The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) released the final guidance on Good Pharmacovigilance Practice (GVP) Module XVI Risk Minimization Measures Revision 31 and Module XVI Addendum II – Methods for Evaluating Effectiveness or Risk Minimization Measures2 on August 5th, 2024. These documents were made effective on August 6th.
Concerning Module XVI Risk Minimization Measures Revision 31,
The following key points were addressed:
- New RMM terminology – Risk Minimisation Measure (RMM), as a term has two components:
- Tool: Routine or additional RMM (aRMM) that delivers a certain message
- Message: Information on the risks and the intended action for the risk minimisation
- RMM material: an individual RMM with full wording as approved by the relevant competent authorities
The following terms were adapted:
- Educational/Safety advice tools – A step away from the “Educational” term. Member states may choose the most applicable term in their local language, to ensure a better engagement with the communities.
- To make sure Healthcare Professionals (HCPs) are following the safety advice, there are Risk Minimization Control Tools - this is what has been previously called ‘’Controlled Access’’. However, it’s not about controlling the access. The aim is to ensure that the RMM is properly adhered to.
- The Risk Awareness Form is now called Risk Awareness Dialogue Form/Aid, highlighting that it’s not a consent form but a checklist for the HCP to improve the dialogue with the patient around the risk.
This guidance may not be immediately applied to existing aRMM. Nonetheless, it should be considered when new aRMMs (or amendment of existing ones) need to be implemented, especially if it is likely to increase the RMM effectiveness, without jeopardizing its familiarity for patients and HCPs using the concerned medicinal product.
Concerning Module XVI Addendum II – Methods for Evaluating Effectiveness or Risk Minimization Measures2
The following key points were addressed:
- Guidance on choosing the relevant data sources
- Patient-reported outcome and patient-reported experience measures were included as behavioral outcomes
- Guidance on how to define thresholds for success or failure (a priori and case-by-case basis)
In terms of RMM effectiveness post-authorization safety studies’ schedule there are now two time points:
- Initial evaluation within 12-24 months after regulatory implementation to allow for sufficient time and the possibility of the necessary changes in healthcare.
- Again within 4 years to assess the overall effectiveness and if applicable to provide the evidence for the time of the renewal of the marketing authorization.
It was also clarified that objectives of RMM effectiveness evaluation, the intended outcomes of the RMM should be assessed at three outcome levels:
1. Dissemination and Knowledge outcome 2. Behavioral outcom 3. Health outcome
Evaluating RMM effectiveness is a multidisciplinary approach that combines qualitative and quantitative methods to look at how RMM are disseminated to assess risk knowledge, behavior and health outcomes. There is no one-fits-all methodology at the concepts provided in GVP XVI. These need to be applied on a case-by-case basis.
References:
- European Medicines Agency and Heads of Medicines Agencies, Guideline on good pharmacovigilance practices (GVP) – Module XVI (Rev 3) EMA/204715/2012 Rev 3 of 26 July 2024 https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-good-pharmacovigilance-practices-gvp-module-xvi-risk-minimisation-measures-rev-3_en.pdf
- European Medicines Agency and Heads of Medicines Agencies, Guideline on good pharmacovigilance practices (GVP) – Module XVI Addendum II EMA/419982/2019 of 26 July 2024 https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-good-pharmacovigilance-practices-gvp-module-xvi-addendum-ii-methods-evaluating-effectiveness-risk-minimisation-measures_en.pdf
