Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Drug utilisation

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine, other

Ketamine
Propofol
Heparin
Diazepam
Lorazepam
Midazolam
Dexamethasone
Prednisolone
Cisatracurium
Rocuronium
Fentanyl
Remifentanil
Esketamine
Sufentanil
Suxametonium (Succinylcholine)
Atracurium
Population studied

Short description of the study population

For population level drug utilisation (Objective 1) study population will include all patients being hospitalised in the respective database, in the study period. The population will be stratified based on ICU admission status (yes/no): those admitted to ICU (ICU cohort) and those hospitalised without ICU admission during their respective hospitalisation (Non-ICU cohort) (Figure 1).
For patient-level drug utilisation (Objective 2 and 3), the study population will include all hospitalised patients who were initiating treatment with selected pre-specified medicines in the study period These patients will be categorised by ICU admission (yes/no) at the time of treatment initiation. This will result in two cohorts: patients who initiate treatment during ICU visit (ICU cohort) and patients who begin treatment during hospital stay outside of ICU, regardless of any prior or subsequent ICU admission during respective hospitalisation (Non-ICU cohort) (Figure 2).
Study design details

Study design

•Population-level cohort study (Objective 1). Population-level drug utilisation study of selected medicines of importance for public health emergencies, specifically used in hospital/ICU.
• New drug user cohort (Objectives 2, 3 and 4), Patient-level drug utilisation study regarding characterisation

Main study objective

1. To estimate the annual proportion of prescribing of selected medicines in a cohort of patients being hospitalised, stratified by ICU admission (yes/no).
2. To characterise the two cohorts of hospitalised patients (ICU admission (yes/no) who initiated treatment with drug of interest in terms of demographics, presence of COVID-19 infection (yes/no), and use of mechanical ventilation (yes/no) at time of first prescribing of drug of interest.
3. To determine the duration of treatment in the cohort of hospitalised patients being treated with drug of interest, stratified by ICU admission (yes/no) and mechanical ventilation (yes/no).
4. To determine the consumption of the specified drugs at hospital level: median cumulative dose per patient, median cumulative dose per hospital and cumulative number of prescriptions as well as median number of prescriptions per patient. Dose will be stratified by route (all/parenteral/non-parenteral/other (including unknown))