Drug utilization study of dexamfetamine in European countries (DUS of dexamfetamine)

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

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N06BA02) dexamfetamine

  dexamfetamine

Population studied

• Short description of the study population:
  For the DUS patients who have been prescribed dexamfetamine at least once during the study period.; A: Identification of reporting sources; Inclusion criteria; •European countries, Denmark, Germany, Netherlands, Norway, UK; •Review, surveys, chart review, medical records, monitoring,; •Monitoring centers, databases, poison control centers; •Stimulants; •Abuse, misuse, overdose, diversion and dependence, problem drug use, non-medical drug use, addiction; Exclusion criteria; •Centers and databases from outside of EU; •Testing methods; B: Identification of information on abuse, misuse, overdose, diversion and dependence associated with dexamfetamine/lisdexamfetamine; Inclusion criteria; •European countries, Denmark, Germany, Netherlands, Norway, UK; •Literature review, surveys, interviews, chart review, medical records, monitoring; •Dexamphetamine, dextroamphetamine, Dexamfetamine, dextroamfetamine, lisdexamfetamine, lisdexamphetamine, Attentin, Dexamed, Dexedrine, other trade names for dexamfetamine, Elvanse, Vyvanse; •Abuse, misuse, overdose, diversion and dependence, problem drug use, non-medical use, addiction; Exclusion criteria; •Reports from outside the EU; •Only information on methylphenidate, only information on stimulants and amphetamine in general; •Reports which only describe use of substances where the use of an authorised medicinal product can be excluded (e.g. different galenic formulations); •Substance use disorder; •Testing methods
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  • to describe how dexamfetamine is prescribed in Europe • to evaluate off-label use in Europe • to collect data on abuse, misuse, overdose, diversion and dependence related to dexamfetamine
• Data analysis plan:
  For the DUS, the analysis of databases will be done descriptively. A detailed statistical analysis plan (SAP) will be agreed on prior to the start of the analysis. Information from drug monitoring centers and poison control centers, other databases, literature and internet searches will be summarized per reporting period and compared with the findings from previous reports.

Documents

Study results

Dexamfetamine DUS Executive Summary on Final Report V1 02-11-2020

Study, other information

Dexamfetamine DUS Abstract of Final Report DAT V2 25-05-2021 privacy

Dexamfetamine DUS Abstract of Final Report LIT V2 28-05-2021 privacy