First published
03/02/2023
Last updated
21/03/2024
EU PAS number:
EUPAS103381
EU PAS number:
EUPAS103381
Study ID
103382
Official title and acronym
DARWIN EU® DUS of Antibiotics in the ‘Watch’ category of the WHO AWaRe classification of antibiotics for evaluation and monitoring of use
This drug utilisation study aims to characterise the incidence of prescription of the 141 antibiotics in the ‘Watch’ list, including indication and treatment duration, for the period 2012-2021, stratified by year and country. For this study, databases from 5 European countries will be used namely IPCI (Nl), CPRD Gold (UK), SIDIAP (Spain), IQVIA DA (Germany), IMASIS (Spain) and CHUBX (France). Specific objectives of this study are the following: (i) To investigate the incidence and prevalence of use of antibiotics (from the WHO Watch list) stratified by calendar year, age, sex and country/database during the study period 2012-2021. (ii) To explore duration of antibiotic use as well as indication for antibiotic prescribing/dispensing.
Study drug and medical condition
Anatomical Therapeutic Chemical (ATC) code
100000095976
TETRACYCLINES
100000096117
BETA-LACTAM ANTIBACTERIALS, PENICILLINS
100000096193
Third-generation cephalosporins
100000096263
MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINS
100000096285
AMINOGLYCOSIDE ANTIBACTERIALS
100000096322
Other quinolones
100000096353
Other antibacterials
The study focused on population-level drug utilisation of antibiotics and patient-level drug utilisation analysis.
The population-level analysis includes individuals with 365 days of database history between 1 January 2012 and 31 December 2021, examining the prevalence and incidence of antibiotic use.
The patient-level analysis includes new users of antibiotics who have not used the antibiotic for 30 days between 1 January 2012 and 31 December 2021, with at least 365 days of visibility prior to their first antibiotic prescription/dispensing.
Department of Medical Informatics – Health Data Science, Erasmus Medical Center (ErasmusMC)
Netherlands
First published:
03/11/2022Last updated
02/05/2024
Institution
Educational InstitutionENCePP partner
PSMAR Spain, CHUBX France, University of Oxford UK
Networks
Data Analysis and Real World Interrogation Network (DARWIN EU®)
Belgium
Croatia
Denmark
Estonia
Finland
France
Germany
Hungary
Netherlands
Norway
Portugal
Spain
United Kingdom
First published:
01/02/2024Last updated
16/04/2024
Network
Sources of funding
EMA
https://catalogues.ema.europa.eu/node/3659/administrative-details
JULIMINATION 
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