Stability and Sterility Data in Pre-Filled Syringes for Zuclopenthixol Acetate and Haloperidol Used in Emergency Tranquilisation

Background: Needle stick injuries are a known risk in the acute hospital setting especially where the patient is agitated. The emotional burden on the staff experiencing this occupational injury is well reported, however there is insufficient data to support storing pre-filled syringes, out of the manufacturer’s pack for longer than for immediate administration. 

Aim: The aim was to investigate the stability and sterility of zuclopenthixol acetate and haloperidol in pre-filled syringes to allow their use as an alternative to drawing the dose from an ampoule or vial prior to administration. 

Method: Two of the commonly used products in rapid tranquilisation were aseptically drawn in suitable syringes and tested for stability and sterility to establish shelf-life. Ten invited medical and nursing staff involved in rapid tranquilisation were invited to a focus group for feedback on the product practicality of use, cost and logistics of stock management. 

Results: The stability and sterility tests show that zuclopenthixol acetate and haloperidol retained stability and sterility when stored under 25°C in a 3 mL disposable plastic syringes, for a period of 60 days with cost of AU$67 and AU$30 per syringe respectively. 

Conclusion: The prefilled syringes provide ease and speed of administration, potential reduction in needle-stickinjuries and proved to maintain sterility. This study demonstrated that zuclopenthixol acetate 150 mg/3mL and haloperidol 15mg/3mL retained stability and remained sterile when stored under 2-8°C in plastic syringes for a period of 60 days. However the proposal was not adopted as dose flexibility was considered a greater priority than the safety gains.