Simulated Use Study of a New, Single-Use Delivery Device for Somatuline® Depot in Untrained Non-Professional Caregivers

Program: Abstracts - Orals, Featured Poster Presentations, and Posters
Session: SUN 281-290-Comparative Effectiveness/Health Outcomes/Quality Improvement/Patient or Provider Education/Endocrine Emergencies
Sunday, June 16, 2013: 1:45 PM-3:45 PM
Expo Halls ABC (Moscone Center)

Poster Board SUN-287
Susan L. Smith*1, Adam Shames2 and Fabien Jeannerot1
1Ipsen Biopharmaceuticals, Inc., Basking Ridge, NJ, 2Core Human Factors, Wynnewood, PA
Background: Somatostatin analogs are used for the treatment of conditions such as acromegaly. To potentially improve treatment options for health care providers and non-professional caregivers (NPCs), we designed a pre-filled, disposable syringe with an integrated passive sharps injury prevention feature for the administration of Somatuline® Depot (SD; lanreotide).

Aim: To evaluate use of the device filled with a simulated gel that mimics the injection dynamics of SD in the hands of inexperienced non-professionals. This study assessed the “worst-case scenario” of untrained use.

Methods: This summative usability study consisted of one-on-one sessions that included 15 NPCs representing potential users who may be asked to perform an injection for someone in their household. The NPCs conducted a series of injection-related tasks using an anatomical model and injection pad. Participants received all packaging including the device, package insert, and written instructions for use (IFU) and were asked to proceed as if they were in a real-life injection situation. They were then evaluated for understanding of the IFU and correct and safe use of the device. Following evaluation of the first injection, training was provided before the second use and they were retested 1 week later to approximate learning in an office and then using the device at home. Training was only provided prior to injection 1 if the participant requested it.

Results: 4/15 NPCs requested training before operating the device for the first time. The other 11 participants reported after study completion that they would have asked for training in real-life. 7/11 (64%) participants that did not request training completed a successful first injection in which the full dose was delivered, the safety feature activated correctly, and no hazards were observed. 93% of NPCs showed good comprehension of the instructions for use including all standards of care (SOC) expectations; 7% made a number of SOC errors (like not washing hands). All participants performed the post-training injection a week later in a safe and effective manner.

Conclusions: This study demonstrated that the instructions for use were comprehended by most participants. While a slim majority (64%) of NPCs who did not request training successfully completed an injection, 100% were successful post-training. This study of untrained NPCs demonstrated the value of injection training, which is recommended before use of SD.

Disclosure: SLS: Employee, Ipsen Biopharmaceuticals, Inc.. AS: Investigator, Ipsen Biopharmaceuticals, Inc.. FJ: Employee, Ipsen Biopharmaceuticals, Inc..

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