Assessment of Self-Administration of Romiplostim in Patients with Immune Thrombocytopenic Purpura after Receipt of Home Administration Training Materials: a Cross-Sectional Study

Martin Schipperus (), Georgia Kaiafa, Louise Taylor, Sally Wetten, Georg Kreuzbauer, Andy Boshier and Anouchka Seesaghur
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Martin Schipperus: Haga Teaching Hospital
Georgia Kaiafa: AHEPA University Hospital
Louise Taylor: Royal London Hospital
Sally Wetten: Amgen Limited
Georg Kreuzbauer: Amgen (Europe) GmbH
Andy Boshier: Amgen Limited
Anouchka Seesaghur: Amgen Limited

Drug Safety, 2019, vol. 42, issue 1, No 8, 77-83

Abstract: Abstract Introduction Romiplostim is a subcutaneously administered thrombopoietin-receptor agonist approved in the European Union for self-administration (or administration by a caregiver) in selected adult patients with chronic primary immune thrombocytopenia refractory to other treatments. To mitigate the risk of medication errors due to self-administration, the manufacturer has implemented additional risk minimisation measures (RMM) in the form of a Home Administration Training (HAT) pack to support the training of both healthcare professionals (HCPs) (guide and checklist for patient selection and training) and patients (a preparation mat, quick guide booklet, step-by-step guide, self-administration diary and DVD/video). Objective The primary objective was to estimate the proportion of patients/caregivers who administered romiplostim correctly after HAT pack training. Methods A multicentre observational study was conducted to evaluate the effectiveness of the HAT pack by recording data on a standardised collection form during direct observation of patients/caregivers in the act of administering romiplostim at the first standard-of-care visit 4 weeks after training with the HAT pack. Results Among the 40 patients/caregivers enrolled across 12 study centres in eight European countries, 35 [87.5%; 95% confidence interval (CI) 73.9–94.5] administered romiplostim correctly, and five (12.5%; 95% CI 5.5–26.1) did not. Conclusion The correct administration of romiplostim by most patients/caregivers supports the effectiveness of the HAT pack as an additional risk minimisation tool in the population and setting of this study.

Date: 2019
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DOI: 10.1007/s40264-018-0723-6

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