美国药物评价与研究中心Barbara R. Cohen小组倡议为非处方纳洛酮提供药品事实说明书。该成果发表在2020年5月28日出版的《新英格兰医学杂志》上。
Title: FDA Initiative for Drug Facts Label for Over-the-Counter Naloxone
Author: Barbara R. Cohen, M.P.A,, Karen M. Mahoney, M.D.,, Elande Baro, Ph.D.,, Claudia Squire, M.S.,, Melissa Beck, B.A.,, Sara Travis, B.S.,, Amanda Pike-McCrudden, M.A.,, Rima Izem, Ph.D.,, and Janet Woodcock, M.D.
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.
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.
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).
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.