XVI.B.4. Developing materials and dissemination plans for additional risk minimisation measures

Additional RMM, the related materials and dissemination plans need to be developed for implementation at national level (see XCI.C.3.1.). To improve implementability and support the implementation of RMM, the development of the materials and the plan may consider, where available input from patient and healthcare professional representatives (see XVI.B.1.2.) and formative evidence on RMM effectiveness and context (see XVI.B.1.3.). RMM materials and activities for their development should be non-promotional (see XVI.B.1.5.).

XVI.B.4.1. Tailoring of materials to target populations

A target population (see XVI.A.1.4.) should be defined for each additional RMM tool required for a medicinal product. RMM materials should be tailored to the target populations, to facilitate the achievement of the intended outcomes (see XVI.B.1.2.). The tailoring should take into account how the RMM materials can support that the actions intended for risk minimisation are taken in the given healthcare system and settings and the typical patient environments, in particular through integration of the intended actions in healthcare processes and home routines. Tailoring in terms of adequacy, comprehensibility of language and usability as well as user-friendliness of the RMM material (see XVI.B.4.1.2.) is specifically relevant for special populations using medicinal products, and the guidance in the communication sections in the Product- or Population-Specific Considerations chapters of GVP are applicable for additional RMM materials.

For additional RMM materials targeted at patients, the guidance provided in the Guideline on the Readability of the Labelling and Package Leaflet of Medicinal Products for Human Use12 should be followed as far as applicable by analogy.

XVI.B.4.1.1. Information items in the materials

The information in additional RMM materials should follow the principles of safety communication (see GVP Module XV) and contain the following tailored information items:

• Name of the RMM tool (see XVI.B.2.) as the heading of the additional RMM material;
• Name of the medicinal product as part of the heading, i.e. the invented name and, in brackets, the name of active substance (for a material which refers to more than one medicinal product, see XVI.C.2.2.); in the subsequent text of the material, the invented name should be used as rarely as possible;
• Statements clearly summarising the nature of the risk and specifying the actions to be taken by healthcare professionals or patients to minimise the risk and use the product safely (where warranted, additional RMM materials may elaborate and contextualise the actions for risk minimisation described in the routine RMM materials or present their RMM messages in a different way by using tables, graphics or other visualisations and enhancements);
• Reference to the SmPC or the package leaflet with a reminder to carefully read the SmPC or package leaflet (this may also contain a reference to the SmPC or package leaflet on the website of the competent authority as applicable);
• Statement explaining that the RMM material fulfils the conditions of the marketing authorisation and has been approved by the competent authority, including the version number and the date of its approval in the format “ ” on the first and/or last page.

National tailoring of RMM materials (see XVI.C.3.1.) may require further information items.

XVI.B.4.1.2. User-testing

Marketing authorisation holders are encouraged where possible or may be required where considered necessary by the competent authority, to user-test draft additional RMM materials with patient and/or healthcare professionals in local contexts (see XVI.B.1.4.). Such user-testing should investigate the materials’ adequacy (e.g. for the target populations’ settings and their circumstances), comprehensibility and usability (so that diverse patients/healthcare professionals can correctly understand the risk information and identify the actions to be taken for risk minimisation), as well as their user-friendliness (e.g. colours, font type/size, typography, layout, bullet points, summary and table of contents in the case of longer guides for risk minimisation).

Methods for user-testing should build on those established in the areas of e.g. health literacy, risk perception and communication, patient preferences, human factors and implementation sciences. These include testing of draft materials in survey, focus group and scenario-based study designs.

Any interaction with patients or healthcare professionals in this context must not be of any promotional nature to any extent or include any promotional element see (see XVI.B.1.5.).

XVI.B.4.2. Dissemination plans

Dissemination is a crucial step to be optimised along the implementation pathway of RMM (see XVI.B.1.3.), to reach the defined target populations with the RMM materials in their respective healthcare settings and environments. Therefore, marketing authorisation holders should develop and submit plans for the dissemination of additional RMM for approval by competent authorities at national level. These dissemination plans should specify the RMM materials, the target populations, timeframes of (re)dissemination, and, if applicable, the use of supportive dissemination channels for the RMM messages, e.g. healthcare professional or patient organisations, scientific journals and conferences, clinical guidelines, point-of-care aids and training activities (see XVI.B.1.3.).

The timeframes of (re)dissemination should ensure the timely and continuous availability of (amended) RMM materials at healthcare and patient level as a prerequisite of sustainable RMM effectiveness. In the case of long-term treatment, processes for periodically repeated delivery of educational/safety advice materials to a patient may be necessary.

If amendments to additional RMM materials or new RMM have been agreed (see XVI.B.6.), a national dissemination plan to replace the existing with the amended materials at the level of the target populations or to disseminate new RMM should be established by the marketing authorisation holder, agreed with the competent authority at national level and be implemented accordingly.

For the content and format of dissemination plans and supportive communication interventions, templates (see GVP Annex II) and guidance on safety communication (see GVP Module XV) may be applicable as such or by analogy.

XVI.B.4.2.1. Direct healthcare professional communications

A direct healthcare professional communication (DHPC) is a safety communication tool (see GVP Annex I) and may be required to support the dissemination of additional RMM and the implementation of the intended actions for risk minimisation in healthcare, in particular when launching a new or amended additional RMM for a medicinal product. If such DHPC is required, it should be included in the RMM dissemination plan (see XVI.B.4.2.) and the guidance on DHPCs in GVP Module XV should be followed.