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

Erin Fox, PharmD, Michelle Wheeler, PharmD


AccessMedicine from McGraw-Hill 

In This Article


Drug shortages in the US continue to affect patients on a daily basis.* Drug shortages range from something as simple as buffered aspirin to life-saving medications such as cancer chemotherapy agents, antibiotics, and emergency medications such as epinephrine. Strategies to identify and prevent drug shortages, along with developing plans to ease their impact, are needed to protect the health of patients, especially those with life-threatening conditions. The US government, drug manufacturers, and health system pharmacists are all key players in helping to alleviate the impact of drug shortages.

* Editor’s Comment, Nelda Murri, PharmD: The public health consequences of national drug shortages are sobering. In my pharmacy practice we recently fell short and were unable to fill a prescription for isoniazid due to a national shortage of the drug. It gave me pause to think that even old reliable drugs like isoniazid that are necessary to prevent a resurgence in the spread of tuberculosis are not immune to the market forces causing national drug shortages. Also troublesome, but less well characterized is the companion to market shortages, price gauging. In my practice, the pharmacy purchasing agent is frequently astounded by the day-to-day increase in the price of market alternatives following the announcement of a new drug shortage. One author has estimated the cost to be $416 million dollars annually.[12]