Drug utilization study of dexamfetamine in European countries

Date of Approval: 
2016-10-24 00:00:00
Lay Summary: 
Attention Deficit Hyperactivity Disorder (ADHD) is a disorder characterised by a persistent pattern of inattention and/or hyperactivity/impulsivity that occurs in academic, occupational or social settings. Dexamfetamine is a stimulant which is indicated for ADHD treatment in children and adolescents aged between 6 and 17 years. The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) requested this study as part of the risk management plan (RMP), due to concerns that patients exposed to dexamfetamine might have a higher risk for drug abuse and dependence compared with other treatments for ADHD. This drug utilisation study (DUS) aims to provide information on the prescribing behaviour of physicians and characteristics of patients using routinely collected health information from multiple European countries in the period 2015 to 2019. CPRD data will be used to characterise the patient population receiving dexamfetamine with respect to age and gender, duration of treatment and investigate the number of patients developing a drug dependence on stimulants during exposure to dexamfetamine.
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.
Application Number: 

Catrina Richards - Chief Investigator - IQVIA - UK
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