In October, the FDA announced a shortage of ADHD drug Adderall, with leading manufacturer Teva Pharmaceuticals forecasting that its generic brands would be in short supply until March 2023. Media reports blame the shortages on workforce issues at Teva and rising demand for the drug associated with the proliferation of online ADHD diagnosis services.
But Adderall is by no means the only drug, active pharmaceutical ingredient (API), or medical supply item that is in short supply. Pharma consulting and research firm Advisory Group reported Nov. 14 that while shortages have declined from an early 2022 peak, “the number of items in a shortage is around five times higher than pre-pandemic levels, according to David Hargraves, SVP of supply chain at Premier, a group purchasing and consulting organization.”
“We have heard from supply chain executives at a number of healthcare systems that it has been a tremendous drain on resources,” Erin Fox, senior pharmacy director at University of Utah Health told Advisory Group.
Premier forecast 15% shortfalls in contrast media and 20% gaps in supplies of surgical automatic tourniquets for three to six weeks, with shorter duration shortages expected for needle and catheter stabilization equipment (used in emergency medicine) and interventional specialty diagnostics, according to the publication.
The antibiotic amoxicillin, frequently prescribed for children is in short supply, too. Madeline Camejo, chief pharmacy officer for Baptist Health, noted that such low-margin antibiotics are frequently at risk because “drug companies have a lot less incentive [compared to higher margin products] to set up robust, resilient supply chains.” Current shortages were driven in part by the rise of respiratory syncytial virus (RSV) among children over the last several months. “For now, suppliers are trying to keep up with the demand, but they have placed limits on how much pharmacies can order,” said Camejo.
Providers are also having difficulty procuring bacteriostatic saline (for diluting IV drugs) and compounds used for localized anesthesia, water retention, and calcium deficiencies.
Pandemic-related disruptions, labor shortages, and general supply chain challenges share the blame—but the largest contributing factor is the United States’ excessive dependence for APIs and drugs on China and India, where pandemic and climate-related disruptions have roiled supply chains. Additionally, India’s pharmaceutical industry is highly dependent on China for key APIs, so disruptions from lower-tier Chinese suppliers ripple up the drug production supply chains. This weakness was highlighted by the Biden Administration in its June 2021 supply chain report. Resilinc also covered this in our Special Report: Life Sciences Industry – Shortages and Outlook.
As covered in Resilinc’s April blog, U.S. and global pharma companies are tackling these supply chain risks by investing in their own manufacturing capacity, vetting more back-up suppliers, reshoring and/or regionalizing supply networks, and by adopting or accelerating digitalization across their enterprises. Premier, for example, has worked with partners and even competitors over the last two years to increase domestic production and sourcing of PPE and APIs. Premier is leveraging its supply chain data to identify supplies most at risk and investing in those categories with “Buy-American” commitments.
Continuous manufacturing that brings API and final dosage manufacturing under one roof also promises greater supply chain resiliency. While complex and expensive to implement, continuous manufacturing streamlines the traditional batch processing model and offers the promise of much greater flexibility. Amgen, GSK, and others have invested in continuous manufacturing, and GSK has achieved significant reductions in water and solvent usage through this technology as well.
Even with continuous manufacturing or similar advanced technology, life sciences firms will continue to rely on third-party suppliers—including those based in China. This underscores the need for pharma and life sciences firms to continue building up their supply chain risk management (SCRM) capabilities, especially those that provide visibility into where APIs and other vital inputs are made and the locations and status of shipments.