Study type

Study topic

Herbal medicinal product

Study type

Non-interventional study

Scope of the study

Drug utilisation

Data collection methods

Secondary data collection
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine, 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

All
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