ArticleDrug safety2017
Effectiveness of Risk Evaluation and Mitigation Strategies (REMS) for Lenalidomide and Thalidomide: Patient Comprehension and Knowledge Retention.
Article in Drug safety, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.
- Quality of Reporting on the Evaluation of Risk Minimization Programs: A Systematic Review.Drug safety · 2020Pooled it
- Effect of a Smart Pill Bottle and Pharmacist Intervention on Medication Adherence in Patients with Multiple Myeloma New to Lenalidomide Therapy.Journal of managed care & specialty pharmacy · 2019Trial
- Communicating Drug Safety and Safe Use Conditions in Risk Evaluation and Mitigation Strategy Materials.Drug safety · 2026Article
- Prescription Drugs Subject to a Risk Evaluation and Mitigation Strategy: Patient Perspectives on Risk Communication and the Value of Educational Materials.Drug safety · 2026Article
- Assessing the effectiveness of the TURALIO (pexidartinib) risk evaluation and mitigation strategy program: patient knowledge, attitudes, and behavior survey (2020-2024).Patient related outcome measures · 2026Article
- A scoping review of pharmacists' clinical activities and impact on the care of patients with multiple myeloma.International journal of clinical pharmacy · 2024Article
- Article
- Financial Toxicity, Time Toxicity, and Quality of Life in Multiple Myeloma.Clinical lymphoma, myeloma & leukemia · 2024Article
- Assessment of the U.S. Food and Drug Administration's risk evaluation and mitigation strategy (REMS) for prasugrel (EFFIENT): A narrative review.American heart journal plus : cardiology research and practice · 2024Article
- Review
- Evolution of Cross-Sectional Survey Protocol Quality Over Time: A Case Series of Index U.S. REMS Knowledge Survey Protocols (2007-2020).Drug safety · 2023Article
- Thalidomide interaction with inflammation in idiopathic pulmonary fibrosis.Inflammopharmacology · 2023Review
- Analysis of risk evaluation and mitigation strategies for teratogenic drugs: Variation in primary and secondary prevention measures.PLoS medicine · 2023Article
- Leveraging Technology in Risk Evaluation and Mitigation Strategy Programs.HCA healthcare journal of medicine · 2023Article
- Patient and Caregiver Experiences With and Perceptions of Risk Evaluation and Mitigation Strategy Programs With Elements to Assure Safe Use.JAMA network open · 2022Article
- The organization, weaknesses, and challenges of the control of thalidomide in Brazil: A review.PLoS neglected tropical diseases · 2020Review
- Use of Risk Evaluation and Mitigation Strategies by the US Food and Drug Administration, 2008-2019.JAMA · 2020Article
- Molecular Mechanisms of the Teratogenic Effects of Thalidomide.Pharmaceuticals (Basel, Switzerland) · 2020Review
- 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.Pharmacology research & perspectives · 2020Article
- Advancing regulatory science and assessment of FDA REMS programs: A mixed-methods evaluation examining physician survey response.Journal of clinical and translational science · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
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.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.