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Blog
Early Planning as the Cornerstone of Effective Risk Minimisation in Pharmacovigilance
Nov 17, 2025
At IQVIA, we see early planning as the foundation for successful risk minimisation in pharmacovigilance. The development of additional risk minimisation materials (aRMMs) and the assessment of their effectiveness and impact must be considered from the outset – not as afterthoughts. This proactive approach ensures that safety strategies are not only regulatory compliant but also truly effective in real-world settings.
Co-Creation and User-Centric Design: Building for Impact
IQVIA champions the co-creation of risk minimisation materials with patients and Healthcare Professionals (HCPs) (not only physicians but also nurses, pharmacists, and carers). Early collaboration ensures that materials are clear, accessible, and tailored to diverse needs. User testing and plain language principles are critical to ensure that RMMs drive real behaviour change, not just information dissemination1. Pharmacists and nurses in particular, play a vital role in reinforcing safety messages and supporting patients throughout their healthcare journey. Early involvement of patient groups learned societies, and cross-functional teams enhances the relevance and usability of materials and should be standard practice.
Early planning is also to ensure that aRMMs are accessible, engaging, and tailored to the needs of both HCPs and patients, which may imply considering different means of dissemination, beyond the paper-based approach currently favoured by the regulatory bodies. We however see that regulatory bodies are increasingly open to innovative/ digital formats, providing that engagement metrics are to be monitored and optimised from the start.
Early Development: Embedding RMMs in Clinical Workflows
While paper-based dissemination tends to be the norm, it is widely accepted that RMMs would be most effective if they were integrated into the platforms and workflows that HCPs already use, such as electronic medical records (EMRs) or the British National Formulary (BNF), driving meaningful behaviour change and supporting safer prescribing practices2,3. By prioritising integration and accessibility from the start, we could avoid common pitfalls like low engagement and workflow disruption. This solution currently presents significant challenges due to the many EMR systems that co-exist in both primary and secondary care and the lack of integration across these should be explored to improve patient safety further.
Early Assessment: Measuring Impact and Effectiveness
Assessing the effectiveness of aRMMs should begin early during the planning phase. IQVIA advocates for the use of implementation science frameworks, such as RE-AIM (5 key outcomes of Reach, Effectiveness, Adoption, Implementation and Maintenance) and Consolidated Framework for Implementation Research (CFIR) to design robust evaluation strategies. These frameworks provide structured approaches for measuring outcomes, ensuring that risk minimisation strategies are not just implemented, but are impactful and measurable in practice4.
In conclusion, the evolution of pharmacovigilance demands ongoing collaboration and a commitment to early planning. At IQVIA, we are dedicated to advancing digital solutions, applying implementation science, and fostering stakeholder co-creation from the very beginning. By prioritising early development and assessment, we can contribute to risk minimisation measures being more effective, measurable, and accessible to all.
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References:
1. McDonald, Isabella R., Blocker, Elizabeth .S., Weyman, Elizabeth A., Smith, Neil and Dwyer, Andrew A. What Are the Best Practices for Co-Creating Patient-Facing Educational Materials? A Scoping Review of the Literature, Healthcare, 2023, 11(19), 2615, https://doi.org/10.3390/healthcare11192615
2. IQVIA 2025 PV Roundtable – providing a platform for 20+ industry specialists and MHRA representatives to exchange on how to improve effectiveness of aRMMs (30th September 2025)
3. Getov, Ilko & Panayotova, Denitsa & Dobrev, Stanimir & Dimitrova, Maria & Petkova, Valentina. (2025). Opportunities for implementing digital applications to monitor the impact of risk-minimization measures within the pharmacovigilance process: Scoping review of published literature. Pharmacia. 72. 1-6. 10.3897/pharmacia.72.e143323, https://www.researchgate.net/publication/387883647_Opportunities_for_implementing_digital_applications_to_monitor_the_impact_of_risk-minimization_measures_within_the_pharmacovigilance_process_Scoping_review_of_published_literature
4. Huynh, L., Toyserkani, G.A. & Morrato, E.H. Pragmatic applications of implementation science frameworks to regulatory science: an assessment of FDA Risk Evaluation and Mitigation Strategies (REMS) (2014–2018). BMC Health Serv Res 21, 779 (2021). https://doi.org/10.1186/s12913-021-06808-3