Drug utilization study of dexamfetamine in European countries

Date of Approval
Application Number
16_192
Technical Summary

The objectives of the study are to characterise patients who are prescribed dexamfetamine, to describe how dexamfetamine is prescribed by physicians and to evaluate non-intended prescription behaviour by physicians in Europe. This DUS is part of the RMP for dexamfetamine which has been proposed by the marketing authorisation holder of dexamfetamine to the PRAC. Drug utilisation data will be extracted from cross-sectional prescription databases for Finland, Germany, Spain, Netherlands and the UK from longitudinal patient level databases. CPRD data will be used to investigate patient characteristics (age, gender), duration of treatment (stratified by age group) and the incidence of drug dependency during dexamfetamine use (diagnosis of mental and behavioural disorders due to use of other stimulants). All analyses in this study will be purely descriptive.

Health Outcomes to be Measured

o separate the population that receives dexamfetamine for the treatment of narcolepsy, patients with a Read code for the indication will be excluded. Duration of treatment and occurrence of drug dependence during treatment will be analysed for the remaining population.

Collaborators

Catrina Richards - Chief Investigator - IQVIA Ltd
Birgit Ehlken - Corresponding Applicant - IQVIA ( IMS Health ) France
Anika Staack - Collaborator - MEDICE Arzneimittel Putter GmbH & Co. KG
Dieter Fritsch - Collaborator - MEDICE Arzneimittel Putter GmbH & Co. KG
Jacco Keja - Collaborator - IQVIA ( IMS Health ) France
Nikolaus Kolb - Collaborator - IQVIA ( IMS Health ) France