IDEAS home Printed from https://ideas.repec.org/a/spr/drugsa/v42y2019i1d10.1007_s40264-018-0723-6.html
   My bibliography  Save this article

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

Author

Listed:
  • 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)

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.

Suggested Citation

  • Martin Schipperus & Georgia Kaiafa & Louise Taylor & Sally Wetten & Georg Kreuzbauer & Andy Boshier & Anouchka Seesaghur, 2019. "Assessment of Self-Administration of Romiplostim in Patients with Immune Thrombocytopenic Purpura after Receipt of Home Administration Training Materials: a Cross-Sectional Study," Drug Safety, Springer, vol. 42(1), pages 77-83, January.
    • Handle: RePEc:spr:drugsa:v:42:y:2019:i:1:d:10.1007_s40264-018-0723-6
    DOI: 10.1007/s40264-018-0723-6
    as

    Download full text from publisher

    File URL: http://link.springer.com/10.1007/s40264-018-0723-6
    File Function: Abstract
    Download Restriction: Access to the full text of the articles in this series is restricted.
    File URL: https://libkey.io/10.1007/s40264-018-0723-6?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    As the access to this document is restricted, you may want to search for a different version of it.

    References listed on IDEAS

    as
    1. Thomas Goedecke & Kathryn Ord & Victoria Newbould & Sabine Brosch & Peter Arlett, 2016. "Medication Errors: New EU Good Practice Guide on Risk Minimisation and Error Prevention," Drug Safety, Springer, vol. 39(6), pages 491-500, June.
    Full references (including those not matched with items on IDEAS)

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. Christina E. Hoeve & Esther Vries & Peter G. M. Mol & Miriam C. J. M. Sturkenboom & Sabine M. J. M. Straus, 2021. "Dissemination of Direct Healthcare Professional Communications on Medication Errors for Medicinal Products in the EU: An Explorative Study on Relevant Factors," Drug Safety, Springer, vol. 44(1), pages 73-82, January.
    2. Victoria Newbould & Steven Meur & Thomas Goedecke & Xavier Kurz, 2017. "Medication Errors: A Characterisation of Spontaneously Reported Cases in EudraVigilance," Drug Safety, Springer, vol. 40(12), pages 1241-1248, December.

    More about this item

    Statistics

    Access and download statistics

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:spr:drugsa:v:42:y:2019:i:1:d:10.1007_s40264-018-0723-6. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Sonal Shukla or Springer Nature Abstracting and Indexing (email available below). General contact details of provider: http://www.springer.com/economics/journal/40264 .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.