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Clinical Corner: The Impact of Drug Shortages on Patient Safety

Posted on 03/05/14

The_Impact_of_Drug_Shortages_on_Patient_Safety

In recent years, the United States has experienced an increasing number of drug shortages, which frustrate clinicians and potentially compromise safe care of patients. Drug shortages affect the timeliness of drug preparation and dispensing and influence the use of alternative agents. Common reasons for drug shortages include business decisions made by manufacturers to decrease production, mergers, scarcity of raw materials, Federal Drug Administration (FDA) enforcement actions, natural disasters, and poor inventory management.

Drug shortages force healthcare providers to use alternative agents, which potentially present increased risk to patients due to misuse or inferior efficacy compared to the intended agent. A national survey revealed that patient safety concerns have resulted from widespread drug shortages across several drug classes [1].

Of the 1,800 healthcare practitioners surveyed:

  • 85% note that there is little or no information available about the duration of the drug shortage
  • 70% lack suitable alternative products
  • 64% believe drug shortages increase the risk of adverse patient outcomes
  • 35% of respondents reported a near miss
  • 25% reported a medication error
  • 20% reported adverse drug events (ADEs), all associated with drug shortages.

Management of drug shortages presents a significant challenge for healthcare organizations and places patients at higher risk for medication-related errors. This increased risk to patient safety has caused professional associations and the FDA to place significant emphasis on the safe management of drug shortages.

On July 9, 2012, President Obama signed into the law the Food and Drug Administration and Innovation Act (FDASIA) of 2012. The FDASIA provides the FDA with the authority to expedite inspections, work with manufacturers willing to increase production, permit temporary foreign importation, and requires the FDA to provide an up-to-date list of drugs in shortage.

The new FDA actions have been noted to improve certain drug shortage situations but have not addressed all concerns that exist today. A recent article published in the Patient Safety and Healthcare Quality Journal provides guidance for the development of an interdisciplinary approach to the management of drug shortages.

The article reviews the standard procedure for drug shortage assessment and management developed at one Massachusetts hospital system, including:

  • Developing a pharmacy drug shortage committee: The committee performs a full risk  assessment of current and new drug shortages
  • Forming a taskforce for critical drug shortages: The taskforce developed a real-time dashboard of medications in shortage; educated leadership and clinicians about the shortages and how to deal with them; and streamlined the response to a specific critical shortage

With drug shortages becoming the “new norm,” healthcare organizations must have a comprehensive drug shortage management program to prevent patient harm and maintain high quality care.

References
Institute for Safe Medication Practices. (2010, July 29). Drug shortages threaten patient safety. ISMP Medication Safety Alert! Available athttp://www.ismp.org/newsletters/acutecare/articles/20100729.asp 

[1] Institute for Safe Medication Practices. (2010, September 23). Drug shortages: National survey reveals high level of frustration, low level of safety. ISMP Medication Safety Alert! Available at http://www.ismp.org/newsletters/acutecare/articles/20100923.asp

 

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About the Author

Christian Hartman, PharmD, MBA, FSMSO