Recommendation of IV Dose Preparation Practices Using Closed System Transfer Devices (CSTD) for Accurate Dosing

Accurate dose preparation and administration are critical components in clinical studies to ensure patient safety and drug efficacy. Closed System Transfer Devices (CSTD) are widely used for the preparation and administration of hazardous drugs. Recent literature has raised concerns about potential under- or over-dosing when doses are prepared using CSTD due to their high hold-up volume. To ensure dose accuracy, it is essential to follow proper preparation methods when using CSTD. Seven commonly used CSTD were evaluated for product transfer accuracy from vials to IV bags using four methods: no bag spike flushing, flushing bag spikes with the original syringes, flushing bag spikes with new syringes, and circle priming. The data confirmed that under- and over-dosing occurred frequently at transfer volume ≤ 2 mL when not flushing bag spikes or flushing bag spikes with the original syringes as suggested by some manufacturers' instructions. The study also demonstrated that flushing bag spikes with the new syringes or using circle priming is effective in enabling accurate volume transfer from vials to IV bags at transfer volumes ≤ 2 mL. Both methods are feasible for implementation in pharmacies or hospitals to ensure dose preparation accuracy using CSTD. It is recommended that clinical sites flush bag spikes with the new syringes or use circle priming method for low volume transfer to ensure dose preparation accuracy. CSTD manufacturers should consider including these methods in their Instructions for Use (IFU).