FDA Initiative for Drug Facts Label for Over-the-Counter Naloxone.

BACKGROUND: The opioid crisis highlights the need to increase access to naloxone, possibly through regulatory approval for over-the-counter sales. To address industry-perceived barriers to such access, the Food and Drug Administration (FDA) developed a model drug facts label for such sales to assess whether consumers understood the key statements for safe and effective use. METHODS: In this label-comprehension study, we conducted individual structured interviews with 710 adults and adolescents, including 430 adults who use opioids and their family and friends. Eight primary end points were developed to assess user comprehension of each of the key steps in the label. Each of these end points included a prespecified target threshold ranging from 80 to 90% that was evaluated through a comparison of the lower boundary of the 95% exact confidence interval. RESULTS: The results for performance on six primary end points met or exceeded thresholds, including the steps "Check for a suspected overdose" (threshold, 85%; point estimate [PE], 95.8%; 95% confidence interval [CI], 94.0 to 97.1) and "Give the first dose" (threshold, 85%; PE, 98.2%; 95% CI, 96.9 to 99.0). The lower boundaries for four other primary end points ranged from 88.8 to 94.0%. One exception was comprehension of "Call 911 immediately," but this instruction closely approximated the target of 90% (PE, 90.3%; 95% CI, 87.9 to 92.4). Another exception was comprehension of the composite step of "Check, give, and call 911 immediately" (threshold, 85%; PE, 81.1%; 95% CI, 78.0 to 83.9). CONCLUSIONS: Consumers met thresholds for sufficient understanding of six of eight components of the instructions in the drug facts label for naloxone use and came close on two others. Overall, the FDA found that the model label was adequate for use in the development of a naloxone product intended for over-the-counter sales.

Navigating towards a moral horizon: a multisite qualitative study of ethical practice in nursing.

This paper reports the results of a qualitative study of nurses' ethical decision-making. Focus groups of nurses in diverse practice contexts were used as a means to explore the meaning of ethics and the enactment of ethical practice. The findings centre on the metaphor ofa moral horizon--the horizon representing "the good" towards which the nurses were navigating.The findings suggest that currents within the moral climate of nurses' work significantly influence nurses' progress towards their moral horizon. All too often the nurses found themselves navigating against a current characterized by the privileging of biomedicine and a corporate ethos. Conversely, a current of supportive colleagues as well as professional guidelines and standards and ethics education helped them to move towards their horizon.The implications for nursing practice and for our understanding of ethical decision-making are discussed.

The context of health care communication in chronic illness.

Patient-professional communication is a critically important element of effective chronic illness care. However, the dynamics of health care communication in supporting self-care management and effective coping with various chronic diseases is not well understood. The present study examined health care communication from the perspective of 38 patients with four distinct chronic conditions: end-stage renal disease (ESRD), non-insulin dependent diabetes mellitus (NIDDM), multiple sclerosis (MS), and fibromyalgia (FM). Analysis revealed the dimensions of courtesy, respect, and engagement to be inherent in communication priorities across conditions. However, distinct "disease worlds" among and between these chronic conditions illuminated salient differences within these dimensions, thereby illustrating the way in which relevant variables such as legitimacy, the availability of conventional treatments, and lifestyle implications shape the meaning of health care communication. The findings enlarge upon patient-centered approaches to health care communication and inform further analysis of the interactional dynamics associated with chronic conditions.

Ethical practice in nursing: working the in-betweens.

BACKGROUND: While contemporary ethical theory is of tremendous value to nursing, the extent to which such theory has been informed by the concerns and practices of nurses has been limited. PURPOSE: With a view to complementing extant ethical theory, a study was undertaken to explore, from the perspective of nurses, the meaning of ethics and the enactment of ethical practice in nursing. DESIGN AND METHODS: Located in the interpretive/constructivist paradigm, using an emergent design, this inquiry employed focus groups to collect the data. Eighty-seven nurses from a wide range of practice settings were interviewed in 19 focus groups of three to nine nurses each. FINDINGS: The nurses described ethics in their practice as both a way of being and a process of enactment. They described drawing on a wide range of sources of moral knowledge in a dynamic process of developing awareness of themselves as moral agents. Enacting moral agency involved working in a shifting moral context, and working in-between their own values and those of the organizations in which they worked, in-between their own values and those of others, and in-between competing values and interests. CONCLUSIONS: Analysis of the experiences and concerns of the nurses offered new understanding of ethics in nursing and direction for the development of ethical theory pertinent to nursing practice.

Navigating towards a moral horizon: a multisite qualitative study of ethical practice in nursing.

This paper reports the results of a qualitative study of nurses' ethical decision-making. Focus groups of nurses in diverse practice contexts were used as a means to explore the meaning of ethics and the enactment of ethical practice. The findings centre on the metaphor of a moral horizon--the horizon representing "the good" towards which the nurses were navigating. The findings suggest that currents within the moral climate of nurses' work significantly influence nurses' progress towards their moral horizon. All too often, the nurses found themselves navigating against a current characterized by the privileging of biomedicine and a corporate ethos. Conversely, a current of supportive colleagues as well as professional guidelines and standards and ethics education helped them to move towards their horizon. The implications for nursing practice and for our understanding of ethical decision-making are discussed.