Clinical Dilemmas and a Review of Strategies to Manage Drug Shortages

Abstract

Objective: The objectives of this article are to review the clinical implications of drug shortages highlighting patient safety, sedation, and oncology and introduce an expanded phase approach for the management of drug shortages. Data Sources: Literature retrieval was accessed through a PubMed search of English-language sources from January 1990 through April 2012 using the medical subject heading pharmaceutical preparations/supply and distribution and the general search term drug shortages. Study Selection and Data Extraction: All original prospective and retrospective studies, peer-reviewed guidelines, consensus statements, and review articles were evaluated for inclusion. Relevance was determined considering the therapeutic class, focus on drug shortages, and manuscript type. Data Synthesis: The increased number of drug shortages has created significant challenges for health care providers. Two particularly vulnerable populations are critically ill and oncology patients. A lack of therapeutic alternatives in critically ill patients may impact patient safety as well as treatment outcomes. Similarly, a chemotherapy agent in short supply may contribute to adverse outcomes in oncology patients. Conclusions: The mounting number of drug shortages has created a health care crisis, requiring changes in management strategies as well as clinical practice. The expanded phased approach outlined here provides a consistent, systematic approach for the management of drug shortages.