US Food and Drug Administration regulation and review is noted as having gaps in process that can affect patient safety. This article discusses reasons for the reluctance of physicians to fully embrace the use of artificial intelligence tools approved by the FDA in their practice. The concerns include lax regulation, poor product development transparency and lack of robust real-world accuracy data.

Drug shortages, while often discussed as a system failure, demonstrate harm at an individual level. This story highlights the work of a patient activist who was inspired by the threat to her daughter’s care posed by a lack of chemotherapy availability, to provide needed medications during system disruptions to keep patients safe.

The National Quality Forum has defined 29 never events—patient safety problems that should never occur, such as wrong-site surgery. Since 2003, Minnesota hospitals have been required to report such incidents. The 2022 report summarizes information about 572 adverse events that were reported, representing a significant increase in the year covered. Earlier reports prior to the last two years reflect a fairly consistent count of adverse events. The rise documented here is likely due to demands on staffing and care processes associated with COVID-19 and general increases in patient complexity and subsequent length of stay. Pressure ulcers and fall-related injuries were the most common incidents recorded. Reports from previous years are available.

Disjointed health care processes contribute to missed test results, incomplete communication, and care omissions that harm patients. This book shares a personal account of how broken care processes serve as a core deterrent in one clinician’s ability to provide the safest care possible.

Safe practice in community pharmacy is challenged by production pressure, workforce shortages, and multitasking. This story examined the mistakes made at major retail pharmacy chains in California. It provides examples perpetrated across the industry to target universal areas of needed improvement and potential strategies to address them.

The President’s Council of Advisors on Science and Technology brings together topic experts to summarize important issues for the consideration of the President of the United States. This report introduces the persistent problem of unsafe care and recommends a federal leadership entity, application of evidence-based solutions, true patient partnership and research funding as avenues to achieve stable improvement.

A variety of supply-chain, quality control, and economic factors complicate access to medications due to drug shortages that put patients at risk. This article discusses specific systemic weaknesses in the drug development process that are reducing the safety of cancer medication therapy in the United States.

The unintended clinical consequences of abortion restrictions are beginning to emerge. This article shares how one woman faced personal health risks due to clinician concerns stemming from barriers to abortion care and how the Emergency Medical Treatment & Labor Act (EMTALA) may be employed to minimize care limitations in emergent pregnancy-related situations.

Nurse staffing and patient care outcomes are linked, yet variation exists in nursing coverage throughout the United States. This submitted bill aims to legislate a national minimum nurse-to-patient staffing ratio as a strategy to enhance safety and quality improvement.

Implementations of electronic health record (EHR) systems are complex efforts that have the potential for injury, should failure occur. This article discusses the Veterans Affairs EHR implementation project that is associated with six incidents of patient harm and calls for improvement at the federal level.

Gaps in care for psychologically vulnerable patients can result in harm to family members and self-harm. This report examines organizational failures in responding to staff and clinical leaders’ concerns regarding access, triage, and care continuity for mental health patients. Recommendations for improvement include same-day access to appropriate specialty care, medication management, and risk documentation.

This series of commentaries discusses a wide range of policy, legal, and operational topics related to patient safety in the British Health system, such as artificial intelligence, patient compensation for harm, and curricula.