Dataset Information

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

ABSTRACT: INTRODUCTION:The 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. METHODS:Results 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. RESULTS:In 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. CONCLUSION:The 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.

SUBMITTER: Brandenburg NA

PROVIDER: S-EPMC5362654 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Brandenburg Nancy A NA Bwire Robert R Freeman John J Houn Florence F Sheehan Paul P Zeldis Jerome B JB

Drug safety 20170401 4

<h4>Introduction</h4>The 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.<h4>Methods</h4>Results 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 measu ...[more]

PMID: 28074423

Similar Datasets

Project description:BackgroundA Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program for certain medications with serious safety concerns required by the U.S. Food and Drug Administration (FDA) of manufacturers to implement to help ensure the benefits of the medication outweigh its risks. FDA is encouraging "the research community to develop novel methods for assessing REMS," conveying the unmet need for a standardized evaluation method of these regulatory-mandated healthcare programs. The objective of this research is to evaluate FDA REMS assessment plans using established implementation science frameworks and identify opportunities for strengthening REMS evaluation.MethodsA content analysis was conducted of publicly available assessment plans for all REMS programs (N = 23) approved 1/1/2014-12/31/2018 for new drug applications (NDAs) and biologics license applications (BLAs) requiring FDA-mandated Elements to Assure Safe Use (ETASU). Blinded reviewers critically appraised REMS assessment measures (n = 674) using three established implementation science frameworks: RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance); PRECEDE-PROCEED (Predisposing, Reinforcing, and Enabling Constructs in Educational/Environmental Diagnosis and Evaluation - Policy, Regulatory, and Organizational Constructs in Educational and Environmental Development); and CFIR (Consolidated Framework for Implementation Research). Framework constructs were mapped to REMS Assessment categories as defined by FDA Guidance for Industry to evaluate congruence.ResultsREMS assessment measures demonstrated strong congruence (> 90% mapping rate) with the evaluative constructs of RE-AIM, PRECEDE-PROCEED, and CFIR. Application of the frameworks revealed that REMS assessment measures heavily emphasize implementation and operations, focus less on health outcomes, and do not evaluate program context and design assumptions.ConclusionsImplementation science frameworks have utility for evaluating FDA-mandated drug safety programs including the selection of primary measures to determine whether REMS goals are being met and of secondary measures to evaluate contextual factors affecting REMS effectiveness in varying organizational settings.

Project description:Background and objectivesLarger weight gain and higher ultrafiltration rates have been associated with poorer outcomes among patients on dialysis. Dietary restrictions reduce fluid-related risk; however, adherence is challenging. Alternative fluid mitigation strategies include treatment time extension, more frequent dialysis, adjunct peritoneal dialysis, and wearable ultrafiltration devices. No data regarding patient preferences for fluid management exist. A survey was designed, tested, and administered to assess patient-stated preferences regarding fluid mitigation.Design, setting, participants, & measurementsA written survey concerning fluid-related symptoms, patient and treatment characteristics, and fluid management preferences was developed. The cross-sectional survey was completed by 600 patients on hemodialysis at 18 geographically diverse ambulatory facilities. Comparisons of patient willingness to engage in volume mitigation strategies across fluid symptom burden, dietary restriction experience, and patient characteristics were performed.ResultsFinal analyses included 588 surveys. Overall, if allowed to liberalize fluid intake, 44.6% of patients were willing to extend treatment time by 15 minutes. Willingness to extend treatment time was incrementally less for longer treatment extensions; 12.2% of patients were willing to add a fourth weekly treatment session, and 13.5% of patients were willing to participate in nocturnal dialysis three nights per week. Patients more bothered by their fluid restrictions (versus less bothered) were more willing to engage in fluid mitigation strategies. Demographic characteristics and symptoms, such as cramping and dyspnea, were not consistently associated with willingness to engage in the proposed strategies. More than 25% of patients were unsure of their dry weights and typical interdialytic weight gains.ConclusionsPatients were generally averse to treatment time extension>15 minutes. Patients more bothered (versus less bothered) by their prescribed fluid restrictions were more willing to engage in volume mitigation strategies. Additional study of patient-stated preferences in hemodialysis treatment practices is needed to guide patient care and identify deficiencies in patient treatment and disease-related knowledge.

Dataset Information

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

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets