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Anticoagulation is a leading cause of medication‐related harm. As a result, there is increasing recognition of the importance of the development of anticoagulation stewardship programs to ensure safe and effective anticoagulation use across health care settings. Securing administrative leadership support to build such programs is a necessary first step but is often a significant barrier to implementation. Herein, we present a structured approach to guide providers advocating to leadership for stewardship programs at their institutions. We divide the approach into four phases: (1) Build the foundation, (2) Select stewardship initiatives, (3) Develop implementation plans, and (4) Prepare and present a business plan. Within each phase, we outline specific actions to consider, all leading up to the end goal of creating a compelling business plan to generate administrative leadership buy‐in. We also provide resources to promote the understanding of institutional needs as well as broader trends across health systems that influence stewardship program development. Our aim is to provide stewardship advocates with the tools to effectively secure leadership support to facilitate the development of Anticoagulation Stewardship Programs across all health care institutions. [ABSTRACT FROM AUTHOR]

Purpose: To describe medication adherence and persistence of HIV PrEP overall and compare between sex and age groups of commercially insured individuals in the United States. Methods: We conducted a national retrospective cohort study of the Merative MarketScan Claims Database from 2011 to 2019 to describe adherence and persistence of PrEP overall and compared between sex and age groups. High adherence was defined as ≥80% of proportion of days covered and persistence was measured in days from initiation to the first day of a 60‐day treatment gap. Results: A total of 29 689 new PrEP users identified. Overall adherence was high (81.9%; 95% confidence interval [CI]: 81.5%–82.3%). Females were more adherent than males (adjusted odds ratio [aOR] 1.87; 95% CI: 1.50–2.34), while those ≥45‐years were less adherent than individuals <45‐years (aOR 0.87: 95% CI: 0.81–0.93). More than half of individuals discontinued therapy within the first year (median 238.0 days; interquartile range 99.0–507.0 days). Females were less persistent than males (hazard ratio [HR] 1.49; 95% CI: 1.34–1.65), and people ≥45‐years old were more persistent (i.e., lower risk of discontinuation) than those <45‐years (HR 0.43; 95% CI: 0.33–0.55). Conclusions: These findings show adherence to daily PrEP is high among commercially insured individuals but the majority still discontinue in the first year. Future research should investigate what factors influence PrEP discontinuation among this population and ways to reduce barriers to therapy maintenance to ensure the population‐level benefits of PrEP treatment. [ABSTRACT FROM AUTHOR]

Purpose: The case‐crossover design is a self‐controlled study design used to compare exposure immediately preceding an event occurrence with exposure in earlier control periods. The design is most suitable for transient exposures in order to avoid biases that can be problematic when using the case‐crossover design for non‐transient (i.e., chronic) exposures. Our goal was to conduct a systematic review of case‐crossover studies and its variants (case‐time‐control and case‐case‐time‐control) in order to compare design and analysis choices by medication type. Methods: We conducted a systematic search to identify recent case‐crossover, case‐time‐control, and case‐case‐time‐control studies focused on medication exposures. Articles indexed in MEDLINE and EMBASE using these study designs that were published between January 2015 and December 2021 in the English language were identified. Reviews, methodological studies, commentaries, articles without medications as the exposure of interest, and articles with no available full text were excluded. Study characteristics including study design, outcome, risk window, control window, reporting of discordant pairs, and inclusion of sensitivity analyses were summarized overall and by medication type. We further evaluated the implementation of recommended methods to account for biases introduced by non‐transient exposures among articles that used the case‐crossover design on a non‐transient exposure. Results: Of the 2036 articles initially identified, 114 articles were included. The case‐crossover was the most common study design (88%), followed by the case‐time‐control (17%), and case‐case‐time‐control (3%). Fifty‐three percent of the articles included only transient medications, 35% included only non‐transient medications, and 12% included both. Across years, the proportion of case‐crossover articles evaluating a non‐transient medication ranged from 30% in 2018 to 69% in 2017. We found that 41% of the articles that evaluated a non‐transient medication did not apply any of the recommended methods to account for biases and more than half of which were conducted by authors with no previous publication history of case‐crossover studies. Conclusion: Using the case‐crossover design to evaluate a non‐transient medication remains common in pharmacoepidemiology. Researchers should apply appropriate design and analysis choices when opting to use a case‐crossover design with non‐transient medication exposures. [ABSTRACT FROM AUTHOR]

Testing guidelines for initiation of pre-exposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) have been developed to ensure appropriate use of PrEP, such as among those with renal dysfunction or at high risk of seroconversion. While many studies have looked at the trends of use of PrEP in the United States, little is known about compliance with these guidelines, the quality of care of PrEP at a national level, or what provider-level factors are associated with high-quality care. We conducted a retrospective claims analysis of providers of commercially insured new users of PrEP between January 1, 2011, and December 31, 2019. Of the 4200 providers, quality of care was low, with only 6.4% having claims for ≥60% of guideline-recommended testing for their patients in the testing window for all visits. More than half of the providers did not have claims for HIV testing at initiation of PrEP and ≥40% did not for sexually transmitted infections at both initiation and follow-up visits. Even when extending the testing window, quality of care remained low. Logistic regression models found no association between provider type and high quality of care, but did find that providers with one PrEP patient were more likely to have higher quality of care than those with multiple patients for all tests [adjusted odds ratio 0.47 (95% confidence interval: 0.33–0.67)]. The study findings suggest further training and interventions, such as integrated test ordering through electronic health records, are needed to increase quality of care for PrEP and ensure appropriate monitoring of patients. [ABSTRACT FROM AUTHOR]

A study was conducted to evaluate the structure, operations, and preliminary findings from the Research on Adverse Drug events And Reports (RADAR) project and related dissemination efforts by pharmaceutical suppliers and the US Food and Drug Administration. The result showed that a new, clinically based, hypothesis-driven approach to postmarketing surveillance may supplement existing regulatory surveillance and improve patients safety.

Reports of epoetin-associated pure red-cell aplasia from the Food and Drug Administration (FDA) and from the manufacturers of Eprex, Epogen and Neorecormon were obtained and analyzed. The results indicate a reduction of more than 80 percent in the incidence of pure red-cell aplasia due to Eprex.