ABSTRACT

The dosage and administration instructions (DAIs) are a step-by-step set of instructions written for healthcare providers, caregivers, and patients to prepare and administer the parenteral agent. As the agents are becoming more specialized, potentially hazardous, and expensive, many institutions are requiring multiple healthcare providers calculate and confirm the dose and preparation calculations prior to preparing the product. The agent should be tested for compatibility with both materials of construction by demonstrating full recovery of the expected product. DAI verification studies are conducted to ensure that the intended dose is delivered to the patients using the materials and methods outlined in the DAI. The verification studies form the basis of the in-use stability for the product that will be required for preparation and administration, as well as the hold times. The end users of the product, healthcare providers and patients, require maximum flexibility in the in-use stability of the product.