Post-authorisation safety study of the incidence rate of medication errors before and after the discontinuation of the lower strength vials for Pharmalgen (NI-PH-X-01)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prospective descriptive case study

Study drug and medical condition

• Name of medicine, other:
  Pharmalgen

Population studied

• Short description of the study population:
  Patient who initiates immunotherapy treatment with either Pharmalgen (801) Apis mellifera or Pharmalgen (802) Vespula spp.
• 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:
  231

Study design details

• Main study objective:
  The purpose of this study is to characterize safety of Pharmalgenproducts after removal of the lower strength vials previously used to prepared doses for up-dosing to evaluate if an increase occurs in medication errors or systemic allergic reactions related to medication errors during the up-dosing phase.
• Data analysis plan:
  The number of medication errors and serious systemic allergicreactions related to medication errors will be recorded in the studyperiod and the rate calculated as number of cases divided bynumber of treatment years. Exact 95% binomial confidenceintervals for the calculated rate will be reported.

Documents

Study results

Pharmalgen PASS summary_final