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 .

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.

Regional Variation in Opioid-Related Emergency Medical Services Transfers During the COVID-19 Pandemic: An Interrupted Time Series Analysis.

BACKGROUND: The COVID-19 pandemic has impacted public infrastructure and healthcare utilization. However, regional variation in opioid-related harm secondary to COVID-19 remains poorly understood. This study aimed to measure the regional variation in the association between stay-at-home orders (SAHOs) and nonfatal opioid-related emergency medical services (EMS) transfers in the United States. METHODS: In this interrupted time series design, counts of nonfatal opioid overdoses were identified in each week between July 29, 2019 and December 27, 2020 from the National Emergency Medical Services Information System Dataset. A longitudinal, interrupted time series model was used to compare the change in the number of nonfatal opioid overdose transfers between the pre-pandemic period (July 29, 2019-January 6, 2020) and the pandemic period (June 1, 2020-December 27, 2020). The time period between January 7, 2020 and May 31, 2020 was treated as a washout period to account for state-level variation in the timing of SAHO implementation. RESULTS: We identified 277 141 adult nonfatal opioid-related overdose EMS transfers in the United States across all census regions. After implementation of the SAHO, EMS transfers significantly increased in all regions, with an increase most notable in the Southern United States (2161, 95% CI: 1699-2623 transfers per week). In the post-SAHO period between June 1 and December 27, 2020, EMS transfers declined from this regional peak in the Southern, Midwestern, and Northeastern United States. No change in trend was observed in the Western United States. CONCLUSION: These findings underscore the importance of tailoring public health policies regionally. While most regions saw a modest decline in opioid-related EMS transfers after an initial increase, the COVID-19 pandemic led to notable increases in opioid-related EMS transfers nationwide. Future research should focus on identifying public health strategies to counteract the deleterious effects of the COVID-19 pandemic on opioid-related morbidity.