Effectiveness of the Additional Risk Minimization Measures in Conveying Safety Information to HCPs Dispensing, Administering or Prescribing Fosphenytoin

Study type

• Study topic:
  Other
• Study topic, other:
  Effectiveness of Risk Minimization Measures
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Descriptive survey
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Population studied

• Short description of the study population:
  Healthcare professionals (HCPs) who have prescribed, prepared or administered fosphenytoin across the study countries (UK, Sweden and France).; ; The survey was conducted among HCPs meeting the following inclusion criteria:; • HCPs with experience prior to the survey administration of prescribing/preparing/administering at least one dose of fosphenytoin; • Willing/consent to participate in this self-administered survey
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Estimated number of subjects:
  200

Study design details

• Main study objective:
  The overall objective is to evaluate the effectiveness of the additional RMMs being implemented across Europe to mitigate the risks of medication errors and off-label use in children under 5 years of age with the use fosphenytoin.
• Data analysis plan:
  The proportions of correct and appropriate answers to selected questions asked in the questionnaire will be provided among HCPs who provided answers to those questions. Depending on the sample size, the endpoints will be assessed overall, by country and among subgroups of HCPs (physician vs. nurse vs. pharmacist).

Documents

Study results

A9821002_FOSPHENYTOIN FINAL STUDY REPORT_V1_25 NOV 2019_EU PAS REGISTER