A Multi-modal Approach to Evaluate the Impact of Risk Evaluation and Mitigation Strategy (REMS) Programs

Sarpatwari, Ameet; Mitra-Majumdar, Mayookha; Bykov, Katsiaryna; Avorn, Jerry; Woloshin, Steven; Toyserkani, Gita A.; LaCivita, C; Manzo, Claudia; Zhou, Esther H.; Pinnow, Ellen; Pan, Gerald J. Dal; Gagne, Joshua J.; Huybrechts, Krista F.; Feldman, William B.; Chin, Kristyn; Kesselheim, Aaron S.

doi:10.1007/s40264-021-01070-2

Cited by 9 publications

(12 citation statements)

References 17 publications

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“…Epidemiologic studies of medication adherence can help provide insight into whether such perceptions translate into improved adherence and patient outcomes. 5 Our study also showed how REMS programs with ETASU can be improved by creating more understandable and informative educational literature for patients. One way to do that would be to use validated educational tools to update REMS program materials.…”

Section: Discussionmentioning

confidence: 69%

“…4 Little is known about the degree to which these programs foster safer drug use, better health outcomes, and improved patient experiences with their illnesses. 5 A 2013 report 6 by the Department of Health and Human Services Office of Inspector General questioned whether the FDA had adequate evidence to determine if the REMS system was achieving its goals. Some studies of prescribing trends using insurance claims data show a variable effect of REMS programs with ETASU.…”

Section: Introductionmentioning

confidence: 99%

“…As of January 2021, 51 FDA-approved drugs or drug classes had REMS programs with ETASU . Little is known about the degree to which these programs foster safer drug use, better health outcomes, and improved patient experiences with their illnesses . A 2013 report by the Department of Health and Human Services Office of Inspector General questioned whether the FDA had adequate evidence to determine if the REMS system was achieving its goals.…”

Section: Introductionmentioning

confidence: 99%

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Patient and Caregiver Experiences With and Perceptions of Risk Evaluation and Mitigation Strategy Programs With Elements to Assure Safe Use

et al. 2022

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IMPORTANCEThe US Food and Drug Administration (FDA) Amendments Act of 2007 authorized the FDA to impose safety requirements on drugs with important risks, such as prescriber certification or routine laboratory testing, to ensure that the benefits of use outweighed the risks. However, little is known about patient and caregiver experiences with these Risk Evaluation and Mitigation Strategy (REMS) programs with Elements to Assure Safe Use (ETASU). OBJECTIVE To understand patient and caregiver experiences with and perceptions of REMS programs with ETASU. DESIGN, SETTING, AND PARTICIPANTS This qualitative study included semistructured qualitative phone interviews conducted between 2016 and 2017, with initial analysis performed in 2017 and reanalysis performed in 2021. Adult patients prescribed natalizumab or sodium oxybate, adult patients or caregivers of adult patients prescribed vigabatrin, and adult female patients of reproductive age prescribed riociguat were included. MAIN OUTCOMES AND MEASURESAssessment of knowledge, decision-making, medication access, and perceptions of medical privacy. RESULTS Among 63 participants, 46 (73%) were female. Twenty-five participants (40%) had taken natalizumab, 10 (16%) riociguat, 15 (24%) sodium oxybate, and 10 (16%) vigabatrin. One participant had taken both natalizumab and vigabatrin; 4 (6%) were caregivers of patients using vigabatrin. Most participants expressed knowledge of REMS program requirements, but many lacked the insight that these requirements were part of an FDA-mandated special safety program and expressed difficulty understanding program education materials. REMS requirements made some participants more likely to initiate treatment. However, many reported burdens accessing medication, including the need to travel to certified prescribers or pharmacies. Manufacturer access to personal health information was also controversial, although some participants expressed an altruistic desire to assist others. CONCLUSIONS AND RELEVANCEThis qualitative study found that REMS programs with ETASU reassured patients and their caregivers about drug safety and helped support medication initiation.However, steps are needed to improve the quality of REMS educational materials, promote efficient medication access, and protect patient privacy.

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Section: Discussionmentioning

confidence: 69%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Patient and Caregiver Experiences With and Perceptions of Risk Evaluation and Mitigation Strategy Programs With Elements to Assure Safe Use

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“…29 An ongoing study designed by the FDA and health system collaborators uses a multimodal approach to evaluating REMS programs. 30 This multiyear study aims to understand patterns of drug use, adherence to safety requirements, and patient outcomes under REMS programs, and the experience of physicians and patients will be incorporated into the outcomes. While this study addresses a gap in the literature, its published protocol does not include outcomes related to the workflow, time burden, data quality, and does not plan to incorporate the experience of pharmacists who are essential stakeholders in the REMS process.…”

Section: Discussionmentioning

confidence: 99%

Implementation and Use of Risk Evaluation and Mitigation Strategies Programs in Practice: A Scoping Review of the Literature

et al. 2022

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Background Risk Evaluation and Mitigation Strategy (REMS) programs intend to improve medication safety but can add significant administrative burdens to providers and health systems. Various stakeholders have made efforts to use technology to improve REMS programs. Objectives The objective of this scoping review is to describe studies evaluating workflows, automation, or electronic data exchange related to REMS programs. Methods A literature search of PubMed, Embase, and Web of Science was performed for articles published between January 2007 and July 2021. Studies were identified using the relevant Medical Subject Headings terms and related keywords. Articles must have described a workflow change and measured the impact of the workflow change. Results Of 299 citations initially identified, 7 were included in the final review after removing duplicates and articles not meeting predefined inclusion criteria. Included studies consisted of three manuscripts and four conference abstracts. Electronic health record interventions, such as customized order sets and clinical decision support alerts, were the most common strategy reported. Other strategies included developing a portal to verify REMS enrollment, requiring prescribers to contact the dispensing pharmacy, provider education, and restrictions based on the provider specialty. One study evaluated automated data exchange for REMS program processes in a mock environment. Although only three studies reported baseline metrics for comparison, all studies noted an improvement or benefit to the implemented workflow process changes. Conclusion There is limited evidence describing REMS workflows, automation, and electronic data exchange. Various strategies to address REMS program requirements were reported, but no studies described the use of data exchange standards in a real-world setting despite efforts by the Food and Drug Administration and other stakeholders. Additional efforts are needed to automate REMS programs.

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“…Since 2007, the US Food and Drug Administration (FDA) has required drug manufacturers to institute risk evaluation and mitigation strategies (REMS) for certain drugs with known safety problems to help ensure that the benefits of use outweigh the risks [ 1 , 2 ]. These REMS may include medication guides for patients, communication plans for prescribers, and more complex elements to assure safe use, such as dispensing restrictions, patient registries, and laboratory testing [ 3 ].…”

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confidence: 99%

Analysis of risk evaluation and mitigation strategies for teratogenic drugs: Variation in primary and secondary prevention measures

2023

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A Multi-modal Approach to Evaluate the Impact of Risk Evaluation and Mitigation Strategy (REMS) Programs

Cited by 9 publications

References 17 publications

Patient and Caregiver Experiences With and Perceptions of Risk Evaluation and Mitigation Strategy Programs With Elements to Assure Safe Use

Patient and Caregiver Experiences With and Perceptions of Risk Evaluation and Mitigation Strategy Programs With Elements to Assure Safe Use

Implementation and Use of Risk Evaluation and Mitigation Strategies Programs in Practice: A Scoping Review of the Literature

Analysis of risk evaluation and mitigation strategies for teratogenic drugs: Variation in primary and secondary prevention measures

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