BACKGROUND: In November 2002, alosetron was reintroduced under a RMP for treatment of female patients with severe, chronic diarrhea-predominant irritable bowel syndrome (IBS-D) who have failed conventional therapy. The RMP is intended to assure safe use of alosetron. A key component of the RMP is the Patient Follow-Up Survey (PFS).
OBJECTIVES: To monitor temporal trends in compliance with the alosetron RMP from the PFS.
METHODS: Patients are invited to enroll in the PFS upon initiation of alosetron and for one year (Wk 5, Wk 10, and then quarterly) receive follow-up questionnaires on risks/ benefits, dosage, and treatment. Descriptive analyses of survey responses were stratified by calendar year of enrollment. Annual participation rates over time (number of PFS participants/ estimated number of new patients receiving alosetron prescriptions) were also evaluated.
RESULTS: Overall, the majority of survey participants met full FDA-approved prescribing criteria over time (range: 82%–89%) with >96% fulfilling 1 IBS-D severity criterion (from alosetron prescribing information). Compliance with use of a sticker on the alosetron prescription was >86% annually. Patient understanding of safety messages in the medication guide has been consistently high (>82%) for each year of the RMP. Among 8096 patients (as of Dec 2009), estimated annual participation rate was 14–16% during the last 4 years and was lower than the annual 22%–36% observed in 2002–2005. Among enrolled patients, completion rates over time for follow-up questionnaires were high (>87%).
CONCLUSIONS: Since inception of the alosetron RMP, participants of the FPS have consistently met eligibility criteria over time. Among participants, patient-reported awareness of and compliance with aspects of the RMP was high across all years of the RMP.
