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 summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000000972
• Study ID:
  1000000972
• Official title and acronym:
  Post-authorisation observational safety study to examine the effectiveness of risk minimization measures in place in persons with an Anapen® prescription (PASS 21-08)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  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 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).; ; 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. 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).;
• Study status:
  Planned

Research institutions and networks

Institutions

Bioprojet Pharma

France

Study timelines

Date when funding contract was signed

Actual:13/03/2023

Study start date

Planned:26/05/2026

Date of final study report

Planned:31/12/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bioprojet Pharma

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)