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Teratogen Warnings and Educational Media

Award Information

Department of Health and Human Services
Award ID:
Program Year/Program:
2005 / SBIR
Agency Tracking Number:
Solicitation Year:
Solicitation Topic Code:
Solicitation Number:
Small Business Information
108 E. 14th Street BLOOMINGTON, IN 47408-
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Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
Phase 2
Fiscal Year: 2005
Title: Teratogen Warnings and Educational Media
Agency: HHS
Contract: 2R44DD000001-03
Award Amount: $754,242.00


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 warni ng 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 concep ts, 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 w arnings 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 multi media 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 sou ght through standards organizations, FDA, and corporate sponsors.

Principal Investigator:

Richard C. Goldsworthy

Business Contact:

Richard Goldsworthy
Small Business Information at Submission:

ACADEMIC EDGE, INC. 108 E. 14th Street BLOOMINGTON, IN 47408

EIN/Tax ID: 611104252
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No