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IntroductionThe effectiveness of patient education activities conducted within the lenalidomide and thalidomide risk evaluation and mitigation strategies (REMS) programs was evaluated by measuring understanding of serious risk and safe-use messages.MethodsResults from mandatory knowledge, attitude, and behavior surveys and voluntary patient surveys completed between June 2012 and June 2013 were analyzed, and responses to questions relating to compliance with birth control measures and understanding of safe-use messages are presented by patient risk category.ResultsIn total, 73,645 patients were enrolled into the REMS programs for lenalidomide and thalidomide and completed mandatory surveys prior to medication dispense. Of these, 2790 (3.8%) completed an additional voluntary survey. Among voluntary survey participants, for all patient pregnancy risk categories, reported compliance with birth control requirements was above 90% when starting therapy and at follow-up. At the beginning of therapy, complete compliance was 96.3%; 3 months later it was 96.4%. Patient understanding of safe-use messages was very high in all pregnancy risk groups, notably for messages repeated at each physician visit. Overall, 98.2% of patients knew that lenalidomide and thalidomide could cause birth defects, which is part of the repeated educational messaging. In contrast, 87.1% recalled that unused product should be returned to their healthcare professional, which is not included in repeated messaging.ConclusionThe lenalidomide and thalidomide REMS programs enhance patient understanding of safe-use messages, resulting in high levels of compliance with the birth control precautions essential to prevent fetal exposure to these known and potential human teratogens. Overall compliance was maintained after 3 months of follow-up and throughout therapy.Electronic supplementary materialThe online version of this article (doi:10.1007/s40264-016-0501-2) contains supplementary material, which is available to authorized users.

OBJECTIVES. Bilateral prophylactic mastectomy is a drastic breast cancer preventive option for which indications are not standardized and efficacy has not been proven. To estimate the magnitude of this controversial practice, surgeons were surveyed on their recommendations about and performance of prophylactic mastectomy. METHODS. A cross-sectional survey was sent to general surgeons (n = 522), plastic surgeons (n = 80), and gynecologists (n = 801) licensed to practice in Maryland in 1992. Proportions responding were 41.9%, 66.3%, and 54.9%, respectively. In addition, there were 30 respondents who identified "other" as their specialty. The respondents were asked about the role of bilateral prophylactic mastectomy and the number of times they had recommended and performed it in a year. RESULTS. Seven hundred forty-two surgeons responded (51.8%). More plastic surgeons (84.6%) than general surgeons (47.0%) and gynecologists (38.3%) agreed that bilateral prophylactic mastectomy has a role in the care of high-risk women. Eighty-one percent of plastic surgeons had recommended the procedure, compared with 38.8% of general surgeons and 17.7% of gynecologists. CONCLUSIONS. Indications and practice patterns reveal heterogeneity of medical opinion and practice of prophylactic mastectomy. This study raises the need for better evaluation of the efficacy and appropriateness of prophylactic mastectomy.