Study identification

EU PAS number

EUPAS37856

Study ID

48010

Official title and acronym

Study of impact of EU label changes for fluoroquinolone containing medicinal products for systemic and inhalation use - post-referral prescribing trends

DARWIN EU® study

No

Study countries

Belgium
France
Germany
Netherlands
Spain
United Kingdom

Study description

In 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.

Study status

Finalised
Research institutions and networks

Institutions

Multiple centres: 6 centres are involved in the study

Contact details

Deborah Layton

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable