease. Policy efforts to reduce opioid prescribing risks may not be sufficient to address the growing opioid crisis.

Study protocol for the Respond to Prevent Study: a multi-state randomized controlled trial to improve provision of naloxone, buprenorphine and nonprescription syringes in community pharmacies.

Access to the opioid antidote naloxone is a critical component of addressing the opioid crisis. Naloxone is a population-level prevention intervention associated with substantial reductions in overdose mortality and reduction of nonfatal overdose. Pharmacies' pivotal role in dispensing medications like buprenorphine for the treatment of opioid use disorder and selling nonprescription syringes places them at the crossroads of opioid access and risk mitigation methods like naloxone provision. Testing ways to optimize pharmacy-based naloxone provision will be key as the country expands the implementation of naloxone through the medical system. In the Respond to Prevent Study, we conducted a large, practical study of a pharmacy-focused intervention in a sample of Washington, Oregon, Massachusetts and New Hampshire community chain pharmacies to increase naloxone dispensing and improve opioid safety. The intervention integrated two evidence-based educational toolkits and streamlined materials to enhance the focus on naloxone policy, stigma reduction, and patient communications around naloxone, nonprescription syringes and buprenorphine access. The real-world study implemented a stepped wedge, clustered randomized trial design across 175 community chain pharmacies to evaluate the effectiveness of the Respond to Prevent intervention in increasing: (a) pharmacy based naloxone distribution rates, naloxone-related patient engagement, and pharmacist and technicians' attitudes, knowledge, perceived behavioral control and self-efficacy toward naloxone; and (b) pharmacy nonprescription syringe sales, and pharmacist and technicians' attitudes, knowledge, perceived behavioral control and self-efficacy toward dispensing buprenorphine for opioid use disorder (secondary outcomes). This commentary provides a brief narrative about the study and presents insights on the design and adaptations to our study protocol, including those adopted during the unprecedented COVID-19 pandemic further compounded by Western wildfires in 2020.

Economics of Multiple Sclerosis Disease-Modifying Therapies in the USA.

PURPOSE OF REVIEW: Multiple sclerosis (MS) is a prevalent and debilitating neuroinflammatory disease associated with a significant economic burden. Direct healthcare costs, which can average $70,000 a year, have risen rapidly over the last decade and are driven by the escalating cost of disease-modifying therapies (DMTs). Despite a growing number of DMTs, annual increases in price for most DMTs have commonly exceeded 10% over the last 15 years. The high cost of MS DMTs has created economic hardships for patients in terms of high out-of-pocket costs and insurance company-induced barriers. Although generic versions of glatiramer acetate and dimethyl fumarate have provided some lower cost options, the median annual price for branded products currently exceeds $90,000. The goal of this paper is to examine the economic landscape of MS DMTs in the USA. RECENT FINDINGS: Recent economic analyses have provided new insights into the relative value of DMTs. Robust economic modeling studies suggest that costs per quality-adjusted life-year for most DMTs exceed commonly endorsed thresholds for what is considered a reasonable value in the USA. Because of higher efficacy and lower net costs, ocrelizumab and alemtuzumab are considered the best value. It is likely that generic versions of dimethyl fumarate and glatiramer acetate are also economically attractive. DMTs provide clinical benefit for patients with MS; however, their high cost can be a financial burden and impede access. High DMT prices are the principal reason why cost-effectiveness studies have indicated the economic value of most DMTs is questionable.

Identifying opioid dose reductions and discontinuation among patients with chronic opioid therapy.

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.

Exploring Patient Perceptions of Opioid Treatment Agreements in a Community Health Center Environment.

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.

Examining nonprescription syringe sales in Massachusetts and Rhode Island community pharmacies.

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.

Prescription Opioid Dispensing Patterns Prior to Heroin Overdose in a State Medicaid Program: a Case-Control Study.

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 < 0.001). For both heroin- and non-heroin-involved overdose cases, the likelihood of receiving an opioid increased with age. Among heroin overdose cases with an opioid dispensed, the rate of multiple pharmacy use was the only high-risk opioid pattern that was greater than non-overdose controls (adjusted odds ratio 3.2; 95% confidence interval 1.48 to 6.95). Discontinuation of long-term opioid use was not common prior to heroin overdose and not higher than discontinuation rates among non-overdose controls. CONCLUSIONS: Although individuals with a heroin-involved overdose were less likely to receive prescribed opioids in the year preceding their overdose relative to non-heroin opioid overdose cases, prescription opioid use was relatively common and increased with age. Discontinuation of long-term prescription opioid use was not associated with heroin-involved overdose.

A comparison of trends in opioid dispensing patterns between Medicaid pharmacy claims and prescription drug monitoring program data.

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 (<50, 50-89, 90-120, >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.

Opioid prescribing on discharge to skilled nursing facilities.

PURPOSE: Skilled nursing facility (SNF) residents are at increased risk for opioid-related harms. We quantified the frequency of opioid prescribing among patients discharged from an acute care hospital to SNFs. METHODS: This was a retrospective cohort study among adult (≥18 years) inpatients discharged from a quaternary-care academic referral hospital in Portland, OR to a SNF between January 1, 2017 and December 31, 2018. Our primary outcome was receipt of an opioid prescription on discharge to a SNF. Our exposures included patient demographics (eg, age, sex), comorbid illnesses, surgical diagnosis related group (DRG), receiving opioids on the first day of the index hospital admission, and inpatient hospital length of stay. RESULTS: Among 4374 patients discharged to a SNF, 3053 patients (70%) were prescribed an opioid on discharge. Among patients prescribed an opioid, 61% were over the age of 65 years, 50% were male, and 58% had a surgical Medicare severity diagnosis related group (MS-DRG). Approximately 70% of patients discharged to a SNF were prescribed an opioid on discharge, of which 68% were for oxycodone, and 52% were for ≥90 morphine milligram equivalents per day. Surgical DRG, diagnoses of cancer or chronic pain, last pain score, and receipt of an opioid on first day of the index hospital admission were independently associated with being prescribed an opioid on discharge to a SNF. CONCLUSION: Opioids were frequently prescribed at high doses to patients discharged to a SNF. Efforts to improve opioid prescribing safety during this transition may be warranted.

Evaluation of an Interdisciplinary Controlled Substance Review Committee on Opioid Prescribing in a Community Health Center.

OBJECTIVE: To describe recommendations made by an interdisciplinary controlled substance committee and acceptance by primary care providers. DESIGN: Retrospective cohort study. SETTING: Multisite federally qualified health center using an interdisciplinary committee to provide patient-specific recommendations to prescribers with patients using prescription opioids and other controlled substances. SUBJECTS: Patients prescribed long-term opioids. METHODS: We 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. RESULTS: The 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 < 0.001). CONCLUSIONS: An 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.

Impact of the RESPOND Toolkit on community pharmacists' opioid safety attitudes, self-efficacy, and knowledge.

OBJECTIVE: Pharmacists are well positioned to reduce risks from opioid-prescribing but often lack resources and training to effectively support these activities. The Resources Encouraging Safe Prescription Opioid and Naloxone Dispensing (RESPOND) Toolkit is an educational package developed to provide community pharmacists with a comprehensive education program and practice resources on prescription drug misuse, prescription drug monitoring programs (PDMPs), and naloxone dispensing. Our objective was to evaluate the effectiveness of the RESPOND Toolkit to improve pharmacists' knowledge and assess changes in pharmacists' attitudes and beliefs toward opioid use disorder (OUD) and PDMPs across a diverse pool of Oregon community pharmacists. METHODS: Pharmacists were recruited using an electronic mailing list of Oregon-licensed pharmacists. Pharmacists were asked to complete a preintervention survey, 3 online educational modules with pre- and post-module quizzes (optional), and a postintervention survey. Data were analyzed using paired t tests, chi-square analyses, and effect size calculations (Cohen's d). RESULTS: A total of 131 pharmacists completed the 3 educational modules and postintervention survey. Respondents were aged 37.6 ± 11.0 (mean ± SD) years and mostly frontline pharmacy staff (n = 86; 65.6%) with 10.5 ± 11.6 years of pharmacy experience. Pharmacists' knowledge and attitudes toward OUD, perceived behavioral control to address OUD, resources to address OUD, and perceptions regarding PDMP-associated difficulties improved significantly as a result of the intervention (all P < 0.001). In addition, 120 pharmacists completed the optional module quizzes, and aggregate knowledge assessment scores improved significantly (P < 0.001). CONCLUSION: The RESPOND Toolkit is an effective and scalable training resource for community pharmacists, with the potential to promote behavioral shifts that support opioid safety among patients. The results demonstrated improved attitudes, knowledge, and perceived behavioral control. Future work on the RESPOND Toolkit should evaluate the effect of implementation on pharmacist clinical activities and dispensing outcomes.

Repository Corticotropin Versus Glucocorticoid for Nephrotic Syndrome: When Will We See the Evidence?

Despite little evidence supporting its superiority to glucocorticoid therapy, use and expenditures for repository corticotropin (rACTH) injection (H.P. Acthar Gel; Mallinckrodt) have increased dramatically in the last 5 years, particularly among a small number of nephrologists, rheumatologists, and neurologists. Recently, the manufacturer justified the extremely high and rapidly increasing cost of rACTH by citing the ongoing need to generate clinical data to support its use. We test this assertion by investigating the quality and provenance of the evidence likely to emerge in the foreseeable future. We identified all completed, in-progress, and proposed studies of rACTH registered at ClinicalTrials.gov. 75 studies representing 2,953 participants met inclusion criteria. Studies addressed primarily nephrologic (n = 23), rheumatologic (n = 28), and neurologic (n =22) indications. Of the 23 studies proposed for renal indications (enrollment, 33 ± 49 [mean ± SD]), 11 were not randomized, 8 compared only different rACTH treatment regimens, and 4 compared rACTH to placebo. No studies of rACTH proposed for renal indications included an rACTH-free arm receiving active treatment (ie, another form of immunosuppression). We conclude that evidence emerging in the foreseeable future is unlikely to broadly support rACTH use over lower-cost glucocorticoid-based alternatives for renal indications.

Does Prescription Opioid Shopping Increase Overdose Rates in Medicaid Beneficiaries?

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.

Effect of Automated Prescription Drug Monitoring Program Queries on Emergency Department Opioid Prescribing.

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.

Pharmacists' Role in Opioid Safety: A Focus Group Investigation.

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.