Status: Finalised First registered on: 30/10/2020
Last updated on: 04/07/2022
1. Study identification
EU PAS Register NumberEUPAS37856
Official titleStudy of impact of EU label changes for fluoroquinolone containing medicinal products for systemic and inhalation use - post-referral prescribing trends
Study title acronym
Study typeObservational study
Brief description of the studyIn November 2018 a referral procedure (EMA/H/A-31/1452) under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data concluded that serious adverse reactions including tendon, muscle and joint disorders, neurologic and psychiatric disorders listed in the product information of different (fluoro)quinolones could in rare cases become long-lasting, disabling and potentially even irreversible and substantially disrupt patients’ daily activities. To maintain a favourable benefit-risk balance for all (fluoro)quinolone containing medicinal products for systemic use, revised indications, warnings, and other changes to the product information, including direct healthcare professional communication (DHPC) were implemented in EU Member States including recommendations for cessation of prescribing for milder, non-severe or self-limiting infections, and restrictions for other indications. The study objectives are: 1.To determine the drug utilisation and prescription patterns of fluoroquinolone containing medicinal products over the period 2016 and 2020 by a)estimating monthly incident drug use, stratified by on label indications and off label indications. b)Estimation of early discontinuation proportion 2. To evaluate the impact of regulatory interventions on fluoroquinolone prescribing patterns using time series analysis. 3. To determine prescribers’ compliance with warnings as described in fluoroquinolones SmPC section 4.4, in particular on tendinitis and tendon rupture as well as on aortic aneurysm/dissection 4. To determine monthly incident prescription rates for alternative antibiotics prescribed in patients where systemic or inhalation use fluoroquinolones have previously been prescribed and discontinued. Data from six European countries namely IPCI (the Netherlands), SIDIAP (Catalonia Spain) and IQVIA (UK IMRD, LPD Belgium, DA Germany and LPD France). Data from these databases have been mapped to the OMOP Common Data Model.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsIQVIA European Data Science Hub
Department/Research groupIQVIA European Data Science Hub
Organisation/affiliationIQVIA
Website/Homepagehttps://www.iqvia.com/
Details of (Primary) lead investigator
Title Professor
Last name Layton
First name Deborah
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?6
Countries in which this study is being conducted
International study

Belgium
France
Germany
Netherlands
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed06/05/2020
Start date of data collection01/01/2016
Start date of data analysis
Date of interim report, if expected
Date of final study report01/06/202201/07/2022
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyEMA100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Layton
First name Deborah
Address line 1210 Pentonville Road
Address line 2 
Address line 3 
CityLondon 
PostcodeN1 9JY 
CountryUnited Kingdom
Phone number (incl. country code)44-07825844639 
Alternative phone number 
Fax number (incl. country code) 
Email address DLayton@uk.imshealth.com
Public Enquiries
Title Professor 
Last name Layton 
First name Deborah 
Address line 1210 Pentonville Road 
Address line 2 
Address line 3 
CityLondon 
PostcodeN1 9JY 
CountryUnited Kingdom 
Phone number (incl. country code)44-07825844639 
Alternative phone number 
Fax number (incl. country code) 
Email address DLayton@uk.imshealth.com 
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