Medication Shortages in the United States

Medication shortages frequently cause disruptions to healthcare delivery in the United States when preferred agents are not available. These shortages can occur due to many reasons, including manufacturing issues, supply chain difficulties, medication discontinuations, monetary or other business decisions, and even natural disasters. While medication shortages can be defined in different ways by various institutions, it is clear that they have been increasing in frequency over the past couple decades. One of the biggest issues with this is the lack of advanced warning systems to alert providers of an impending shortage. Manufacturers are only required to give advanced notice to the FDA if they plan to discontinue a single-source, medically necessary drugs, and a significant amount of leeway is given to the manufacturers in making these decisions. As a result, the vast majority of reporting is voluntary.

According to the ASHP/UUCP drug shortage program, as of 2011, manufacturing problems were reported as the most common known source of medication shortages, followed by supply and demand issues. More than 55% of the shortages, however, were due to unknown reasons. More recently, supply chain issues due to the COVID-19 pandemic have been significant and have caused shortages of many medications. These supply chain issues are due to both increased demand via increased anticipatory purchasing and decreased supply due to manufacturers shutting down in order to minimize the spread of disease.

The impacts of medication shortages are widespread and have the potential to be severe. Some of the consequences of shortages include increased costs, increased workloads, and medications errors. Increased costs are often due to higher expenses associated with alternate agents and their preparation, and the increase in workload can also lead to higher costs. Additionally the need for committees to manage shortages creates separate costs that otherwise wouldn’t need to exist. Medication errors can also increase during medication shortages as physicians and prescribers are often less familiar with the alternate agents which can lead to mistakes.

Pharmacists can have a role in managing shortages in several ways by managing medication usage. Switching patients to alternative agents based on priority and individual patient characteristics is one of the primary ways that this is done. This includes actions like limiting use of certain medications to the highest risk patients and utilizing alternative agents in patients with lower risk. Another mechanism by which pharmacists can impact the outcomes of medication shortages is by educating prescribers about the alternative agents and properly dosing patients in order to minimize medication errors that result from shortages.