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Learning Objectives

After completing this chapter, the reader will be able to:

  • Describe the reasons why drug shortages occur.

  • Describe actions taken to ameliorate the drug shortage problem.

  • Formulate management strategies for drug shortage situations.

  • Analyze drug shortage situations for potential medication-safety implications.

  • List methods for identifying and reporting potential counterfeit drugs.


Key Concepts

  • image Drug shortages are a significant public health problem, affecting patients, clinicians, and all aspects of the medication supply chain.

  • image The leading cause of drug shortages is manufacturing problems, mostly related to quality or not following the Food and Drug Administration’s (FDA’s) Current Good Manufacturing Practices (CGMPs).

  • image The FDA works to prevent shortages by expediting reviews of new manufacturing sites, processes, or new products.

  • image Every health care setting should have a plan that addresses how drug shortages are managed.

  • image Managing drug shortages requires complex problem-solving skills. Health care professionals must assess how a shortage will impact patient care, medication safety, and workflow in order to develop the best management plan.

  • image Drug shortages increase the risk of medication errors and can result in delayed patient care or adverse patient outcomes.

  • image Most counterfeit medications found in the United States are purchased over the Internet, or from unlicensed or foreign suppliers.


image Drug shortages are a significant public health problem, affecting patients, clinicians, and all aspects of the medication supply chain. Defining a drug shortage is not easy as the definition can differ depending on perspective. At the most basic level, a shortage exists if a medication is not available for a patient. However, there can be many reasons besides a shortage that a medication may not be available. Short-term situations where a medication is not ordered or delivered on time are common. Most health care organizations use just-in-time inventory systems to prevent the cost burden of excess inventory, but this system can result in short-term shortages. Likewise, weather delays can prevent deliveries from wholesalers, also resulting in short-term shortages. This chapter will address longer-term drug shortages that impact the entire supply chain on a national scale.


Definition of a Drug Shortage

There are two key sources of information regarding drug shortages. The FDA ( and the American Society of Health-System Pharmacists (ASHP) ( both provide information about drug shortages on frequently updated websites.1 The University of Utah Drug Information Service (UUDIS) provides drug shortage content for ASHP. These data are recognized by the Government Accountability Office (GAO) as the most comprehensive source of drug shortage information.2 Both sources differ with regard to their definition of a drug shortage. The FDA defines a shortage as “a situation in which the total supply of all clinically interchangeable versions of an FDA-regulated drug is inadequate to meet the current or projected demand at ...

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