Post-authorisation observational safety study to examine the effectiveness of risk minimization measures in place in persons with an Anapen® prescription (PASS 21-08)

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:
  This study is an observational, prospective, multicentric, national, study.

Study drug and medical condition

• Medicinal product name:
  ANAPEN

  ANAPEN JUNIOR
• Study drug International non-proprietary name (INN) or common name:
  EPINEPHRINE
• Anatomical Therapeutic Chemical (ATC) code:
  (C01CA24) epinephrine

  epinephrine
• Medical condition to be studied:
  Anaphylaxis treatment

Population studied

• Short description of the study population:
  The target study population will be all individuals complying with the following inclusion criteria:; ; - Adult person;; - Person who has been informed and who does not oppose to participate (“non-opposition” according to French provisions for observational studies);; - Person with Anapen® prescription (first or renewal) for himself/herself or for a relative;; - Person to whom the pharmacist has issued an Anapen® box in the current practice of pharmacy;; - Person participating to this study for the first time.; ; There are no exclusion criteria in the study.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Study design details

• Study design:
  This study is an observational, prospective, multicentric, national, study. Primary data are collected via surveys.; Most relevant way to meet the primary objective is to assess the users' ability to perform a correct injection using a Trainer as they are expected to do in a situation of emergency.
• Main study objective:
  The primary objective is to assess the effectiveness of the risk minimization measures associated with Anapen® at the time of delivery by the pharmacist, in measuring the patients’ and relatives' knowledge on how to use Anapen® prior to its use.; ; The secondary objectives are to describe, the participant education with Anapen® provided by healthcare professionals the use of the disposable educational materials and the level of knowledge of the good practice for Anapen® using.
• Setting:
  Participants: Adults coming to the pharmacy with a prescription for an Anapen® box, whether this prescription is for themselves or for a relative, and willing to participate could be enrolled after having been duly informed and given their oral consent (“non-opposition”).; Pharmacies: An estimation of 100 pharmacies spread over the national territory will participate as investigation sites. In each pharmacy, the pharmacist who will be designated as the site's principal investigator will be trained on the study requirements, in particular on filling out the CRF.; Start of the study: first participant included;; End of the study: last participant included;; Estimated total duration of the study:; - Inclusion period: one year;; - Maximum participation time of each participant: single visit of approximately one hour after obtaining the oral consent of the participant duly informed
• Outcomes:
  For primary objective: The injection will be simulated using Anapen® Trainer. Injection ability measurement will be standardized using a specific grid. The grid will list each action and distinguish minor errors that may affect the quality of the injection process without undermining its potential effectiveness from major errors that can lead to failure/inefficiency of the injection. Number of errors will be listed for each participant and the percentage of participants able to use the device correctly without major error will be calculated. Possibly, the percentages of participants able to use the device correctly will be assessed according to the participants’ level of education (i.e. knowledge of educational materials vs. lack of prior access).; ; For secondary: Knowledge and understanding will be controlled using a questionnaire based on the main items of the prescriber's checklist and patient educational materials. The questionnaire will be carried out by the participant himself (patient or patient’s relative).; will be assessed according to participants’ level of education (i.e. knowledge of educational materials vs. lack of prior access).
• Data analysis plan:
  Descriptive statistics will be employed to analyze the data. In brief, statistics for continuous variables will include mean, standard deviation, median, and range (minimum/maximum). Categorical variables will be presented as frequency counts and percentages. In addition, for all variables, a 95% confidence interval will be estimated.; A detailed statistical analysis plan describing the planned analysis and the approach for handling missing data will be developed prior to the data review
• Summary results:
  The summary of the final study report will be transmitted according to the local regulation within 1 year after the end of the study or within 3 months following the temporary interruption or early termination