H-1051 Budapest, Zrínyi u. 3.

Tel.: (1) 8869-300, E-mail: ogyei@ogyei.gov.hu

Mail: 1372 P.O. Box: 450.

MAGYAR

Direct Healthcare Professional Communication (DHPC)

Direct Healthcare Professional Communications (DHPCs), which prompt about significant new drug safety information that influence the benefit-risk balance and/or the conditions of use of medicinal products require urgent dissemination. Marketing authorization holders (MAHs) are obligated to deliver this information without delay, in an efficient manner, directly to healthcare professionals.

We would like to provide applicants with detailed guidance below on the implementation of additional risk minimisation tools and programs in Hungary in a Question and Answer format

Guidance to the MAHs is provided below in a Question and Answer format about the national and international requirements of the preparation of DHPCs.

1. When is dissemination of DHPCs required?

The DHPC is an important notification that draws the attention to a newly identified drug safety concern already before the update of Product Information and provides recommendation on how to manage it. Guideline on good pharmacovigilance practices (GVP) Module XV – Safety communication lists the circumstances when the dissemination of DHPC is mandatory or needs to be considered.

Due to its importance, DHPCs should be reserved for the circumstances listed in the module. MAHs are requested to abstain from communication of commercial decisions concerning marketing of medicinal products via DPHC (e.g. market launch), and from using DHPC as a cover letter (e.g. accompanying the distribution of educational materials).

2. What to do if the concerned medicinal product is not marketed in Hungary?

If the medicine concerned by the DHPC is not marketed in Hungary, the Hungarian translation should still be prepared and submitted to the Institute for approval. The approved Hungarian translation will be published on the Institute’s website. This new approach follows recent changes in the publication of DHPCs on the Institute’s website. Currently DHPCs appear assigned to medicinal products rather than exclusively as a single list. Thus, if DHPCs were not published for non-commercialised medicinal products this could suggest a false impression that the product is not associated with any safety concern.

Nevertheless, dissemination of the DHPC is required only if the concerned medicinal product is administered to at least one patient in Hungary. Pertinent information should be submitted to the Institute beforehand. In case no patient receives the medicinal product, the dissemination will be deferred to a date when the product becomes available, or it will not be necessary if the changes have already been implemented in the product information by the time of market launch. The MAH should inform the Institute about it. If the medicinal product is not marketed in Hungary, but it is administered to patient(s), the dissemination of the DHPC and the determination of the target population are subject to a case-by-case evaluation.


3. What to do if several MAHs are involved simultaneously?

If several MAHs are involved in the process (e.g. the subject of the DHPC is a drug interaction, or it refers to a group of drugs or numerous generic medicinal products contain the concerned active substance), the possible confusion originating from the fact that healthcare professionals received several letters with different content from various MAHs should be avoided. Therefore, in this case, the aim is the dissemination of a single DHPC. It is the explicit request of the Institute that in these cases the MAHs liaise with each other and a single DHPC is distributed to healthcare professionals. The Institute has to be informed about the cooperation, because in case of an inspection any MAH should be able to prove that they complied with their obligation to disseminate the information.

4. What requirements apply to DHPC dissemination?

DHPCs can be disseminated via various channels (e.g. via email, postal letter or packed together with professional journals for healthcare professionals). MAHs should consider what the most efficient way to cover the entire target population concerned is; nonetheless, combination of various communication channels can also be applied. The actual receipt and its rate should be demonstrated to the Institute in each case. The Institute expects a proven rate of receipt of at least 75% in the total target population (and if it is highly diverse then this level should be reached in each target group, respectively). The data concerning the effectiveness of dissemination must be submitted to the Institute via adr.box@ogyei.gov.hu within 2 months after initiation of the dissemination. In case of a receipt rate lower than 75%, the causes thereof should be investigated by the MAHs and in consultation with the Institute corrective actions may be required.

Furthermore, the Institute requests that MAHs indicate the sentence 'Important drug safety information' on the envelopes or in case of electronic delivery, in the subject of the email of the DHPCs intended for dissemination;thus,facilitating its easier differentiation from other correspondence, and at the same time it is ensured that more healthcare professionals read its content.

5. How DHPCs should be submitted for approval and what documents need to be attached?

The proposed text, the target population, way and date of dissemination of the DHPC should be approved by the Institute in advance. To ensure quick and efficient processing of the request for approval, the communication package should be sent to the following email address:adr.box@ogyei.gov.hu. The communication package should include the followings:

· draft DHPC(i.e. the text intended for dissemination) in Hungarian and in English inwordformat and if applicable, allannexed materials(e.g. modified product information);

· communication plan that contains

o the timetable(e.g. deadline for comments, approval of translation and final letter, DHPC distribution and follow-up)

o the proposal regarding thetarget group(s) of healthcare professionalsand

o the proposed ways of dissemination;

· other related documents, if applicable (e.g. press releases);

· draft plan for thepost-communication strategyand the intended way to assess the effectiveness of the DHPC, if applicable;

· the contact details of the person submitting the DHPC;

· information on whether the medicinal product is marketed in Hungary or it is administered to any patient.

Please always indicate in the request that as part of which obligation you seek approval.

Regarding the preparation and wording of the DHPC, the MAHs should follow the guidance provided in theGuideline on good pharmacovigilance practices (GVP) Module XV – Safety communicationand theDHPC templateincluded in its annex.

The Institute approves the communication package within the deadline included in the communication plan and provides suggestions for modifications if considered necessary.

6. Are MAHs required to notify the Institute about the dissemination of the DHPC separately?

The MAH is obliged to notify the Institute on the exact start date of dissemination prior to or simultaneously to the launch of the DHPCs. Furthermore, the MAH should return a final, signed copy of the DHPC in pdf format to the Institute via an email sent to adr.box@ogyei.gov.hu. The Institute will also publish the final, signed DHPC letter on its website on the first day of dissemination.

7. Where can queries be placed on DHPCs?

Any further questions regarding the preparation or management of DHPCs may be sent to adr.box@ogyei.gov.hu.

Last updated: 2019.01.14 17:51