Teratogen Warnings and Educational Media

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$754,242.00
Award Year:
2005
Program:
SBIR
Phase:
Phase II
Contract:
2R44DD000001-03
Award Id:
94232
Agency Tracking Number:
DD000001
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
ACADEMIC EDGE, INC., 108 E. 14th Street, BLOOMINGTON, IN, 47408
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
157743451
Principal Investigator:
RICHARD GOLDSWORTHY
(812) 333-9543
RICK@ACADEMICEDGE.COM
Business Contact:
RICHARD GOLDSWORTHY
() -
info@academicedge.com
Research Institution:
n/a
Abstract
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.

* information listed above is at the time of submission.

Agency Micro-sites


SBA logo

Department of Agriculture logo

Department of Commerce logo

Department of Defense logo

Department of Education logo

Department of Energy logo

Department of Health and Human Services logo

Department of Homeland Security logo

Department of Transportation logo

Enviromental Protection Agency logo

National Aeronautics and Space Administration logo

National Science Foundation logo
US Flag An Official Website of the United States Government