DHPC: direct healthcare professional communication
A direct healthcare professional communication (DHPC) is a letter agreed with authorities that alerts prescribers and pharmacists to urgent safety issues.
DHPCs are described in GVP Module XV on safety communication. They are sent by the marketing authorisation holder, or occasionally by the authority itself, when healthcare professionals need to act on new safety information: a product suspended, withdrawn or revoked for safety reasons, a new contraindication or restriction of indication, a change to the recommended dose, a new serious risk, a quality defect with clinical consequences, or a shortage that requires patients to be switched. Routine SmPC updates do not warrant one.
The content and the recipients are agreed before anything is sent. For centrally authorised products, and for products in a referral or PSUSA, the text is agreed with EMA and the PRAC; for national, MRP and DCP products it is agreed with the national competent authorities, with the RMS coordinating in MRP and DCP. The holder submits a draft DHPC and a communication plan that states who receives the letter, in which countries, through which channels and when. The DHPC follows a standard structure: a headline summary, the background to the safety concern, the recommended actions, a call for reporting of adverse reactions and the contact details of the holder.
Each Member State may require translation into its language and adaptation to local practice, such as the wording on how to report. Many authorities publish the final DHPC on their websites, and EMA publishes DHPCs for centrally authorised products. A DHPC often accompanies a Type II variation or a safety referral outcome, so the product information change and the letter should be planned together.
What goes wrong: national versions that drift from the agreed text, which creates inconsistency across countries that a referral may then have to fix; letters that go out before the authority has agreed them; mailing lists that reach the wrong specialties; a communication plan without a date for the SmPC update, so prescribers receive a letter that the product information does not yet support; and the failure to issue the same DHPC in every Member State where the product is marketed. Holders also underestimate the time needed for translation and national review in a multi-country dissemination.
Timing
GVP Module XV does not set a single statutory deadline; the authorities set the schedule case by case according to urgency. In practice the holder submits the draft and communication plan, the lead authority reviews it and agrees the text within days for urgent issues, and national dissemination follows on dates fixed in the plan. In a referral or PSUSA the DHPC is dispatched on a date agreed with the CMDh or the CHMP, usually in the weeks after the outcome is published.
Used in
Safety and regulatory teams keep each country's DHPC version, dispatch date and recipients in one record in Atlas.
Related terms
- PRAC: Pharmacovigilance Risk Assessment CommitteeThe PRAC is the EMA committee that assesses the safety of human medicines in the EU, from risk management plans and PSURs to signals and safety referrals.
- USR: urgent safety restrictionAn urgent safety restriction (USR) is a provisional change to a medicine's product information imposed at once because of a risk to public health.
- Referral: EU-level assessment of a disputed or safety issueA referral is an EU procedure that resolves a scientific or regulatory issue about a medicine, or a class of medicines, in a single EU-level assessment.
- Signal detection: identifying new safety information from pharmacovigilance dataSignal detection is the process of finding information that suggests a new or changed causal link between a medicine and an adverse event.
- SmPC: summary of product characteristicsThe summary of product characteristics (SmPC) is the approved document that tells healthcare professionals how to use a medicine safely and effectively.
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