A primer on managed care pharmacy.

This primer defines the practice of managed care pharmacy and introduces key competencies of managed care pharmacy organizations, including pharmacy benefit design and implementation, formulary and medication utilization management, clinical program development and implementation, quality and safety program management, and promotion of affordability.

Meeting report: an exploration into the scientific and regulatory aspects of pharmaceutical drug quality in the United States.

INTRODUCTION: The University of Florida College of Pharmacy, Department of Pharmaceutical Outcomes and Policy hosted a seminar 6-7 March 2021, on the quality of pharmaceutical products in the United States. This meeting report summarizes the topics presented at the seminar and highlights the expert opinions offered by the presenters. AREAS COVERED: The seminar, held virtually due to the COVID-19 pandemic, included slide presentations and faculty-moderated panel discussions from experts in the field. These experts from regulatory, academic, and private sectors discussed bioequivalence standards, existing and emerging efforts to promote quality in brand and generic manufacturing, as well as market-based solutions throughout the drug supply chain. EXPERT OPINION: The time spent understanding bioequivalence standards during the seminar felt especially important and relevant in our current pandemic environment, given the present need to have confidence in the science of drug development and to advocate for the safety of pharmaceuticals. Also an important point to emphasize from the seminar, was that every stakeholder along the drug supply chain has a responsibility to do their part to maintain its quality. And those in attendance, many of whom were students of healthcare sciences, were encouraged to be leaders in their fields and develop strategies to advance innovative improvements.

Managed Care Pharmacy Research on Inappropriate Opioid Use Interventions.

DISCLOSURES: No funding contributed to the writing of this commentary. The authors have nothing to disclose.

Distinguishing Predatory from Reputable Publishing Practices.

The preponderance of journals with dubious publishing practices has resulted in a new term in academic publishing: predatory journals. Although there is no standard definition, predatory journals generally subvert the traditional peer-reviewed system for financial gain. Common practices of predatory journals include publishing almost all submissions, a lack of transparency about publication fees, aggressive solicitation of contributors irrespective of relevant expertise and credentials, and even closely mimicking names of reputable journals-effectively acting as a decoy to attract authors and readers. Left unchecked, these journals have the potential to threaten the evidence base relied on by managed care pharmacists. Given the importance of peer-reviewed literature to managed care pharmacy practice, how is one to discern between a predatory journal and a reputable one? There are 5 key practices that distinguish reputable journals. First, reputable journals rely on peer reviewers who are experts in their respective fields to carefully review submitted manuscripts for suitability to publish. Second, reputable journals have a board of experts in relevant areas that serve in an advisory capacity to the editorial staff. Third, reputable journals follow recognized publishing standards to guide their policies, which range from determining authorship, to journal management, to handling allegations of misconduct. Fourth, reputable journals are transparent and fair about their levied fees, avoiding any real or perceived conflict of interest. Finally, reputable journals are indexed in searchable databases that have quality selection criteria for inclusion. These 5 criteria should be used by managed care authors and researchers when determining where to publish their papers and whether to serve as an editorial board member or peer reviewer when requested. Studies published in journals meeting these criteria can be deemed as reputable and suitable for review by managed care and health policymakers. It is essential that everyone involved in producing and using peer-reviewed literature is informed about the threat of predatory publishing and avoids engaging in any activities with these journals. DISCLOSURES: No funding was received for the writing of this article. The author is editor-in-chief of the Journal of Managed Care & Specialty Pharmacy and has nothing to disclose.

Application of a Graphical Depiction of Longitudinal Study Designs to Managed Care Pharmacy Research.

Managed care pharmacists apply real-world evidence (RWE) to support activities such as pipeline forecasting, clinical policy development, and contracting for pharmaceutical products. Managed care pharmacy researchers strive to produce studies that can be applied in practice. While asking the right research question is necessary, it is not sufficient. As with all studies, consumers of RWE look for internal and external validity, as well as sources of bias, to determine how the study findings can be applied in their work. To date, however, some of the safeguards that exist for clinical trials-such as public registration of study protocols-are lacking for RWE. Several leading professional organizations have initiatives dedicated to improving the credibility and reliability of such research. One component common to these initiatives is enhanced transparency and completeness of methodologic reporting. Graphical representations of study designs can improve the reporting and design of research conducted in health care databases, specifically by enhancing the transparency and clarity of often complex studies. As such, Schneeweiss et al. (2019) proposed a graphical framework for longitudinal study designs in health care databases. Herein, we apply this framework to 2 studies published in the Journal of Managed Care & Specialty Pharmacy that represent common research designs and report how application of the framework revealed deficiencies in reporting. We advocate for adoption of this framework in the effort to increase the usability of RWE studies using health care databases by managed care pharmacy. DISCLOSURES: No funding was provided for this work. Gatwood has received research funding from Merck & Co., AstraZeneca, and GlaxoSmithKline, unrelated to this work. Schneeweiss is a consultant to Aetion, of which he also owns equity. He is the principal investigator of investigator-initiated grants to the Brigham and Women's Hospital from Bayer, Genentech, Boehringer Ingelheim, and Vertex. Wang reports support from investigator-initiated grants from Novartis, Boehringer Ingelheim, and Johnson & Johnson to Brigham and Women's Hospital, unrelated to this work. Happe and Brown have nothing to disclose.