6. Direct healthcare professional communication. Communicating medicines safety information directly to healthcare professionals: an introduction to DHPC

The general process of a DHPC can be described in seven steps which are followed by EMA and the national competent authority (NCA):

1. Request or initiative: The EMA or an NCA can request a DHPC. The MAH may also take the initiative to disseminate a DHPC. In both cases, the MAH should seek the agreement of the relevant NCA or the EMA regarding the DHPC prior to dissemination.

1. Preparation of the draft DHPC: The MAH prepares a draft DHPC using a template provided by the EMA. Where there are several MAHs of the same active substance for which a DHPC is to be issued, usually a single consistent message should be delivered. The template  reflects the EMA guideline. It contains extensive details for the type of content, style and layout.

1. Preparation of the communication plan: The MAH prepares a communication plan including the intended recipients and the timetable for disseminating the DHPC. Involvement of healthcare professionals organisations or scientific societies is advised to better target audiences and improve future dissemination.

1. Submission to regulatory authorities: The MAH submits the draft DHPC and the communication plan (including the intended recipients and the timetable for disseminating the DHPC) to regulatory authorities according to the route of authorisation previously taken for the medicinal product. The regulatory authority should coordinate the review process by its scientific committees.

1. Evaluation and authorisation: The EMA will coordinate the review of DHPCs within its scientific committees/groups as appropriate. Once the content of a DHPC and communication plan from the MAH are agreed by national competent authorities or the EMA, they should exchange the final DHPC and communication plan using the Early Notification System (ENS)*, and the EMA should coordinate any subsequent safety announcement.

1. Dissemination: Typically, it is the responsibility of the MAHs to disseminate the DHPC. However, a competent authority may disseminate a DHPC in any situation where it considers that it is necessary for the continued safe and effective use of a medicinal product. The DHPCs are always disseminated in national languages. When medicinal products have been authorised at the EU level or consecutively in different member states, the DHPC proposal is prepared in English. Once the text of the DHPC is agreed, the MAH will prepare translations in the official national languages. The MAH is responsible for giving feedback about the dissemination of the DHPCs. The competent authorities need to be informed on the efficiency of the dissemination and on any difficulties met in the process.

1. Publication: The final step is the publication of DHPCs. EMA and NCAs may also decide to publish the final DHPC and disseminate it to relevant healthcare professionals’ organisations.

* The purpose of the ENS is to notify the European Union (EU) regulatory network (European Medicines Agency [EMA], National Competent Authorities [NCAs] and the European Commission [EC]) and international partners of emerging safety issues for which regulatory action and communication are envisaged. Notification is given every month in advance of the Committee for Medicinal Products for Human Use (CHMP) meeting. Before the end of the CHMP meeting, the completed communication material is disseminated within the EU regulatory network and to international partners prior to publication on the EMA website.