DARWIN EU® - Drug utilisation study on medicinal use of cannabis flos

Study type

• Study topic:
  Herbal 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

• Medicinal product name, other:
  Cannabis flos (dried, whole or fragmented, flowering tops of Cannabis sativa L.) - Bedrocan, Bedrobinol, Bediol, Bedrolite, Bedica and any other Cannabis flos containing products, provided such products are available in the datasets of interest.
• Medical condition to be studied:
  Cancer pain

  Anxiety disorder

  Muscle spasticity

  Multiple sclerosis

  Spinal cord injury

  Epilepsy

  Tourette's disorder

  Huntington's disease

  Parkinson's disease

  Amyotrophic lateral sclerosis

  Glaucoma

  HIV infection

  Anorexia nervosa

  Insomnia

  Inflammatory bowel disease

  Fibromyalgia

  Rheumatoid arthritis
• Additional medical condition(s):
  Neuralgic pain, cancer, anxiety-related disorders, neurological disorders (epilepsy, Tourette Syndrome, Huntington, Parkinson disease, amyotrophic later sclerosis (ALS), Alzheimer and other dementias), sleep disorders (insomnia, sleep apnea), rheumatoid arthritis.

Population studied

• Short description of the study population:
  Population-level utilisation of selected medicinal products of interest: Population-level drug utilisation analyses will include all individuals registered in the respective databases between 1st of January 2014 and 31st of December 2023, with at least 1 year of data visibility prior becoming eligible for study inclusion. ; This requirement of at least 1 year of prior data history will not hold for children <1 year of age.; ; Patient-level utilisation of selected medicinal products of interest: ; Patent-level drug utilization analyses will include new users of selected medicinal products registered in the respective databases between 1st of January 2014 and 31st of December 2023. ; Patients need to have at least 1 year of data visibility prior to the index date, and no use of the respective medicinal products in the previous 1 year. ; This requirement of at least 1 year of prior data history will not hold for children < 1 year of age.
• Age groups:
  • Paediatric Population (< 18 years)

    • Preterm newborn infants (0 – 27 days)
    • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Study design details

• Study design:
  A cohort study will be conducted using routinely collected health data from 2 databases.
• Main study objective:
  1. To estimate incidence rates and prevalence of use of Cannabis flos, overall and stratified by pre-specified medicinal product of interest, age, sex and country/database, during the study period from 2014 to 2023.; 2. To characterise the cohort of patients being treated with the Cannabis flos at the time of new prescription/dispensation of the selected medicinal products in terms of demographics, indication for prescribing/dispensing, comorbidities and comedication. ; Additionally, to determine duration of treatment with Cannabis flos products and optionally, to describe the route of administration. ; Results will be stratified by pre-specified medicinal product of interest and database.;
• Setting:
  This study will be conducted using routinely collected data from 2 databases in 2 EU countries. All databases were previously mapped to the OMOP Common Data Model (CDM).; 1. Integrated Primary Care Information Project (IPCI), the Netherlands; 2. IQVIA Disease Analyzer Germany (IQVIA DA Germany), Germany
• Outcomes:
  For this study, outcome of interest was use of Cannabis flos (dried, whole or fragmented, flowering tops of ; Cannabis sativa L.) containing products during the study period, as recorded in the study data sources.
• Summary results:
  CONCLUSION ; This study provides insights into the prescribing patterns of Cannabis flos containing products and characteristics of patients using them as captured in two real-world data sources from Germany and the Netherlands. The IQVIA DA Germany database revealed low incidence rates and prevalence potentially related to primary care setting of the database and absence of certain Cannabis flos prescribing specialties. Similarly, low incidence rates and prevalence observed in the IPCI database may also be related to the primary care focus of the database and absence of specialist care data. At patient level, anxiety, cancer and sleep disorders were identified as the most frequent pre-specified conditions, while pain diagnoses and pain management medication and gastrointestinal health agents emerged as commonly recorded diagnoses and medications. Overall, the findings of this study suggest that Cannabis flos containing products are mainly prescribed through specialty care setting, which are not routinely collected in our currently available data sources. This study may provide useful information for future studies on Cannabis flos containing products, which should consider including data from specialised healthcare practices.