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. The EMA has requested a study to estimate how often, for which types of infections, and for how long certain types of antibiotics are being used in the UK and in 4 other European countries.
While antibiotics are crucial in the treatment of infections caused by bacteria, one of the major concerns is the risk of resistance evoked through an inappropriate use. To improve the appropriate use of antibiotics, Antibiotic Steward Ship programs have been installed with the aim to monitor antibiotics use and ensure that guidelines on the use of antibiotics are strictly adhered to.
The objective of this study is to estimate the annual number of new users (also called incidence rate) and existing users
(prevalence) of antibiotics under specific surveillance by the World Health Organisation. Secondly, we will look at the reasons and duration of use for those antibiotics. We will also explore characteristics of patients prescribed/dispensed antibiotics in terms of comorbidity and concomitant drug use.
BACKGROUND: Primary care records provide a unique source of data for estimating drug utilisation in the community. The DARWIN EU© initiative created by the European Medicines Agency (EMA) intends to draw upon such data to inform regulatory decision-making, and has requested a drug utilisation study on antibiotics under specific surveillance by the World Health Organisation (WHO). While antibiotics are crucial in the treatment of infections caused by bacteria, one of the major concerns is the risk of resistance evoked through an inappropriate use. To improve the appropriate use of antibiotics, Antibiotic Steward Ship programs have been installed with the aim to monitor antibiotics use and ensure that guidelines on the use of antibiotics are strictly adhered to.
STUDY DESIGN: Cohort study
POPULATION: All people in CPRD GOLD between 2012 and 2021 with at least 365days of data availability before the day they become eligible for study inclusion.
DRUGS OF INTEREST: Antibiotics from the WHO watch list, particularly those given orally and thus likely to be prescribed in primary care
VARIABLES: Exposure to antibiotics will be based on prescription data in
CPRD GOLD [product codes mapped to the OMOP Common Data Model].
In addition, the characteristics of patients being prescribed antibiotics will be summarised, and the use
of antibiotics over time will be assessed in terms of indication of use and duration.
ANALYSES:
1) Estimation of annual period prevalence and annual incidence rates of use of antibiotics on the WHO watch list. For the calculation of incidence rates, observation time of the respective use of the antibiotic of interest is excluded during use and 30 days afterwards.
2) Characterisation of new users of antibiotics, including medical history and co-medication use.
The proportion of individuals with pre-specified indication at index date will be assessed and treatment duration will be estimated.
Drug utilisation: Incidence and Prevalence of antibiotics on the WHO watch list; Characterisation of
new users of antibiotics
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Annika Jodicke - Corresponding Applicant - University of Oxford
Albert Prats Uribe - Collaborator - University of Oxford
Edward Burn - Collaborator - University of Oxford
Martí Català Sabaté - Collaborator - University of Oxford