ESPE Abstracts (2016) 86 P-P2-670

Growth P2

A New Reusable Manual Pen Device for Injection of Human Growth Hormone: Results of a Convenience and Functionality Evaluation Study

Maritta Sauera & Marie-Nathalie Castelb


aMerck KGaA, Darmstadt, Germany; bMerck Biopharma, Coinsins, Switzerland

Background: This multi-country study, conducted in the USA, is also ongoing in France, Germany, Brazil and South Korea (52 healthcare professionals (HCPs) and 30 patients/caregivers in total). The new device consists of a reusable aluminium body and cap, with a multi-use cartridge system, viewing window, dose-display window, dose-selection knob and injection button.

Method: Semi-structured 60-min qualitative interviews were conducted in six major US cities with 22 HCPs and five adults with GH deficiency/caregivers administering GH to children. HCPs had to be responsible for training on use of GH devices and to see ≥4 GH patients/caregivers per month, while patients/caregivers had to be responsible for GH administration.

Results: Eighty-two percent of HCPs described the device as ‘simple’ or ‘easy’, and 55% described it as ‘sleek’. The aluminium body was perceived as attractive and comfortable to hold and operate, and the ease of preparation and use made it suitable for children and adults. The injection button was considered smooth and easy to press, with a reassuring click, and required less pressure to inject than other devices. Fifty percent of HCPs spontaneously mentioned the ability to dial back the dose, if entered incorrectly, as a major benefit, as other devices need several user steps to reset. Patients/caregivers liked being able to see the plunger move through the cartridge window, providing reassurance that the full dose had been given. Overall, 86% of HCPs and 80% of patients/caregivers would be likely to recommend or request the new device, respectively. Moreover, patients/caregivers rated the device higher than their current reusable pens in terms of ease of learning, preparation, administration and ease of use.

Conclusions: The new pen device was very well accepted by HCPs and patients/caregivers for ease of use, design and functionality.

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