Quality of Reporting on the Evaluation of Risk Minimization Programs: A Systematic Review

Russell, Andrea M.; Morrato, Elaine H.; Lovett, Rebecca M.; Smith, Meredith Y.

doi:10.1007/s40264-020-00905-8

Cited by 9 publications

(6 citation statements)

References 59 publications

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“…In addition, standardising the reporting of risk minimisation evaluations coupled with transparent dissemination of such information is crucial to improving the quality of reporting on RMM design and implementation [28,29]. In turn, publicly available information enables researchers to conduct systematic reviews to increase knowledge on the effectiveness of various interventions and advance the evidence base to understand what types of programmes work best for minimising certain risks, in what type of settings and for which patient populations.…”

Section: Discussionmentioning

confidence: 99%

“…Other recent systematic reviews have found mixed or insufficient evidence on the effectiveness of RMMs as well [21,26,27]. Researchers have also documented the uneven reporting quality in published studies on risk minimisation evaluation, citing this as a barrier to robustly appraising the scientific rigor of these studies, interpreting the results and advancing the science in this area [21,28,29]. Mazzaglia et al [22], in a study assessing the impact of RMMs for cardiovascular, endocrine and metabolic drugs, concluded that there was a need for more comprehensive, real-time reporting of programme implementation metrics to allow for timely programme modifications.…”

Section: Bridging the Gap: Current Reality Versus Envisioned Statementioning

confidence: 99%

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Risk Management for the 21st Century: Current Status and Future Needs

Mouchantaf

Auth²,

Moride

et al. 2021

Drug Saf

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Global adoption of risk management principles outlined in the International Conference on Harmonisation (ICH) E2E guideline and the Council for International Organizations of Medical Sciences (CIOMS) Working Group VI guidance introduced greater proactivity and consistency into the practice of pharmacovigilance and benefit-risk management throughout the lifecycle of a drug. However, following the release of these guidelines there have been important advances in the science and practice of risk minimisation itself, especially in terms of how risk minimisation measures (RMMs) are designed, implemented, disseminated and evaluated for effectiveness in real-world healthcare settings. In this article, we describe how the field of design, implementation, dissemination and evaluation of RMMs has advanced in recent years while highlighting current areas of challenge and possible solutions. Where possible we cite global examples to demonstrate how evidencebased approaches have informed the development of RMMs. In this context, while taking into consideration local healthcare system policies and national legislations, we conclude with a call for a global effort to harmonise certain areas that focus on, but are not limited to, standardising certain terms and definitions, consistent application of robust methodologies, and outline of best practices for risk minimisation design, implementation, and dissemination.

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Section: Discussionmentioning

confidence: 99%

Section: Bridging the Gap: Current Reality Versus Envisioned Statementioning

confidence: 99%

Risk Management for the 21st Century: Current Status and Future Needs

Mouchantaf

Auth²,

Moride

et al. 2021

Drug Saf

Self Cite

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“…Unfortunately, high-quality evidence on the incremental effectiveness of different REMS elements is sparse, and the quality of evidence and reporting in REMS evaluation studies is substandard. 40,41 Our study showed that the prevalence of prenatal exposure to drugs with REMS in 2017 was higher than during the baseline year (2006) primarily because of increased overall utilization. More research is needed to understand the root causes of REMS program failures and what criteria should be employed to decide whether and which REMS elements should be used for teratogenic medications.…”

Section: Research Implicationsmentioning

confidence: 72%

Prenatal exposure to teratogenic medications in the era of Risk Evaluation and Mitigation Strategies

Sarayani

Albogami

Thai

et al. 2022

American Journal of Obstetrics and Gynecology

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“…Reporting standards for risk minimization communication and program evaluation have been described by members of the International Society for Pharmacoepidemiology (40). A systematic review of the published literature on pharmaceutical risk minimization evaluation found limited use of conceptual frameworks guiding process and outcome measurement selection and program design and implementation (41).…”

Section: Discussionmentioning

confidence: 99%

Adaptation for Regulatory Application: A Content Analysis of FDA Risk Evaluation and Mitigation Strategies Assessment Plans (2014–2018) Using RE-AIM

Toyserkani

Huynh

Morrato

2020

Front. Public Health

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Background: Risk Evaluation and Mitigation Strategies (REMS) are safety programs that U.S. Food and Drug Administration can require to ensure a drug's benefits outweigh its risks and can be considered public health interventions. FDA's 2019 draft Guidance for Industry on REMS Assessments encourages the development of "novel methods for assessing REMS [to] help advance the science of post-market assessment of effectiveness of risk mitigation strategies." Objective: To characterize REMS assessment plans using RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework and identify areas for advancing methods for evaluating REMS programs. RE-AIM was selected for its wide application evaluating the translation of scientific advances into practice for public health impact. Methods: A content analysis of REMS assessment plans (N = 18) and measures(n = 540) was conducted for REMS programs approved by FDA between 1/1/2014-12/31/2018. Eligibility criteria were: a new drug application or biologic license application, included FDA-mandated mitigation strategies called elements to assure safe use (ETASU), and represented a single product REMS program. Assessment plans were collected from publicly available regulatory approval letters from REMS@FDA website. Blinded reviewers categorized each REMS assessment measure to a RE-AIM dimension, adjudicated their application (average IRR 75%), and refined the adapted dimensions' definitions. Dimensions were also mapped to REMS Assessment guidance categories. Results: The median number of assessment measures per REMS assessment plan was 31 (IQR: 21-36). Frequency of measures per RE-AIM criteria per REMS program was: Reach (median = 2; IQR: 2-4); Effectiveness (median = 2.5; IQR:1-4); Adoption (median = 3.5; IQR: 2-5); Implementation (median = 18; IQR: 15-24); Maintenance (median = 0; IQR: 0-1). Adoption (among prescriber, health system agents of implementation) was more commonly assessed than Reach (population-attributable number of patients affected). Assessment of heterogeneity of Adoption and Reach was generally absent. Toyserkani et al. Adaptation of RE-AIM for FDA REMS Assessments Implementation assessment measures were most common among drugs requiring evidence of safe-use conditions before dispensing or administering the drug. Patientlevel Effectiveness and Maintenance assessments were most common among drugs requiring patient monitoring. Discussion: Implementation science frameworks, such as RE-AIM, can be applied to characterize REMS assessment measures and identify opportunities for standardizing and strengthening their evaluation. Methods to measure Maintenance are needed to provide real-world evidence of REMS integration into the healthcare system.

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Quality of Reporting on the Evaluation of Risk Minimization Programs: A Systematic Review

Cited by 9 publications

References 59 publications

Risk Management for the 21st Century: Current Status and Future Needs

Risk Management for the 21st Century: Current Status and Future Needs

Prenatal exposure to teratogenic medications in the era of Risk Evaluation and Mitigation Strategies

Adaptation for Regulatory Application: A Content Analysis of FDA Risk Evaluation and Mitigation Strategies Assessment Plans (2014–2018) Using RE-AIM

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