COVID-19 Evidence Accelerator: A parallel analysis to describe the use of Hydroxychloroquine with or without Azithromycin among hospitalized COVID-19 patients.

BACKGROUND: The COVID-19 pandemic remains a significant global threat. However, despite urgent need, there remains uncertainty surrounding best practices for pharmaceutical interventions to treat COVID-19. In particular, conflicting evidence has emerged surrounding the use of hydroxychloroquine and azithromycin, alone or in combination, for COVID-19. The COVID-19 Evidence Accelerator convened by the Reagan-Udall Foundation for the FDA, in collaboration with Friends of Cancer Research, assembled experts from the health systems research, regulatory science, data science, and epidemiology to participate in a large parallel analysis of different data sets to further explore the effectiveness of these treatments. METHODS: Electronic health record (EHR) and claims data were extracted from seven separate databases. Parallel analyses were undertaken on data extracted from each source. Each analysis examined time to mortality in hospitalized patients treated with hydroxychloroquine, azithromycin, and the two in combination as compared to patients not treated with either drug. Cox proportional hazards models were used, and propensity score methods were undertaken to adjust for confounding. Frequencies of adverse events in each treatment group were also examined. RESULTS: Neither hydroxychloroquine nor azithromycin, alone or in combination, were significantly associated with time to mortality among hospitalized COVID-19 patients. No treatment groups appeared to have an elevated risk of adverse events. CONCLUSION: Administration of hydroxychloroquine, azithromycin, and their combination appeared to have no effect on time to mortality in hospitalized COVID-19 patients. Continued research is needed to clarify best practices surrounding treatment of COVID-19.

Extemporaneous compounding: a return to regulatory limbo?

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.

Implementing HIPAA privacy regulations in pharmacy practice.

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.

The role of pharmacy computer systems in preventing medication errors.

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.