3. What should be consulted when preparing the content of and assembling risk minimisation tools or programs?
When preparing the text of and assembling risk minimisation tools or programs, MAHs should observe the provisions of the below guidance:
· Guideline on good pharmacovigilance practices (GVP) Module XVI – Risk minimization measures: selection of tools and effectiveness indicators,
· Guideline on good pharmacovigilance practices (GVP) Module XVI – Addendum I – Educational materials,
· Guideline of the OGYÉI regarding the national implementation of risk minimisation measures (please see below).
As a general rule, risk minimisation measures should be prepared in Hungarian, independent of the final format of the tool. If the MAH wishes to deviate from this, a justification should be provided in the application, and OGYÉI will carefully investigate whether it is acceptable. If the risk minimisation tool is intended for patients, no other language is acceptable, but Hungarian.
Content not relevant for risk minimisation
It is particularly essential that the risk minimisation tool or program contains guidance about the concerned safety issue(s) only. Information that does not directly promote the safe use of the medicine (e.g. promotional elements or efficacy data) should not be included in the risk minimisation material. Information should be presented in a clear, plain and succinct manner, and should be adapted to the knowledge and characteristics of the target group (e.g. physicians or patients). In order to improve the quality of risk minimisation tools, OGYÉI may check the content of previously approved materials if submitted for an update, and may request the deletion of content irrelevant for risk minimisation.
In case of extensive risk minimisation materials there is a risk that the target group will not even read them, or that the main message is lost among too much information; therefore the drug safety message will not meet its goal. In order to enhance the effectiveness of the risk minimisation program, OGYÉI intends to rationalise the length of risk minimisation materials. The length of the patient cards, check lists, reminder cards, etc. should not exceed 800 words (approximately 2 pages), whereas in case of longer materials, following a short introduction of the medicine (a maximum of 400 words), specific safety issues should be addressed in a maximum of 400-400 words (approx. 1-1 page) per safety issue (per key element). The overall length of the risk minimisation material should not exceed 8000 words (approx. 20 pages). Please also keep this in mind when updating risk minimisation materials. When choosing font size, please consider appropriate readability of the text. The reason for deviating from the aforementioned length can only be based on the nature of the safety issue and a justification thereof should be submitted in writing to OGYÉI. Furthermore, in case OGYÉI notices redundant information in the risk minimisation material that does not closely relate to the safe use of the medicinal product, OGYÉI will not endorse the material until removal of such information.
Inclusion of product information in risk minimisation tools or programs
If any part of the product information is defined as a key element of the risk minimisation program or tool, that should be handed over to the patient or the physician, the risk minimisation material should contain the relevant product information. In case of extensive printed material, the product information may be disseminated on a pendrive or a CD for healthcare professionals. Patients should always be provided with hardcopies.
Otherwise, the risk minimisation material should not contain the product information as an annex; it is sufficient to include an electronic link in the material which refers the reader to an official website containing the product information. This website should contain product information that are approved by the authorities, and are effective, in a non-promotional environment (e.g. website of OGYÉI or EMA).
If the MAH would like to insert the logo of the company or the medicine in the risk minimisation material, these should appear only once, and should look exactly the same as it appears on the approved packaging of the medicine (e.g. outer carton). Other logos or slogans should not appear in the risk minimisation material. Tables or illustrations promoting easier understanding of the safety issue may be included if justified.
Graphical/visual items other than those submitted at the beginning of the procedure and approved by OGYÉI are not allowed to be included in the final material. This is the reason why it is important for the MAH to submit a mock-up or all planned graphical items already at the beginning of the procedure.
Inverted black triangle
If the medicine is subject to additional monitoring the inverted black triangle should appear beside the name of the medicine and the explanatory sentence should be included in footnote. Please click here to find out more on the implementation of the inverted black triangle.
Call for reporting of ADRs
If size of the risk minimisation measure permits it, it should contain guidance for healthcare professionals and patients how and where to report suspected side effects. As a general rule, please indicate contact details of OGYÉI first, but that of the MAH may also be included. It is important to distinguish clearly between the reporting requirements of cases resulting in an ADR and those without an ADR (please see below).
Click here to see an example on a call for reporting ADRs.
Collection of cases without an ADR
During the use of medicines, some incidents may happen that are not accompanied by the development of ADRs, but the collection and the assessment of such cases is still relevant for patient safety (e.g. medication errors, misuse, drug exposure during pregnancy, off-label use, etc.). These cases should be collected by the MAH and not by the national competent authorities. Therefore, only contact details of the MAH are acceptable in relation to the collection of such cases.
Click here to see specific examples of call for reporting of events of special interest accompanying medicine use without any ADRs.
Contact details of the MAH
As several questions may arise either from healthcare professionals or patients in relation to a risk minimisation material, please always include contact details where these questions are addressed by the MAH. This should be a Hungarian availability. A foreign address or phone number can only be included in the material if well justified, and approved by OGYÉI.