Per the American Society of Health-System Pharmacists (ASHP) current drug shortage database, Baxter has the Clinisol 15% injection (sulfite-free) on shortage due to manufacturing delays. The panel has listed the following products as available options, but did not make any comments regarding their interchangeability with Clinisol 15%: Aminosyn II (sulfite-free) injection 10%, Aminosyn II (sulfite-free) injection 15%, Plenamine injection 15%, Premasol (sulfite-free) injection 10%, Prosol (sulfite-free) injection 20%, Travasol injection 10%, and TrophAmine injection 10%. It was stated that Baxter has 15% Clinisol 500 mL containers available in limited supply. While the American Society for Parenteral and Enteral Nutrition (ASPEN) guidelines provide general recommendations for managing shortages of parenteral nutrition products, no specific substitutions for any product were suggested. [1], [2]
A 2018 paper presented at the National Home Infusion Association annual conference provides systematic strategies for surviving shortages and managing parenteral nutrition (PN) patients. It was highlighted that product substitution, though often seen as a simple solution for shortages, can cause compounding challenges with PN components, affecting compatibility, stability, and sterility due to differences in pH, electrolytes, active components, and excipients. Substituting therapeutically equivalent products can present unique challenges, particularly with amino acid (AA) solutions. Table 1 outlines the pH differences across various brands of standard AA solutions available in the U.S., while Table 2 lists specialty AA solutions. The author stated that the AA products in Table 1, including Aminosyn 8.5% and 10%, Aminosyn II 10% and 15%, Travasol 10%, Clinisol 15%, Prosol 20%, FreAmine III 10%, and Plenamine 15%, are considered therapeutically equivalent gram for gram and can be substituted with the expectation of achieving similar clinical outcomes. Though no other discussion on Clinisol was provided, it was mentioned that substituting Aminosyn for Travasol in a total nutrient admixture (TNA) compromises stability due to Aminosyn’s lower pH, while FreAmine III is acceptable because its higher pH supports stability. However, FreAmine’s higher pH increases the risk of calcium-phosphate precipitation, especially if phosphorus content or a specific solubility curve isn’t accounted for. Sulfite preservatives in AA solutions mainly affect vitamin stability, such as thiamine. The article did not discuss Clinisol or its acceptable alternatives in further detail. [3]
In a 2020 letter B. Braun Medical Inc. informed their consumers regarding a temporary allocation of Plenamine™ 15% Amino Acids Injection 1000 mL due to a temporary delay in the release of Active Pharmaceutical Ingredient (API) impacting product manufacturing. In the meantime, the manufacturer recommended the use of either a 15% Clinisol amino acid injection or the 15% Aminosyn™ II as substitutes. It’s important to note that the manufacturer did not supply any comparative evidence to support this recommendation. [4]