Defining the Pharmaceutical System to Support Proactive Drug Safety

ISSN: 2212-3911 (Online)
ISSN: 1574-8863 (Print)

Volume 9, 3 Issues, 2014

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Current Drug Safety

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Dr. Seetal Dodd
University of Melbourne
Geelong, 3220

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Defining the Pharmaceutical System to Support Proactive Drug Safety

Author(s): Vicki R. Lewis, Angelica Hernandez and Margaret Meadors

Affiliation: MedStar National Center for Human Factors in Healthcare, 3007 Tilden St. NW, Suite 7M, Washington, D.C. 20008, USA


The military, aviation, nuclear, and transportation industries have transformed their safety records by using a systems approach to safety and risk mitigation. This article creates a preliminary model of the U.S. pharmaceutical system using available literature including academic publications, policies, and guidelines established by regulatory bodies and drug industry trade publications. Drawing from the current literature, the goals, roles, and individualized processes of pharmaceutical subsystems will be defined. Defining the pharmaceutical system provides a vehicle to assess and address known problems within the system, and provides a means to conduct proactive risk analyses, which would create significant pharmaceutical safety advancement.

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Article Details

Volume: 7
First Page: 1
Page Count: 1
DOI: 10.2174/15748863112079990004

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