The Reporting Recommendations Intended for Pharmaceutical Risk Minimization Evaluation Studies: Standards for Reporting of Implementation Studies Extension (RIMES-SE)-Reference-Cited by-同舟云学术

The Reporting Recommendations Intended for Pharmaceutical Risk Minimization Evaluation Studies: Standards for Reporting of Implementation Studies Extension (RIMES-SE)

Published:2024-03-13 Issue:7 Volume:47 Page:655-671
ISSN:0114-5916
Container-title:Drug Safety
language:en
Short-container-title:Drug Saf

Author:

Smith Meredith Y.^ORCID,Morrato Elaine H.,Mora Nallely,Nguyen Viviana,Pinnock Hilary,Winterstein Almut G.

Funder

National Center for Advancing Translational Sciences

Publisher

Springer Science and Business Media LLC

Link

https://link.springer.com/content/pdf/10.1007/s40264-024-01417-5.pdf

Reference47 articles.

1. European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): module XVI—risk minimization measures: selection of tools and 5 effectiveness indicators (Rev 3). 2021. [cited 2023 Nov 20]. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-good-pharmacovigilance-practices-gvp-module-xvi-risk-minimization-measures-selection-tools_en.pdf.

2. Food and Drug Administration. Risk evaluation and mitigation strategies assessment: planning and reporting; draft guidance for industry; availability 2019 [1153–5]. 2019. [cited 2023 Nov 20]. https://www.govinfo.gov/content/pkg/FR-2019-02-01/pdf/2019-00676.pdf.

3. Smith MY, Morrato E. Advancing the field of pharmaceutical risk minimization through application of implementation science best practices. Drug Saf. 2014;37(8):569–80. https://doi.org/10.1007/s40264-014-0197-0.

4. Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, et al. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021;374: n2061. https://doi.org/10.1136/bmj.n2061.

5. PRAC recommends new measures to avoid valproate exposure in pregnancy: new restrictions on use; pregnancy prevention programme to be put in place. 2018. [cited 2023 Dec 4]. https://www.ema.europa.eu/en/documents/referral/valproate-article-31-referral-prac-recommends-new-measures-avoid-valproate-exposure-pregnancy_en.pdf.