In the first few months of the COVID-19 pandemic, US prescription drugs flagged for potential supply-chain disruptions were nearly five times more likely to go into shortage than those without such warnings, finds a University of Pittsburgh–led study.
For the study, published today in JAMA Network Open, the researchers used the IQVIA Multinational Integrated Data Analysis database to match 571 drugs with supply-chain disruption reports to 7,296 control drugs without such reports from 2017 to 2021.
Shortages were defined as at least a 33% drop in drug units sold within 6 months of a supply chain–disruption report to the US Food and Drug Administration (FDA) or the American Society of Health-System Pharmacists (ASHP). Examples of such reports include those involving quality problems (eg, microbial contamination), unforeseen circumstances (eg, natural disasters), and discontinuation.
"Drug shortages have reached record highs," the study authors noted. "Shortages have been associated with missed or delayed dosages, medication errors, increased spending, and death."
Shortages returned to baseline by May 2020
After adjustment for drug characteristics, 13.7% of supply chain issue reports were linked to subsequent drug shortages vs 4.1% of controls (marginal odds ratio [mOR], 3.7). From February to April 2020, 34.2% of drugs with supply chain reports and 9.5% of control drugs experienced shortages (mOR, 4.9), but they returned to prepandemic levels by May 2020 (9.8% of drugs with reports and 3.6% of controls; mOR, 2.9).
There were significant differences by formulation (non-oral mOR, 1.9 vs oral mOR, 5.4), World Health Organization (WHO) essential medicine status (essential mOR, 2.2 vs nonessential mOR, 4.6), and brand-versus-generic status (brand-name mOR, 8.1 vs generic mOR, 2.4).
Ongoing policy work is needed to protect US drug supplies from future shocks and to prioritize clinically valuable drugs at greatest shortage risk.
Generic drugs were overrepresented in supply-chain reports (84% vs 60% for control drugs), as were drugs 20 years old or older (51% vs 33%), drugs with five or more manufacturers (52% vs 30%), WHO essential medicines (43% vs 30%), and those with less than $5 million baseline sales (32% vs 30%).
Drug makers didn't cite a reason for the disruption on 264 reports (36%), with the percentage of reports with unknown or unspecified reasons climbing to 42% from February to April 2020 and 47% after May. During the total study period, more than half of reports were due to recalls or discontinuations (68%), mostly owing to quality problems.
"Ongoing policy work is needed to protect US drug supplies from future shocks and to prioritize clinically valuable drugs at greatest shortage risk," the researchers wrote.
Surveillance system needs updating
In a related commentary, Mariana Socal, MD, PhD, and Joshua Sharfstein, MD, both of Johns Hopkins University, said the public health surveillance system should be upgraded to monitor the frequency of demand-related shortages and distribution problems, identify the drugs most affected, and provide greater transparency.
Understanding the trajectories of drugs that avoided going into shortage and appreciating how other drugs recover from shortages is important to identify key factors and actions that can help target policies to increase supply.
"Such information is needed to help target policies to the drugs and regions most vulnerable to supply disruptions, and to respond to shortages in real time," they wrote.
Socal and Sharfstein called for more attention to early signs of an impending drug shortage. "Understanding the trajectories of drugs that avoided going into shortage and appreciating how other drugs recover from shortages is important to identify key factors and actions that can help target policies to increase supply," they said.
An evaluation of the strength of policy solutions against different types of shortages should also be completed. "There are supply shields that may help lessen shortages, such as using residual supplies, lengthening expiration dates of remaining supplies, importing supply from other countries, or shifting production lines to increase production output," they concluded. "A taxonomy of shortage solutions is urgently needed, along with corresponding data on the utility of different interventions."
