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Current Drug Safety
ISSN (Print): 1574-8863
ISSN (Online): 2212-3911
Epub Abstract Ahead of Print
DOI: 10.2174/15748863112079990004      Price:  $95









Defining the Pharmaceutical System to Support Proactive Drug Safety

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Author(s): Vicki R. Lewis, Angelica Hernandez and Margaret Meadors
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Abstract:
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.
Affiliation:
MedStar National Center for Human Factors in Healthcare, 3007 Tilden St. NW, Suite 7M, Washington, D.C. 20008, USA