Hollis KA, Tennis P, Nicandro J, Chuang E, Sweeney CT, Bennett L, Andrews E. Temporal trends in compliance with the alosetron risk management program. Poster presented at the 26th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 25, 2010. Brighton, United Kingdom.

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.

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