Effectiveness of Risk Evaluation and Mitigation Strategies (REMS) for Lenalidomide and Thalidomide: Patient Comprehension and Knowledge Retention

Abstract

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.

Effect of the patient information brochure in communicating the risks associated with crizotinib treatment to patients with non‐small cell lung cancer (NSCLC) in Europe

“…In our study, most patient respondents reported receiving the PIB (77%), of which 93% reported reading it. Our results are similar to results reported in the limited number of studies identified in the literature that directly evaluated the effectiveness of RMMs with patients . Specifically, levels of receipt/reading of patient‐directed RMMs in other studies were as follows: 88%/93% (Landsberg et al), 93%/86% (Enger et al), and 89%/86% (Brandenburg et al).…”

“…Our results are similar to results reported in the limited number of studies identified in the literature that directly evaluated the effectiveness of RMMs with patients . Specifically, levels of receipt/reading of patient‐directed RMMs in other studies were as follows: 88%/93% (Landsberg et al), 93%/86% (Enger et al), and 89%/86% (Brandenburg et al). Awareness of the side effects and precautions for use of crizotinib, and reasons for contacting the physician was high for vision‐, hepatic‐, and dizziness‐related items, with knowledge levels ranging from 61% to 85%.…”

“…Similarly, a study that evaluated knowledge levels of precautions for use for, and risks associated with, varenicline reported patient knowledge levels of 19%‐82% . Knowledge levels in our study were lower than those reported by Brandenburg et al, where knowledge levels of teratogenic‐related risks for lenalidomide and thalidomide assessed by 5 survey questions ranged from 87% to 98% . However, it is not surprising that knowledge levels for teratogenic‐related risks were high, given the severity of this risk as well as the restricted distribution REMS program in the US specifically employed to minimize teratogenic risks associated with lenalidomide and thalidomide.…”

2020 American College of Rheumatology Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases

“…Paternal use of CYC may impair spermatogenesis or be mutagenic for DNA and should be discontinued 3 months prior to attempting conception. Thalidomide is detectable in seminal fluid and is strongly teratogenic when given to pregnant women , and should be discontinued at least 1 month prior to attempting conception. The remaining medications are recommended either strongly or conditionally for continuation during peri‐ and post‐conception periods.…”

Age of onset in genetic prion disease and the design of preventive clinical trials

“…While this model would be a departure from the more conventional design of most post-marketing studies required for recent Accelerated Approval drugs 2 , precedents exist for regulatory innovation in this area. For example, FDA's Risk Evaluation and Mitigation Strategies (REMS) program for drugs with serious safety concerns entails indefinite post-market enrollment and monitoring of treated patients 51 , and post-approval study requirements for medical devices often include registries or surveillance efforts and are not always industry-funded 52,53 .…”