Protocol for the development of a consensus practice guideline To address clinical and regulatory barriers to buprenorphine dispensing in community pharmacy.

BACKGROUND: Less than half of community pharmacies in the United States stock buprenorphine products indicated for the treatment of opioid use disorder. This lack of access to buprenorphine in community pharmacies is a significant barrier to care. To address this issue, this protocol outlines a comprehensive approach to develop a practice guideline aimed at improving access to safe and effective opioid use disorder treatment in community pharmacies. METHODS: The guideline development process will proceed in three phases, following a technique closely aligned with the Institute of Medicine's guidance on guideline development. The first phase will involve conducting qualitative interviews with pharmacists in three states to identify their beliefs toward buprenorphine dispensing. As limitations on buprenorphine supply are related to constraints at all levels of the drug supply and regulatory system, the second phase, we will recruit representatives from regulatory agencies, pharmacy organizations, the Drug Enforcement Administration, pharmaceutical wholesalers as well as addiction medicine physicians and psychiatric pharmacists to develop consensus recommendations through a modified Delphi design. This will be followed by a public comment period and external expert review of the recommendations led by the National Association of Boards of Pharmacy. Finally, in the third phase, a national, mixed media dissemination campaign will be led by the National Community Pharmacists Association (NCPA) to convey recommendations to practicing pharmacists. DISCUSSION: The guideline development process aims to incorporate the perspectives of multiple stakeholders and emphasize the importance of addressing the regulatory and pharmacy-specific aspects of care in addition to clinical evidence and guidance. The development of this guideline will provide targeted, multidisciplinary guidance for pharmacists, improving access to safe and effective opioid use disorder treatment in the community setting. PREREGISTRATION: This protocol was registered with the Open Science Framework in March of 2023. Registration may be found at: https://doi.org/10.17605/OSF.IO/6S9DY .

Leveraging prescription monitoring program data to evaluate the implementation of buprenorphine telehealth flexibilities: An interrupted time series analysis in Texas.

Background: In March 2020, policy changes by the Substance Abuse and Mental Health Services Administration and the Drug Enforcement Administration aimed to maintain access to office-based opioid treatment services by easing telehealth buprenorphine prescribing restrictions. However, the effectiveness of these changes remains largely unmeasured. The objective of this study was to measure the effectiveness of COVID-19-related telehealth flexibilities in an all-payer cohort from the Texas Prescription Monitoring Program. Methods: Using Texas Prescription Monitoring Program data, we identified oral buprenorphine and buprenorphine/naloxone prescriptions dispensed in Texas between September 1, 2019, and September 26, 2020. Weekly counts of prescriptions, prescribing physicians, and dispensing pharmacies were analyzed. An autoregressive integrated moving average (ARIMA) model estimated changes in prescription volume between pre-implementation (September 1, 2019 - February 15, 2020) and post-implementation (April 12, 2020 - September 26, 2020) periods. Results: Pre-flexibility, an average of 8898 (SD: 342) buprenorphine prescriptions were dispensed to 7829 (SD: 326) patients weekly. This declined to 8360 (SD: 247) prescriptions and 7661 (SD: 229) patients post-flexibility. Adjusted for seasonality, this represented a statistically significant average decline of -257.27 (95% CI: -426.06, -88.49) patients and -647.01 (95% CI: -856.67, -437.36) prescriptions per week. Discussion: Our results suggest a modest decline in buprenorphine dispensing volume early in the COVID-19 pandemic. While difficult to assess its significance, it can be assumed that telehealth flexibilities mitigated a potentially larger decline. Future research should explore system and individual-level barriers to telehealth utilization.

Trajectories and Predictors for the Development of Clinically Significant Weight Gain in Children and Adolescents Prescribed Second-Generation Antipsychotics.

Background: As many as 60% of pediatric patients taking second-generation antipsychotics (SGA) experience weight gain (antipsychotic-induced weight gain). However, the subgroup that experienced substantial weight increase was poorly understood. This study aimed to identify the development and predictors of clinically significant weight gain (CSWG) among pediatric SGA recipients. Methods: A retrospective analysis of the 2016 to 2021 IQVIA Ambulatory EMR-US database was conducted. The study cohort comprised SGA-naive patients ages 5 to 19, continuously prescribed SGA for ≥90 days. CSWG was defined as a weight gain in BMI z-score >0.5. The development of CSWG was described using the group-based trajectory model approach, and multinomial logistic regression analysis was conducted to examine the risk factors associated with the CSWG trajectories. Results: Of the 16,262 SGA recipients who met the inclusion criteria, 4 distinctive CSWG trajectories were identified: (1) Rapid (14.6%), (2) Gradual (12.6%), (3) Transit (7%), and (4) no CSWG (65.8%). Factors associated with a higher likelihood of having rapid or gradual CSWG versus nonsignificant weight gain were being younger (OR [95% CI] = 12-17 vs. 5-11, Rapid, 0.727 [0.655-0.806]; Gradual, 0.776 [0.668-0.903]), male (Rapid, 1.131 [1.021-1.253]), non-Hispanic White (Black vs. White: Rapid, 0.833 [0.709-0.98]), with lower baseline BMI z-score (Rapid, 0.376 [0.361-0.392]; Gradual, 0.449 [0.424-0.476]), and receiving olanzapine as the initial SGA (Rapid, 1.38 [1.093-1.74]). The Area under the Receiver operating characteristic (ROC) Curve for the comparison of rapid and gradual CSWG with no CSWG trajectory were 0.83 and 0.80, respectively. Conclusions: SGA recipients experienced four distinctive CSWG trajectories (Rapid, Gradual, Transient, and No CSWG). The risk of CSWG could be predicted using patient characteristics at the SGA initiation. This insight highlights the importance of personalized monitoring and timely intervention strategies for at-risk individuals who experienced persistent CSWG in real practice.

Why the increase? Examining the rise in prescription medication expenditures in the United States between 2011 and 2020.

The objective of this cross-sectional analysis was to identify determinants of increasing medicine expenditures in the US between 2011 and 2020. Prescription medication expenditures from the 2011-2020 Medical Expenditures Panel Survey (MEPS) were used to calculate total annual medication expenditures by payer categories (Out-of-pocket, Medicare, Medicaid, TRICARE/Veterans Administration/CHAMPVA (TVAC), Other Government Sources, Private Insurance, and Other Sources). From here, expenditures were stratified by therapeutic category using Multum Lexicon Drug Class to examine trends in expenditures by therapeutic area. Linear regression was used to identify temporal trends in medication expenditures. From 2011 to 2020, total annual prescription medication expenditures rose from $341.49 to $473.12 billion per year with metabolic agents being the most costly category. Among the metabolic agents, antidiabetic agents were the most costly therapeutic area, with an increasing trend observed from $27.15 to $89.17 billion over the same period. Medicare, Medicaid, Private Insurance, TVAC, and Other Sources also saw an increasing trend in antidiabetic agent expenditure, while no trend was observed for Out-of-pocket and Other Government Sources. Insulin had the highest expenditure among antidiabetic agents. Further studies are warranted to explore specific factors contributing to the increasing trend.

Group-Based Trajectory Modeling to Identify Patterns of Antipsychotic-Associated Weight Gain Among Children and Adolescents.

PURPOSE/BACKGROUND: Antipsychotic-associated weight gain (AAWG) is a common adverse effect of second-generation antipsychotic (SGA) medications among children and adolescents. This study applied group-based trajectory modeling to identify latent trajectories of AAWG among children and adolescents and associated risk factors. PROCEDURES: This was a retrospective analysis of the IQVIA Ambulatory EMR-US database from 2016 to 2021. The cohort consisted of patients aged 6 to 19 years who were SGA naive and received at least 90 days of continuous SGA prescriptions. Group-based trajectory modeling was used to identify latent trajectories of AAWG development during a 24-month period since SGA initiation, and multinomial logistic regression analysis was conducted to examine the risk factors associated with the identified AAWG trajectories. FINDINGS/RESULTS: A total of 16,262 patients were included. Group-based trajectory modeling identified the following 4 distinctive AAWG trajectories: persistent severe weight gain (4.2%), persistent moderate weight gain (20.1%), minor weight change (69.6%), and gradual weight loss (6.1%). Compared with the minor weight change group, younger age (12-17 vs 5-11: odds ratio [OR], 0.634; 95% confidence interval [CI], 0.521-0.771), lower baseline body mass index z -score (OR, 0.216; 95% CI, 0.198-0.236), and receiving olanzapine as the initial SGA (olanzapine vs aripiprazole: OR, 1.686; 95% CI, 1.673-1.699) were more likely to follow severe weight gain trajectories. The area under the receiver operating characteristic curves for comparing severe weight gain versus minor weight change groups and moderate weight vs minor weight change groups in the multinomial regression model were 0.91 and 0.8, respectively. IMPLICATIONS/CONCLUSIONS: A quarter of pediatric SGA recipients experienced persistent weight gain during the SGA treatment. The risk of having persistent AAWG can be predicted using patient characteristics collected before SGA initiation and the initial SGA agent.

Physician perspective on the implementation of risk mitigation strategies when prescribing opioid medications: a qualitative analysis.

OBJECTIVE: To understand the physician perspective on the barriers and facilitators of implementing nine different opioid risk mitigation strategies (RMS) when prescribing opioid medications. METHODS: We created and dispersed a cross-sectional online survey through the Qualtrics© data collection platform among a nationwide sample of physicians licensed to practice medicine in the United States who have prescribed an opioid medication within the past year. The responses were analyzed using a deductive thematic analysis approach based on the Consolidated Framework for Implementation Research (CFIR) to ensure a holistic approach to identifying the barriers and facilitators for each RMS assessed. In concordance with this method, the themes and codes for the thematic analysis were defined prior to the analysis. The five domains within the CFIR were used as themes and the 39 nested constructs were treated as the codes. Two members of the research team independently coded the transcripts and discussed points of disagreement until consensus was reached. All analyses were conducted in ATLAS.ti© V7. RESULTS: The completion rate for this survey was 85.1% with 273 participant responses eligible for analysis. Intercoder reliability was calculated to be 82%. Deductive thematic analysis yielded 2,077 descriptions of factors affecting implementation of the nine RMS. The most salient code across all RMS was Knowledge and Beliefs about the Intervention, which refers to individuals' attitudes towards and value placed on the intervention. Patient Needs and Resources, a code referring to the extent to which patient needs are known and prioritized by the organization, also emerged as a salient code. The physicians agreed that the patient perspective on the issue is vital to the uptake of each of the RMS. CONCLUSIONS: This deductive thematic analysis identified key points for actionable intervention across the nine RMS assessed and established the importance of patient concordance with physicians when deciding on a course of treatment.

Student-led podcasts to enhance literature evaluation skills.

BACKGROUND AND PURPOSE: Critical evaluation and understanding of primary literature is essential to pharmacy practice. This project evaluated student confidence and learning outcomes in a critical care elective course where podcasts were used as an active learning assignment for literature evaluation. EDUCATIONAL ACTIVITY AND SETTING: Third-year pharmacy students created a 15- to 20-min podcast episode that reviewed a landmark critical care trial. A pre/post survey was used to assess student perceptions of confidence in evaluating primary literature. A standardized rubric was used to assess literature evaluation skills in several domains. FINDINGS: Ninety-two third-year pharmacy students were enrolled in the critical care elective course, and 93% (86 of 92) completed the survey. Student perceptions of their ability to evaluate literature improved for all seven questions, including comfort in interpreting study methodology and applying findings of literature to patient care. Students scored proficient on most components of the standardized rubric, with ability to discuss results and conclusions being the lowest performing domain (78.2% fully proficient). After completing the activity, students felt more confident in interpreting results, applying findings, and orally presenting a journal article to peers. Most students felt the podcast activity helped them strengthen their literature evaluation skills and recommended this activity to a peer. SUMMARY: Third-year pharmacy students reported an improvement in confidence in the interpretation and application of primary literature after creating a podcast episode reviewing a critical care trial. Additional research with creation of podcasts or other audio/visual methods should be studied in the future.

Outpatient opioid prescribing by Alzheimer's diagnosis among older adults with pain in United States.

OBJECTIVE: To examine opioid prescribing practices for pain in older adults with and without Alzheimer's Disease and Related Dementias (ADRD). METHODS: This cross-sectional study used National Ambulatory Medical Care Survey data (2014-2016, and 2018). Adults aged ≥ 50 years with pain were analyzed. Prescribing of opioid and concomitant sedative prescriptions (including benzodiazepines, Z-drugs, and barbiturates) were identified by the Multum lexicon code. Multivariable logistic regression evaluated the risk of opioid prescribing or co-prescribing of opioid and sedative associated with ADRD in older adults with pain. RESULTS: There were 13,299 office visits in older adults with pain, representing 451.75 million visits. Opioid prescribing occurred in 27.19%; 30% involved co-prescribing of opioids and sedatives. ADRD was not associated with opioid prescribing or co-prescribing of opioid and sedative therapy. CONCLUSIONS: Opioid and sedatives are commonly prescribed in older adults with pain. Longitudinal studies need to understand the etiology and chronicity of opioid use in older patients, specifically with ADRD.

The impact of the mainstreaming addiction treatment act and associated legislative action on pharmacy practice.

The recent passage of the Mainstreaming Addiction Treatment (MAT) Act will expand access to treatment for opioid use disorder (OUD) by eliminating prescriber registration requirements introduced as part of the Drug Abuse Treatment Act (DATA) of 2000. Without the X-Waiver, and Drug Enforcement Administration (DEA) registered prescriber can now prescribe buprenorphine. Eliminating DATA-2000 registration is the first step in improving access to buprenorphine, but additional barriers, including unclear restrictions on wholesale buprenorphine supply and insurance coverage, remain. Recently, the DEA formally clarified that suspicious order monitoring programs were managed entirely by wholesalers and manufacturers and that DEA does not set suspicious order monitoring limits. In this commentary, we address the somewhat conflicting implications of the MAT Act and recent DEA guidance on buprenorphine dispensing in community pharmacies. We also discuss innovative practice models that leverage pharmacists' cognitive skills to manage pharmacotherapy for persons with OUD. Recent policy changes and emerging evidence suggest that pharmacists are better positioned than ever to provide low-barrier access to treatment for OUD and to show their value in this practice area by actively engaging patients with prescribed buprenorphine.

Parents' intention to have their child vaccinated at a community pharmacy: A national cross-sectional survey.

BACKGROUND: During the coronavirus disease 2019 pandemic, pediatric vaccination rates for routine childhood vaccines have been declining. To boost pediatric immunizations, pharmacists in the United States may order and administer age-appropriate vaccines to children of 3 years of age and older without a prescription. OBJECTIVE: The objective of this study was to examine parents' intention to have their young children between 3 and 10 years of age vaccinated in a community pharmacy setting. METHODS: A survey instrument was designed based on the health belief model (HBM). The cross-sectional survey was administered online via Qualtrics Panels to parents in the United States with at least 1 child between the ages of 3 and 10 years. Confirmatory factor analysis was used to estimate the correlation between each of the HBM constructs and a 3-item scale measuring parents' intention to have their children between the ages of 3 and 10 vaccinated in a community pharmacy. RESULTS: There were 416 usable responses collected for an effective response rate of 25.95%. Most participants were white (79.09%) and female (51.44%), and many had a graduate degree (48.32%). More than half of parents (69.7%) indicated they would be willing to have their child vaccinated in a community pharmacy. Intention to have their child vaccinated in a pharmacy was most strongly corrected with health benefit beliefs (ψ 0.79 [95% CI 0.75-0.83]), (ψ 0.86 [95% CI 0.83-0.89])cues to action, and perceived convenience.(ψ 0.71 [95% CI 0.66-0.76]). CONCLUSION: Many parents have high intention to vaccinate their young children in community pharmacies. Parents should be educated and informed about services that community pharmacies offer. Stakeholders need to engage in interventions targeted at promoting health benefits of getting vaccinations at a pharmacy and strong recommendations from health care providers.

Comparing Two Databases to Identify Access to Buprenorphine Treatment for Opioid Use Disorder.

OBJECTIVE: The objective of this study is to assess the differences in buprenorphine prescribers from a county level in the state of Texas by comparing the Substance Abuse and Mental Health Services Administration (SAMHSA) Buprenorphine Practitioner Locator to the Drug Enforcement Administration's (DEA) Controlled Substance Act (CSA) database. METHODS: County-level counts of buprenorphine prescribers were calculated from both the publicly available SAMHSA buprenorphine practitioner locator list and the DEA CSA database. These were then used to estimate the number of providers per 100,000 residents in each county. Regional variation in access to buprenorphine was compared descriptively across the state using poverty data from the US Census and county-level demography from the Texas Demographic Center. RESULTS: This study found 68.8% more X-waivered providers on the DEA CSA database (n = 2,622) with at least one provider reported in 125 of 144 counties in the state (49.2%) compared to the SAMHSA Buprenorphine Practitioner Locator (n = 1,553) with at least one provider reported in 103 counties (40.5%). CONCLUSIONS: The lack of a complete public registry of buprenorphine prescribers can inhibit the ability of patients to identify a convenient treatment. More work is needed to quantify the gap between treatment capacity and treatment need.

Association of cash payment with intensity of opioid prescriptions.

BACKGROUND: It is difficult to track use and outcomes in patients who pay cash for their prescriptions at the pharmacy. In Texas, 14% of all opioid prescriptions are paid with cash, often by uninsured patients and pharmacy shoppers. OBJECTIVE: To evaluate the association of cash payment with intensity of opioid prescriptions. METHODS: Using a prescription drug monitoring program and the U.S. Census data for the 2019 calendar year, this cross-sectional descriptive study analyzed more than 4 million opioid prescriptions in Texas residents aged 18-64 years. The payment type was coded as insurance if the prescription was paid in whole or in part by a health plan and as cash otherwise. Daily morphine milligram equivalent (MME) dose was used to compare the intensity of opioid prescriptions. The association of uninsured rates with mean daily MME and the number of opioid prescriptions paid with cash per 100,000 persons were assessed at a county level. RESULTS: Cash payment was associated with 30% higher mean daily MME (59 vs. 45; P < 0.001) than insurance payment. This difference was driven by the prescriptions for patients aged 25-34 years and from the highest decile of prescribers based on the percentage of opioid prescriptions paid by cash. For instance, cash payment was associated with 82% higher mean daily MME (91 vs. 50; P < 0.001) when patients aged 25-34 years obtained their prescriptions from the highest decile of prescribers. At a county level, uninsured rates were not associated with mean daily MMEs or the number of opioid prescriptions paid with cash. CONCLUSION: Cash payment was associated with a higher intensity of opioid prescriptions, mirroring the rates of drug overdose deaths across the patient age groups. Further research and policy actions need to address unmet pain management needs in uninsured patients and potential pharmacy shopping with cash payment and fraudulent identifications.

Investigation of racial differences in survival from non-small cell lung cancer with immunotherapy use: A Texas study.

Background: The use of immunotherapy is associated with improved survival among patients with Non-Small Cell Lung Cancer (NSCLC) and has gained widespread use in its management. However, there is limited information on whether the survival benefits associated with immunotherapy differ among races and ethnicities. Objective: This study aimed to investigate racial differences in survival amongst patients with NSCLC who received immunotherapy as the first-line treatment in Texas. Methods: Patients with NSCLC who received immunotherapy between October 2015 to December 2018 were identified from the Texas Cancer Registry (TCR). Disease-specific survival was evaluated and compared among patients across racial/ethnic categories using the Kaplan-Meier survival analysis, log-rank test, and a multivariable Cox proportional hazard regression model following an inverse probability treatment weighting (IPTW) propensity score analysis. Results: A total of 1453 patients were included in the analysis. Median survival (in months) was longest among Asians (34, 95% CI: 15-Not Estimable), followed by African Americans (AAs) (23, 95% CI: 15-34), Hispanics (22, 95% CI: 16-26), and Whites (19, 95% CI: 17-22). The adjusted regression estimates had no statistically significant differences in survival among AAs (aHR = 0.97; 95% CI = 0.78-1.20; P =0.77) and Hispanics (aHR = 0.96; 95% CI = 0.77-1.19, P =0.73) when compared to White patients. Asians on the other hand, had 40% reduction in mortality risk compared to Whites (aHR = 0.60; 95% CI = 0.39-0.94, P = 0.03). Conclusions: Our study indicated that African Americans and Hispanics do not have poorer survival compared to White patients when receiving immunotherapy as first-line treatment. Asians however had longer survival compared to Whites. Our findings suggest that existing racial disparity in NSCLC survival might be mitigated with the use of immunotherapy and should be considered in providing care to these minority groups.

Switching pharmacies leads to gaps in medication possession in individuals treated with buprenorphine.

BACKGROUND: Not all pharmacies stock and dispense buprenorphine, potentially complicating continuous access to care for patients with opioid use disorder (OUD). This may become problematic if a patient's primary pharmacy can no longer provide buprenorphine, and the patient cannot locate a new pharmacy. OBJECTIVES: To identify how often patients treated with buprenorphine for OUD switch pharmacies and to estimate the association between switching pharmacies and a clinically significant gap in therapy of 7 days or longer. METHODS: A retrospective repeated measures longitudinal cohort design was used. Patients initiating treatment with a buprenorphine product indicated for OUD were identified from the 2016-2018 Texas Prescription Monitoring Program. The predictor of interest-switching pharmacies-was defined by comparing the dispensaries used between subsequent prescriptions. The outcome of interest was defined as a gap in medication possession of 7 days or longer on the basis of the National Quality Forum's definition of continuity of pharmacotherapy for OUD. A generalized estimating equation approach was used to estimate a repeated measures logistic regression measuring the association between switching pharmacies and a gap in therapy. RESULTS: Of 13,375 eligible patients, 29.6% switched pharmacies at least once during treatment, and 51.6% of these did so more than once. The median time to initial switch was 30 days (interquartile range: 13-66 days). When patients switched pharmacies, they were significantly more likely to have a gap in therapy of between 7 and 29 days (adjusted odds ratio 1.67 [95% CI 1.57-1.78]). CONCLUSION: Patients receiving buprenorphine switch pharmacies early and frequently in treatment, which leads to clinically significant gaps in therapy. Although qualitative explanatory work is needed to understand why patients switch pharmacies so often, pharmacists and prescribers must ensure that patients have reliable access to a convenient source of buprenorphine to prevent gaps in therapy.

Clinical decision making involving prescription drug monitoring programs: A factorial, vignette-based study among student pharmacists.

OBJECTIVES: Prescription drug monitoring programs (PDMPs) are state-maintained databases that providers may reference when deciding to prescribe or dispense controlled substances. As more states begin to mandate PDMP use at the point of care, it is imperative to assess how pharmacists use PDMP information when determining whether to fill a controlled substance prescription (CSP). The objective of this study was to evaluate which factors affected fourth-year student pharmacists' decision to fill an opioid prescription, their level of confidence in their decision making, and familiarity with the PDMP. METHODS: We used a 24 factorial design to present a series of text-based vignettes to fourth-year student pharmacists. Each participant received 8 vignettes (5 randomly selected, 3 fixed), representing a hypothetical hydrocodone-acetaminophen combination prescription with varying levels of the following dichotomous factors: doctor shopping, dosage, pharmacy shopping, and concurrent benzodiazepine prescription. Participants were asked to decide whether or not they would fill each of the hypothetical prescriptions they received. A multilevel model was used to measure the association between each of the vignette factors, age, race, sex, experience with PDMP, and the decision to refuse to fill a prescription. Each vignette response served as an independent observation. RESULTS: A total of 87 participants yielded 696 vignette responses. Participants were significantly more likely to refuse to fill prescriptions with doctor shopping (adjusted odds ratio [aOR] 19.86 [95% CI 10.78-36.58]), pharmacy shopping (6.78 [4.13-11.12]), dosage (1.83 [1.16-2.90]), or if the student pharmacist was of female sex (1.73 [1.02-2.93]). Concomitant benzodiazepine use was not associated with a no-fill decision (1.45 [0.92-2.27]). CONCLUSION: This study reveals that student pharmacists' decision to fill a prescription is dependent on both prescription characteristics and a patient's CSP history. The importance of PDMP history cannot be downplayed and suggests that PDMP use may be effective in informing patient care decisions. Still, the variability in filling decision highlights the need to teach a formulaic approach to CSP dispensing in colleges of pharmacy.

Factors associated with the use of the prescription monitoring program by prescribers and pharmacists in Texas.

PURPOSE: To describe Texas Prescription Monitoring Program (PMP) use and identify predictors of PMP query for opioid and benzodiazepine prescriptions by prescribers and pharmacists. METHODS: Dispensation and query records from the Texas PMP for opioid and benzodiazepine medications dispensed between October 1, 2016 and December 31, 2018 were linked using common patient identifiers. Autoregressive linear regression was used to assess trends in utilization. Hierarchical logistic models were specified to identify factors associated with provider and pharmacist query of opioid and benzodiazepine prescriptions. RESULTS: Despite a significant increase in the total number of pharmacists (ß = 169.85, p < 0.0001) and prescribers (ß = 301.59, p < 0.0001) who used the PMP every month, the ratio of active to registered pharmacists (ß = -0.0001, p = 0.75) and prescribers (ß = -0.0015, p = 0.10) did not change. Pharmacists and prescribers were significantly more likely to query opioid and benzodiazepine prescriptions of 14 days or more, and those issued to patients new to their practice. Pharmacists were most likely to query opioid prescriptions for oxycodone (aOR = 4.51, 95%CI = 4.42-4.60) and prescribers were most likely to query prescriptions for buprenorphine (aOR = 2.24, 95%CI = 2.15-2.35) compared to codeine. CONCLUSION: Changes in PMP utilization between October 2016 and December 2018 were driven by increasing registration, not increasing frequency of use among registered users. Use of the PMP is inconsistent and dependent upon patient characteristics thus limiting the utility of the PMP as a decision support tool. These results support the need for policy mandating PMP use in Texas and provide a useful baseline and framework to evaluate the effectiveness of mandate implementation.

Impact of COVID-19 related policy changes on filling of opioid and benzodiazepine medications.

BACKGROUND: Healthcare access has changed drastically during the COVID-19 pandemic. Elective medical procedures, including routine office visits, were restricted raising concerns regarding opioid and benzodiazepine provider and prescription availability. OBJECTIVE: To examine how the cancelation of elective medical procedures due to COVID-19 impacted the dispensing of opioid and benzodiazepine prescriptions in Texas. METHODS: Interrupted time series analyses were preformed to examine changes in prescription trends for opioids and benzodiazepines before and after the restriction on elective medical procedures. Samples of patients who filled an opioid or benzodiazepine prescription from January 5, 2020 to May 12, 2020 were identified from the Texas Prescription Monitoring Program. Elective medical procedures were restricted starting March 23, 2020 indicating the beginning of the intervention period. RESULTS: Restricting elective procedures was associated with a significant decrease in the number of patients (ß = -6029, 95%CI = -8810.40, -3246.72) and prescribers (ß = -2784, 95%CI = -3671.09, -1896.19) filling and writing opioid prescriptions, respectively. Also, the number of patients filling benzodiazepine prescriptions decreased significantly (ß = -1982, 95%CI = -3712.43, -252.14) as did the number of prescribers (ß = -708.62, 95%CI = -1190.54, -226.71). CONCLUSION: Restricting elective procedures resulted in a large care gap for patients taking opioid or benzodiazepine prescriptions.

Impact of COVID-19 Related Policy Changes on Buprenorphine Dispensing in Texas.

OBJECTIVES: To measure the change in the daily number of patients receiving buprenorphine and buprenorphine prescribers during the early phase of the COVID-19 (SARS-CoV-2) pandemic in Texas. METHODS: Counts of the number of patients filling and number of providers prescribing buprenorphine were calculated for each weekday between November 4, 2019 and May 12, 2020. The change in daily patients and prescribers between March 2, 2020 and May 12, 2020, was modeled as a change in slope compared to the baseline period using autoregressive, interrupted time series regression. RESULTS: The rate of change of daily buprenorphine prescriptions (ß = -1.75, 95% CI = -5.8-2.34) and prescribers (ß = -0.32, 95% CI = -1.47-0.82) declined insignificantly during the COVID-19 period compared to the baseline. CONCLUSIONS: Despite a 57% decline in ambulatory care utilization in the south-central US during March and April of 2020, health services utilization related to buprenorphine in Texas remained robust. Protecting access to buprenorphine as the COVID-19 pandemic continues to unfold will require intensive efforts from clinicians and policy makers alike. While the presented results are promising, researchers must continue monitoring and exploring the clinical and humanistic impact of COVID-19 on the treatment of substance use disorders.

Applying the capability, opportunity, motivation, and behavior model to identify opportunities to increase pharmacist comfort dispensing naloxone in Texas: A structural equation modeling approach.

BACKGROUND: The prevalence of opioid use and misuse in the United States contributed to 48,000 opioid related deaths in 2018. Naloxone, a potent opioid reversal agent, can be dispensed by pharmacists without a prescription, however few do so. Previous studies on naloxone dispensing have contributed to our understanding of the determinants of naloxone in community pharmacy, however, none have focused on comprehensive behavioral change. This study utilized the Capability, Opportunity, Motivation, and Behavior (COM-B) model, a behavioral change and intervention design framework, to examine community pharmacists' comfort dispensing naloxone. METHODS: A 48-item questionnaire grounded in the COM-B and theoretical domains framework was developed and mailed to 1,000 community pharmacists in Texas, USA using a modified Dillman cross-sectional survey design. Confirmatory factor analysis was used to refine and establish dimensionality of the hypothesized scales and structural equation modeling was used to estimate the fit of the COM-B in explaining pharmacists' comfort dispensing naloxone. RESULTS: The usable response rate was 19.4%. Of surveyed pharmacists, 29.7% had ever had a patient request naloxone and 35.1% had dispensed naloxone without a prescription. Capability and opportunity explained 60% of the variance in motivation. Opportunity and motivation were the most salient predictors of comfort dispensing naloxone. Together, capability, opportunity, and motivation explained 78.1% of variance in pharmacists' comfort dispensing naloxone, indicating that the COM-B model is useful in this setting. CONCLUSION: Despite previous findings, policy interventions to increase naloxone dispensing should go beyond providing additional education to the pharmacy workforce. Rather, these results suggest that a complex intervention designed with pharmacist input that enables them to act autonomously and evaluate whether patients need naloxone may increase their comfort dispensing. Without collaboration from pharmacy and managed care corporations, dissemination efforts will continue to be limited.