Shortages Without Frontiers: Antimicrobial Drug and Vaccine Shortages Impact Far Beyond the Individual!

Guillaume Beraud

doi:10.3389/fmed.2021.593712

Abstract

Among increasingly common drug shortages, antimicrobial drug and vaccine shortages are the most frequently reported. This could be related to the smaller size of the market, compared to statins or antidepressant drugs. But there are multiple causes to shortages, such as flawed manufacturing processes, modification of quality control processes and scarcity of raw materials. Besides, concentration of manufacturing in emerging economies, dependence on a single producer and pressure on profit margins amplify the consequences of any manufacturing problem. Antimicrobial drug shortages have an impact on patient outcomes and antimicrobial resistance (AMR) by leading to choices of alternatives with an inadequately large spectrum, and consequently with deleterious side effects and increased costs. Moreover, vaccine shortages result in controversies exacerbated by the antivax community. Given the transmissibility of infectious diseases, antimicrobial drug and vaccine shortages will impact both individual and population health through herd effect. For these reasons, they represent a worldwide threat that goes beyond impact at the individual level. There has been no coordinated response to this threat hitherto. In order to provide an adequate response plan, precise data on shortage occurrences and their causes are a prerequisite. Moreover, efficient action will not be possible without a transnational will. Examples of useful actions could be: Incorporating a standardized survey into the WHO surveillance programs on antimicrobial use; creating a communication channel between pharmaceutical companies, providers and national agencies so as to recognize upcoming shortages; licensing some laboratories to manufacture out-of-stock drugs, for the duration of the shortage.

Highlights

Antimicrobial drug and vaccine shortages have been increasingly reported worldwide
As antimicrobial drugs and vaccines are completely different from other drugs, shortages cannot be regarded as similar, insofar as they present specificities in both causes and consequences
We aim at highlighting the specificities regarding causes, consequences and challenges related to antimicrobial drug and vaccine shortages

Summary

INTRODUCTION

Antimicrobial drug and vaccine shortages have been increasingly reported worldwide. Multiple reasons have been put forward, quality issues and narrow profit margins among others, suggesting that drug shortages are going to become more and more common. To stop the outbreak of antimicrobial and vaccine shortages before reaching the level of a pandemic would require: [1] ensuring uninterrupted supply through local manufacturing and appropriate stock management; [2] strengthening the supply chain by ensuring that there are multiple supplies competing at different levels of the production chain, at critical levels Those two crucial steps call for complete rethinking of the market. To offer a long-term solution, a useful policy would be to offer incentives to manufacturers to reinvest in the antimicrobial drug and vaccine market, to avoid monopoly, to strengthen the supply chain and to actively participate in information exchange with governmental and national/supranational agencies through a global reporting system linking antimicrobial and vaccine consumption, outbreaks and tension over the supply chain In addition to this global approach, more specific strategies should be explored. In 2012, the GAIN Act which provided incentives such as extension of 5-year non-patent exclusivity for some antimicrobial in the USA turned out to be poorly efficient if not counter-productive, but resulted in a better understanding of the market and potentially useful proposals [32]

CONCLUSION

Findings

DATA AVAILABILITY STATEMENT