Publications

BACKGROUND: Migraine prevalence is estimated to be 15% (approximately 50 million people) in the United States, posing a significant burden on the health care system and a top cause of years lived with disability. Consequently, migraine leads to increased work-related disability, including presenteeism and absenteeism. Novel prophylactic treatments for migraine that target the calcitonin gene-related peptide pathway, including monoclonal antibodies to the calcitonin gene-related peptide ligand or the calcitonin gene-related peptide receptor (calcitonin gene-related peptide monoclonal antibodies) and gepants, offer new options for migraine prevention. The advent of new medications presents an opportunity for development of outcomes-based agreements, particularly because these agents are more costly than traditional, nonspecific treatment alternatives. Outcomes-based agreements are pricing agreements between pharmaceutical manufacturers and payers, centered around predefined performance metrics to better align incentives and create shared risk between them.

OBJECTIVE: To report results of an outcomes-based agreement that was executed in a large integrated delivery and finance health system for patients with migraine who were prescribed erenumab, an anti-calcitonin gene-related peptide pathway monoclonal antibody.

METHODS: This is a prospective real-world analysis of commercial or health insurance exchange data from a large regional health system, based on parameters of an outcomes-based agreement. Eligible patients were new to calcitonin gene-related peptide monoclonal antibodies. Outcomes of interest included an erenumab adherence metric and changes in work absenteeism and rescue medication use. Proportion adherent and rescue medication use were assessed for the entire eligible patient cohort, whereas work absenteeism was only evaluated for a subset of eligible patients for whom work outcomes data were available.

RESULTS: There were 5,507 patients who filled erenumab during the contract period, and 1,281 patients were new to calcitonin gene-related peptide monoclonal antibodies medications. Of those, 865 constituted the eligible patient cohort and 224 constituted the work outcomes cohort. Patient adherence to erenumab was 80.5% and 81.7% for the entire patient cohort and work outcomes cohort, respectively. Absenteeism was reduced by 5.5% (21.64 vs 20.44 hours; P = 0.664) and rescue medication use was decreased by 3.6% (0.362 vs 0.349 doses; P = 0.589). Absenteeism could have been impacted by the onset of the COVID-19 pandemic.

CONCLUSIONS: As measured, adherence to erenumab was high within the cohort. The inclusion of a work outcomes cohort provided valuable insights about the clinical benefits of erenumab for migraine prevention. Our findings provide additional insights on the real-world use of erenumab within the context of an outcomes-based agreement.

OBJECTIVE: This study sought to identify: (1) the demographic and clinical characteristics of very high-cost users (defined as patients with pharmaceutical expenditures that were equal to or greater than the 99th percentile), (2) whether or not these characteristics changed over time, (3) sociodemographic and clinical correlates of being very high-cost users, (4) the average pharmaceutical costs of very-high cost users, and (5) the therapeutic classes and medications that contributed to these high costs.

BACKGROUND: There are growing public concerns about rising drug costs, in part due to increased availability, greater effectiveness, and market considerations. There is a concentrated portion of patients that accounts for a disproportionately large portion of pharmaceutical expenditures.

METHODS: A large serial cross-sectional study was conducted with De-identified, member-level pharmacy claims (n = 65,739,791) from a large, national pharmacy benefits manager from January 1, 2018 to December 31, 2022. The main outcome and measures were 2018-2022 pharmaceutical expenditures; amounts were adjusted for inflation to reflect 2022-dollar values.

RESULTS: Across the study period, the odds of being classified as a very high-cost user were 1.31 times as high for those 45-64 years old compared with those 18-44 years old (reference category); the odds were 1.42 times as high for males compared with females; 1.13 times as high before those identifying as non-Hispanic Black compared with non-Hispanic white; 1.11 times as high for those enrolled in a health care exchange plan compared with a commercial plan. In addition, very high-cost users lived in areas with higher social needs. Human immunodeficiency virus, inflammatory conditions, multiple sclerosis, and cancer accounted for the largest share of costs among this group.

CONCLUSIONS: This study identified the unique characteristics of very high-cost pharmaceutical users and identified the top conditions and prescription drugs that drove high pharmaceutical expenditures among this population. These findings are essential to understanding rising pharmaceutical costs in the United States and can help identify the issues and solutions of specific cost drivers within our health care policies.

Pediatric vaccination rates in the United States lag national goals. Policies that expand pharmacy-based vaccinations among children could help improve vaccination rates. Opponents argue, however, that such policies will result in delayed or missed well-child visits as most children receive routine vaccinations in primary care settings. We evaluated the likelihood of having a timely well-child visit following a routine vaccination in pharmacies and primary care settings among children aged 4-17 years. We conducted a retrospective cohort analysis with commercial claims data from 2016-2019, using conditional logistic regression models. A timely well-child visit was defined as one within 12 months after a preceding well-child visit for primary analysis and 15 months for secondary analysis. Approximately 95% of the sample consisted of children with influenza among their index vaccine(s). The odds of having a timely well-child visit were similar between children who received vaccines in pharmacies and those who received them in primary care settings. Findings suggest that guardians or parents who choose pharmacy-based pediatric vaccinations for their commercially insured children do not forgo well-child visits and may actually be more likely to obtain a timely well-child visit. Extending pharmacy-based vaccinations to patients of all ages can help improve pediatric vaccination rates.

OBJECTIVE: To describe the creation of a curated, shared repository of pharmacogenomics cases for pharmacy educators and lessons learned during the process.

METHODS: The 2019-2020 American Association of Colleges of Pharmacy Pharmacogenomics Special Interest Group (PGx SIG) formed an ad-hoc committee charged with creating a pharmacogenomics patient case repository for educational use. Following a needs assessment, a standardized case framework was developed using the Pharmacists' Patient Care Process. A guidance document was also created for case authors. The maintenance of the repository and the involvement of students is also described.

RESULTS: A total of 44 pharmacogenomics cases were accepted at various levels of difficulty, including 17 introductory cases, 18 intermediate cases, and 9 advanced cases. These cases cover 9 therapeutic areas and are freely available in an online network and information sharing platform (i.e., AACP Connect). Over the last 36 months, cases have been downloaded 427 times.

CONCLUSION: The AACP Pharmacogenomics SIG successfully created a shared repository of educational pharmacogenomics cases using a standardized framework. This approach can serve as a model for other Sections, SIGs or educators who desire to develop their own case repository in another field of study. Future work will measure direct outcomes of this available resource in the academic setting.

Adults living in rural communities of Alabama have limited or no access to hearing healthcare for a variety of reasons. Hearing loss can result in decreased social contact, potentially leading to loneliness, and it has been associated with depression and cognitive decline. To improve access to hearing healthcare, the FDA released its Final Rule in 2022 stating that adults with perceived mild-to-moderate hearing loss can purchase over-the-counter hearing aids (OTC HAs) on their own without clearance from a physician or through the care of an audiologist. Current research suggests, however, that adults benefit from professional support when purchasing and setting their OTC HAs. Understanding how much support is needed and how to best provide the support will be necessary for successful OTC HA use. Considering that these devices can now be purchased at pharmacies, one model in rural areas could involve the pharmacy technician who could assist and support those with hearing loss in community pharmacies. This article outlines a pharmacy technician educational training program that will incorporate didactic, interactional, and experiential learning components to promote the use of OTC HAs. The outcomes from this project will provide the foundation for the development and implementation of one model for improving access to hearing healthcare in rural communities.

IMPORTANCE: Community pharmacies are crucial for public health, providing essential services such as medication dispensing, vaccinations, and point-of-care testing. Addressing disparities in pharmacy access, particularly in underserved rural and low-income areas, is critical for health equity.

OBJECTIVE: To identify areas in the US at risk of becoming pharmacy deserts through the development of a novel pharmacy vulnerability index.

DESIGN, SETTING, AND PARTICIPANTS: This population-based cross-sectional study in the contiguous 48 states performed geographic information systems analysis of pharmacy data from the National Council for Prescription Drug Programs (NCPDP) dataQ. Participants included all open-door pharmacies (community or retail pharmacies open to the general public without restrictions on who can access its services) in the US as of February 2024. Statistical analysis was performed from July to August 2024.

EXPOSURE: The primary exposure was travel time to pharmacies across the US.

MAIN OUTCOMES AND MEASURES: A pharmacy desert was defined as a census tract where the travel time to the nearest pharmacy exceeds the supermarket access time for that region and urbanicity level. Building on this definition, a pharmacy vulnerability index was developed, which indicates the number of pharmacies that would need to close for a census tract to become a pharmacy desert. Tracts with a pharmacy vulnerability index of 1, depending solely on a single pharmacy for access, were identified as at risk of becoming deserts. Subpopulation totals and percentages living in pharmacy deserts or relying on keystone pharmacies were computed, and then stratified by urbanicity and race.

RESULTS: Among 321.3 million individuals (39.7 million [12.3%] Black, 59.0 million [18.2%] Hispanic, 195.0 million [60.3%] White) in the contiguous US, 57.1 million (17.7%) were identified as living in pharmacy deserts, with 28.9 million (8.9%) additionally relying on a single pharmacy for access. Small rural areas were particularly affected, with a higher dependency on single pharmacies (4.1 million individuals [14.3%]).

CONCLUSIONS AND RELEVANCE: In this cross-sectional study of pharmacy access in the US, significant disparities in pharmacy access were identified, especially pronounced in small rural areas. Targeted policy interventions, such as incremental reimbursement rates or other monetary incentives, are needed to ensure the financial sustainability of pharmacies that serve as the sole source of pharmacy services in at-risk areas.

PURPOSE: We compare trends in gabapentinoid and opioid utilization overall and by economic development category. We also sought to predict future trends and assess correlations in gabapentinoid and opioid utilization.

METHODS: We conducted a repeated cross-sectional analysis of retail prescriptions for 72 countries from Q1 2012 to Q3 2023. We measured standardized units/1000 population for gabapentinoid and opioid sales, stratified by development category, and used time-series models to predict trends for the following 3 years. Granger causality tests examined predictive relationships between gabapentinoid and opioid sales.

RESULTS: Global gabapentinoid annual sales rose by 114.5% from 2012 to 2022, with a higher increase in developing (180.9%) than developed economies (110.0%). In contrast, annual opioid sales declined globally by 25.4%, with a 27.9% decrease in developed and a 16.8% increase in developing economies. Assuming current trends persist over the following 3 years, gabapentinoid quarterly sales are forecasted to rise by 7.7% in developed and 18.6% in developing economies, while opioid quarterly sales are expected to decrease by 9.5% and increase by 15.1%, respectively. Granger causality tests indicated that gabapentinoids may predict opioid sales globally for the following year, but opioids did not predict gabapentinoid sales.

CONCLUSION: We evaluated the global trends in gabapentinoid and opioid sales, suggesting important differences in pain management practices across developed and developing economies. Our findings highlight the need to ensure the safe use of gabapentinoids and opioids while balancing proper pain management.