Tackling medicine supply shortages starting with their ingredients

This article was published by Gersande Chavez , Vice President, Global Health Programs at US Pharmacopeia

How to secure upstream pharmaceutical supply chain risks with data and advanced technologies to increase access to quality medical products for patients

Disruptions to the global supply chain are more than just a logistical inconvenience. For many patients around the world who depend on a reliable supply of quality-assured medicines, these disruptions can cost them their lives.

Alongside the 77th session of the United Nations General Assembly (UNGA) at the?Clinton Global Initiative annual meeting, Ngozi Okonjo-Iweala, Director-General of the World Trade Organization (WTO), reiterated this point when she?shared her concerns?about the impact of COVID-19 on global supply chains.

“We should be talking about how to deconcentrate these supply chains, using it as a tool to bring in countries or populations who have been at the margin of the global value system." - Ngozi Okonjo-Iweala, WTO

More specifically,?disruptions in the medicine supply chain?caused by an over-consolidation of producers impedes access to essential medicines for millions of patients, often times including those who are most vulnerable.

Diversifying production of active pharmaceutical ingredients (APIs)

There are many underlying factors that contribute to fragile pharmaceutical supply chains. While downstream risks, like logistics, procurement, and distribution, are certainly contributors to medicine shortages, the global community often overlooks?upstream vulnerabilities?like sources of raw materials or ingredients.

Given the?geographic concentration of pharmaceutical manufacturing, there is currently an over-reliance on a handful of production sites to manufacture active pharmaceutical ingredients (APIs), which has ripple effects across the medicine supply chain and ultimately, puts patients at risk worldwide.

According to the U.S. Food and Drug Administration (FDA), in the U.S. alone,?72 percent of API manufacturers supplying the U.S. market are overseas, with 13 percent in China. As a result, when disruptions occur at those limited sites, whether from natural disasters, geopolitical events, or pandemic-related shutdowns, patients both at home and abroad suffer the consequences.

Mapping APIs and medicine supply to quantify risk

To avoid unnecessary and life-threatening disruptions to the medicine supply chain, it’s essential to know where and how many APIs are produced to better anticipate potential risks and take action.

To help tackle this challenge, USP created an early-warning system that aggregates data from more than 40 dynamic data sets and from our own proprietary data of more than 22,000 locations worldwide where USP quality standards are used. Our?Medicine Supply Map?provides timely information on potential shortages of medical products by leveraging available data on raw materials, APIs, and finished products, to identify and quantify risk to mitigate supply shortages before they happen. This can help decision-makers, including governments, manufacturers, hospitals, and wholesalers pivot quickly in advance of potential disruptions, prioritize investments, and develop plans.

Increasing speed and improving efficiency through continuous manufacturing

Having a clearer picture of potential upstream supply constraints is just a start. Once we know where potential problems are, we need to be able to take swift action to find alternative sources or treatments for patients. In some cases, the solution may be to diversify production of a particular medicine or vaccine to another economically viable location.

One way to prevent medicine supply chain disruptions is through?advanced manufacturing technologies, like?continuous manufacturing, which produce medicines more efficiently than traditional technology, with a smaller environmental footprint.

Currently, most medicines are produced using batch manufacturing, which involves multiple steps – like blending, weighing, compressing, or coating – at multiple times, across multiple locations, with starts and stops throughout the process, including confirming the quality of the product.

In addition, with traditional batch manufacturing, if a quality issue comes up, the entire batch is discarded, wasting time and valuable resources. But with continuous manufacturing, a medicine can be produced from start to finish in one facility and in one continuous process. Quality monitoring is automated, ensuring the quality of the final medical product without slowing production.

Continuous manufacturing requires significant upfront costs, making capital investments a must if we expect to expand this technology and use it to leapfrog traditional approaches to medicines manufacturing in Africa and other regions.

Investing in manufacturing in low- and middle-income countries

To improve equitable access to vaccines and medicines, some regions are?expanding their manufacturing capacity?to reduce reliance on external forces and markets. This includes Africa, where approximately 70-90 percent of medicines are imported from outside the continent.

To support these efforts, it’s critical to invest in the entire pharmaceutical manufacturing ecosystem. This includes increased investment from governments, the private sector, and donors to?strengthen regulatory processes, including regional entities like the African Medicines Agency, to ensure that patients have access to safe, effective, and quality-assured medical products no matter where they live.

Learning lessons from COVID-19, we must prevent disruptions in the medicine supply chain by diversifying manufacturing processes across regions, promoting advanced manufacturing technologies where feasible, and financing approaches that may succeed or fail but that allows us to advance access to quality pharmaceutical products for all patients. This will help protect consumers from poor-quality medicines, promote global health security, and improve health equity worldwide.

This article was originally published on the?USP Quality Matters blog