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Learning Objectives

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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.

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Key Concepts

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

  • 2 The leading cause of drug shortages is manufacturing problems, mostly related to quality or not following FDA's Current Good Manufacturing Practices (CGMPs).

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

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

  • 5 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.

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

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

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Introduction

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1 Drug shortages are a significant public health problem, affecting patients, clinicians, and all aspects of the medication supply chain.1 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.

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Drug Shortages

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DEFINITION OF A DRUG SHORTAGE

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There are two key sources of information regarding drug shortages. The Food and Drug Administration (FDA) and the American Society of Health-System Pharmacists (ASHP) both provide information about drug shortages on frequently updated websites. The University of Utah Drug Information Service (UUDIS) provides drug shortage content for ASHP.2 These data are recognized by the Government Accountability Office (GAO) as the most comprehensive source of drug shortage information.3,4 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 the patient level.”...

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