Examining Drug Shortages Before and During the COVID-19 Pandemic
There is no doubt that drug shortages are a detriment to the pharma supply chain, but how commonplace were they during the COVID era?
Drug shortages can occur for a plethora of reasons, such as under-reimbursement, quality concerns (i.e., contamination), or natural disasters, but the fact of the matter is that they are becoming more commonplace. These shortages have often been to tied to increased spending, medication errors, missed dosages, and even death.1
As a way to get out in front of the issue, since 2012, the FDA has required that companies report issues that are impacting the supply chain that could ultimately cause shortages. Any discontinuations or recalls are also published by the agency
However, having these types of standard operation procedures does not necessarily guarantee success. The COVID-19 pandemic presented a record number of supply chain issue reports, and despite being aware of these issues, there was no way of specifically knowing how often supply chain issues were associated with subsequent shortages.
As a result, the authors of a study published in JAMA Network Open1 sought to estimate the proportion of supply chain issue reports that were related to not only drug shortages overall, but during the COVID-19 pandemic.
Investigators conducted a population-based, longitudinal cross-sectional study of US prescription drug purchases from January 2017-December 2021, identifying any medications with supply chain issue reports and matching them to drugs that did not have reports. Based on a conceptual framework, they then chose supply chain qualities while comparing the odds of shortages for each group.
The main factor was drug shortage, which needed to represent at least a 33% decrease in units purchased within six months of a supply chain issue report. Investigators used random-effects logistic regression models, analyzing the marginal odds of shortages for drugs with versus without reports.
Heterogeneity was also examined before versus during the COVID-19 pandemic and by drug characteristics (formulation, age, essential medicine status, clinician- vs self-administered, sales volume, and number of manufacturers).
Overall, 571 drugs were exposed to 731 supply chain issue reports and were connected to 7,296 comparison medications that contained no reports. Keeping drug characteristics in mind, 13.7% (95% confidence interval or CI, 10.4%-17.8%) of supply chain issue reports were associated with resulting drug shortages compared to 4.1% (95% CI, 3.6%-4.8%) of comparators (marginal odds ratio [mOR], 3.7 [95% CI, 2.6-5.1]).
The number of shortages rose amongst drugs with and without reports from February-April 2020 (34.2% of drugs with supply chain issue reports and 9.5% of comparison drugs; mOR, 4.9 [95% CI, 2.1-11.6]), but decreased after May 2020 (9.8% of drugs with reports and 3.6% of comparison drugs; mOR, 2.9 [95% CI, 1.6-5.3])
There were statistical significance associations when it came to formulation (parenteral mOR, 1.9 [95% CI, 1.1-3.2] vs oral mOR, 5.4 [95% CI, 3.3-8.8]; P for interaction = .008), WHO essential medicine status (essential mOR, 2.2 [95% CI, 1.3-5.2] versus nonessential mOR, 4.6 [95% CI, 3.2-6.7]; P = .02), and for brand-name vs generic status (brand-name mOR, 8.1 [95% CI, 4.0-16.0] vs generic mOR, 2.4 [95% CI, 1.7-3.6]; P = .002).
Various limitations arose from the study, including the possibility of underreporting during the start of the COVID era (February-April 2020), as noted by the increase in drugs without supply chain issue reports. There also was no manner in which to determine the downstream impact that these shortages had on the patients themselves, according to the study.
Overall, the investigators concluded that one in seven supply chain issue reports were related to drug shortages, and “although the shortages increased early in the COVID-19 pandemic, we observed a return to pre-pandemic levels after May 2020. As the public health emergency ends, continued policy effort is needed to mitigate shortages and to prepare pharmaceutical supply chains for future, unanticipated shocks.”
Reference
1. Callaway Kim K, Rothenberger SD, Tadrous M, et al. Drug Shortages Prior to and During the COVID-19 Pandemic. JAMA Netw Open. 2024;7(4):e244246. doi:10.1001/jamanetworkopen.2024.4246
