FROM THE EDITOR: FDA Effective Date for Aluminum Labeling Approaching
Carol Rollins, MS, RD, PharmD, BCNSP
Coordinator, Nutrition Support Service/Clinical
Pharmacist for Home Infusion, Arizona Health
Sciences Center, Tucson, Arizona
It is important for nutrition support practitioners to recognize a potentially life-threatening situation that could arise as emphasis is placed on limiting inadvertent aluminum administration. Products that are selected for lower aluminum content must be carefully evaluated for their effect on compatibility within the TPN formulation. Calcium chloride,
for example, has a lower level of aluminum
contamination than does calcium gluconate, based on previous reports.4 Whether this will hold true with newer data is uncertain; however, a decision to substitute calcium chloride for calcium gluconate in TPN formulations could prove disastrous. This is especially true in TPN formulations made for neonatal patients where the calcium and phosphorus concentrations are typically maximized.
Calcium and phosphorus compatibility in TPN formulations is affected by multiple factors, including the calcium salt utilized for TPN compounding.5 Calcium gluconate is generally the "salt of choice" for TPN compounding since it dissociates to a limited extent, whereas calcium chloride almost completely dissociates into free ions, making the calcium more available to interact with phosphate, thus increasing the risk of dibasic calcium phosphate precipitation. This means less calcium chloride can be added to a TPN formulation, and substitution of an equal amount of calcium chloride in place of the gluconate salt could result in precipitation that was otherwise avoided. Solubility equations are designed for use with calcium salts5 but have limited application based on admixture ingredients and composition. Failure to recognize incompatibility can result in serious harm, even death.6 In April 1994, the FDA issued a safety alert related to the hazards of precipitates associated with parenteral nutrition.7 Two deaths and at least 2 cases of respiratory distress resulted from infusion of TPN formulations that contained insoluble dibasic calcium phosphate. Subacute interstitial pneumonitis has also been associated with infusion of calcium phosphate precipitates.8 It is critical that nutrition support practitioners use caution in selecting components for TPN compounding; both the aluminum content and compatibility must be carefully evaluated to avoid patient harm.
References
1. Department of Health and Human Services. Food and Drug Administration. Aluminum in large and small volume parenterals used in total parenteral nutrition. Federal Register. 2000;65:4103-4111. 2. Department of Health and Human Services. Food and Drug Administration. Aluminum in large and small volume parenterals used in total parenteral nutrition; delay of effective date. Federal Register. 2001;66:7864-7865. 3. Department of Health and Human Services. Food and Drug Administration. Meeting Summary: HIMA/FDA; Discussion of final rule provisions, LVP: Aluminum labeling. [Docket No. 90N-0056]. 4. Koo WW, Kaplan LA, Horn J, Tsang RC, Steichen JJ. Aluminum in parenteral nutrition solutionŠsources and possible alternatives. J Parenter Enteral Nutr. 1986;10:591-595. 5. Rollins CJ. General pharmacologic issues. In: Matarese LE, Gottschlich MM, eds. Contemporary Nutrition Support: A Clinical Guide. Philadelphia, Pa: WB Saunders Company; 1998:303-323. 6. National Advisory Group on Standards and Practice Guidelines for Parenteral Nutrition. Safe practices for parenteral nutrition formulations. J Parenter Enteral Nutr. 1998;22:49-66. 7. Lumpkin MM, Burlington DB. Safety alert: hazards of precipitation associated with parenteral nutrition. Am J Hosp Pharm. 1994;51:1427-1428. 8. Knowles JB, Cusson G, Smith M, Sitrin MD. Deposition of calcium phosphate crystals as a complication of home parenteral nutrition. J Parenter Enteral Nutr. 1989;13:209-213.
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