TY - JOUR
T1 - Quality of Reporting on the Evaluation of Risk Minimization Programs
T2 - A Systematic Review
AU - Russell, Andrea M.
AU - Morrato, Elaine H.
AU - Lovett, Rebecca M.
AU - Smith, Meredith Y.
N1 - Funding Information:
Andrea Russell was awarded a risk communication pre-doctoral fellowship by Amgen, Inc. for a portion of the study conduct. Meredith Smith is an employee of Amgen, Inc. and an adjunct professor, School of Pharmacy at the University of Southern California. Elaine Morrato has received funding from the US Food and Drug Administration. The views expressed in this manuscript are those of the authors solely and do not reflect the official policies or views of the FDA, or of Amgen, Inc. Rebecca Lovett has no conflicts to disclose.
Publisher Copyright:
© 2020, Springer Nature Switzerland AG.
PY - 2020/5/1
Y1 - 2020/5/1
N2 - 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.
AB - 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.
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U2 - 10.1007/s40264-020-00905-8
DO - 10.1007/s40264-020-00905-8
M3 - Review article
C2 - 32020558
AN - SCOPUS:85082440186
SN - 0114-5916
VL - 43
SP - 427
EP - 446
JO - Drug Safety
JF - Drug Safety
IS - 5
ER -