From the Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD.
N Engl J Med. 2020 May 28;382(22):2129-2136. doi: 10.1056/NEJMsa1912403.
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.
阿片类药物危机凸显了增加纳洛酮获取途径的必要性，这可能需要通过监管批准将其作为非处方销售。为了解决行业认为的这种获取途径存在的障碍，美国食品和药物管理局（FDA）开发了一种模型药品说明书标签，用于评估消费者是否理解安全有效使用的关键说明。
在这项标签理解研究中，我们对 710 名成年人和青少年进行了个体结构式访谈，其中包括 430 名使用阿片类药物的成年人及其家人和朋友。我们制定了 8 个主要终点来评估每个标签关键步骤的用户理解程度。这些终点中的每一个都包括一个预先设定的目标阈值，范围从 80%到 90%，通过比较 95%精确置信区间的下限来评估。
在六个主要终点中的六个结果符合或超过了阈值，包括“检查疑似过量”（阈值为 85%；点估计[PE]为 95.8%；95%置信区间[CI]为 94.0%至 97.1%）和“给予第一剂”（阈值为 85%；PE 为 98.2%；95%CI 为 96.9%至 99.0%）。其他四个主要终点的下限范围在 88.8%至 94.0%之间。一个例外是对“立即拨打 911”的理解，但这一说明接近 90%的目标（PE 为 90.3%；95%CI 为 87.9%至 92.4%）。另一个例外是对“检查、给予并立即拨打 911”这一综合步骤的理解（阈值为 85%；PE 为 81.1%；95%CI 为 78.0%至 83.9%）。
消费者达到了对纳洛酮使用药品说明书标签中八项说明内容的六个组成部分的充分理解的阈值，对其他两个内容也接近这一要求。总体而言，FDA 认为该模型标签足以用于开发拟作为非处方销售的纳洛酮产品。
