Drug Shortages in the US: Causes and What the FDA Is Doing to Prevent New Shortages

Erin Fox, PharmD, Michelle Wheeler, PharmD

Disclosures

AccessMedicine from McGraw-Hill 

In This Article

What Types of Drugs Are in Short Supply and Why?

The majority of drug shortages are injectable generic products (ranging from 45 to 71% since 2001). A point-in-time prevalence study showed 23.1% of all injectable FDA-approved medications were short on June 1, 2011.[4] Common drug classes in short supply include antibiotics, chemotherapy agents, pain medications, and electrolytes (Figure 3).[3] The reasons for drug shortages are complex. In the case of sterile injectables, four key reasons contribute to the drug shortage problem. First, there are few manufacturers of generic injectable products. The majority of the market is supplied by just seven manufacturers.[5]Next, generic suppliers manufacture multiple drugs on existing manufacturing lines. Redundancy is not built into the manufacturing process and there is no resiliency for manufacturing problems. Third, the manufacturing process is also complex. When quality problems such as metal shavings or a lack of sterility are identified, these problems typically affect multiple products and are not easy to fix.[5] Lastly, many generic injectable products are older drugs that are sold very cheaply with low profit margins.

Figure 3.

Common Drug Classes in Short Supply – 2010, 2011, 2012. Data collected by the University of Utah Drug Information Service.

The US Department of Health and Human Service’s Office of the Assistant Secretary for Planning and Evaluation (ASPE) published an economic analysis of the causes of generic drug shortages noting several reasons for this situation.[6] In general, these medications have few substitutions and demand for product rarely changes with prices as the clinical need for the product remains constant. The report also noted that for forty-four oncology products in short supply since 2008, prices for those products decreased by a mean of 26.5% between 2006 and 2008. Oncology products not impacted by drug shortages did not show the same price decreases during the same 2-year period.[6]

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....