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Recommendation of IV Dose Preparation Practices Using Closed System Transfer Devices (CSTD) for Accurate Dosing
Qunhui Liu1, Ka Po Chu1, Armando Cardenas1
1Formulation Development, Regeneron Pharmaceuticals, 777 Old Saw Mill River Road, Tarrytown, New York, 10591, USA.
The AAPS Journal
|May 16, 2025
Summary
Accurate drug dosing with Closed System Transfer Devices (CSTD) requires proper preparation. Flushing new syringes or circle priming ensures accurate low-volume transfers, preventing under- or over-dosing.
Area of Science:
- Pharmaceutical Sciences
- Clinical Pharmacy Practice
- Drug Delivery Systems
Background:
- Accurate dose preparation and administration are crucial for patient safety and drug efficacy in clinical studies.
- Closed System Transfer Devices (CSTD) are essential for handling hazardous drugs but may lead to dosing inaccuracies due to high hold-up volumes.
- Concerns exist regarding potential under- or over-dosing when using CSTD, necessitating optimized preparation methods.
Purpose of the Study:
- To evaluate the impact of different preparation methods on the accuracy of drug volume transfer using commonly used CSTD.
- To identify effective strategies for ensuring accurate dose preparation with CSTD, particularly for low-volume transfers.
- To provide recommendations for clinical practice and CSTD manufacturers to improve dose accuracy.
Main Methods:
- Seven common CSTD were assessed for product transfer accuracy from vials to IV bags.
- Four preparation methods were compared: no bag spike flushing, flushing with original syringes, flushing with new syringes, and circle priming.
- Transfer accuracy was evaluated, with a focus on volumes less than or equal to 2 mL.
Main Results:
- Under- and over-dosing were frequent with volumes ≤ 2 mL when bag spikes were not flushed or flushed with original syringes.
- Flushing bag spikes with new syringes and circle priming effectively ensured accurate volume transfer for volumes ≤ 2 mL.
- Both recommended methods are feasible for implementation in hospital and clinical pharmacy settings.
Conclusions:
- Proper preparation techniques are vital for accurate dosing when using CSTD, especially for low-volume preparations.
- Flushing bag spikes with new syringes or employing circle priming are recommended methods to ensure dose accuracy with CSTD.
- CSTD manufacturers should consider incorporating these validated methods into their Instructions for Use (IFU).
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