The FDA released the long-awaited Drug Shortages Task Force report, “Drug Shortages: Root Causes and Potential Solutions.” The report identifies three root causes of drug shortages and recommends specific solutions to address these underlying issues. Overall, the report concludes that that there is no simple approach to address drug shortages and that the solutions proposed in the report will “require multi-stakeholder efforts and rethinking of business practices throughout the health care system.

We are waiting for the FDA’s Drug Shortage Task Force to submit its findings and final report to Congress. Based on its recommendations, we expect the House of Representatives and Senate to develop legislation to address the challenges and problems identified in the report. ACEP’s DC staff will be actively involved with those discussions and the drafting of potential legislative solutions. Stay tuned: When the time comes, we will be asking for your help to communicate ACEP’s recommended solutions to lawmakers.

ACEP submitted its official response to the FDA Drug Shortage Task Force. We explained how emergency physicians are directly affected by drug shortages each day and how much it negatively affects patient care.

“Shortages of commonly-used but essential medications remain an acute problem throughout the health care system, but these shortages tend to disproportionately affect emergency medicine(both hospital and pre-hospital) due to its reliance upon generic medications for rapid sequence intubation, seizures, antidotes, resuscitation, as well as analgesics, antiemetics, and anticoagulants.”

ACEP’s letter of response to the FDA Drug Shortage Task Force

ACEP attends FDA Drug Shortage Task Force public meeting.

ACEP President Dr. Vidor Friedman participated in a listening session with the FDA Drug Shortage Task Force. ACEP was one of only 10 groups invited to participate, and Dr. Friedman provided important perspectives on how drug shortages impact care for emergency patients in particular.

ACEP Board member Aisha Liferidge, MD, MPH, FACEP, participated in a two-day workshop hosted by the National Academies of Sciences, Engineering, and Medicine (NASEM) on medical product shortages during disasters. Dr. Liferidge discussed the unique challenges emergency physicians and their patients face during natural disasters and disease outbreaks and discussed opportunities to lessen the effects of medical product shortages through information sharing, improved supply-chain infrastructure, and enhanced collaboration among public, private, and non-profit stakeholders.

ACEP President Paul Kivela, MD, MBA, FACEP, attended a drug shortage summit hosted by the American Society of Anesthesiologists, American Hospital Association, and the American Society of Health-System Pharmacists. The summit focused on the national security implications of drug shortages and ways to improve the nation’s health care infrastructure. Dr. Kivela engaged government speakers about steps that could be taken to lessen shortages for essential medications needed on a daily basis in the ED.

In direct response to the congressional letters authored by ACEP, FDA Commissioner Gottlieb announced the creation of a new Drug Shortage Task Force charged with identifying and addressing the root causes of drug shortages affecting the health care system. This was an important step forward for ACEP’s drug shortage advocacy efforts; it was exactly what our Congressional letter had requested.

The New York Times reached out to ACEP after seeing our press release on the drug shortages survey results, and we worked with them to develop this article that brought more national attention to the issue.

“So many substances are short, and we’re dancing every shift,” said Dr. James Augustine, an [emergency physician] in Cincinnati.

The New York Times - July 1, 2018

ACEP conducted a survey of members and found that 9 out of 10 emergency physicians had experienced a drug shortage in the last month.

We drafted a congressional sign-on letter urging FDA Commissioner Scott Gottlieb to establish a task force to identify the root causes of drug shortages and develop recommendations to address them. We then secured bipartisan, bicameral sponsors for the House and Senate letters – Reps. Brett Guthrie (R-KY) and Mike Doyle (D-PA); Sens. Bill Cassidy, MD (R-LA) and Chris Murphy (D-CT) – respectively.

ACEP’s public relations team distributed a press release of drug shortage survey results in the lead up to the 2018 Leadership and Advocacy Conference.

At LAC18 (May 22), the drug shortage problem was one of two topics we raised on the Hill that day (the other being our opioid bills). LAC participants urged members of Congress to sign the letter asking the FDA to establish the task force. Ultimately, the House letter closed with 107 congressperson signatures, and the Senate letter was signed by 31 senators.