Effect of integration of prescription drug monitoring program data in the electronic health record on queries by primary care providers.

Objective: To evaluate the impact of PDMP integration in the EHR on provider query rates within twelve primary care clinics in one academic medical center. Methods: Using linked data from the EHR and state PDMP program, we evaluated changes in PDMP query rates using a stepped-wedge observational design where integration was implemented in three waves (four clinics per wave) over a five-month period (May, July, September 2019). Multivariable negative binomial general estimating equations (GEE) models assessed changes in PDMP query rates, overall and across several provider and clinic-level subgroups. Results: Among 206 providers in PDMP integrated clinics, the average number of queries per provider per month increased significantly from 1.43 (95% CI 1.07 - 1.91) pre-integration to 3.94 (95% CI 2.96 - 5.24) post-integration, a 2.74-fold increase (95% CI 2.11 to 3.59; p < .0001). Those in the lowest quartile of PDMP use pre-integration increased 36.8-fold (95% CI 16.91 - 79.95) after integration, significantly more than other pre-integration PDMP use quartiles. Conclusions: Integration of the PDMP in the EHR significantly increased the use of the PDMP overall and across all studied subgroups. PDMP use increased to a greater degree among providers with lower PDMP use pre-integration.

Changes in Buprenorphine Prescribing in Community Health Centers.

This cohort study characterizes changes in buprenorphine prescribing among community health center clinicians between 2016 and 2021.

"I go out of my way to give them an extra smile now:" A study of pharmacists who participated in Respond to Prevent, a community pharmacy intervention to accelerate provision of harm reduction materials.

BACKGROUND: Community pharmacies are well-positioned to improve the health of people with opioid use disorder and who use drugs by providing naloxone and other essential public health supplies. Respond to Prevent (R2P) is a clinical trial which sought to accelerate provision of harm reduction materials through a multicomponent intervention that included in-store materials, online training, and academic detailing. OBJECTIVES: The objective of this study was to explore pharmacists' attitudes, knowledge, and experiences in providing naloxone, dispensing buprenorphine, and selling nonprescription syringes following participation in the R2P program. METHODS: Two online asynchronous focus groups were conducted with community-based chain pharmacists across Massachusetts, New Hampshire, Oregon, and Washington who had participated in the R2P program. Participants accessed an online repository of group interview items and responded to questions over a short period. Each pharmacist participated anonymously for approximately 30 min over 2 ½ days. Pharmacists answered questions on experiences with pharmacy-based harm reduction care and R2P intervention implementation barriers and facilitators. Qualitative data analysis was conducted by a multidisciplinary team using an immersion-crystallization approach. RESULTS: A total of 32 pharmacists participated in the two focus groups. Most participants were female (n = 18, 56%), non-Hispanic (n = 29, 91%), and white (n = 17, 53%). Four major themes were identified related to (1) addressing bias and stigma toward people with opioid use disorder and who use drugs, (2) familiarity and comfort with naloxone provision, (3) perspective and practice shifts in nonprescription syringe sales, (4) structural challenges to harm reduction care in the pharmacy. CONCLUSIONS: Community pharmacists across the four states identified attitudes, knowledge, and experiences that create barriers to providing care to people with opioid use disorder and who use drugs. R2P approaches and tools were effective at reducing stigma and changing attitudes but were less effective at addressing structural challenges from the pharmacists' perspective.

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.

Analgesic methadone prescribing in community health centers among patients with chronic pain.

OBJECTIVE: To examine analgesic methadone prescriptions among community health center (CHC) patients with chronic pain. DESIGN: Observational; two cross-sectional periods. SETTING: Oregon and California CHCs. PATIENTS: Chronic pain patients with ≥1 visit in 2012-2013 or 2017-2018 (N = 158,239). OUTCOMES: Changes in adjusted relative rates (aRRs) of receiving no opioids, short-acting only, long-acting only other than methadone, and methadone; characteristics associated with ≥1 methadone prescription. RESULTS: Opioid prescribing declined over time, with the largest decrease in methadone (aRR = 0.19, 95 percent confidence interval: 0.14-0.27). Among patients receiving ≥1 long-acting opioid, variables associated with methadone prescribing included being aged <65 years, having nonprivate insurance, and an opioid use disorder (OUD) diagnosis. From 2012-2013 to 2017-2018, aRR increased among patients with OUD and decreased for those aged 18-30 (vs ≥65), uninsured and Medicaid-insured (vs private), and race/ethnicity other than non-Hispanic Black (vs non-Hispanic White). CONCLUSIONS: Methadone prescribing decreased in CHCs but remained elevated for several high-risk demographic groups.

Economic burden of multiple sclerosis in the United States: A systematic literature review.

BACKGROUND: Multiple sclerosis (MS) is chronic progressive disease that poses a significant economic burden to patients and health care systems in the United States. We conducted a systematic literature review to provide up-to-date insights on the economic burden of MS in the United States. OBJECTIVE: To comprehensively review and summarize the latest published evidence on the economic burden of MS with a focus on cost, resource use, and work productivity. METHODS: A systematic literature search was conducted using the Embase and Medline databases to identify studies, published between January 2011 and July 2022, reporting cost, resource use, or work productivity outcomes among people with MS in the United States. Clinical trials, economic modeling studies, and review articles were excluded. Details of eligible studies, including study design, patient population, and study outcomes for the overall population, as well as subgroups of interest, were extracted and summarized qualitatively. RESULTS: Overall, 65 studies reporting cost, resource use, or work productivity data were included with majority of studies using claims data. The direct costs associated with MS ranged from $16,614 (2006) to $72,744 (2017) per patient per year with diseasemodifying therapies (DMTs) being the major cost contributors accounting for 43%-78%. The indirect costs reported ranged from $9,122 (2017) to $30,601 (2011) per patient per year with absenteeism, early retirement, and informal care being the key drivers for indirect costs. Costs, resource use, and work impairment were significantly higher for patients with severe disability compared with those with mild disability. Pharmacy costs were the major cost drivers in patients with mild, moderate, and severe disability. Similarly, patients with relapses incurred significantly higher costs, resource use, and work impairment compared with those without relapses. Additional hospitalization charges were the major driver of higher costs in patients who experienced relapses compared with those without relapses. CONCLUSIONS: Direct costs, particularly DMTs, appear to be the major cost drivers for people with MS in the United States. Availability of lower-cost therapies may considerably decrease the economic burden on these patients and the health care systems. Future research focusing on indirect costs, intangible costs, and their contributors would contribute to further understanding of economic burden to avoid underestimation of the financial burden experienced by the patients.

Chronic overlapping pain conditions and long-term opioid treatment.

OBJECTIVES: One in 5 people in the United States lives with chronic pain. Many patients with chronic pain experience a subset of specific co-occurring pain conditions that may share a common pain mechanism and that have been designated as chronic overlapping pain conditions (COPCs). Little is known about chronic opioid prescribing patterns among patients with COPCs in primary care settings, especially among socioeconomically vulnerable patients. This study aims to evaluate opioid prescribing among patients with COPCs in US community health centers and to identify individual COPCs and their combinations that are associated with long-term opioid treatment (LOT). STUDY DESIGN: Retrospective cohort study. METHODS: We conducted analyses of more than 1 million patients 18 years and older based on electronic health record data from 449 US community health centers across 17 states between January 1, 2009, and December 31, 2018. Logistic regression models were used to assess the relationship between COPCs and LOT. RESULTS: Individuals with COPCs were prescribed LOT 4 times more often than individuals without a COPC (16.9% vs 4.0%). The presence of chronic low back pain, migraine headache, fibromyalgia, or irritable bowel syndrome combined with any of the other COPCs increased the odds of LOT prescribing compared with the presence of a single COPC. CONCLUSIONS: Although LOT prescribing has declined over time, it remains relatively high among patients with certain COPCs and for those with multiple COPCs. These study findings suggest target populations for future interventions to manage chronic pain among socioeconomically vulnerable patients.

"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.

Fatal and nonfatal opioid overdose risk following release from prison: A retrospective cohort study using linked administrative data.

INTRODUCTION: Among individuals who are released from prison, opioid overdose is a leading cause of death with a risk more than ten-fold the general population. Although the epidemiology of opioid-related fatalities has been described, few studies have characterized both fatal and nonfatal opioid-related poisonings. The objective of this study was to estimate risk of fatal and nonfatal opioid overdose among adults released from prison. METHODS: The study estimated fatal and nonfatal opioid overdose rates using linked corrections, Medicaid, hospital discharge, and vital statistics from the state of Oregon from 2014 to 2018. Multivariable proportional hazards models identified demographic and prison-related factors associated with overdose. RESULTS: Between 2014 and 2017, 18,258 individuals were released from prison. A majority of individuals were male (87 %) and ages 26 to 64 (83 %). Two-thirds had a documented substance use disorder treatment need and 20 % demonstrated mental health treatment need. Following prison release, 579 opioid overdose events occurred; 65 (11 %) were fatal. The rate of opioid overdose was 1085.7 per 100,000 person-years (PY). Rates were highest in the first two weeks (2286.7 per 100,000 PY), among women (1582.9 per 100,000 PY), and those with mental health (1624.3 per 100,000 PY) or substance use disorder treatment needs (1382.6 per 100,100 PY). Only mental health (adjusted hazard ratio [aHR] 1.54, 95 % CI 1.24 to 1.90) and substance use need (aHR 2.59; 95 % CI 2.01 to 3.34) remained significant in multivariable models. CONCLUSIONS: The rate of opioid overdose is markedly elevated after prison release, particularly in the first two weeks. In women, the higher rate of opioid overdose is mediated by a greater mental health burden.

Sedative-hypnotic Co-prescribing with Opioids in a Large Network of Community Health Centers.

OBJECTIVE: When prescribed with opioids, sedative-hypnotics substantially increase the risk of overdose. The objective of this paper was to describe characteristics and trends in opioid sedative-hypnotic co-prescribing in a network of safety-net clinics serving low-income, publicly insured, and uninsured individuals. METHODS: This retrospective longitudinal analysis of prescription orders examined opioid sedative-hypnotic co-prescribing rates between 2009 and 2018 in the OCHIN network of safety-net community health centers. Sedative-hypnotics included benzodiazepine and non-benzodiazepine sedatives (eg, zolpidem). Co-prescribing patterns were assessed overall and across patient demographic and co-morbidity characteristics. RESULTS: From 2009 to 2018, 240 587 patients had ≥1 opioid prescriptions. Most were White (65%), female (59%), and had Medicaid insurance (43%). One in 4 were chronic opioid users (25%). During this period, 55 332 (23%) were co-prescribed a sedative-hypnotic. The prevalence of co-prescribing was highest for females (26% vs 19% for males), non-Hispanic Whites (28% vs 13% for Hispanic to 20% for unknown), those over 44 years of age (25% vs 20% for <44 years), Medicare insurance (30% vs 21% for uninsured to 22% for other/unknown), and among those on chronic opioid therapy (40%). Co-prescribing peaked in 2010 (32%) and declined steadily through 2018 (20%). Trends were similar across demographic subgroups. Co-prescribed sedative-hypnotics remained elevated for those with chronic opioid use (27%), non-Hispanic Whites (24%), females (23%), and those with Medicare (23%) or commercial insurance (22%). CONCLUSIONS: Co-prescribed sedative-hypnotic use has declined steadily since 2010 across all demographic subgroups in the OCHIN population. Concurrent use remains elevated in several population subgroups.

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.

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.

Association Between Pharmacy Benefit Restrictions and Disease-Modifying Therapy Use in the Medicare Part D Program.

Background and Objectives: 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 (Parts A, B, and D), an MS diagnosis, and 1 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 ≥80%, MS-related emergency department 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 vs 58 years; p < 0.001), more likely to live in the south (38% vs 23%; p < 0.001), eligible through disability (67% vs 60%; p < 0.001), and more likely to have several chronic comorbid conditions. Patients enrolled in restrictive plans were less likely to be adherent to their DMT (54% vs 57%; p < 0.001; adjusted odds ratio [aOR] 0.92, 95% confidence interval [CI] 0.88-0.98) and had a higher rate of MS-related outpatient visits (1.7 vs 1.4 per year; p < 0.001; aRR 1.27, 95% CI 1.23-1.31). Discussion: 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.

Association between treatment setting and outcomes among oregon medicaid patients with opioid use disorder: a retrospective cohort study.

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.

Medicare Part D Coverage Restrictions and Patient Cost-Sharing for Opioids Commonly Used for Cancer Pain, 2015-2021.

PURPOSE: Nation-wide rapid declines in prescription opioid dispensing gave rise to concerns regarding restricted access to effective pain management for patients with cancer-related pain. One important mechanism for such restrictions could be through more restrictive insurance coverage for opioids. This study aims to assess recent changes in Medicare Part D formulary designs for opioids commonly used for cancer-related pain. METHODS: We used data from the 2015-2021 Medicare Prescription Drug Plan (PDP) Formulary Files to assess formulary changes for six opioid-dose combinations commonly used for cancer-related pain. We estimated % of PDPs adopting prior authorization, quantity limits (and limits adopted), and a higher cost-sharing tier for each opioid-dose combination. We further estimated median and mean out-of-pocket (OOP) costs across all PDPs for a 30-day supply of the drug. Trends in proportions were tested using the Cochrane-Armitage test; trends in continuous measures were tested using the Jonckheere-Terpstra test. RESULTS: Proportion of PDPs adopting prior authorization increased from close to 0% to about 50% for two long-acting opioids (P < .001). Distribution of quantity limits across PDPs shifted over time to being more restrictive for all opioids considered (P < .001). For four of the six opioids, the proportion of PDPs adopting tier 3 or above increased from below or about 50% to well over 70% (P < .001). For the same four opioids, median OOP costs doubled to quadrupled (P < .001). CONCLUSION: Medicare PDP coverage has become increasingly restrictive for opioids commonly used for cancer-related pain, with multifold increases in patient OOP costs over the past 7 years. These changes pose concerns for patients with cancer needing opioid therapies for pain control and call for strategies to effectively exempt cancer-related pain from insurance and pharmacy rules intended to apply to opioids for noncancer chronic pain.

Characteristics of Prescription Drug Use Among Individuals With Multiple Sclerosis in the US Medicare Population.

Background: Few studies have characterized the full spectrum of prescription drug use for individuals with multiple sclerosis (MS). The objective of this study was to describe patterns and expenditures for disease-modifying therapies (DMTs) and other prescription drugs among Medicare beneficiaries with MS. Methods: Using Medicare claims data in 2014, we identified a cohort of Medicare beneficiaries with 12 months of continuous eligibility and 3 or more MS-related inpatient, outpatient, or prescription claims. We quantified the number, type, and costs of prescribed DMTs and other medications for MS-related symptoms. Medication costs were calculated according to whether beneficiaries received additional subsidies, which eliminate most out-of-pocket costs. Results: Of 43,283 Medicare beneficiaries identified with MS, 70% were DMT users. Most used self-administered DMTs (67%), and 3% used natalizumab; 93% received a supportive care medication. Among the 82% of individuals without subsidies, the annual median total and out-of-pocket DMT costs were $56,794 (interquartile range [IQR], $44,837-$62,038) and $4566 (IQR, $849-$5270), respectively. The most commonly used supportive care drugs were antidepressants (62%), opioid analgesics (50%), antispasticity drugs (47%), and anticonvulsants (46%). Annual median total and out-of-pocket costs for these drugs were $15,134 (IQR, $6571-$19,620) and $255 (IQR, $56-$877), respectively. Conclusions: Most Medicare beneficiaries with MS using DMTs face considerable out-of-pocket costs. Beneficiaries also used a significant number of medications potentially used for MS-related symptoms, although total and out-of-pocket costs were modest.

The Economic Burden of Multiple Sclerosis in the United States: Estimate of Direct and Indirect Costs.

BACKGROUND AND OBJECTIVES: A recent report estimated that approximately 1 million adults were living with multiple sclerosis (MS) in the United States. Although MS is rarely the direct cause of death, its debilitating effects on normal body functions can result in considerable disruption to daily living and life roles including work, physical independence, mobility, social interaction, and participation in leisure activities. This study estimated the total economic burden of MS in the United States in 2019. METHODS: This study used a prevalence-based approach to estimate the national economic burden of MS. Claims from 3 sources (Medicare Current Beneficiary Survey, Medicare Standard Analytical File, and Optum de-identified Normative Health Information System) were used to obtain direct costs and a survey was developed to collect indirect costs (e.g., labor market productivity losses, costs of paid and unpaid caregivers, home modification) from 946 patients with MS (PwMS). Direct medical costs reflected the difference in the total average annual amount paid for PwMS vs matched controls without MS. Future earnings loss due to premature death attributable to MS was calculated using Centers for Disease Control and Prevention mortality data and Medicare claims data. RESULTS: The estimated total economic burden was $85.4 billion, with a direct medical cost of $63.3 billion and indirect and nonmedical costs of $22.1 billion. Retail prescription medication (54%); clinic-administered drugs, medication, and administration (12%); and outpatient care (9%) were the 3 largest components of the direct costs. The average excess per-person annual medical costs for PwMS was $65,612; at $35,154 per person, disease-modifying therapies (DMTs) accounted for the largest proportion of this cost. The cost per DMT user ranged from $57,202 to $92,719, depending on sex-age strata. The average indirect and nonmedical costs were $18,542 per PwMS and $22,875 per PwMS if caregivers' costs were included. Lost earnings due to premature death, presenteeism, and absenteeism losses were the largest indirect cost components. DISCUSSION: MS is a costly chronic disease, with direct costs of prescription drugs and indirect productivity loss being important cost drivers. Our findings suggested that the burden of MS in the United States has been underestimated.

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.

The impact of CARA mandates on nurse practitioner controlled substance prescribing in Oregon: a cohort study.

BACKGROUND: In 2017, the United States Comprehensive Addiction and Recovery Act (CARA) expanded authorization to prescribe buprenorphine for opioid use disorder (OUD) to nurse practitioners (NPs). Compared 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 evaluated the impact of this requirement on both NP 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 identified 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-Whitney 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 NPs. CONCLUSIONS: 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 already using opioids, and these findings may represent transitions in practice and patient setting.