Abstract
BackgroundThe risk of pancreatitis and potential risk of medullary thyroid carcinoma associated with glucagon-like peptide-1 receptor agonists prompted the US Food and Drug Administration to require a Risk Evaluation and Mitigation Strategy for albiglutide, including education for prescribers and subsequent assessment of their knowledge of the risks and safe use of albiglutide via a quantitative survey.ObjectiveThe objective of this study was to assess prescribers’ knowledge of the risks related to medullary thyroid carcinoma, pancreatitis, and the appropriate patient population for albiglutide.MethodsTwo Risk Evaluation and Mitigation Strategy surveys were conducted 18 months and 3 years after albiglutide was launched. Primary analyses evaluated correct response rates for each question. Secondary analyses evaluated the number of correct responses and the percentage of respondents scoring at/above the target comprehension thresholds (75% at 18 months; 80% at 3 years), which were selected based on discussion with the Food and Drug Administration and current standards for Risk Evaluation and Mitigation Strategy assessments, for each key risk message.ResultsThe correct response rate for individual questions ranged from 68.2 to 97.9% (18-month survey) and from 69.4 to 98.1% (3-year survey). For the secondary analysis, 79.5, 86.7, and 86.7% of respondents in the 18-month survey answered ≥ 75% of the questions correctly and 70.8, 90.9, and 54.1% of respondents in the 3-year survey answered ≥ 80% of the questions correctly for key risk messages related to medullary thyroid carcinoma, pancreatitis, and appropriate patient population, respectively.ConclusionsSurvey results indicated most, but not all, prescribers are knowledgeable regarding the risks and safe use of albiglutide. Additional education to address gaps in knowledge could further improve risk mitigation.Electronic supplementary materialThe online version of this article (10.1007/s40801-017-0128-3) contains supplementary material, which is available to authorized users.
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