A web-based survey assessing the impact of storage flexibility on the daily life of patients and caregivers administering growth hormone

Abstract

Many growth hormone (GH) products require refrigeration after first use or reconstitution. This may reduce adherence by affecting patients’ daily activities. Persistent treatment adherence is essential for effective GH therapy. A web-based survey was used to compare the impact of storage-flexible GH products (stable at room temperature [<25°C] for up to 21 days after first use) with refrigeration-only GH products on patients’ and caregivers’ daily lives. Compared with refrigeration-only GH products, storage-flexible GH products were associated with shorter injection times, greater adherence, less GH wastage and fewer missed activities due to difficulties with injection, and were the preferred type of GH product. When offered a choice of GH product, the majority of patients chose a storage-flexible product.

Keywords:

• adherence
• administration
• flexible
• growth hormone
• preference
• refrigeration
• storage

Acknowledgements

The authors would like to thank all endocrinologists, patient groups, patients and caregivers who took part in the study. Kira Signer-Romero was involved in the design of the study, the acquisition, analysis, and interpretation of data for the work, as well as drafting the work and reviewing it critically for important intellectual content. At the time of the study Kira Signer-Romero, was an employee of Instar Research, which received funding from Novo Nordisk Health Care AG to conduct the study. The authors are grateful to Mun Yeen Chong for data processing and statistical analysis.

Financial & competing interests disclosure

This study was sponsored by Novo Nordisk Health Care AG. Novo Nordisk Health Care AG reviewed and approved the questionnaire and discussed the interpretation of the data with InStar. A-M Kappelgaard is a consultant for, and shareholder in, Novo Nordisk. D Schnabel is member of the German Novo Nordisk scientific advisory board. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Writing assistance and editorial support was utilized in the production of this manuscript and were provided by Watermeadow Medical, Witney, UK, supported by Novo Nordisk Health Care AG. Medical writing assistance was provided by Leon Adams and submission assistance provided by Mark Nelson.

Key issues

• GH therapy is a long-term treatment and adherence is often poor.

• Poor adherence to GH therapy is associated with substantial reductions in clinical efficacy.

• Reasons for poor adherence are multi-faceted and involve patient- and product-related factors.

• All available GH products have specific storage requirements and the majority of products require constant refrigeration after reconstitution or first use.

• Patients and caregivers find the need to keep GH refrigerated burdensome, especially when traveling, which can lead to missed injections.

• At the time of the survey, Norditropin® and Genotropin® MiniQuick® were the only GH products that could be stored outside of the refrigerator. Norditropin can be stored at room temperature (< 25°C for 21 days) after first use, if refrigerated after first use, this product can be used for up to 28 days. Genotropin MiniQuick can be stored at room temperature for ≤ 3 months prior to reconstitution, but must be used within 24 h and stored in the refrigerator if not used immediately.

• This survey demonstrates that patients and caregivers spend less time performing an injection, miss fewer injections, dispose of less GH due to potential wastage and miss fewer activities when using storage-flexible GH products than with refrigeration-only GH products.

• Physicians should consider the storage requirements of GH products when helping patients make an informed choice of GH product.

Notes