EMA Self-Controlled Case Study of Fluoroquinolones and Retinal Detachment in The Health Improvement Network database

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/15151
• EU PAS number:
  EUPAS6708
• Study ID:
  15151
• Official title and acronym:
  EMA Self-Controlled Case Study of Fluoroquinolones and Retinal Detachment in The Health Improvement Network database
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Further to it's assessment of a signal of risk of retinal detachment (RD) in association with use of systemic fluoroquinolones (FQ), the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency (EMA) recommended at its April 2013 meeting that the EMA perform a Self-Controlled Case Study on RD and FQ in The Health Improvement Network (THIN) database of electronic health records. The SCCS methodology can be applied to those patients who have experienced the outcome of interest and have been exposed to risk factor(s) over some period of time. The method considers how frequently the outcome occurs during exposure compared to non-exposed times.All patients in THIN who had a code for RD and for a FQ in the interval from 1 Jan 1990 to 31 Dec 2012 were considered for the study. The study period began once a patient has attended a THIN practice for at least one year and any record of RD during this screening period resulted in exclusion from the study.The risk period was calculated using information on the prescribed quantity and the dosage regimen from the THIN dosage file. The primary analysis considered the risk period to be only those days when the patient was judged to be taking the FQ. When there was insufficient information to calculate the risk period it was imputed using the modal calculated value for the particular product prescribed. A sensitivity analysis used the minimum and maximum credible values for each product and the number and proportion of imputed values has been reported.Other risk factors for retinal detachment included in the model were traumatic events which encompassed cataract or other ocular surgery, eye infections, ocular trauma and head or neck injuries, exposure to corticosteroids, age and season.
• Study status:
  Finalised

Research institutions and networks

Institutions

European Medicines Agency (EMA)

European Medicines Agency

Study timelines

Date when funding contract was signed

Planned: 30/04/2013

Actual: 30/04/2013

Study start date

Planned: 01/05/2013

Actual: 01/05/2013

Date of final study report

Planned: 02/06/2014

Actual: 02/06/2014

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