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

Overview

Journal Drug Saf

Specialties Pharmacology
Toxicology

Date 2020 Feb 6

PMID 32020558

Citations 5

Authors

Andrea M Russell

Elaine H Morrato

Rebecca M Lovett

Meredith Y Smith

Affiliations

Soon will be listed here.

Abstract

Introduction: Risk minimization programs are interventions mandated by regulatory agencies to ensure that benefits of pharmaceutical products outweigh risks. Many regulatory agencies require programs be evaluated for effectiveness; however, the quality of evidence has limited the ability to definitively determine if programs improve drug safety.

Objective: The aim of this systematic review was to assess and describe the current status of reporting on the effectiveness of pharmaceutical risk management programs.

Methods: Peer-reviewed articles published between January 2012 and December 2018 were selected from three online databases (MEDLINE, PubMed, Embase). Eligible studies reported on effectiveness evaluations of mandated risk minimization measures (beyond labeling) and were written in English. Two reviewers independently examined 2744 titles of articles and 52 full articles were included. Forty-eight sources of gray literature from conference abstract presentations and publicly available regulatory documents were also included.

Results: Key opportunities for improvement in reporting included the provision of information regarding (1) selection, design, and testing of risk minimization measures, (2) implementation of programs, (3) process and outcome metrics, including the extent to which programs reached the intended audience, were integrated into the target healthcare settings, or were sustained over time, and (4) burden of the program on the healthcare system and implications for patient access.

Conclusions: Gaps in reporting of risk minimization program evaluation studies were identified. Addressing gaps will help build the evidence base regarding risk minimization initiatives, as well as ensure that programs are maximally effective and minimally burdensome on the healthcare system, and do not unduly interfere with patient access to the medicine.

Citing Articles

Using Mixed Methods to Evaluate Risk Minimisation Programs in Europe and the USA: An Innovative Blueprint.

Smith M, Davis R, Bahri P, Saragoussi D, Nguyen V, Toyserkani G Drug Saf. 2025; .

PMID: 40075031 DOI: 10.1007/s40264-025-01533-w.

Use of Reporting Recommendation Intended for Pharmaceutical Risk Minimisation Evaluation Studies (RIMES) Checklist in Risk Minimisation/Mitigation Studies: A Review and Survey.

Duckworth S, Druelles S, Brouwer E, Brown D, Hakkarainen K, Guleria S Drug Saf. 2024; 48(4):415-423.

PMID: 39688763 DOI: 10.1007/s40264-024-01504-7.

Behavioral Science: Enhancing Our Approach to the Development of Effective Additional Risk Minimization Strategies.

Treacy J, Morrato E, Horne R, Wolf M, Bakhai A, Wilson M Drug Saf. 2024; 47(8):733-743.

PMID: 38594553 PMC: 11706363. DOI: 10.1007/s40264-024-01420-w.

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

Smith M, Morrato E, Mora N, Nguyen V, Pinnock H, Winterstein A Drug Saf. 2024; 47(7):655-671.

PMID: 38478350 PMC: 11182855. DOI: 10.1007/s40264-024-01417-5.

Pragmatic applications of implementation science frameworks to regulatory science: an assessment of FDA Risk Evaluation and Mitigation Strategies (REMS) (2014-2018).

Huynh L, Toyserkani G, Morrato E BMC Health Serv Res. 2021; 21(1):779.

PMID: 34362367 PMC: 8348874. DOI: 10.1186/s12913-021-06808-3.

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