How can risk communication in pharmacovigilance evolve toward more effective, traceable, and sustainable models? Although the EU Good Pharmacovigilance Practices (GVP) offer a harmonized regulatory framework, implementation varies significantly across Member States. Italy, in particular, presents a fragmented landscape that illustrates the urgent need for innovation. In this article, we examine the key findings and proposals from the “Rethink Safety Communication” project—an initiative developed by a multidisciplinary working group and presented during Italy’s national AFI Symposium 2025.

“Rethink Safety Communication” is a project presented during the pharmacovigilance session of the AFI Symposium 2025. It was promoted by a working group composed of Cittadinanzattiva, F.A.V.O. (Italian Federation of Volunteer Oncology Associations), the Federation of Italian Pharmacists’ Orders (FOFI), Federfarma, FISM (Federation of Italian Medical-Scientific Societies), SIFO (Italian Society of Hospital Pharmacy and Pharmaceutical Services of Healthcare Organizations), UNIAMO (Italian Federation for Rare Diseases), AFI (Italian Association of Pharmaceutical Industry Professionals), and IQVIA.

The goal: to analyze the current national approach to managing Educational Risk Minimisation Materials (EMs) and Direct Healthcare Professional Communications (DHPCs), benchmark it against best practices in other EU countries, and outline a scalable, digitally driven model that could serve as a reference for wider adoption.

The methodology included:

1. Regulatory analysis of the EU GVPs;
2. A survey involving 27 Roche affiliates across Europe;
3. In-depth reviews of five key national frameworks (Finland, France, Germany, Spain, UK) and Italy;
4. Interviews with working group affiliates in those countries;
5. Discussions with Italian healthcare stakeholders;
6. A multidisciplinary think tank for collecting insights.

The resulting position paper “Rethink Safety Communication: A new way to disseminate aRMM and DHPC” outlines a phased strategy to modernize risk communication in Italy and potentially beyond.

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Although GVPs define a harmonized foundation, their implementation is left to national discretion, leading to varied levels of maturity across EU Member States. While several countries have adopted centralized digital infrastructures, Italy still relies on fragmented and paper-based systems.

Within this context, the dissemination of Educational Materials and Direct Healthcare Professional Communications presents critical inefficiencies. Communications concerning the same active substance are often issued independently by multiple MAHs, using inconsistent formats and delivery methods—resulting in information overload and lack of clarity.

EMs are frequently difficult to distinguish from promotional content, lacking standardized layouts and visual cues to highlight key safety messages. Visual recognition—an essential factor for capturing attention in clinical workflows—remains underutilized.

Printed materials continue to dominate, particularly for patient-oriented communications. This generates a number of operational drawbacks: high production costs, long lead times, and complex logistics. More importantly, traceability is extremely limited. There is no reliable way to confirm whether a document was received, when it was delivered, or whether it was understood. Every update requires a new print run, increasing the risk that outdated versions remain in circulation. In 2024 alone, the companies involved in the “Rethink Safety Communication” project distributed more than 8.7 million sheets—equivalent to 43.6 tons of paper—raising clear concerns about environmental sustainability and process efficiency.

Italy also lacks a centralized institutional repository. While other EU countries provide searchable digital platforms, Italian DHPCs are posted as press releases on the AIFA website, and EMs are partially tracked in a static Excel file—limited to patient cards. This setup lacks real-time access, completeness, and transparency.

Furthermore, integration with healthcare IT systems is minimal. Approved EMs and NIIs are not linked to the software used in prescribing or dispensing, hindering point-of-care access to the most up-to-date safety information.

These structural weaknesses limit the effectiveness, measurability, and patient-centricity of risk communication—even when formal GVP compliance is in place.

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Based on the analysis conducted, the AFI working group developed a set of actionable proposals to overcome the challenges identified.

A top priority is the establishment of a centralized institutional repository, managed by AIFA, the Italian authority, or an authorized entity. This repository would consolidate all approved EMs and DHPCs in a single platform, with tailored access levels for healthcare professionals and patients, advanced search functions, printable formats, usage analytics and interoperability with clinical and hospital IT systems.

A second recommendation is to standardize the structure and design of safety communications. All materials should use consistent formatting, a clear tone of voice, and a visual identity that immediately distinguishes them from promotional content, for example, with color codes or pictograms (e.g. a blue hand for EMs and a red hand for DHPCs). Summaries of key messages and QR codes linking to the most updated version would further enhance traceability and usability.

The project also emphasizes the importance of valuing the role of healthcare professionals and local field staff in the dissemination of safety communications. Verbal explanation during the delivery of printed or digital materials is considered essential to support comprehension. Training programs should also be strengthened to help all stakeholders — including patient associations — understand the purpose and relevance of EMs and DHPCs.

Finally, a particularly strategic aspect concerns the integration of EMs and DHPCs into healthcare IT systems. This includes features such as contextual alerts at the moment of prescribing, automatic updates via repository synchronization, tracking of consultation rates and early communication in special regulatory programs (e.g. compassionate use or early access pathways).

The “Rethink Safety Communication” project outlines a clear path for evolving the Italian risk communication system: building a model that is more efficient, accessible, and aligned with the real-world needs of both patients and healthcare professionals. Standardisation, digitalisation, and communication quality are key pillars for strengthening patient safety throughout the entire drug lifecycle.

For further information, please refer to:
Position paper “Rethink Safety Communication: A new way to disseminate aRMM and DHPC”
Summary “Rethink Safety Communication: A new way to disseminate aRMM and DHPC”