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Data show how care providers shifted their mindsets to prioritize efficacy, safety, tolerability and availability factors during the 2022 formula supply shortage and recall crises.
A significant majority of pediatric health care providers prioritized safety, efficacy and tolerability factors when considering families switch their cow milk protein-allergic (CMPA) infant or toddler’s formula during the global supply chain shortages of 2022, according to a new survey.
New data assessing the strategies employed by health care providers navigating the nationwide shortage of infant formula amid global supply chain crises and major domestic formula recalls last year showed little difference in preference across 4 alternative amino acid formula options from pediatric care providers. Rather, the findings show that only availability of said formulas were the statistically significant factors influencing such a recommendation.
In the research—presented in an abstract at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) 2023 Annual Meeting in San Diego this week— a team of investigators analyzed the factors that which influenced healthcare providers’ clinical strategies when switching between amino acid formulas for managing infants and toddlers <24 months old with CMPA during last year’s formula shortage.
Led by Jessica Baran, MS, a third-year medical student at Florida Atlantic University, investigators described the minimal context currently available for what was an extended crisis in pediatric care through 2022.
“This shortage posed challenges for pediatric healthcare providers managing infants with CMPA,” they wrote. “Providers had to make critical decisions based on the limited availability of infant formulas. The existing literature on healthcare providers' clinical decision-making during formula shortages is limited.”
Baran and colleagues conducted their research including pediatric health care providers with experience treating CMPA in infants and young toddlers during the national formula shortage, a period defined as January - November 2022. A 26-item survey assessing driving factors in clinical decision-making was delivered to survey participants via a real-time mobile data collection tool.
The questionnaire required participants answer yes/no questions, as well as use a 1 -10 rating scale (with 1 - 3 indicating low strength and 8 - 10 indicating high strength) to determine how factors including efficacy, safety and tolerability influenced their CMPA formula decision-making.
The final survey included 75 pediatric health care provider participants. Investigators observed that participants rated formula safety more greatly askey factor following the national shortage than they had before the shortage (88% vs 93%). The same trend was true for the factor of formula being able to provide effective symptom relief for infants and toddlers with CMPA (87% vs 92%). Efficacy and safety were in fact the most importantly-rated factors when switching formulas in said patients.
Interestingly, participants considered the availability of formulas as the third most important factor prior to the shortage (87%)—but after the shortage, the formula’s tolerability and acceptability by patients succeeded it as the third most important factor (87%).
In analysis of the importance of factors when switching amino acid formulas among infants and toddlers with CMPA, participants again most highly rated safety (85%), efficacy (83%) and tolerability (73%). The only factor to be found with a statistically significant difference in perceived performance among participants considering 4 different amino acid formulas was the availability of specific formulas (P <.05).
Baran and colleagues concluded their findings elucidated the aspects of pediatric health care provider decision-making that were most prioritized when managing CMPA infants and toddlers seeking amino acid formulas during the shortage and recall periods of 2022.
“The findings highlight the significance of safety, tolerability, and efficacy in HCPs' decision-making processes,” investigators wrote. “The identification of formula availability as a significant factor when switching between amino acid formulas underscores the need for robust supply chain management and contingency plans during formula shortages to ensure optimal care for infants with CMPA.”
Baron J, Brown J, Farrar A, Oliver’s L, et al. Impact of the 2022 Formular Shortage on Clinical Decision-Making of Healthcare Providers in Switching Amid Acid Formulas for Infants with Cow’s Milk Protein Allergy: A Survey-Based Study. Paper presented at: North American Society for Pediatric Gastroenterology, Hepatology and Nutrition 2023 Annual Meeting; October 4 - 7; San Diego, CA. Accessed October 7, 2023.