Drug shortages have plagued the United States (US) markets for decades. The influx of critical patients from COVID-19 has brought this problem to the forefront, leaving many hospitals scrambling to find people with paralysis for intubation, dialysis medications, and the now well-known chloroquine and hydroxychloroquine.
As of September, 119 drugs are currently listed on the Food and Drug Administration’s (FDA) website as “currently in shortage”. For over 20 years now, the FDA has run a drug-shortage tracking program, intending to detect potential and current drug shortages in the US. This program defines a shortage as “a situation in which the total supply of all clinically interchangeable versions of an FDA-regulated drug is inadequate to meet the current or projected demand at the patient level.”
In 2011, drug shortages reached an all-time high with 251 medications on the list, including cancer treatments, anesthesia, and other critical care medications. This shortage prompted President Obama to issue an executive order urging manufacturers to report supply issues early to help prevent manufacturing delays and address issues promptly.
In 2018, a survey of infectious disease specialists found that antibiotic shortages were forcing 75% of physicians to use broad-spectrum antibiotics, potentially adding to the growing threat of antibiotic resistance. The survey also found that 45% of physicians had to prescribe less effective therapies due to shortages.
Why shortages happen
Drug shortages can happen due to several factors, including manufacturing quality and safety concerns, discontinuation, issues with the production of active ingredients, company mergers, and natural disasters. As we have all seen, a sudden increase in demand can put a serious strain on the system.
According to the U.S. Senate Committee on Finance, around 80% of all active ingredients for medications are manufactured in either China or India, leaving the supply chain vulnerable.
The FDA has put certain preventative measures in place to try and mitigate the effects of shortages and better prepare the country should a shortage happen. There is an entire department within the FDA dedicated to preventing and responding to shortages. Additionally, the US Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) is responsible for maintaining the Strategic National Stockpile. The purpose of which is to provide support in the event of a public health threat by maintaining an alternative emergency medical supply chain.
Drug shortages have far-reaching implications
Drug shortages can be very costly. In 2013, $209 million was spent on purchasing more expensive drug substitutes. Aside from not being able to obtain a preferred medication, drug shortages can lead to increases in spending, less effective treatment, and severely impact patient care.
As medical communicators, we are in a unique position to help others understand drug shortages and other healthcare issues. Despite the safeguards in place, shortages still happen, and alerting the wider public can help prepare patients and give them the knowledge and tools to speak with their providers about alternative medications.