Research ArticleOriginal Article
Open Access

Assessment of clinician adherence to Fingolimod instructions and its effect on patient safety

Alaa A. Alhubaishi, Lolwa M. Alsharekh, Haya F. Almoharb, Faisal A. Alqarni, Abdalhadi M. Alqahtani, Mohammed K. Alghazwni, Modhi A. Alfuraydi, Abdulmajed Z. Alsadi, Raad Y. Altalhi, Tariq M. Almutairi and Ghadah H. Alshehri
Neurosciences Journal July 2024, 29 (3) 184-189; DOI: https://doi.org/10.17712/nsj.2024.3.20240040

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Tables

  • Table 1

    - Drug manufacturer’s recommendations to reduce risks associated with fingolimod.

    Monitoring parameterWhen
    BradycardiaAt least 6 hours after first dose
    Pulse and blood pressureHourly during observation
    Electrocardiograms (ECGs)Prior to dosing and at end of observation
    Ophthalmic examinationsBefore and 3–4 months after treatment
    Liver transaminase and bilirubin levelsBefore initiation of therapy and within 6 months of initiation
    Complete blood cells (CBC)During treatment and for 2 months after discontinuation
  • Table 2

    - Multiple sclerosis patients characteristic on fingolimod.

    VariablesFrequency (n)Percent (%)
    Age (Mean (SD))34.82 (11.36)
    Gender
    Male5640.0
    Female8460.0
    Comorbidities
    Diabetes mellitus42.86
    Blood disorder21.43
    Skin cancer10.71
    Arrhythmia42.86
  • Table 3

    - Clinician adherence categories based on following manufacturer’s recommendations.

    Clinician adherence classificationNumber of cliniciansPercentage
    Poor adherence (1 or no recommendation was followed)72(51.43)
    Moderate adherence (2-3 recommendations were followed)65(46.43)
    Full adherence (all recommendations were followed)3(2.10)
  • Table 4

    - Clinician adherence to applying each manufacturer’s recommendation point.

    VariablesApplied or notn (%)
    Observe all patients for bradycardia for at least 6 hours; monitor pulse and blood pressure hourly. Electrocardiograms (ECGs) prior to dosing and at the end of observation period required.Yes113 (80.7)
    No27 (19.3)
    Ophthalmic examinations before and 3–4 months after start of treatment to assess for macular edema.Yes22 (15.7)
    No118 (84.3)
    Liver transaminases (aspartate transaminase and alanine transaminase) plus total bilirubin levels should be available before initiation of therapy and obtained within 6 months of Fingolimod initiation.Yes77 (55.0)
    No63 (45.0)
    Obtain complete blood cells, monitor for infection during treatment and for 2 months after discontinuation.Yes12 (8.6)
    No128 (91.4)
  • Table 5

    - Fingolimod complications reported during study of monitored patients.

    ComplicationNumber of patients affected
    Bradycardia with first dose18 out of 113 monitored patients
    Macular edema4 out of 22 monitored patients
    InfectionUrinary tract infection4 out of 12 monitored patients
    Liver enzyme elevation
    AST (Mean ± SD) (U/L) 87±99.1
    ALT (Mean ± SD) (U/L) 158±163.4
    Total bilirubin (Mean ± SD) (ummol/l) 11.5±11.3    		6 out of 77 monitored patients
  • Table 6

    - The impact of clinician adherence to fingolimod instructions on patient treatment.

    Impact of clinician adherencePoor adherenceModerate adherenceFull adherenceP-value
    Treatment incompleteness10430.0001*
    Non-compliance656420.024*
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