Teratogen Warnings and Educational Media

描述(申请人提供)：在过去的十年中，随着Acutane、沙利度胺和其他导致出生缺陷的药物的大量使用，具有致畸作用的药物的处方迅速增加。疾控中心发现，在研究一些致畸药物时使用的警告符号令人困惑，容易受到有害的误解。警告标签通常是第一个也是中央干预。因此，迫切需要符号、警告标签和教育媒体来传达怀孕或怀孕期间服用致畸药物的危险。根据ANSI的符号开发和评估指南，研究人员仔细研究了现有的符号，生成了根概念，并在内部为新符号开发了初步的候选图像和样式。随着项目的实施，开展了重点小组活动。随着时间的推移，焦点小组的目的从产生新的符号、文本和标签想法转移到评估预先开发的符号、文本和文本符号组合。最终选择了六个导频符号。在全国分布的实地试验中，使用一对一访谈方法(n=300，每幅图像50个)对六个试点符号进行了评估。这项评估表明，在实现有效的药物标签方面取得了重大进展。结果已被接受并发表。第二阶段将进一步完善和验证药品标志和标签，创建一系列类似的标志和警告，用于其他环境和其他危险，并创建一系列教育媒体单元，以提高对标志和警告的认识，并教育专业人员和公众有关致畸的知识。这些材料将包括一个多媒体模块、一个参考网站、一套供药房和从业者使用的小册子以及供展示的小型媒体材料。所有材料将以英语和西班牙语交付。将通过标准组织、FDA和企业赞助商寻求符号和媒体的许可和商业化。

DESCRIPTION (provided by applicant): The prescription of pharmaceuticals with teratogenic properties has increased rapidly over the past decade, with the heightened use of Accutane, thalidomide and other birth-defect inducing drugs. The CDC found the warning symbol in use at the time of the study on some teratogenic pharmaceuticals to be confusing and subject to harmful misinterpretation. The warning label is often the first and central intervention. There is, therefore, an urgent need for symbols, warning labels, and educational media that convey the danger of taking teratogenic pharmaceuticals while pregnant or preconceptional. Following ANSI guidelines for symbol development and evaluation, the researchers canvassed existing symbols, generated root concepts, and internally developed preliminary candidate images and styles for a new symbol. As the project ensued, focus groups were conducted. The purpose of the focus groups shifted over time from generation of new symbol, text, and label ideas to evaluation of pre-developed symbols, text, and text symbol combinations. A final set of six pilot symbols were selected. The six pilot symbols were evaluated in a nationally distributed field trial that utilized a one-on-one interview methodology (n=300, 50 per image). The evaluation demonstrated significant progress toward a validated pharmaceutical label. Results have been accepted for publication. Phase II will further refine and validate the pharmaceutical symbol and label, create a series of similar symbols and warnings for use in other settings and with other hazards, and create a series of educational media modules to increase awareness of the symbols and warnings and to educate professionals and the public on teratogenicity. These materials will include a multimedia module, a reference web-site, a set of brochures for pharmacies and practitioners and small media materials for display. All materials will be delivered in both English and Spanish. Licensing and commercialization of the symbols and media will be sought through standards organizations, FDA, and corporate sponsors.