Countries often establish national medical stockpiles to prepare for public health crises and unexpected drug shortages. This emergency cache serves as a buffer inventory when a demand spikes while also giving pharmaceutical producers time to catch up. This article will delve deeper into the challenges of establishing and maintaining one.
Why are national stockpiles critical?
National stockpiles enable countries to increase their self-reliance in case of a major public health crisis. For countries like the U.S. achieving pharmaceutical self-reliance is a significant challenge. Currently, 87% of API facilities for generic medicines are located outside the United States. Most of the pharmaceutical supply chain is controlled by India and China, with this country accounting for 23% of all U.S. pharmaceutical imports in 2021 (equivalent to 190 million kilograms).
Medical stockpiles usually are classified into four kinds: user/hospital-level, manufacturer-level, state-level, and national-level. A national medical stockpile is characterized by not having the same pressure manufacturers have over moving supply. National governments spend more resources on inventory management than user/hospitals, allowing states to optimize their medical stockpiles according to regional needs. The EU uses a very similar categorization, but instead of centralizing the national stockpile, it has opted to host it between one or several member states and move it periodically.
Challenges of building a medical stockpile
A well-run national pharmaceutical cache is an excellent asset in a public health emergency as it is a reserve of medicines, vaccines, and protective equipment that can deter outages. Yet, building and maintaining a national medicine stockpile is an expensive endeavor even for governments. Here are some reasons why:
Scope of the stockpile
The selection of the inventory is a crucial decision while building any kind of medical stockpile. Communication between all the existing levels of stockpiles (national, state, user/hospital, manufacturer) is critical to avoid overstocking a specific formulation while leaving another out. For example, mountain regions without hot, humid summers do not need malaria vaccines, which are best for areas where an outbreak is more likely, with the national stockpile as a fallback.
A potential way to deal with the limits of choosing specific formulations is to store active ingredients in the national medical stockpile. In Spring 2024, a bipartisan committee reintroduced legislation to establish an emergency reserve of essential components for critical generic medications and encourage the production of these components.
Fiscal and political red tape
In 2020, the former U.S. Strategic National Stockpile director stated that the inventory would not be enough for all 50 states to withstand the pandemic. One of the main reasons for this was that the stockpile had been underfunded for years.
Another example is how Brexit affected the UK’s medicine supply. Establishing mutual recognition of medicine efficacy between the UK and Europe is ongoing. Many EU suppliers stopped selling to the UK market, as they would have to go through two approval processes (the EU and the UK), which requires resources and time.
Limited shelf-life
Countries often choose to have a list of essential medicines to keep in stock since many medications, vaccines, and even protective gear have a limited shelf-life. Thus, inventory replacement is an ongoing cost, and expired equipment often goes to waste.
To extend the lifecycle of U.S. federal stockpiles, the FDA set the Shelf Life Extension Program (SLEP) in 1986, allowing specific formulations to stay in stock as long as they passed periodic FDA stability testings. A 2023 report from the Congressional Research Service stated that the long-term sustainability of the U.S. Strategic National Stockpile Depends on balancing life-cycle costs, including acquisition, storage, and resupply, as well as preparedness objectives.
Timely and efficient delivery
Push packages, a general assortment of antibiotics, medications, and personal protection equipment, comprise about 5% of the U.S. national stockpile. Ensuring all U.S. states and territories can receive them within 12 hours if necessary. While this allows a quick reaction to many kinds of emergencies, the contents of push packagers do not target a particular scenario.
Often, national governments work with manufacturers, hospitals, and local governments to design the stockpile supply chain. The tenderization process is quite critical as it allows the government to negotiate issues such as price, manufacturing priority, delivery arrangements, and maximum product shelf life.
There is also a need to build national stockpiles with intelligent inventory management systems. Having a live view of the current stocks helps decision-makers to prioritize better. However, matters of contention are how available this data is, where it is captured, and how it is accessed.
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