Liquid Medication Dosing Errors: Comparison of a Ready-to-Use Vigabatrin Solution to Reconstituted Solutions of Vigabatrin Powder for Oral Solution
Year: 2025
Type: article
Abstract: 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. 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. 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. 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. Vigabatrin, an approved treatment for infants diagnosed with infantile spasms (IS), is available as a powder for oral solution and as a ready-to-use solution. Vigabatrin doses are frequently modified by physicians during treatment. Vigabatrin powders require caregivers to perform a multistep preparation process before measuring out the prepared solution; whereas a ready-to-use solution can be measured directly. A study with 30 lay users (15 caregivers with vigabatrin powder experience and 15 users without oral syringe experience) required users to deliver a single dose of both products to a sample collection bottle (representing a child’s mouth) without instruction from a healthcare professional. This study’s goal was to determine whether caregivers could provide accurate doses within ± 10% of the target dose of 1125 mg using both the ready-to-use vigabatrin solution and a commercially marketed vigabatrin powder for oral solution. Delivered doses were measured, and all 30 participants administered calculated doses of the ready-to-use solution within ± 5% of the target. Only 23 of 30 vigabatrin powder doses were within ± 10%. Users were equally able to accurately deliver the prescribed volumes of both products proving that differences in accuracy and variability were due to caregiver errors that occurred when caregivers made a solution using the vigabatrin powder product. The study concluded that caregivers provided more accurate (p < 0.01) and less variable (p < 0.0001) doses (mg) of a ready-to-use vigabatrin oral solution compared to doses prepared and provided from commercially available vigabatrin powders.
Source: Advances in Therapy
Authors: Raenel Gibson, Ron Klima, Jay Van Horn
Language: English
Subfield: Emergency Medical Services
Field: Health Professions
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,790
Funder: Upsher-Smith
OpenAlex ID: W4407103702