The American Hospital Association (AHA), American Society of Anesthesiologists (ASA), American Society of Clinical Oncology (ASCO), ASHP (American Society of Health-System Pharmacists), and the Institute for Safe Medication Practices (ISMP) announced their strong support for the Mitigating Emergency Drug Shortages (MEDS) Act, introduced today by Senators Susan Collins (R-ME) and Tina Smith (D-MN). The legislation includes key policy recommendations long supported by the five healthcare organizations, which have worked collaboratively on drug shortage prevention efforts since 2010.
Severe and critical drug shortages have become the norm for the nation's healthcare system. Over the last several years, natural disasters, such as Hurricane Maria, quality problems, manufacturer consolidation, and other issues, have disrupted pharmaceutical manufacturing and left the U.S. healthcare system on the brink of a significant public health crisis multiple times.
There were well over 200 shortages in 2018, and that number has continued to grow in 2019. Healthcare organizations, including hospitals, health systems, and clinics, often struggle to obtain medications, some of which are essential to maintain basic levels of patient care, such as sodium bicarbonate and IV immunoglobulin.
The MEDS Act provides increased authority for the U.S. Food and Drug Administration (FDA), enhanced manufacturing reporting requirements, and new market-based incentives to help mitigate the risks drug shortages pose to both our patients and the healthcare system.
The five organizations jointly convened a summit on drug shortages in November 2010 and worked together to build support for drug shortage provisions included in the 2012 FDA Safety and Innovation Act (FDASIA). Most recently, the groups hosted a summit, "Drug Shortages as a Matter of National Security: Improving the Resilience of the Nation's Health Care Critical Infrastructure," resulting in 19 recommendations, including the following, which are included in the MEDS Act:
- Requires manufacturers to disclose the root causes and the expected duration of shortages
- Extends reporting requirements to include contract manufacturers and active pharmaceutical ingredients (API)
- Requires manufacturers to develop contingency plans to ensure an ongoing supply
- Develops recommendations to incentivize manufacturers to enter the market for drugs in shortage
- Examines the national security risks of shortages
Over the past decade, America's hospitals and health systems have experienced far too frequent shortages of widely used drugs that are absolutely crucial to patient care and public health. The AHA thanks Senators Susan Collins and Tina Smith for their bipartisan commitment to tackling the issue of drug shortages by introducing today's legislation. We look forward to working with Congress to advance the MEDS Act, which will help prevent, mitigate and resolve drug shortages and secure the supply of these life-saving products for patients and the hospitals and health systems that proudly care for them."
Tom Nickels, AHA Executive Vice President
"ASA is proud to endorse this important legislation that will help ensure critical drugs are available for procedures so physician anesthesiologists can provide patients safe, timely care," said ASA President Linda J. Mason, M.D., FASA. "As leaders in patient safety, it is critical that the MEDS Act advance in Congress to decrease the risks of drug shortages and the impact on patient care. We applaud Senators Collins and Smith for their leadership on this legislation and encourage Congress to continue exploring ways to address this patient safety risk."
"In oncology, there are often no replacements or work-arounds for therapies shown to improve survival," said ASCO President Howard A. "Skip" Burris III, MD, FACP, FASCO. "We support this legislation, which gives the FDA greater authority to prevent or mitigate shortages before they even begin."
"The ongoing shortages of vital, life-saving medications dangerously interfere with patient care," said ASHP CEO Paul W. Abramowitz, Pharm.D., Sc.D. (Hon.), FASHP. "ASHP strongly supports the MEDS Act. We believe this legislation is a significant step in addressing our nation's drug shortage crisis, and supports our goal of ensuring patients have reliable access to the medications they need, when they need them."