July Event Examined National Security Implications of Global Drug Manufacturing
The American Hospital Association (AHA), American Medical Association (AMA), ASHP (American Society of Health-System Pharmacists), and the United States Pharmacopeia (USP) recently released the proceedings of their July 2020 joint summit “Safe, Effective, and Accessible High-Quality Medicines as a Matter of National Security.” The five-day event examined the resilience of the U.S. pharmaceutical supply chain in light of the current state of global pharmaceutical manufacturing.
Published in AJHP, the proceedings highlight five days of themed presentations, including an overview of the current state and challenges of foreign manufacturing, national security and sourcing, production and quality, and international partnerships.
Representatives from clinician groups, industry, supply chain, and the public sector discussed global pharmaceutical manufacturing as a national security priority. Summit participants identified opportunities to strengthen the U.S. and global regulatory system and foster greater transparency across the supply chain. Participants also identified key findings for the private sector and public sector to consider in developing a national security and public health strategy that ensures a consistently safe, effective, and uninterrupted supply of quality medicines to the American public.
One of the issues discussed by summit participants was the need for a regularly updated list of essential medicines and the need to invest in scalability of domestic manufacturing capacity without imposing barriers to international manufacturing. The Food and Drug Administration (FDA) in November published a list of 223 drugs, biological products, and medical countermeasures it deemed medically necessary to have available at all times to meet patient needs as required by a presidential executive order.
The rapid global outbreak of COVID-19 and its negative ripple effect on patients’ access to critical medicines have called attention to increasing concerns about the U.S. drug supply's stability and security. Overseas consolidation of manufacturing of active pharmaceutical ingredients (API), limited visibility into the origins and sourcing of drug ingredients, and drug shortages caused by natural disasters like Hurricane Maria contribute to the vulnerability of the supply chain. According to the FDA, 72 percent of API manufacturers are located outside of the United States, and 13 percent are in China.[1]
The proceedings are published ahead of print at https://doi.org/10.1093/ajhp/zxaa392 and will appear in print in AJHP in 2021.
About the AHA
The AHA is a not-for-profit association of health care provider organizations and individuals that are committed to the improvement of health in their communities. The AHA is the national advocate for its members, which include nearly 5,000 hospitals, health care systems, networks and other providers of care and 43,000 individual members. Founded in 1898, the AHA provides education for health care leaders and is a source of information on health care issues and trends. For more information, visit www.aha.org.
About AMA
The American Medical Association is the physicians’ powerful ally in patient care. As the only medical association that convenes 190+ state and specialty medical societies and other critical stakeholders, the AMA represents physicians with a unified voice to all key players in health care. The AMA leverages its strength by removing the obstacles that interfere with patient care, leading the charge to prevent chronic disease and confront public health crises and, driving the future of medicine to tackle the biggest challenges in health care.
About ASHP
ASHP represents pharmacists who serve as patient care providers in acute and ambulatory settings. The organization’s more than 55,000 members include pharmacists, student pharmacists, and pharmacy technicians. For 78 years, ASHP has been at the forefront of efforts to improve medication use and enhance patient safety. For more information about the wide array of ASHP activities and the many ways in which pharmacists advance healthcare, visit ASHP’s website, ashp.org, or its consumer website, SafeMedication.com.
About USP
USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. Through our standards, advocacy and education, USP helps increase the availability of quality medicines, supplements and food for billions of people worldwide. For more information about USP, visit www.usp.org.
