In Italy, Direct Healthcare Professional Communications are known as Note Informative Importanti di Sicurezza, or NIIS. Their management requires a process capable of connecting content, recipients, distribution and outcome verification. Starting from the presentation delivered by Amanda Mattavelli and Francesca Rollo during the pharmacovigilance session of the 65th AFI Symposium, we analyse the main criticalities discussed for the Italian context and the proposed roadmap to make the process more recognisable, traceable and measurable.
What are DHPCs and NIIS?
Direct Healthcare Professional Communications, or DHPCs, are communications addressed directly to healthcare professionals to inform them of new evidence, risks or measures relevant to the safe use of a medicinal product.
In the Italian context, DHPCs correspond to Note Informative Importanti di Sicurezza, or NIIS. They may be prepared by the Marketing Authorisation Holder in agreement with the competent authority or distributed directly by the regulatory authority.
For example, they may concern the identification of a new risk, a restriction of use, a change to contraindications or new recommendations for patient monitoring. Their function is operational: the recipient must understand which medicinal products are involved, which safety information has emerged and which actions should be taken.
How to manage a DHPC in Italy: the phases of the process
A DHPC achieves its objective when it reaches the appropriate recipients, is recognised, understood and translated into actions in clinical practice. The scientific quality of the content must therefore be supported by a process in which approval, targeting, distribution, traceability and evaluation remain connected.
During the pharmacovigilance session of the 65th AFI Symposium, Amanda Mattavelli of Johnson & Johnson and Francesca Rollo of DOC Generici, both AFI representatives, analysed this process from the perspective of a pharmaceutical company, linking communication effectiveness, impact evaluation and operational efficiency.
Content and approval of a DHPC
The management of a DHPC starts with the definition of the message and the interaction with the competent authority. At this stage, scientific consistency, clarity of recommendations and alignment among the parties involved must be ensured.
The document must allow the recipient to quickly identify the medicinal product concerned, the risk or new safety information, the intended recipients and the actions required in clinical practice.
Regulatory rigour must therefore be accompanied by a readable structure and clear language. Text approval, preparation of materials and distribution must also proceed in a timely and coordinated manner.
How to identify the recipients of a DHPC
The target of a DHPC varies according to the medicinal product, therapeutic indication, risk communicated and actions required. Specialists, general practitioners, hospital or community pharmacists and other healthcare professionals may be involved.
Identifying the recipients does not simply mean collecting addresses. It requires defining which professional categories are actually concerned and verifying the quality of the data used.
A mailing list that is too broad and poorly selective may dilute the message; an incomplete database, on the other hand, may exclude directly involved professionals. Clear selection criteria and up-to-date contacts therefore affect both the coverage and the relevance of the communication.
Distribution of DHPCs: coordinating paper and digital channels
DHPCs may be distributed through paper and electronic channels, according to the methods agreed with the authority and the characteristics of the target audience.
The use of multiple channels can increase coverage, provided that the paper version, e-mail, attachments and online publication remain aligned in terms of content and timing.
The new pictogram introduced by AIFA responds to the need to make these communications immediately identifiable. It is intended to accompany the document, the outer envelope and the e-mail message.
A consistent visual identity facilitates recognition of the DHPC. Campaign management still requires unified oversight of versions, media and activities assigned to the different parties involved.
Traceability of DHPCs: monitoring sends and outcomes
Tracing a DHPC means being able to reconstruct the selected recipients, the version distributed, the channel used, the sending date and the recorded outcome.
When this information is managed through spreadsheets, local archives, external providers and separate reports, consolidation becomes more complex and process visibility is reduced.
Centralised management can facilitate list control, monitoring of sends, collection of outcomes and preservation of evidence. Traceability therefore supports both the verification of the individual campaign and the overall governance of the process.
How to evaluate the effectiveness of a DHPC
Confirmation of sending documents the distribution, but it is not sufficient to demonstrate the effectiveness of the communication.
Evaluation may consider four levels:
- distribution, meaning the ability to reach the intended recipients;
- receipt and recognition of the DHPC;
- understanding of the risk and recommendations;
- impact on clinical practice.
Depending on the channels and objectives, delivery evidence, consultation data, questionnaires or other agreed measures may be used. Distinguishing these levels helps understand whether a potential criticality concerns coverage, message comprehension or its application.
Current criticalities in DHPC management
The presentation identified the following main criticalities.
From a communication perspective, limited visibility of DHPCs on the AIFA portal emerged, together with the need to make language and format more suitable for the intended recipients.
From an operational perspective, the key points of attention concern timelines, target selection, contact updates and management of recipient preferences.
These aspects are compounded by the difficulty of measuring comprehension and impact, the presence of manual activities, limited integration between systems, differences between paper materials and online publications, and the absence of a single archive for DHPCs and Educational Materials.
The proposed roadmap to improve DHPC management in Italy
Starting from these criticalities, Amanda Mattavelli and Francesca Rollo presented a roadmap structured into four phases, with reference to the evolution of the DHPC/NIIS process in the Italian context.
The first phase concerns simplification and recognisability, through interventions on language, the subject line of the communication and visual identity. The pictogram introduced by AIFA represents a first concrete response in this direction.
The second phase focuses on infrastructure and centralisation, with a single repository for DHPCs/NIIS and Educational Materials, more structured recipient management and tools capable of consolidating information.
The third phase envisages an advanced digital transition, oriented towards digital as the prevailing mode of distribution, supported by tracking tools and greater integration between distribution and reporting.
The fourth phase concerns refinement and real-world data, with the aim of making targeting more precise and evaluating the clinical effectiveness of communications through data from real-world practice.
The roadmap therefore proposes a gradual evolution for the Italian process: from message recognisability to the construction of a centralised, digital and measurable model. In this pathway, a DHPC/NIIS is not considered merely as a document to be distributed, but as a safety communication to be governed and evaluated throughout its operational lifecycle.
