Teratogen Warnings and Educational Media

Period of Performance: 09/01/2005 - 08/31/2006


Phase 2 SBIR

Recipient Firm

Academic Edge, Inc.
Bloomington, IN 47408
Principal Investigator


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.