(SLA-003) Evaluating Effectiveness of Risk Minimization Through Healthcare Professional Education: A Literature Review

Background: Good Pharmacovigilance Practices (GVP) recommend a priori specification of the targets, or “thresholds”, for risk minimization measures (RMMs). These thresholds are determined using baseline or historical data, or expected frequency in similar populations (EMA GVP Module XVI 2024). An analysis of post-authorization safety studies from 2016-2021 suggested that only half of RMMs used included a pre-defined threshold.(Grupstra 2023) We updated this analysis and summarized the rationales for threshold selection.

Objectives: To review the thresholds and rationales used to determine the effectiveness of RMMs through knowledge-based surveys among healthcare professionals (HCPs) between 2022-2024.

Methods: We searched the Heads of Medicines Agencies-European Medicines Agency (HMA-EMA) Catalogue to identify real-world studies assessing the effectiveness of RMMs between January 2022 and December 2024. We screened study titles using keywords such as “risk minimization”, “survey”, “effectiveness”, “knowledge”, and “healthcare professional” and included survey-based studies with quantitative measures of process indicators (e.g., dissemination and knowledge outcomes) among HCPs.

Results: Of 720 studies identified, 180 were deemed eligible based on title screening. Of the 180 studies for further content screening, we excluded studies that were not related to RMMs (n=156), qualitative only (n=1), studies focused exclusively on patients (n=2) and those lacking information on threshold selection (e.g., protocols unavailable) (n=4), leaving 17 studies included in this review. Thresholds for RMMs effectiveness were pre-defined in 15 of 17 studies (88.2%). Overall, thresholds ranged between 60% to 80%, with the majority (13/15, 86.7%) set at 80%. Specifically, thresholds for assessing awareness, knowledge, and utilization were set at 80%, 60%-80%, and 75%-80%, respectively. However, the rationales for determining the thresholds were provided in only eight studies (8/15, 53.3%). Among these, six studies described the rationales were in accordance with success rates applied in other comparable studies, while two studies relied on subjective criteria without specifying prior knowledge, experience, or established scientific evidence.

Conclusions: Among the studies we examined, a threshold of 80% was pre-defined in most knowledge-based surveys for determining the effectiveness of RMMs. However, only half of studies provided the rationales for selecting these thresholds. Clearly specifying the rationales behind success thresholds in knowledge-based studies is critical for objectively evaluating whether educational materials effectively improve understanding and influence behavior as part of RMMs.