Fingolimod safety considerations in real world practice - Assessing screening for macular oedema


05 Feb 2018

Dr Paul Gallagher and Dr Sarah-Jane Martin from the Institute of Neurological Sciences in Glasgow undertook their MS Masterclass project to understand if patients in their Centre on Fingolimod were adequately screened for macular oedema.

Fingolimod is a first in class sphingosine-1 phosphate (S1P) receptor modulator and was the first oral DMT licensed for use in MS. It has been available for use in the UK since 2012 and in Scotland licensed for use as a single DMT in highly active relapsing remitting MS for patient who meet certain criteria. Within England patients are required to have failed in first - line DMT before being eligible. Macular oedema is one of the associated risks of treatment and patients should be adequately screens for this within 120 day’s of initiation or before treatment if high risk.

Drs Gallagher and Martin undertook a retrospective analysis of electronic medical records in their regional tertiary Neurology Centre. The institute in Glasgow is the referral centre for the West of Scotland covering a catchment area of 2.5 million people. Using admission records all patients commencing Fingolimod between May 2016 and May 2017 were identified. As each NHS patient in Scotland has a unique identifier this enabled access to a wide range of records which included GP referrals, laboratory results and all secondary care correspondence.

Secondary objectives of the audit were also;

  • Higher risk patients continue to be identified and pre-screened for macular oedema
  • Referral to ophthalmology is made on day of discharge (in conjunction with discharge letter)
  • Standard ophthalmology referral including statement ‘must be seen within four months’
  • Consider ‘pre-referrals’ for patients planning to start fingolimod
  • Potentially inappropriate if patients do not start treatment as expected
  • ?‘OCT only’ assessment by ophthalmology technician
  • Avoids need for consultant appointment
  • Ensure clear advice to patient to seek medical attention if visual symptoms occur
  • Patient given fingolimod information sheet already
  • ?need for first-dose admission for cardiac monitoring

The findings of this audit will be presented to the local MS team to decide on interventions and will be re-audited thereafter, once the interventions are implemented.

Forty patients were commenced on Fingolimod in the study period and you can read the results and details of the full project here

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