AMCP's new election process: Designed for organizational effectiveness.

The AMCP Board of Directors appointed a Task Force on Leadership Development in 2021 with the charge to recommend a volunteer leadership structure that aligns with AMCP's contemporary needs and fosters the development of future Board members. Based on the Task Force's recommendations and with input from AMCP members, the AMCP Board of Directors amended AMCP's governance model in early 2023. The most notable changes involve the process for electing AMCP Board members and officers, which will be implemented for the 2024-25 election. The goal of the new election process is to assemble an effective Board with diverse experiences and complementary skills and attributes that will continue to lead AMCP into the future. In this viewpoint article, we share insights into the steps that led to these governance changes.

Milestones in managed care pharmacy.

Managed care pharmacy has a relatively short history, but one that is defined by significant achievements. Since the late 1960s, managed care pharmacists have applied their unique skills to formulary management, clinical programs, benefit design, and contract negotiations to support patient access to life-saving therapies, while also ensuring cost-effective use of limited health care resources. Key milestones include establishing the pharmacy benefit as an essential component of the U.S. health care system, launching the Medicare Part D program, and expanding medication therapy management services. The year 2020 brings another milestone-the 25th anniversary of AMCP's flagship publication, the Journal of Managed Care + Specialty Pharmacy. This year also serves as an inflection point. As managed care pharmacy professionals prepare for change and the challenges ahead-including the imperative to address the rising costs of health care and health disparities-the use of evidence, utilization management strategies, and innovation will support our continued success. DISCLOSURES: No funding supported the writing of this commentary. The authors have nothing to disclose.

Improving the Quality of Compounded Sterile Drug Products: A Historical Perspective.

The term compounding generally refers to the practice of combining, mixing, or altering ingredients of a drug product to create a medication tailored to the needs of an individual patient. Compounding has long been a common activity within the practice of pharmacy. The scope of pharmacy compounding includes the compounding of sterile products, a practice that is especially prevalent within hospitals, home infusion pharmacies, and, more recently, outsourced compounding facilities. Reports of patient morbidity and mortality associated with compounded products have led many over the years, including the US Food and Drug Administration (FDA), to call for more stringent federal oversight of pharmacy compounding to ensure patient safety. A tipping point was reached in 2012 with the emergence of a multistate outbreak of fungal meningitis and other infections in patients who received contaminated steroid injections compounded by the New England Compounding Center in Framingham, Massachusetts. This article describes the history of the practice and regulation of pharmacy compounding, culminating in the passage by Congress of the Compounding Quality Act of 2014.

Medicines in Pregnancy Forum: Proceedings on Ethical and Legal Considerations.

To raise awareness and promote dialogue leading to action, this article provides proceedings on ethical and legal considerations associated with medicine use during pregnancy discussed during the 2014 DIA Medicines and Pregnancy Forum. A key focus of discussion at the forum was "When is it ethically appropriate to include or unethical not to include pregnant patients in clinical studies, and how can ethical barriers be addressed?" Also debated was the question "What are the most appropriate methods to collect and share data on medication use in pregnancy, and what is the best process for sharing such information?" Goals of the forum were to gain participant alignment on answers to these ethical questions, offer rationale for the answers, and provide insight into which stakeholders might be needed to facilitate discussion and action. Participants felt that under the right circumstances, drug research in pregnant women is justified and necessary. Multiple ideas and opinions on the handling of pregnant patients in clinical research, treating pregnant women in clinical practice, and communicating data to physicians and patients are presented.

A Proposed Framework to Address Needs of Clinical Data for Informed Medication Use in Pregnancy.

The objective of this paper is to communicate a proposed framework for addressing research limitations and communication barriers that contribute to a lack of data for making clinical treatment decisions about medication use in pregnancy. To address this global public health concern, a cross-stakeholder coalition composed of several workstreams is proposed. The intent is to foster collaborative discussion regarding potential solutions to address gaps in communication, engagement, and data generation and collection. Topic areas that require focus include development of awareness initiatives, cultural transformation efforts, collaboration initiatives, research standards, data compilation projects, and new data capture methods. Objectives to aid these efforts are outlined, and collaboration among researchers, regulators, health care providers, and patients is emphasized.

Clinical Data for Informed Medication Use in Pregnancy: Strengths, Limitations, Gaps, and a Need to Continue Moving Forward.

The objective of this paper is to explore the strengths, weaknesses, gaps, and needs in research on medication use in pregnancy, where opportunities have been bypassed to develop standards and collaborations for collecting data to better understand how medications can impact clinical outcomes in pregnant women and developing fetuses. The availability of existing data and the methods of its capture are reviewed, including registries, claims and health record databases, and meta-analyses. The paper focuses on why these efforts have not fundamentally provided benefit-risk information and clinical treatment algorithms for medication use in pregnant women. Methodological issues, such as lack of standardization and central data collection, are discussed. Common barriers are examined, including a lack of awareness and education, cultural hurdles, collaboration deficiency, and an insufficient development of new data collection methods.