Impact of Drug Shortages on U.S. Health Systems

Rola Kaakeh; Burgunda V. Sweet; Cynthia Reilly; Colleen Bush; Sherry DeLoach; Barb Higgins; Angela M. Clark; James Stevenson

Disclosures

Am J Health Syst Pharm. 2011;68(19):1811-1819. 

In This Article

Abstract and Introduction

Abstract

Purpose. A study was performed to quantify the personnel resources required to manage drug shortages, define the impact of drug shortages on health systems nationwide, and assess the adequacy of information resources available to manage drug shortages.
Methods. An online survey was sent to the 1322 members of the American Society of Health-System Pharmacists who were identified as directors of pharmacy. Survey recipients were asked to identify which of the 30 most recent drug shortages listed affected their health system, to identify actions taken to manage the shortage, and to rate the impact of each shortage. Employees responsible for completing predefined tasks were identified, and the average time spent by each type of employee completing these tasks was estimated. Labor costs associated with managing shortages were calculated.
Results. A total of 353 respondents completed the survey, yielding a response rate of 27%. Pharmacists and pharmacy technicians spent more time managing drug shortages than did physicians and nurses. There was a significant association between the time spent managing shortages and the size of the institution, the number of shortages managed, and the institution's level of automation. Overall, 70% of the respondents felt that the information resources available to manage drug shortages were not good. The labor costs associated with managing shortages in the United States is an estimated $216 million annually.
Conclusion. A survey of directors of pharmacy revealed that labor costs and the time required to manage drug shortages are significant and that current information available to manage drug shortages is considered suboptimal.

Introduction

The American Society of Health-System Pharmacists (ASHP) defines a drug shortage as "a supply issue that affects how the pharmacy prepares or dispenses a drug product or influences patient care when prescribers must use an alternative agent."[1] Drug shortages can be caused by natural disasters, a lack of available raw or bulk materials, manufacturing difficulties, regulatory issues, recalls of the affected or related products, or changes in product formulations.[1,2] ASHP and the Food and Drug Administration (FDA) have noted an increase in drug shortages in the past decade.[3,4] The drug information service at University of Utah Health Care (UUHC), the organization that supports the ASHP drug shortage program, tracked a total of 224 drug shortages between January 1996 and June 2002.[3,5] In 2007, UUHC identified 129 new drug shortages, with 166 additional new shortages identified in 2009.[6] In 2010, the number of drug shortages reached 211, the highest number recorded to date in a single year.

While many shortages can be effectively managed, considerable personnel resources are often required to identify available alternative products or therapeutically equivalent agents and to ensure operational changes are made to accommodate the product change.[3,7] Pharmacists often spend a large amount of time communicating with manufacturers and wholesalers, providing education to facility personnel on alternative agents, developing or modifying policies or clinical guidelines, and updating electronic databases and medication administration systems.[1–3,8,9] Although the pharmacy department often plays a leadership role in managing drug shortages, a collaborative effort of all health care providers affected by the shortage is essential.[7] This is particularly true when the supply of medication cannot meet the clinical need, in which case existing supplies must be allocated to those patients with the greatest need, with alternative therapies identified for other uses. This allocation process requires interdisciplinary collaboration among pharmacy, medical, and nursing staff.[3] The amount of time required by pharmacy and nonpharmacy personnel to effectively manage drug shortages can be extensive.[3,9]

The purpose of this study was to quantify the personnel resources required to manage drug shortages in health systems in the United States. Secondary objectives included defining the extent to which 30 recent drug shortages affected health systems across the country and determining the adequacy of existing resources available for information regarding drug shortages.

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