Formulation errors in compounding can significantly affect patient safety by leading to incorrect drug concentration, dosing errors, contamination, and inconsistent quality of compounded medications. Such errors have serious consequences, including overdose, underdose, toxicity, adverse side effects, and treatment failure.
Key impacts on patient safety include:
-
Concentration errors: These are common in compounded medications prepared for individual patients and disproportionately affect vulnerable populations like children and the elderly. Incorrect concentration can cause overdosing or underdosing, leading to toxicity or ineffectiveness of the medication. For example, errors with drugs like 4-aminopyridine and liothyronine have resulted in serious patient harm.
-
Dosing errors: Miscalculations or improper measuring of compounded drugs, especially injectables like semaglutide, can cause adverse events requiring hospitalization. Confusion over units of measurement and syringe size contributes to these errors. Dosing mistakes can lead to gastrointestinal issues, fainting, pancreatitis, or other serious side effects.
-
Contamination risks: Errors during compounding processes can introduce bacteria, fungi, or other contaminants, potentially causing infections or serious outbreaks. Contamination is a key source of harm associated with compounded drugs.
-
Lack of standardization and oversight: Since compounded drugs do not undergo FDA premarket review, inconsistent preparation practices increase patient risk and can result in products that vary in strength and purity.
-
Inadequate checks: Failures in independent double checks and calculation verification during compounding can lead to these formulation errors going unnoticed until patient harm occurs.
Overall, formulation errors in compounding elevate patient risk by reducing medication safety, efficacy, and quality, underscoring the need for robust safety protocols, thorough verification, and close clinical monitoring
