The 'Data Analysis and Real World Interrogation Network (DARWIN EU)' is an initiative created by the European Medicines Agency (EMA) to generate timely evidence from real-world healthcare data sources from across Europe. One area of research relates to estimating how often, what strengths, and for how long specific drugs of interest are prescribed and/or dispensed. For regulators it is important to have access to this information as it provides insight in the uptake of specific drugs in the community and whether use of these drugs changes over time influenced by regulatory measures such as drug suspension/withdrawal, change in labelling, safety warnings etc.
The objective of this study is to estimate the new users of a medicine (also called incidence rate) and existing users (prevalence) of a medicine. All these will be calculated in specific populations of interest based on age and sex groups, and over calendar years to look at possible changes over time. Secondly, we will look at the indications or reasons for these medicines, and how long and at what strength they are prescribed. We will also explore characteristics of patients prescribed/dispensed the drugs in terms of comorbidity and concomitant drug use.
Primary care records provide a unique source of data for estimating the incidence and prevalence of medication use in the community, as most medicines are prescribed by general practitioners. The DARWIN EU initiative created by the European Medicines Agency (EMA) intends to draw upon such data to inform regulatory decision-making. To understand the uptake of specific drugs of interest and to study the effect of regulatory actions on drug prescribing/dispensing, EMA will commission several drug utilisation studies to the DARWIN Coordination Centre. Data sources will be mapped to the OMOP common data model (CDM) prior to analysis.
Study design: Cohort study
Population: All people in CPRD GOLD or CPRD Aurum with >=1 year of prior history will be eligible, with sensitivity analyses using different prior history requirements.
Variables: Drug exposure based on prescription data as available within CPRD GOLD or CPRD Aurum. Drugs will be selected by means of the respective RxNorm codes.
In addition, the characteristics of patients being prescribed/dispensed the drug(s) of interest will be described, and the use of the prescribed medicine over time assessed in terms of indication of use, duration, strength and/or dose.
Drug of interest as expressed by EMA:
• Valproate/valproate containing drugs and other anti-epileptics in women of childbearing age
• Antibiotics from the WHO Watch list, particularly those given orally
• Naloxone (take-home preparations) for the emergency treatment of opioid overdoses
• Prokinetic medicines in children and adults with gastroparesis
• Opioids
• GLP-1 receptor agonists and medicines for weight loss
Additional medicines will be declared in future protocol amendments upon request by EMA to the DARWIN Coordination Centre.
Analyses: Incidence rates and prevalence stratified by age, sex, and calendar year. Description of patient characteristics at therapy initiation, and use of medicine/s over time.
Drug Utilisation
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Annika Jodicke - Corresponding Applicant - University of Oxford
Albert Prats Uribe - Collaborator - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Daniel Dedman - Collaborator - CPRD
Edward Burn - Collaborator - University of Oxford
Hezekiah Omulo - Collaborator - University of Oxford
Junqing Xie - Collaborator - University of Oxford
Kim López-Güell - Collaborator - University of Oxford
Mandickel Kamtengeni - Collaborator - University of Oxford
Marta Pineda Moncusi - Collaborator - University of Oxford
Martí Català Sabaté - Collaborator - University of Oxford
Mike Du - Collaborator - University of Oxford
Theresa Burkard - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of Oxford
Xintong Li - Collaborator - University of Oxford
Yuchen Guo - Collaborator - University of Oxford
Zara Cuccu - Collaborator - CPRD