The ACG Board of Governors meets regularly throughout the year to discuss important clinical and practice management issues impacting ACG members and our patients. The ACG Governors recently met in Las Vegas during the 2018 ACG IBD School & Board of Governors/ASGE Best Practices Course. Of note, the ACG Governors conveyed the continued concerns of many of our colleagues across the country regarding saline shortages. As ACG members are aware, saline shortages have been a significant issue over the past several months. The ACG Governors continue to represent your interests and advocate on your behalf. Thus, saline shortages have been an important priority for ACG leadership.
This week, the FDA provided an update on saline shortages:
We recognize that managing the thousands of flu-related hospitalizations has increased the demand for certain saline products – which are commonly used to both hydrate and deliver medications via intravenous routes. As we’ve shared over the past several months, across the country, there remains a shortage of IV saline bags, which have long faced supply issues. These supply issues were worsened by the impact of Hurricane Maria on the medical products manufacturing sector in Puerto Rico, which impacted small volume IV bags. Although the saline shortage is improving, this year’s worse-than-normal flu season and workarounds deployed by health care providers in the wake of this shortage have increased demand for saline and other products.
The products include large volume saline bags typically used to hydrate patients; small volume IV saline bags (generally in 50 and 100 ml sizes) that are often used to deliver other medicines; as well as empty IV containers of varying sizes that are being used by many health care providers to compound their own IV saline solutions by filling these empty containers. As such, we’re actively working to improve the large and small IV bag shortage and tracking potential shortages of critical medical products, such as the empty IV containers.
The FDA also provided an update on when ACG members may expect an increased availability of supply:
“While we expect supplies of saline to increase over the next month, having adequate supplies, especially during this severe flu season, is a critical matter of public health. Most recently, the FDA was able to extend the expiration dates of certain products, including some 500 ml size saline bags, after carefully examining the data submitted by the company to ensure that it meets the FDA’s quality and safety standards. We continue to encourage companies to submit data to extend expiration dates for drugs in shortage. We’ve also been working with manufacturers such as Baxter and B. Braun to import products into the U.S. from their foreign facilities, including most recently additional products from a Baxter facility in Brazil.
We’ve also been proactively engaging with providers, manufacturers, distributors and other partners to identify and address issues impacting other products – like the empty IV containers I mentioned. By engaging with these partners, we can better identify the types of empty IV containers and other medical products that are most in demand. We’re also working to identify the specific features of products that are preferred or required by health care providers, such as size or function of the containers. We’re using this aggregated information — and sharing it with existing and new manufacturers — to help identify existing supply gaps. We’re taking steps to fill these gaps. Several manufacturers have indicated to us that they have the potential to initiate or ramp up production of empty IV containers to help address these public health risks. We’re grateful that they have indicated a willingness to do their part to help mitigate these challenges. We’re communicating directly with these companies, which include Douglas Medical Products Inc., Summit Medical Products Inc. and Valmed SRL.”
Please visit the FDA’s website to learn more, or stay up-to-date on ACG’s alerts for the latest information on saline shortages. Also this week, more than 90 U.S. Senators and Representatives raised concerns to FDA Commissioner Scott Gottlieb about the shortage of medical supplies, including saline bags. “To avoid any further harm to consumers, we request that the FDA use every authority at its disposal to address this crisis and present a plan to ensure immediate and sustained production of IV bags.”
Remember to contact your ACG Governor on important state and local issues impacting you and your practice.
The ACG Board of Governors is one of the most unique aspects of the American College of Gastroenterology. Governors are ACG Fellows that are elected from the membership of a particular state or region. There are currently 76 Governors across seven different regions in the U.S. and abroad. The Board of Governors acts as a two-way conduit between College leadership and the membership at-large. This helps the College make certain it is meeting the evolving needs of the membership. Contact your ACG Governor today.