A new pen device for injection of recombinant human growth hormone: a convenience, functionality and usability evaluation study

  Maritta Sauer,1 Carole Abbotts2 1Global Strategic Insights, Merck KGaA, Darmstadt, Germany; 2Pharmaceutical Market Research Consultant, London, UK Purpose: Adherence to recombinant human growth hormone (r-hGH) is critical to growth and other outcomes in patients with growth disorders, but the requirement for daily injections means that ease of use is an important factor. This study assessed the perceived ease of use and functionality of the prototype of a reusable pen injector (pen device) for r-hGH that incorporates several advanced features. Participants and methods: Semi-structured 60-minute qualitative interviews were conducted in 5 countries with 57 health care professionals (HCPs) and 30 patients with GH deficiency/caregivers administering r-hGH to patients, including children. HCPs had to be responsible for training in the use of r-hGH pen devices and to see ≥4 r-hGH patients/caregivers per month. Patients/caregivers had to have experience with r-hGH administration for at least 6 months.Results: Thirty-seven (65%) of HCPs described the pen device as “simple” or “easy” to use. The aluminum body was generally perceived as attractive, high quality and comfortable to hold and operate. The ease of preparation and use made it suitable for both children and adults. The ability to dial back the r-hGH dose, if entered incorrectly, was mentioned as a major benefit, because other devices need several user steps to reset. Patients/caregivers felt the pen device was easy to use and the injection-feedback features reassured them that the full dose had been given. Overall, 40 (70%) HCPs and 16 (52%) patients/caregivers were likely to recommend or request the pen device. Moreover, patients/caregivers rated the pen device higher than their current reusable pens and almost equal to the leading disposable device for ease of learning, preparation, administration and ease of use.Conclusion: The prototype pen device successfully met its design objectives and was very well accepted by HCPs and patients/caregivers for its ease of use, appearance and functionality. Keywords: growth hormone deficiency, qualitative interviews, injection feedback, reusable, health care professionals, patients, caregivers, adherenc