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。

阿片类药物危机凸显了增加纳洛酮使用的必要性，可能通过监管部门批准非处方药销售。为了解决业内人士认为的此类获取障碍，美国食品药品监督管理局（FDA）为此类销售开发了一种药品事实说明书，以评估消费者是否理解安全有效使用的关键声明。

在这项标签理解研究中，研究组对710名成年人和青少年进行了个性化结构访谈，其中包括430名使用阿片类药物的成年人及其家人和朋友。研究组开发了八个主要终点来评估用户对说明书中每个关键步骤的理解。

六个主要终点的表现达标，包括“检查疑似过量用药”和“第一次给药剂量”。四个主要终点的下限范围为88.8％至94.0％。一个不达标的终点是理解“立即拨打911”，但该指令非常接近90％的目标。另一个不达标的是理解“检查，给予和立即拨打911”的复合步骤。

总之，消费者可充分理解纳洛酮药品事实说明书八个组成部分中的六个，且其他两个也接近达标。该模型说明足以用于开发非处方销售的纳洛酮产品。

附：英文原文

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.

Issue&Volume: 2020-05-27

Abstract: 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.

DOI: 10.1056/NEJMsa1912403

Source: https://www.nejm.org/doi/full/10.1056/NEJMsa1912403