Abstract
The Fingolimod Patient Support Program (F-PSP) is an interprofessional specialty pharmacy service designed to ensure responsible use of fingolimod by promoting patient safety and medication adherence. This study aims to evaluate the safety and medication adherence of patients who joined the F-PSP between 2013 and 2016. Sociodemographic and medical characteristics, patient safety data (patient-reported symptoms, discontinuations due to adverse events (AEs), repeated first-dose monitoring), and medication adherence (implementation, persistence, reasons for discontinuation, influence of covariates, barriers and facilitators) were described. Sixty-seven patients joined the F-PSP. Patients reported a high frequency of symptoms. Due to AEs, 7 patients discontinued fingolimod, 3 took therapeutic breaks, and 1 reduced the regimen temporarily. Three patients repeated the first-dose monitoring. Patients had a high medication adherence over the 18-month analysis period: implementation decreased from 98.8 to 93.7%, and fingolimod persistence was 83.2% at 18 months. The patients’ level of education, professional situation, and living with child(ren) influenced implementation. Patients reported more facilitators of medication adherence than barriers. The F-PSP seems valuable for supporting individual patients (ensuring responsible use of fingolimod and inviting patients for shared-decision making) and public health (indirectly gathering real-world evidence).
Highlights
The Fingolimod Patient Support Program (F-PSP) is an interprofessional specialty pharmacy service designed to ensure responsible use of fingolimod by promoting patient safety and medication adherence
Patients should be warned about the symptoms of potential serious adverse events (AEs), and women of childbearing potential should be informed about the teratogenic risk and use of effective contraception[2]
This study aims to evaluate the safety and medication adherence of patients participating in the F-PSP during the first three years post-implementation
Summary
The Fingolimod Patient Support Program (F-PSP) is an interprofessional specialty pharmacy service designed to ensure responsible use of fingolimod by promoting patient safety and medication adherence. Sociodemographic and medical characteristics, patient safety data (patient-reported symptoms, discontinuations due to adverse events (AEs), repeated first-dose monitoring), and medication adherence (implementation, persistence, reasons for discontinuation, influence of covariates, barriers and facilitators) were described. It consists of regular pharmacist-led motivational interviews supported by a secure web platform (from SISPha SA), which includes a clinical decision aid system, patient health records, and a data collection system (recording, e.g., patient administrative data, adherence data, patient-reported outcomes). Patient safety is ensured through pharmacovigilance activities by informing patients regarding the responsible use of fingolimod (e.g., missed dose management, active contraception, co-treatment management), remind them about recommended medical tests, and track and monitor patient-reported symptoms (especially those who would signal potential serious adverse fingolimod reactions). This study aims to evaluate the safety and medication adherence of patients participating in the F-PSP during the first three years post-implementation
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