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PRACTICE MANAGEMENT
The Challenges of Drug Shortages
Christan M. Thomas, PharmD BCOP
Clinical Pharmacy Specialist, Oncology
James H. Quillen VA Medical Center
Johnson City, TM
Marc Geirnaert, BSc Pharm
Director of Provincial Oncology Drug Program
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Drug shortages have created significant challenges for oncology
pharmacists over the past few years. In 2014, Fox and colleagues
reported that the financial effect of drug shortages is estimated
to be hundreds of millions of dollars annually for health systems
across the United States.1 At the time, the authors also reported
more than 15 documented deaths from lack of available drugs or
suitable alternatives.1
Unfortunately, manufacturing issues, allocations, and unavail-
ability have become a reality in pharmacy practice. Dealing with
these shortages continues to be a hot topic within institutions and and when it will be resolved), stock on hand, and ability to obtain
has spurred much discussion in the oncology pharmacy community.
The American Society of Health-System Pharmacists (ASHP)
defines a drug product shortage as a supply issue that affects how
Table 1: Contrasting the FDA and ASHP Drug Shortage Websites
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the pharmacy prepares or dispenses a drug product or influences
patient care when prescribers must use an alternative agent.2 The
U.S. Food and Drug Administration (FDA) defines a drug shortage
as a situation in which the total supply of all clinically interchange-
able versions of an FDA-regulated drug are inadequate to meet
the current or projected demand at the patient level. Some of the
differences between the FDA and ASHP drug shortages websites
are listed in Table 1.3
When a drug shortage occurs, it is important for pharmacies
to develop action plans that clearly identify the drug shortage and
the impact it will have on patients’ treatments and the pharmacy
operations. ASHP describes a process for decision making in the
management of drug product shortages (Figure 1).2
The ASHP decision-making process outlines a systematic
approach to drug shortages. Initially, a thorough evaluation of the
situation should be performed—including both an operational and
a therapeutic assessment. Operationally, there should be a review
of the details of the shortage (e.g., the reason for the shortage
additional product.2 Each institution should review usage and the
supply of any alternative products that may be substituted. Parallel