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Extemporaneous compounding of medications has been an integral component of the practice of pharmacy and medicine since the practices began. A staple of early medical and pharmacy practice, even today many patients benefit from compounding at some point in their care. Unfortunately, the regulation of the practice has not been so consistent. With a recent decision by the US Supreme Court, compounding regulation is again uncertain. This commentary reviews compounding practice, the history of compounding regulation, and discusses the current regulatory status of the practice. [ABSTRACT FROM AUTHOR]

Purpose: The oncology quality, characterization, and assessment of real-world data (Oncology QCARD) Initiative was formed to develop a set of minimum study design and data elements needed to evaluate the fitness of the real-world data (RWD) source(s) proposed in an initial study concept as part of early interaction with scientific reviewers., Methods: A multidisciplinary executive committee (EC) was established to guide the Oncology QCARD Initiative. The EC conducted a landscape review of published literature, guidances, and guidelines to evaluate relevant dimensions of data quality measurement. Guided by the review and informed by expert feedback, the Oncology QCARD Initial Protocol Characterization (IPC) provides a summary of minimum elements needed to adequately describe an initial clinical study concept that involves RWD and is intended to support decision-making., Results: Fit-for-use data and fit-for-purpose design emerged as themes from the landscape analysis. Data that are fit-for-use are both relevant (sufficiently capturing exposure, outcomes, and covariates) and reliable (understanding data accrual and quality control and whether the data represent the underlying concepts they are intended to represent) to answer a specific research question. A fit-for-purpose design takes appropriate steps to ensure internal and external validity and allows for transparency in reporting. The QCARD-IPC focuses on high-level characteristics of RWD sources and study design domains including data temporality, population, medical product exposure, comparators, and covariates, endpoints, statistical analysis, and data quality assurance plans., Conclusions: Evaluation of studies including RWD requires understanding the data source, study design, and potential biases to preliminarily evaluate whether selected RWD are fit-for-use for the research question. The Oncology QCARD-IPC provides a structured, transparent approach to facilitate early review and enhanced communication between study sponsors and scientific reviewers of initial study proposals including RWD., (© 2024 John Wiley & Sons Ltd. This article has been contributed to by U.S. Government employees and their work is in the public domain in the USA.)

A worthy goal of HIPAA is to protect the privacy of patient health information. Final regulations for achieving this goal have been issued, and all covered entities, including all pharmacies that transmit health information electronically, must comply with these regulations by April 14, 2003. Pharmacists are strongly advised to begin educating themselves about the HIPAA privacy regulations and taking steps toward implementation as soon as possible. Because of the complexity of the privacy rule and the lingering ambiguities about how to implement the regulations, pharmacies also are encouraged to obtain expert guidance and stay up-to-date with the regulations and implementation recommendations posted by OCR.

Objective: To describe the controversies and review the evidence about computer-aided prospective drug utilization review (PDUR) systems., Data Sources: MEDLINE search of the literature., Study Selection: Published studies of the effectiveness of computer-aided prescription screening., Data Synthesis: One randomized, controlled trial and four nonrandomized studies constitute the evidence base. The five studies are inconclusive with respect to whether computer-aided prescription screening causes health care providers to take action, either because of a no difference finding or because there was no comparison group. In the one randomized, controlled trial, a substantial number of actions were taken by the control group whose members did not receive alerts. No study evaluated the total effect of screening by in-store and payer (online) systems. Specific research recommendations are made to increase the evidence base., Conclusion: Limited and inconclusive evidence about whether these systems are effective and what system features are optimal may explain the wide variation among systems in terms of what problems are screened and may also explain clinicians' uncertainty about their value. A comprehensive national research agenda for reducing medical errors should include research on the effectiveness of computer-aided PDUR.