Defining the Pharmaceutical System to Support Proactive Drug Safety

Title:Defining the Pharmaceutical System to Support Proactive Drug Safety

Volume: 8 Issue: 1

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

Affiliation:

Keywords: Healthcare, industry, manufacturing, pharmaceutical, supply chain, system 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.

Cite this article as:

Lewis Vicki R., Hernandez Angelica and Meadors Margaret, Defining the Pharmaceutical System to Support Proactive Drug Safety, Current Drug Safety 2013; 8 (1) . https://dx.doi.org/10.2174/1574886311308010005