United States Drug Crises: Why Are There So Many Drug Shortages? A Stakeholder Analysis

[摘要] Purpose: The purpose of this capstone project is to explain from a market perspective the reasons for drug shortages that anesthesia, as well as the overall medical community, are experiencing. This capstone project will increase the anesthesia profession;;s awareness of root causes of sterile injectable drug shortages. The project will provide the anesthesia community with an understanding of the breadth of the problem, the underlying economical motivations, and the various stakeholders;; positions.Methods: Stakeholder analysis and pharmaceutical market evaluation were conducted by examination of current literature, white papers, subject-matter expert interviews, and government agency reports. Information collected is analyzed using economic market theories, carefully aggregated/categorized to develop a clear understanding of the current drug shortage crisis.Results: Key stakeholders, drug manufacturers, government agencies;; regulations, group purchasing organizations (GPOs), and raw material suppliers are cited most often as a ;;Primary Effects;; or a root cause of the sterile injectable drug shortages. The ;;Secondary Effects;; category does not cause drug shortages; they exacerbate existing shortages. Drug manufactures, healthcare facilities, and wholesaler distributors were implicated in the ;;Secondary Effects;; category. Eight of the nine stakeholders were linked to ;;Safety Issues;; related to drug shortages. Five stakeholders contributed to a category that addressed ;;Consequences of Drug Shortages;;. While these consequences do not playa role in the root cause of drug shortages, they have a significant effect on stakeholders and the market environment.Conclusions: The sterile generic pharmaceutical market shortages are unlikely to equilibrate on their own. Complicated relationships among stakeholders and non-market issues impede the generic market from self-correcting. Therefore, some form of intervention is needed to resolve the shortages. Options will need to be carefully analyzed to avoid further market disruptions, as previous well-intended interventions to correct the market had unintended consequences.Data Sources: Google Search, Google Scholar, PubMed, Government Archives, ProQuest Business, and Government Web Sites

[发布机构] University of Michigan

[效力级别] drug shortages

[关键词] anesthetic drug;drug shortages;drug shortage causation;drug shortage explanation;market failure;Anesthesia;Medicine;Doctor of Anesthesia Practice