Pharmaceutical Regulatory Affairs: Open Access

The United States Food & Drug Administration requires under Title 21 of the Code of Federal Regulations (21 CFR) Part 820.100, that medical device manufacturers must establish a system to address Corrective And Preventive Actions (CAPAs) to meet regulatory standards. This article provides insight into medical device quality issues relating to CAPA through the evaluation of warning letters issued by the US Food and Drug Administration (FDA) between 2013 and 2022. The results of this study indicate that despite the medical device regulations being in place since 1976 violations of 21 CFR 820.100 (CAPA related violations) continues to be a significant issue for medical device companies.

Pharmacy automation refers to the use of technology to streamline and automate various processes in the pharmacy, including drug dispensing, inventory management, medication administration, and documentation. This can be achieved through the use of various software programs, robots, and other automated systems. Pharmacy automation, medication, drug interactions.

Pharmacy automation has become increasingly important in recent years due to a variety of factors, including an aging population, the increasing complexity of medications, and the need for healthcare providers to manage large amounts of patient data efficiently. By automating many of the routine tasks involved in pharmacy operations, pharmacists and other healthcare providers can improve patient safety, reduce medication errors, and increase efficiency.

Drug Utilization Review (DUR) is a critical component of healthcare systems aimed at ensuring the safe and effective use of medications. This article explores the significance of Drug Utilization Review in promoting safer healthcare practices. By examining patient outcomes, minimizing adverse drug events and optimizing therapeutic regimens, DUR plays a pivotal role in enhancing overall healthcare quality. The article delves into the key aspects of DUR, its methodologies and the impact it has on patient safety. Additionally, it discusses the role of technology in advancing DUR capabilities and the importance of collaboration among healthcare professionals for successful implementation.

The process of managing medications can often resemble a complex maze, with various healthcare providers, prescriptions and potential interactions. Medication reconciliation, a critical aspect of patient care, aims to streamline this process and enhance patient safety. This comprehensive guide explores the importance of medication reconciliation, its components, challenges and strategies for effective implementation. By providing a roadmap through the medication maze, this article empowers healthcare professionals and patients alike to navigate the complexities of medication management.