Date of Award

January 2015

Document Type

Thesis

Degree Name

Medical Doctor (MD)

Department

Medicine

First Advisor

Arjun K. Venkatesh

Subject Area(s)

Public policy

Abstract

Background: Drug shortages are common in the United States and may be especially harmful in the setting of unscheduled care for high acuity conditions. Early evidence suggest that the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 has decreased the number of new national drug shortages overall. However, anecdotal evidence suggests that drugs that are often used for acute care in setting such as the emergency department (ED) may be under shortage with increasing frequency and duration.

Objective: To describe trends in national drug shortages between 2001 and 2014 for acute care drugs in comparison to non-acute care drugs.

Methods: We retrospectively analyzed all reported national drug shortages from January 2001 to October 2014 collected by the University of Utah Drug Information Service. Shortages of drugs removed from the market or shortages missing exact start or end date for reasons other than being ongoing were excluded. For each year that a shortage existed, we attributed the shortage to the year, and calculated its duration in days during that year. An acute care drug is defined as one that is used in the ED as part of an ED protocol or standard practice for the management or diagnosis of acute conditions. Two emergency physicians (Arjun K. Venkatesh and M. Kennedy Hall) reviewed each drug under shortage to determine its status as an acute care drug; differences were adjudicated. Acute care drugs are compared to non-acute care drugs using the Chi-square statistic for trend and departure.

Results: A total of 1,898 national drug shortages occurred from 2001 to 2014; 275 shortages occurred each year on average; and 52% of shortages (n=987) affected acute care drugs. During the period studied, the shortage of acute care drugs is highest in 2014 (n=249) with a trend over the past decade that is statistically different from non-acute care drugs, which peaked in 2012 (n=242), p=0.0064 (Figure 4). The median durations of shortage for acute and non-acute care drugs were lowest in 2007 at 82 days and 93 days respectively, then increased significantly more for acute care drugs in 2013 (365 vs. 264 days) (p=0.0001 for trend).

Conclusions: Half of all reported drug shortages in the past 15 years involve acute care drugs, and these shortages are increasingly frequent and prolonged.

Comments

This thesis is restricted to Yale network users only. This thesis is permanently embargoed from public release.

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