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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48010
• 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

IQVIA NL, Real-World-Evidence

Netherlands

Multiple centres: 6 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 06/05/2020

Study start date

Actual: 01/01/2016

Date of final study report

Planned: 01/06/2022

Actual: 01/07/2022

Sources of funding

EMA

Study protocol

Initial protocol

Fluroquinolone - Study Protocol

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable