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Liquid Medication Dosing Errors: Comparison of a Ready-to-Use Vigabatrin Solution to Reconstituted Solutions of

Raenel Gibson¹, Ron Klima², Jay Van Horn²

¹Pyros Pharmaceuticals Incorporated, 2001 Route 46, Suite 310, Parsippany, NJ, 07054, USA. Raenel.Gibson@Upsher-Smith.com.

Advances in Therapy

|February 3, 2025

Insights

Caregivers accurately administered ready-to-use vigabatrin oral solution, unlike vigabatrin powder which required reconstitution. The ready-to-use solution ensures more precise dosing for infantile spasms (IS) treatment.

Area of Science:

Pediatric Neurology
Pharmacology
Patient Safety

Background:

Vigabatrin (VGB) is a crucial treatment for infantile spasms (IS) in infants aged 1 month to 2 years.
Current VGB formulations require caregivers to reconstitute vigabatrin powder, introducing potential dosing errors.
Accurate VGB dosing is critical for managing IS and minimizing adverse events.

Purpose of the Study:

To compare the accuracy and variability of VGB dosing by caregivers using a ready-to-use (RTU) oral solution versus a vigabatrin powder formulation.
To assess caregiver performance in preparing VGB doses without healthcare professional instruction.

Main Methods:

A crossover comparative usability study involving 30 lay users (caregivers with and without prior VGB powder experience).
Participants administered single doses of both VGB-RTU surrogate solution and vigabatrin powder to a collection bottle.
Dose accuracy was analytically measured, with the primary endpoint being delivery within ±10% of the target 1125 mg dose.

Main Results:

All participants achieved VGB-RTU solution doses within ±5% of the target.
Only 23/30 vigabatrin powder doses were within ±10% of the target.
Both naïve and experienced caregivers demonstrated significantly higher accuracy and lower dose variability with the VGB-RTU solution compared to the vigabatrin powder.

Conclusions:

Caregivers achieve more accurate and less variable VGB doses with the ready-to-use oral solution compared to reconstituted vigabatrin powder.
Caregiver errors during the reconstitution of vigabatrin powder are the primary cause of dosing inaccuracies.
The VGB-RTU solution offers a safer and more reliable method for home administration of VGB for infantile spasms.

Read full analysis

Abstract

Introduction:

Vigabatrin (VGB) is intended for use by caregivers of infants (1 month to 2 years old) diagnosed with infantile spasms (IS). Commercially available vigabatrin powders require caregiver reconstitution prior to oral administration. This study compared the ability of caregivers to accurately provide a targeted dose of vigabatrin using a ready-to-use (RTU) vigabatrin oral solution (VGB-RTU solution) and SABRIL^® (vigabatrin) powder for oral solution, Lundbeck LLC, (vigabatrin powder) without instruction from a healthcare professional.

Methods:

A crossover comparative usability study with 30 lay users (15 caregivers with vigabatrin powder experience and 15 oral-syringe/medication preparation naïve users) which required users to deliver a single dose of both VGB-RTU surrogate solution and vigabatrin powder to a sample collection bottle was performed. Doses were measured analytically with a primary endpoint to deliver doses within ± 10% of the target dose of 1125 mg.

Results:

All 30 participants administered VGB-RTU solution doses within ± 5% of the target, while only 23/30 of the vigabatrin powder doses were within ± 10%. All naïve users delivered vigabatrin doses using VGB-RTU solution within ± 5% of the target; whereas only 13/15 delivered doses within ± 10% for vigabatrin powder. All experienced vigabatrin users delivered calculated vigabatrin doses using VGB-RTU solution within ± 3%; whereas only 10/15 delivered doses within ± 10% for vigabatrin powder. Users were equally able to accurately deliver the prescribed volumes of both products. Calculated doses of VGB-RTU solution (mg) were significantly less variable (p < 0.0001) and more accurate (p < 0.01) than doses of vigabatrin powder.

Conclusion:

Caregivers delivered more accurate and less variable doses of the ready-to-use solution compared to solutions prepared from vigabatrin powders for oral solution. These differences were shown to be due to caregiver errors in reconstituting vigabatrin powders for oral solution.

Keywords:

Dosing errors Epilepsy Infantile spasms Oral solution Powder Reconstitution Vigabatrin

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