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To produce a consensus list of the top 10 signs and symptoms suggestive of adverse drug events (ADEs) for monitoring in residents of long-term care facilities (LTCFs) who use antipsychotics, benzodiazepines, or antidepressants. A 3-round Delphi study. Geriatricians, psychiatrists, pharmacologists, general practitioners, pharmacists, nurses, and caregivers from 13 Asia Pacific, European, and North American countries. Three survey rounds were completed between April and June 2023. In Round 1, participants indicated their level of agreement on a 9-point Likert scale on whether 41 signs or symptoms identified in a systematic review should be routinely monitored. Participants considered signs and symptoms that reduce quality of life or cause significant harm, are observable or measurable by nurses or care workers, and can be assessed at a single time point. Round 1 statements were included in a list for prioritization in Round 3 if ≥ 70% of participants responded ≥7 on the Likert scale. Statements were excluded if ≤ 30% of participants responded ≥7. In Round 2, participants indicated their level of agreement with statements that did not reach initial consensus, plus amended statements based on Round 1 participant feedback. Round 2 statements were included in Round 3 if ≥ 50% of the participants responded ≥7 on the Likert scale. In Round 3, participants prioritized the signs and symptoms. Forty-four participants (93.6%) completed all 3 rounds. Four of 41 signs and symptoms reached consensus for inclusion after Round 1, and 9 after Round 2. The top 10 signs and symptoms prioritized in Round 3 were recent falls, daytime drowsiness or sleepiness, abnormal movements (eg, shaking or stiffness), confusion or disorientation, balance problems, dizziness, postural hypotension, reduced self-care, restlessness, and dry mouth. The top 10 signs and symptoms provide a basis for proactive monitoring for psychotropic ADEs. [ABSTRACT FROM AUTHOR]

As a method of research, pragmatic trials are recommended so as to generate results that are applicable to real-world care. This intent is especially important for the millions of older adults who receive long-term care in thousands of nursing homes and assisted living communities across the country—and many millions more around the globe. This article presents key points raised by experts participating in a conference funded by the National Institute of Aging held at the 2021 conference of the Society for Post-Acute and Long-term Care Medicine. The purpose of the conference was to convene leading clinicians, researchers, and industry partners to address special considerations of pragmatic trials in long-term care. Cross-cutting and unique challenges and solutions to conducting pragmatic trials were discussed focusing on 3 areas of clinical relevance to long-term care: (1) functional care and outcomes, (2) psychosocial care and quality of life, and (3) medical care and outcomes, with a special focus on persons with dementia. Challenges and innovative solutions were organized across the 9 domains of the revised Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) Tool, and future research recommendations for pragmatic trials in long-term care were identified. [ABSTRACT FROM AUTHOR]

The prescribing and dispensing of controlled substances within long-term care facilities is an important and complex issue from both the clinical and the public policy perspectives. This article reviews the regulatory background and clinical concerns regarding the enforcement of the Controlled Substances Act by the Drug Enforcement Administration within the institutional pharmacies serving long-term care facilities. The article argues that the processes implemented since 2009 in response to concerns about Drug Enforcement Administration enforcement are suboptimal at many levels. A robust solution that meets the needs of all parties involved will require multiple levels of collaboration and respect for several legitimate agendas pertinent to this issue. The comprehensive solution must address at least 4 concerns. It must ensure that (1) residents and patients of long-term care facilities receive appropriate and timely administration of controlled substances when they are part of their individualized plans of care; (2) long-term care facilities have rigorous processes in place to prevent diversion of controlled substances; (3) required processes for prescribing controlled substances are reasonable and not overly burdensome to the clinicians caring for this population; and (4) all parties are in compliance with statutory and regulatory requirements. The solution, however, will likely require legislative amendments to the Controlled Substances Act and regulatory revisions for optimal outcomes. The debate surrounding the enforcement of the Controlled Substances Act within long-term care facilities is ongoing and the parameters are in flux. This article provides a historical perspective and policy framework for understanding the topic, reviews various proposed solutions, and suggests a collaborative process for resolution. [Copyright &y& Elsevier]