The alarming national rise of COVID-19 cases underscores the urgent need to further strengthen our pharmaceutical supply chain and make it a national security priority for the patients we serve.
Drug shortages and vulnerabilities in our supply chain existed long before the COVID-19 pandemic. After Hurricane Maria devastated manufacturing capability in Puerto Rico, we saw firsthand the impact on our supply chain and the shortages of critical drugs that followed. ASHP was proud to have joined with the American Society of Anesthesiologists, the American Hospital Association (AHA), the American Society of Clinical Oncology, and the Institute for Safe Medication Practices to convene a September 2018 summit that made wide-ranging recommendations to address drug shortages.
ASHP advocated for drug-shortage provisions based on our summit recommendations that recently passed as part of the Coronavirus Aid, Relief, and Economic Security (CARES) Act. This was a major milestone toward the resolution of drug shortages, but there is still work to be done. The pandemic has further exposed vulnerabilities in our pharmaceutical supply chain, as seen by ongoing shortages of critical medications, personal protective equipment, syringes, and other supplies.
Meanwhile, nitrosamine contamination and other quality-related issues continue to prompt recalls of drug products. Within the last month, the Food and Drug Administration announced recalls of metformin products from six manufacturers, adding to the growing concern over the presence of probable carcinogens in angiotensin II receptor blockers and ranitidine products.
We have learned many lessons throughout this public health crisis, and we continue to do so as our healthcare community and society respond to the virus. Now is the time to evaluate our approach to the risk of supply chain disruption by the pandemic and future healthcare crises and to prevent disruptions from harming patients.
To that end, we are pleased to share that our originally planned in-person summit in partnership with the AHA, the American Medical Association (AMA), and the United States Pharmacopeia (USP) – which I announced in November 2019 and was postponed in March due to the pandemic – will now convene as a virtual event July 27–31. The Safe, Effective, and Accessible High-Quality Medicines as a Matter of National Security summit will include representatives from clinician groups, industry organizations, supply chain leaders, and government agencies who will identify actionable solutions to improve supply chain safety in the United States, including global regulatory cooperation, quality expectations, and operational efficiencies.
The summit will feature daily themes that will allow for a concentrated exchange of ideas across diverse sectors. Themes will include:
- An Overview of the Current State and Challenges of Foreign Manufacturing, and Lessons Learned from the COVID-19 Pandemic
- National Security Perspectives and Sourcing Opportunities
- Advances in Production and Manufacturing and in Ensuring Quality Drug Supplies
- International Partnerships, Vulnerabilities, and Learnings
- Outputs and Recommendations
ASHP, AHA, AMA, and USP will develop recommendations to improve the quality and availability of medications and support clinical decision-making and communications with patients and others involved in healthcare delivery. Proceedings and recommendations from the summit will be published in AJHP.
The summit firmly aligns with ASHP’s vision that medication use will be optimal, safe, and effective for all people all of the time. ASHP stands committed to delivering short-term and long-term solutions to this critical issue of supply chain management. We look forward to sharing more with you about the virtual summit findings and recommendations.
Thank you for being a member of ASHP and for everything that you do for your patients and our profession.