The right safety message. Before practice stays the same.
A focused learning resource about Direct Healthcare Professional Communications: why they exist, when they may be needed, how pharmaceutical companies and authorities coordinate them, and why clear communication to the right doctors, pharmacists and other healthcare professionals can directly support safer patient care.
TargetedNot every healthcare professional needs every DHPC.
AgreedContent and communication planning are coordinated with competent authorities.
ActionableThe purpose is to inform a concrete change, precaution or safety action.
Regulatory scope: EU/EEA human medicinal products, with a Greece/EOF reference layer. DHPCs are specialised pharmacovigilance safety communications — not routine educational or promotional material.REGULATORY REVIEW · 09 SEP 2026
Why DHPC exists
Safety information only protects patients if it reaches practice.
A regulatory decision, a newly characterised risk or a new risk-minimisation recommendation has limited public-health value if the healthcare professionals who prescribe, dispense, monitor or manage the medicine do not receive the information clearly and in time to act.
What a DHPC is
A targeted communication intervention delivering important safety information directly to individual healthcare professionals, normally from a marketing authorisation holder or competent authority, when they need to take action or adapt practice in relation to a medicinal product.
Focused on an important medicine-safety issue.
Designed for healthcare professionals who can act on that issue.
Prepared in cooperation with the competent authority.
Linked to a communication plan covering audience, timing, tools and channels.
May complement other safety communication and risk-minimisation measures.
What a DHPC is not
It should not be treated as a general company mailing, marketing asset or ordinary education campaign.
Not promotional communication.
Not a routine newsletter.
Not a response to an individual healthcare-professional enquiry.
Not routine educational material used for ordinary risk minimisation.
Not a substitute for the approved SmPC/Package Leaflet, the RMP, official regulatory decisions or company procedures.
Public-health chain
From evidence to safer care.
The communication step sits between regulatory/safety knowledge and day-to-day patient management. Its quality matters because ambiguity, wrong targeting or inconsistent messages can undermine risk minimisation.
01
Safety knowledge
A risk, change in benefit-risk, medication-error issue, supply problem or other important concern is identified.
02
Regulatory alignment
The safety action and communication need are assessed with the competent authority.
03
Targeted message
The right HCP population receives concise, consistent and actionable information.
04
Practice changes
Prescribing, dispensing, monitoring, counselling or treatment processes can be adapted.
05
Patient protection
Better-informed clinical decisions help minimise preventable medicine-related harm.
When DHPC may be used
Not every safety update needs direct communication.
GVP Module XV distinguishes situations where a DHPC should be disseminated when immediate action or a change in practice is needed, and other situations where a DHPC should be considered. Final decisions remain product- and authority-specific.
Strong GVP trigger
Safety-driven suspension, withdrawal or revocation
Where a marketing authorisation is suspended, withdrawn or revoked for safety reasons and healthcare professionals need to change practice.
Strong GVP trigger
Important change in use for safety reasons
For example, restriction of an indication, a new contraindication or a change in recommended dose because of safety concerns.
Strong GVP trigger
Availability restriction with patient-care impact
Restriction in availability or discontinuation when the change could have detrimental effects on patient care and HCP action is needed.
Consider DHPC
New major warning or precaution
An important new warning or precaution in product information may justify targeted direct communication depending on clinical impact and urgency.
Consider DHPC
New or materially changed risk
New data may identify a previously unknown risk or a meaningful change in the frequency or severity of a known risk.
Consider DHPC
New prevention or management recommendation
New recommendations may be required to prevent or treat adverse reactions, or to reduce misuse and medication errors.
Consider DHPC
Reduced effectiveness or evolving important potential risk
New evidence of reduced effectiveness, or an important potential risk still under assessment, can also create a need for direct HCP awareness and monitoring.
Coordination principle
Class-wide or multi-MAH issue
When several marketing authorisation holders are affected, a single consistent message should normally be pursued rather than competing company messages.
Important: these are educational trigger categories based on GVP Module XV. They do not create an automatic company decision rule. Whether a DHPC is required, its scope, wording, recipients, timetable and dissemination method must follow the applicable regulatory procedure and agreement with the competent authority.
Communication lifecycle
A DHPC is a controlled safety process.
The visible letter is only one output. Behind it is a coordinated workflow connecting pharmacovigilance evidence, regulatory decisions, medical accuracy, communication planning, local implementation and documentation.
01
Recognise the communication need
Clarify the safety concern, regulatory context and why healthcare-professional action may be necessary.
02
Define the communication objective
State the intended practice change: stop, avoid, monitor, dose-adjust, screen, counsel, switch, report or follow another specific safety measure.
03
Map the affected healthcare professionals
Identify who can encounter the medicine, the risk and the required action: prescribers, pharmacists, specialist teams or other relevant HCP groups.
04
Coordinate with competent authorities
The marketing authorisation holder and competent authority should agree the DHPC content and communication plan before company dissemination.
05
Align one consistent safety message
Keep the DHPC consistent with the agreed regulatory outcome, product information and any complementary communication. Coordinate a common message when multiple MAHs/products are involved.
06
Localise without changing the safety meaning
Translations and national targeting are reviewed through the applicable national process. Relevant HCP organisations or learned societies may support practical audience adaptation where appropriate.
07
Disseminate on the agreed timetable
Use the approved communication channels and timing. There is no single universal “DHPC deadline” that should be invented outside the agreed plan.
08
Document, reinforce and evaluate
Maintain evidence of the communication process and use complementary risk-minimisation or safety-communication tools where appropriate. Evaluate effectiveness when required by the risk-management strategy.
Interactive case learning
DHPC Scenario Guide.
Choose a situation and build an educational communication pathway. The tool contains no free-text fields and collects no patient or company data. It teaches what to consider — it does not decide that a DHPC is legally required or generate an authority-ready communication.
Build the scenario
Use a generic training situation only. For real issues, follow your pharmacovigilance system, QPPV governance, regulatory procedure, authority instructions and approved SOPs.
Educational communication lens
Start with the safety objective.
No scenario analysed
A DHPC should not begin with “we need to send a letter.” It begins with the safety concern, the healthcare-professional action needed and the regulatory communication strategy.
First questionWhat patient risk could persist if current practice does not change?
Second questionWhich HCP can actually prevent or reduce that risk?
Safety ruleDo not use this educational tool to delay urgent safety action, regulatory reporting, escalation or contact with the responsible competent authority.
Focused learning curriculum
Eight focused learning chapters.
This topic is specialised. The objective is not to turn every employee into a DHPC specialist, but to help relevant pharmaceutical and healthcare stakeholders understand the public-health logic, governance and interfaces behind direct safety communication.
01
Why safety communication matters
Understand how communication quality affects risk minimisation, prescribing, dispensing, monitoring and patient protection.
Learn what makes a communication a DHPC and why it is distinct from promotion, routine education, medical information replies and ordinary company updates.
Work through safety-driven authorisation changes, major warnings, changed risk, reduced effectiveness, medication errors and important potential risks.
Learn how an effective DHPC makes the safety issue, affected population and healthcare-professional action easy to identify without promotional framing.
Identify the HCPs who need to act, and understand why the communication plan covers recipients, timetable, communication tools and dissemination channels.
Specialised, cross-functional — and ultimately clinical.
DHPC work is not “for everyone”, but it is also not owned by a single job title. It connects safety governance inside a pharmaceutical company with regulators and the healthcare professionals whose actions protect patients.
Company safety governance
Pharmacovigilance / QPPV
Safety issue interpretation, pharmacovigilance governance, regulatory context and consistency with the wider safety system.
Needs: deep DHPC / GVP understanding.Company regulatory interface
Regulatory Affairs
Authority procedures, product-information changes, submission/coordination steps and country implementation requirements.
Needs: procedural and product-specific depth.Clinical accuracy
Medical / Safety Physicians
Clinical meaning, affected population, practical recommendations and medically accurate explanation of the risk.
Needs: strong safety communication competence.Controlled process
Quality / Compliance
SOP interfaces, documentation, approved workflows, training and evidence that agreed processes were followed.
Needs: process-awareness rather than authorship in every company.Regulatory governance
EMA / National Competent Authorities
Regulatory assessment and agreement of safety communication content/plan under the applicable procedure.
Authority involvement is central to an official DHPC.Point of care
Doctors, Pharmacists & Relevant HCPs
The target recipients. Their ability to recognise the issue and apply the recommended action is the public-health reason the DHPC exists.
They need the right message — not every internal process detail.
Communication quality
What the healthcare professional needs to see.
A DHPC must be authoritative and practical. The exact official template and product-specific wording are agreed through the regulatory process, but the communication logic remains consistent: make the safety concern and required action easy to understand.
Illustrative anatomy — not a real DHPC
Safety message structure
Subject / medicinal productIdentify the product and safety issue clearly.
SummaryPut the critical safety information and healthcare-professional recommendation first.
BackgroundExplain enough context to support correct clinical interpretation without burying the action.
Recommended actionState what prescribers, pharmacists or other relevant HCPs should change or monitor.
Reporting / further informationPoint to approved reporting routes and official product information as applicable.
Objective, not promotional
Safety communication must not use the urgency of a risk message as a vehicle for product promotion.
Action before detail
A busy healthcare professional should be able to identify the practical implication quickly.
Correct audience
Target the professionals who prescribe, dispense, administer, monitor or otherwise manage the medicine/risk.
Consistent across channels
DHPC, product information and complementary safety messages should not create contradictory instructions.
Country-aware
Language, target groups and distribution channels may need national adaptation and authority agreement.
Traceable process
Real implementation should be governed by controlled company procedures and documented regulatory communication plans.
Official regulatory map
Always go back to the source.
dhpc.gr explains the logic for learning. For a real safety communication, use the current effective legal text, GVP, product-specific regulatory outcome, official DHPC/communication plan, national authority requirements and your controlled pharmacovigilance procedures.
EOF publishes Greek pharmacovigilance updates and Direct Communications to Healthcare Professionals. In 2026 its pharmacovigilance pages continue to publish product-specific “Απευθείας επικοινωνία προς επαγγελματίες υγείας” notices. For Greek implementation, always use the current EOF instructions and the product-specific authority-agreed communication rather than assuming that an EU-level target group, translation or distribution route can be copied unchanged. EOF HCP announcements ↗
Use safely
This is a learning resource, not a regulatory decision system.
The strongest protection against misuse is to make the boundary explicit.
Do not use dhpc.gr to make or delay a real patient-safety decision.The Scenario Guide does not determine whether a DHPC is legally required, approve wording, identify an exhaustive target population, set a regulatory deadline, authorise dissemination or replace medical/regulatory judgement.
For a real safety concern, escalate through the responsible pharmacovigilance/QPPV and regulatory process without delay.
Follow current competent-authority instructions, product-specific decisions, approved product information, RMP and company SOPs.
Do not enter patient, reporter, healthcare-professional or confidential company data into this educational page.
Emergency or urgent safety measures follow their own regulatory and clinical processes; this website must never be used as a reason to wait.
Regulatory requirements can change. Verify the current effective source before operational use.