Disruptions in supply chains due to restricting exports and imports
There is a global reliance on all components of the supply chain. While the advantages of globalization may include lower costs, it poses a challenge in situations of natural disasters or where countries may limit or restrict imports and exports due to pandemics – as we have seen with India and China.(1-3)

With an estimated 20% of the world’s generic drug supply being manufactured in India, India’s decision to restrict 26 pharmaceutical ingredients and medications (accounts for 10% of its exports) last month led to significant concerns and questions regarding the impact of such a decision on the global supply chain.(2-5)  India relies on China for almost 70% of its active pharmaceutical ingredients and has been impacted by China’s decisions and efforts to control the pandemic.(1-5) The global supply chain depends significantly on both India and China. While such decisions are made in order to prevent drug shortages within the country, the potential impact on the global supply chain is worth noting. Although we may see a relaxing of restrictions on exporting and importing of certain medications over time,(6) the existence of these restrictions as options (now or in the future) makes the supply chain susceptible to potential disruptions. This reality has triggered individuals to question whether manufacturers should start focusing their efforts locally – this includes obtaining active ingredients and transferring their production efforts locally rather than globally.  This necessitates not only the option of increasing the number of manufacturers locally but an overhaul of the geographical location component of the supply chain (raw materials and finished medications).(1)

Emergence of more unregulated supply chains
As suppliers and manufacturers rapidly change due to closures, new and existing restrictions, and shortages begin to impact access, we have and will continue to see an emergence of unregulated supply chains.  When shortages and restrictions occur,  we are left with a limited number of sources and concerns of quality, reliability, and safety linger.(1,7) The United States Pharmacopeia (USP), stresses the need for strong regulatory and quality assurance oversight and provides quality standards and resources for COVID-19.(1)

Introduction of adulterated and falsified medications to the supply chain
The current vulnerable environment and the introduction of these unregulated supply chains become breeding grounds for the introduction of adulterated and falsified medications. More considerable attention and caution is advised when evaluating the source, quality, and safety of the raw materials and finished products.(7-8) Within the United States, the FDA has created a website for individuals to report medications that falsely claim to prevent or treat COVID-19.(8)

Several factors should be taken into account in attempts to understand the real impact on the supply chain. Delivery of materials and products, workforce capabilities, and the availability of complete information remain a significant concern.

Interruption of the delivery and transportation of raw materials and finished medications
The pandemic has reduced distribution channels and opportunities for quick delivery of products – both internationally and locally. (2,9)

Impact on the workforce
Global and local restrictions imposed by the current pandemic have impacted not only the physical infrastructure of the supply chain but also its workforce capabilities. We have seen a drastic reduction in the workforce across the globe, as facilities have shut down due to social distancing measures.  All the diverse individuals responding to crises are affected – e.g.,  individuals that work at the various facilities in the supply chain to those that work in all the health care facilities that dispense or administer medications. 

Even pre-COVID, any disruptions in the supply chain lead to a significant increase in workforce time and effort.  In addition to the added costs of acquiring the medications, drug shortages management consumes a significant amount of personnel time – e.g., time of pharmacists, pharmacy technicians, physicians, and nurses, among many others. Based on two surveys, the labor costs associated with managing shortages in health systems translated to an estimated annual impact of $216 million nationally in 2011 and $359 million in 2018.(10,11) Drug shortages during a pandemic will only add to the workforce burden.

Lack of information
Information sharing will continue to be vital.  There is a lack of complete publicly available information regarding resupply dates, reasons for shortages, location of raw materials and manufacturing facilities, and many other items. This has been an ongoing issue throughout the years. Health systems are often not given clear definitive end dates or resolution dates.  There is a need to build and optimize reporting and surveillance systems continuously.

Numerous reasons for disruptions of the supply chain
A focus on collective action and multiple interventions simultaneously is needed.

Continuous planning and change during uncertainty
Things are constantly changing – by the day, hour, and minute. Each decision has a ripple effect on the supply chain, whether positive or negative.

Time urgency
There is an urgency associated with administering or providing many medications – particularly in the case of a pandemic.

Price and Cost
U.S. Department of Health and Human Services (HHS) has reported that manufacturers, such as Sandoz and Bayer Pharmaceuticals, have donated millions of doses of hydroxychloroquine sulfate and Resochin (medical grade chloroquine phosphate) to the stockpile.(12) Societal gains have taken priority over financial gains, but for how long? What remains unclear is how pricing regulation will change, given our current realities and into the future.

Stockpiling and hoarding
In general, stockpiling and hoarding reduce the amount of medications available for others to obtain. This could accelerate the occurrence of a potential drug shortage. Greater attention and evaluation is needed to determine the impact of stockpiling on access to medications across geographies.

Sustainability of interventions
How sustainable are our approaches and solutions? Are the processes temporary versus long term solutions or lasting interventions? If they are temporary, how long will they last, and what is next?