Hospital Group Urges FDA to Help More with Product Shortages
The American Hospital Association (AHA) has urged FDA to intervene and “expedite the resolution of the worsening shortages of small-volume parenteral solutions that are so fundamental to patient care in hospitals.” In an 11/10 letter to FDA commissioner Scott Gottlieb, AHA said the shortages of widely-used, critical products are “quickly becoming a crisis and looming threat to the public’s health. Therefore, we call on the FDA to both vigorously pursue strategies with the current manufacturers of these products and to seek out new suppliers in order to ameliorate the current shortage, as well as prevent such shortages from occurring in the future.”
The products that AHA is most concerned about are small volume parenteral solutions, such as 50 and 100 ml injection bags of sodium chloride 0.9%, dextrose 5%, and intravenous (IV) nutritional products. “Currently, hospitals are scrambling to manage the shortfall, and have employed strategies including switching patients to appropriate alternative products, such as oral products, changing selected medications from IV piggyback to IV push administration, and prioritizing patients based on clinical factors,” the group’s letter said.
“To make matters worse,” AHA continued, “hospitals are struggling to use syringes as a replacement, due to the lack of available syringe pumps and unclear guidance from FDA regarding whether drugs may be stored in syringes. In addition, shortage management and conservation measures, while crucial to extending supplies during shortages, put hospitals in the difficult situation of explaining to patients why these seemingly simple products are unavailable, potentially impacting patient confidence in their care when they are at their most vulnerable.”
AHA acknowledged the agency’s work with Baxter Healthcare and other major manufacturers, and its efforts to secure alternative sources from overseas suppliers. “However, we strongly urge FDA to do more by pushing current manufacturers to not only continue to produce these products at their maximum capacity but also to make investments to ensure an increasing supply for the future,” it said. “We also encourage FDA to seek out and approve new domestic suppliers of these products in locations that are not prone to natural disasters. This will help make the market more resilient when there are unexpected interruptions in supply from one or two manufacturers and when sudden increases in demand occur.” Presumably, AHA is referring to ongoing manufacturing issues occurring in Puerto Rico after hurricanes devastated the island and medical product makers operating there.