A Multicentre, Non-interventional, Prospective, Observational Drug Utilisation Study of Ayendi Nasal Spray Prescribed as Treatment in Emergency Departments in the United Kingdom (UK) (DIAPASS)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Case-only, prospective study

Study drug and medical condition

• Medicinal product name, other:
  Ayendi

Population studied

• Short description of the study population:
  Any patient who has been prescribed Ayendi as part of routine treatment in the ED.; To be eligible for inclusion into this study the subjects must fulfil all of the following criteria:; 1. Patient has been administered Ayendi Nasal Spray by the attending ED Healthcare Professional as part of ED treatment; 2. Parent(s)/legal guardian/adult patient (whichever is applicable) must be able and willing to provide written informed consent before the patient is discharged from the ED; 3. Where possible, child patients should assent to allow their data to be used for the study
• Age groups:
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
• Estimated number of subjects:
  400

Study design details

• Main study objective:
  To evaluate the practical usage of Ayendi Nasal Spray as a treatment post marketing in UK EDs.The study will assess patterns of drug utilisation with respect to aspects that may have an impact on its safety (e.g. co-medication including other opioids, medication errors) and evaluate the effectiveness of risk minimisation activities.
• Outcomes:
  To determine the rates of:Doses given (mg/kg) which deviate from the posology as written in the SmPC.Previous opioid usage immediately prior to Ayendi (%), Administration Time (pre-arrival at hospital, if appropriate), Dose Prescribed (mg/kg) vs Dose Given (mg/kg), Product strength and Number of sprays given, Diagnosis Ayendi prescribed for (and % off-label indications), Participating ED practice setting (%), Administrator (%), Concomitant medication, Patient demographics (including patients not within the SmPC-defined categories), Adverse events (%)
• Data analysis plan:
  A statistical analysis plan (SAP) will be developed by a qualified statistician and analysis will be performed according to this document. The SAP will specifically include details of how all: Analysis Populations, Demographic and Baseline Characteristics, Completion and Discontinuation information, Medication details and All Analyses (rate of incorrect dosing, rate of previous opioid usage immediately prior to Ayendi, time of dosing, product strength and number of sprays, indication, ED practice setting, administrator, concomitant medication, and adverse events) will be classified and described. The sample size chosen for the study is considered appropriate based on previous experience. This is an observational study of patients receiving prescribed Ayendi in a UK Hospital Emergency Department. The sample size will have sufficient power to estimate both the rate of incorrect dosing and use in association with other opioids.