XVI.B.2. Categories and tools of risk minimisation measures
XVI.B.2.1. Categories of risk minimisation measures and their relationship
In terms of the tool, RMM can be categorised into routine (see XVI.B.2.2.) and additional (see XVI.B.2.3.) RMM.
The SmPC is the fundamental routine RMM tool, where the risk of the medicinal product and the intended actions for risk minimisation are described. As such the SmPC forms the basis for the descriptions of the risk and the intended actions in the package leaflet and for other routine RMM and, where required, additional RMM.
Where applicable, the SmPC should mention that additional RMM materials exist for a specific risk and may include information where they can be accessed. If an additional RMM material is targeted at patients, the package leaflet should contain information on the availability of this material and may include accessibility information too.
Additional RMM tools are meant to emphasise the information on the risk and the intended actions for risk minimisation contained in the SmPC and to support and/or control the adherence to the intended actions.
XVI.B.2.2. Tools of routine risk minimisation measures
Routine RMM tools are those which apply to every medicinal product; an exception are visual enhancements and special warnings/information on precautions on the packaging which are routine RMM tools that are not needed for every medicinal product and have to be specifically included in the marketing authorisation if required (see XVI.C.1.1.).
Routine RMM tools include those listed in Table XVI.1. and are detailed in XVI.Appendix 1.
Further, the pharmaceutical form or formulation of a medicinal product may play an important role in minimising the risk, e.g. in minimising the risk of incorrect dosing or administration, misuse or abuse.
XVI.B.2.3. Tools of additional risk minimisation measures
A variety of additional RMM tools are available for use on their own or in combination. Two additional RMM tools can also be merged into one RMM material as part of tailoring where this is relevant to the target population (see XVI.B.4.1.).
Additional RMM tools are sub-categorised as follows:
- Educational/Safety advice tools; and
- Risk minimisation control tools.
Other tools can become additional RMM tools if they meet the definition of RMM (see XVI.A.1.1.).
XVI.B.2.3.1. Educational/Safety advice tools
Educational tools, or synonymously safety advice tools, target either patients or healthcare professionals with the RMM messages and are meant to support adherence to the intended actions for risk minimisation. Educational/Safety advice tools for healthcare professionals may also be intended to support the dialogue with the patient about the risks and intended actions for risk minimisation.
Educational/Safety advice tools include those listed in Table XVI.2. and are detailed in XVI.Appendix 2.
XVI.B.2.3.2. Risk minimisation control tools
Control of adherence to the intended actions for risk minimisation may be facilitated by additional RMM tools which aim at ensuring the necessary healthcare support to patients for using the medicinal product safely, the prevention of diversion of the medicinal product and/or the traceability of the medicinal product. Such risk minimisation control tools are intended for application in one or more healthcare settings, depending on whether the required control concerns the step(s) of prescribing, distribution, dispensing and/or administration of the medicinal product and where these steps occur in the given healthcare system.
Risk minimisation control tools include those listed in Table XVI.3.
In practice, each risk minimisation control tool may need, for its implementation, several RMM materials (e.g. for healthcare qualification as a tool, materials for training and qualification and a qualification certificate form will be needed; or for traceability, a set of forms will be needed for completion by the different distribution points; or for documented information exchange as a tool, forms will be needed to be completed by different healthcare professionals).