The RDSP Maps the U.S. Drug Supply to Predict and Prevent Shortages (Part 2 of 2)

The Resilient Drug Supply Project (RDSP) has created the world’s largest database of pharmaceutical manufacturing, supply and distribution. Comprised of more than 60 public and proprietary datasets, it can monitor the drug supply chain from start to finish and predict likely critical drug shortages affecting the United States.

Launched in 2018, this large-scale project is one of the goals of the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, publisher of CIDRAP News.

RDSP’s mission is to build and maintain a map of the global supply chain for every prescription drug used in the United States to reduce or avoid disruption from any cause and for any reason. The resilient medicine supply map will be a tool for stakeholders, policy makers and consumers as they work to ensure that prescription medicines are available and accessible when patients need them. This objective includes ensuring both public health and national security.

RDSP’s predictive models and algorithms are evidence-based and designed to evolve and adapt to changing situations, said RDSP Pharmacy Research Scientist David Margraf, PharmD, PhD. “The quantitative models we develop are validated by testing them for past and new shortages,” he added.

Supported by the personal philanthropy of Christy Walton through the Walton Family Foundation, the RDSP was launched to map drug supply chains and predict shortages using drug characteristics and other factors such as geographic concentration of contract manufacturers who manufacture active pharmaceutical ingredients (APIs) and finished drugs. some products.

So far, more than 25 people, including professionals and students in pharmacy, public health, biostatistics, computer science and epidemiology, have worked on data aggregation and processing.

“When prescription drugs are not affordable or accessible for whatever reason, consumers can experience lost workdays, disease progression and complications, more emergency room visits, more hospitalizations and even death. premature infants,” said Stephen Schondelmeyer, PharmD, PhD, who leads the RDSP with CIDRAP director Michael Osterholm, PhD, MPH.

Osterholm said the project’s goals have expanded since its inception. “Our interest in this project was initially directed at the inability to provide patients with appropriate and life-saving antibiotics” as these critical drugs have faced shortages, he said.

“While all lifesaving drugs are essential, we continue to focus on the challenge of antimicrobial resistance and finding the right drug for the bug.”

Develop a global vision of supply chains

Most drug shortages, Schondelmeyer said, result from issues in the upstream supply chain, such as quality issues, recalls, shipping delays, raw material shortages, and geopolitical and economic issues. , which the COVID-19 pandemic has propelled into the public eye. .

“COVID has not only seen an increase in demand for certain drugs, but it has also revealed unexpected disruptions in supply chain production capacity,” he said. “The pandemic and the side effects of factory and shipping lane closures have had a significant impact on drug supply chains.”

By tracking and analyzing these issues in addition to other factors such as weather, import and export routes, critical infrastructure and geopolitical risks, Schondelmeyer said the RDSP team hopes to transform the chain of American drug supply into a system in which future shortages can be anticipated and mitigated and not just managed after the fact.

Although there is some overlap in purpose between the RDSP card and the United States Pharmacopeia (USP) Generic Drug Supply (MSM) card presented in Part 1 of this series, the RDSP card encompasses each name brand, generic, biologic, biosimilar, and vaccine in the US market. The RDSP map includes the 90,000 unique drugs on the market, of which 34.2% are brand name prescription products and 65.8% generics.

The RDSP map includes information from numerous US Food and Drug Administration (FDA) databases; however, FDA information on specific drug products is sometimes incomplete or disjointed, and data in different files often cannot be easily combined or linked to other datasets due to inadequate identifiers. The RDSP goes beyond FDA data to include other public and commercial datasets and more than 200 potential drug shortage risk factors, including inert ingredients and packaging and administration components. medicines such as needles and inhalers.

The RDSP team collaborates with many other organizations such as USP; the FDA; the National Academies of Science, Engineering, and Medicine (NASEM); Angels for Change, CivicaRx; Phlow Pharmaceuticals; Drugs 4 All; Walmart; Amérisource Bergen; Biomedical Advanced Research and Development Authority (BARDA); the Alliance to End Drug Shortages; Vizient; the New Zealand Medicines and Medical Devices Safety Authority; and many more.

“We rely on public FDA databases, and we have edited, validated, and checked them against other sources to fill in the gaps,” Schondelmeyer said.

“We also add the number of defined daily doses produced at each facility to create a quantitative measure of drug supply. This will calculate the percentage contribution or concentration of drug consumption in the United States from a specific country. It’s a much better measure than the number of factories as an indicator of our nation’s dependence on a particular country’s drug supply.”

Monitoring of critical drugs

The RDSP team has already mapped the National Drug Codes (NDCs) for the 156 drugs it has identified as essential for the treatment of acute conditions and the 40 drugs considered essential for the treatment of COVID-19. Critical drugs are those that, if not available, could cause serious illness or death within hours or days.

“It’s not enough to have drugs approved for the treatment of acute conditions unless they’re available when they’re needed, and that’s why this project is so important,” Osterholm said.

NDCs identify each pharmaceutical product and its dosage form, strength, package size and manufacturer, as well as product labeling. RDSP tracks and updates shortages of these products weekly on its website, based on data from the American Society of Health-System Pharmacists (ASHP) and the FDA. “We map drugs from manufacturing of key starting materials to distribution at the patient level,” Margraf said.

Overall, Schondelmeyer said, the mapping showed that the availability of the most prescribed generic and brand name drugs in the United States is highly dependent on foreign sources for APIs and finished pharmaceuticals.

RDSP’s work found, for example, that 90% of the 30 top-selling brand name drugs in the United States are manufactured outside the country and only 10% of their APIs are manufactured in this country. Similarly, 90% of the top 30 generic drugs are manufactured abroad or their country of origin is not declared. India, which depends on China for up to 70% of its main raw materials, is the main source of generic drugs for the American market.

The roots of these shortages are often complex. For example, sodium chloride solution, or saline, an essential product used in hospitals to reconstitute or administer drugs, hydrate patients and flush intravenous lines, has recently been in short supply due to the surge in the variant. Omicron and the war in Ukraine.

“Saline solution is one of the most popular products, but we have shortages,” Schondelmeyer said. These shortages, however, are not due to a lack of sodium chloride but rather to supply chain issues affecting the products used to store and administer saline solution, such as heparin, needles and caps. vials, as some factories producing these products were reoriented during the pandemic. to produce other low-volume, high-consequence drugs.

“Even if you have a lot of sodium chloride, that doesn’t mean you have hot flashes,” he said.

Although the detailed data found in the RDSP map is not publicly available, the RDSP team has published reports, including a COVID-19 CIDRAP viewpoint, “Ensuring a Resilient US Prescription Drug Supply,” as well as testimony to the US Senate on lessons from the pandemic and recommendations for moving forward. This summer, the team is developing a tool to provide geographic visualizations of supply chain data for most pharmaceutical products available on a website.

The purpose of the RDSP card is to recognize potential drug shortages and develop solutions to avoid them. And while some RDSP data cannot be made public because it belongs to other entities, the RDSP team plans to release most of the non-proprietary data for use by stakeholders and other specialists. Datas.

“We bring great value as a center focused on drug shortages in terms of disseminating knowledge and resources that benefit public health and patient care,” Margraf said.

This is part 2 of a 2-part series on tracking drug supply chain issues. The first story, on the U.S. Pharmacopeia supply map, was published on March 31.

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