ASCO Resources Related to Drug Shortages
The medical community is currently experiencing ongoing, and in some cases, worsening shortages of critical basic drugs. ASCO has developed this page as a resource for its members, and plans to update this information on a regular basis. Below are links to the most recent updates and information on drug shortages from the Food and Drug Administration (FDA) and the American Society of Health-System Pharmacists (ASHP).
Today the FDA released an updated statement from Commissioner Scott Gottlieb, MD, on the IV fluid shortage. Dr. Gottlieb provided updates on product availability and on efforts to extend expiration dates, and discussed the demand for empty IV containers as an alternative to filled bags. Highlights of today’s statement include the following:
- The FDA is working with manufacturers to ensure that their Puerto Rico facilities can operate at full capacity, and has worked with manufacturers such as Baxter and B. Braun to import product into the U.S. from their foreign facilities including most recently from a Baxter facility in Brazil
- The FDA is also looking at additional potential import sites for both small and larger volume IV saline bags; FDA approval of IV saline products from additional companies, specifically Fresenius Kabi and Laboratorios Grifols, is expected to result in increasing product supply in U.S. market in the next several weeks
- The FDA is also asking companies to submit data to extend expiration dates for these products; if expiration dates can be safety extended, it would allow some near-expiry product that remains at the hospital level to be used - updates, including new supply sources and extensions of expiration dating, will be posted on the FDA’s drug shortage website as soon as they’re available
- The repackaging or compounding of IV saline fluids and utilization of empty IV containers is resulting in diminished supplies of these containers and concerns that supplies of empty bags could tighten further. These empty containers are regulated by the FDA as class II medical devices, and are manufactured by some of the same companies as the filled bags as well as other medical supply manufacturers
- The FDA has been in direct communication with manufacturers, distributors, hospitals and other health care providers, including the Department of Veterans Affairs, about this issue, and is assessing existing product supply, demand trends, and the capacity of manufacturers of these bags to ramp up their production; while the FDA believes the demand for empty containers will recalibrate as the supply of filled bags increases, in the meantime, they want to see what steps they can take to ensure that shortages of these empty containers do not occur, given their clinical importance and their utility as an alternative to filled bags
- The FDA encourages health care organizations and hospitals to contact FDA directly if they aren’t receiving the products they need
You can read Dr. Gottlieb’s full statement here.
Current IV Fluid Shortage Information
- Statement by FDA Commissioner Scott Gottlieb, M.D., on efforts to address impact of IV fluid shortages following hurricane destruction and resolve manufacturing shortfalls
- The FDA posted information on its ongoing efforts to resolve the IV fluid shortage. FDA has not objected to the temporary import of IV fluids from Baxter facilities in Ireland, Australia, Mexico and Canada and from B. Braun in Germany; however, B. Braun recently announced they were slowing production.
- In addition to the temporary imports, FDA continues to expedite review of drug applications that may help relieve shortages. The agency recently approved Fresenius Kabi and Laboratorios Grifols saline products and anticipates that availability of these products will help address the shortage. Currently, Fresenius Kabi anticipates limited availability in December 2017, and Laboratorios Grifols has listed their estimated date as “TBD.”
- For more information on the availability of sodium chloride 0.9% injection, including information provided by the companies, see this dedicated web page available on the FDA website. Information on all current drug shortages is also available from the FDA drug shortage database
- Baxter Healthcare Corporation in conjunction with FDA has initiated temporary importation of some intravenous drug products from its facilities in other countries. See these Dear Healthcare Professional (HCP) letters from Baxter for further information on specific products and availability
- It is extremely important that you report occurrences of drug shortages that you may be experiencing, so that FDA has the most complete information from practitioners “on the ground.” Report your shortages here
- The American Society of Health-System Pharmacists (ASHP) and the University of Utah Drug Information Service has compiled a fact sheet on Small-Volume Parenteral Solutions Shortages: Suggestions for Management and Conservation.
- The FDA has provided information on Extended Use Dates Provided by Pfizer to Assist with Emergency Syringe Shortages.
- In January 2017, the FDA released guidance for industry on Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities
The ongoing IV fluid shortage was recently exacerbated by the impact of recent hurricanes on Puerto Rico. The Food & Drug Administration (FDA) Office of Drug Shortages has been tracking these shortages and continues their efforts to find ways to mitigate them. In general, FDA responds to potential drug shortages by taking actions to address their underlying causes and to enhance product availability. For manufacturing/quality problems, FDA works with the firm to address the issues. FDA also works with other firms making the drugs that are in shortage to help them ramp up production, if they are willing to do so. When a shortage occurs and a firm has inventory that is close to expiry or already expired, if the company has data to support extension of the expiration dating for that inventory, FDA is able to review and approve the extended dating to help increase supplies until new production is available.
When the US manufacturers are not able to resolve a shortage immediately and the shortage involves a critical drug needed for US patients, FDA may look for a firm that is willing and able to redirect product into the U.S. market to address a shortage. FDA considers a list of criteria to evaluate the product to ensure efficacy and safety. These criteria include the formulation and other attributes of the drug as well as the quality of the manufacturing site where the drug is made.
Drug Shortage Listings
The FDA maintains a list of drugs in shortage with information on expected duration of shortage and alternative suppliers, when available.
The American Society of Health-System Pharmacists (ASHP) also maintains a list of drugs in shortage with information on expected duration of shortage and alternative suppliers, when available. This list differs from the FDA’s list as ASHP lists every drug shortage reported through their online report form as soon as it is investigated and confirmed, usually within 24-72 hours, whereas the FDA site focuses only on shortages of medically necessary drugs, as these have the potential to impact public health.
Additional Information on Drug Shortages
- FDA provides to Congress annually a report on drug shortages. Access the 2016 report here.
- In July of 2016 the US Government Accountability Office (GAO) released its report on drug shortages, Certain Factors Are Strongly Associated with This Persistent Public Health Challenge.
- ASCO also provides oncology-related drug shortage information through ASCO in Action.