Hollis K, Calingaert B, Gilligan TM, Sweeney C, Price M, Perez-Gutthann S, Andrews E. Quinolones REMS evaluation surveys. Poster presented at the 27th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 18, 2011. Chicago, IL.

BACKGROUND: The quinolone antimicrobials, ciprofloxacin and moxifloxacin, are covered by a medication guide-only Risk Evaluation and Mitigation Strategy (REMS). The goal of the medication guides (MGs) is to inform patients of serious risks associated with the use of ciprofloxacin and moxifloxacin, particularly tendonitis and tendon rupture.

OBJECTIVES: To assess whether patients are receiving and reading the MGs and whether they understand the key safety messages outlined therein.

METHODS: Cross-sectional surveys were conducted with US adult patients who filled a prescription (Rx) for ciprofloxacin (n¼204) or moxifloxacin (n¼215) within 30 days of survey administration. Patients were identified either through a clinical or pharmacy database, ensuring that they had filled an Rx. Participants could complete the survey by paper, telephone, or Internet questionnaire. Participants were asked questions evaluating their awareness of the key safety messages. Results were assessed both overall and stratified by factors, including whether the respondent read the MG, age, education, and time since Rx fill.

RESULTS: The surveys were closed upon reaching the quota for each group; thus, response rate could not be calculated. However, comparison of respondents and nonrespondents found little difference in key demographic variables. Approximately 78% of respondents overall reported that they remembered receiving the MG; of those, 58% of ciprofloxacin and 63% of moxifloxacin respondents indicated they read it or had it read to them. Respondents who read the MG demonstrated better knowledge of key risks associated with ciprofloxacin or moxifloxacin than those who did not. Among those who read the MG, >70% could identify 1 serious side effect associated with treatment, compared with <20% of those who did not read it. Respondents who read the MG were more likely to have been counseled by a health care professional. Recall of the key safety information did not appear to diminish over the 4 weeks from filling an Rx.

CONCLUSIONS: The results of the survey suggest that the MGs, particularly in combination with the counseling of a health care professional, have a positive impact on patient awareness of key safety messages.