Effectiveness of the Nplate Additional Risk Minimisation Materials Implemented in Australia (20210176)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Online survey

Study drug and medical condition

• Name of medicine:
  NPLATE
• Medical condition to be studied:
  Thrombocytopenia

Population studied

• Short description of the study population:
  An online survey of haematologists and haematology nurses who had treated patients with immune thrombocytopenia (ITP) with Nplate for the period of 12 December 2018 to 31 December 2021.
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  30

Study design details

• Main study objective:
  To assess whether the aRMMs implemented by Amgen Australia are effective in minimizing the risk of medication errors in patients being treated with NPlate by determining usage and utility of the aRMMS and if the incidence of medication errors in Australia has changed.
• Data analysis plan:
  This study is analyzing secondary data from the Amgen drug safety database and no safety data will be collected.

Documents

Study results

20210176_ORSR_Abstract_Redacted