title: Defining the pharmaceutical system to support proactive drug safety.
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.
authors: MedStar National Center for Human Factors in Healthcare, Washington, DC 20008, USA. Vicki.R.Lewis@medicalhfe.org
authors: Vicki R
authors: VR
authors: Lewis
authors: Angelica
authors: A
authors: Hernandez
authors: Margaret
authors: M
authors: Meadors
mesh_terms: D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence; D064420:Drug-Related Side Effects and Adverse Reactions; D017408:Guidelines as Topic; D006801:Humans; D017146:Models, Organizational; D012308:Risk Management / Q000379:methods*; D014481:United States