ASPEN Offers Recommendations and Resources for Infant Formula Shortage
The American Society for Parenteral and Enteral Nutrition (ASPEN), an organization whose members provide clinical nutrition therapies to the most acute patients, is concerned about the infants and children for whom formulas—either consumed orally or through a feeding tube—serve to provide their nutrition in the face of metabolic, gastrointestinal, immunological, or neurological diseases and/or other critical medical conditions. ASPEN offers key recommendations and resources to all stakeholders.
“Nutrition-related product shortages have been a long-standing issue without resolution,” says ASPEN President-Elect, Ryan T. Hurt, MD, PhD. “Over the past 30 years, ASPEN has partnered with the US Food and Drug Administration and consulted with product manufacturers to assist with shortage notifications, development of alternative products, and other considerations for shortage management. Unfortunately, we find ourselves once again in a crisis where critical shortages exist; but this time, across all modalities of providing nutrition support—both enteral and parenteral (intravenous) nutrition.”
In addition to the significant infant formula shortage, there are ongoing shortages of parenteral nutrition ingredients, parenteral nutrition compounding and administration supplies, and nutrition medical devices. These supply disruptions threaten the ability to provide adequate nutrition to all vulnerable patient populations across all routes of delivery.
ASPEN provides the following recommendations, which have been helpful in the past, with the goal of alleviating the current shortages and preventing future shortages. It is time for progress to be made to assure that adequate nutrition support can be provided to all patients at all times. These suggestions come from Drug Shortages: Root Causes and Potential Solutions, a report written by the 2018 Drug Shortage Working Group, of which ASPEN was a member.
- Encourage early shortage alerts and ongoing stakeholder communication.
- Enhance transparency requirements for shortage information and strengthen manufacturer shortage disclosures.
- Prevent manufacturer shutdowns and expedite facility inspections and manufacturing processes.
- Develop manufacturer shortage action plans.
- Better develop and integrate shortage lists.
- Develop a senior-level FDA shortage navigator and develop a multistakeholder advisory panel.
- Encourage and reward redundancy in the market.
- Facilitate temporary importation of formula before a shortage crisis occurs.
In addition to reiterating these recommendations, ASPEN has developed and maintains updated and dedicated resources for both enteral and parenteral nutrition shortages on the ASPEN website:
“In this dire situation, we ask everyone to contact their government leaders to urge legislation regarding maintenance of supply chain of nutrition support products, both enteral and parenteral,” says ASPEN President Gail A. Cresci, PhD, RD, LD. “In many cases, there are no alternative products for these patients. Their survival is dependent on an already unstable supply chain without adequate redundancy in the market. In this current shortage environment, they are at extreme risk for malnutrition or disease exacerbation, which may lead to hospitalization, higher medical cost, and poorer clinical outcomes, including death.” More information on how to contact legislators can be found at nutritioncare.org/publicpolicy.
ASPEN remains willing and able to provide clinical expertise to the clinical, regulatory, legislative, and executive offices as needed, and is hopeful that changes will occur to prevent such shortages from happening in the future.
Source: American Society for Parenteral and Enteral Nutrition