Risk minimisation is a topical talking point in the world of pharmacovigilance with the introduction of GVP Module XVI Risk minimisation measures (Rev 3) and Addendums I and II in 2024/2025.

The recent DIA Risk Minimisation Measures training course provided a useful forum for discussing the updated guidance and how this impacts current practice.

Throughout the training there were insightful discussions on designing the tools for risk minimisation (additional risk minimisation measures [aRMMs]) and their dissemination, implementation, and evaluation. These are my take home messages.

Designing the risk management strategy

Understanding the objective of the risk minimisation and how this will be achieved throughout the patient journey lays the groundwork for presenting the intended outcomes.

The risk management strategy is a collaborative effort and the importance of early dialogue both internally and with the regulators is a helpful step when planning.

Understanding enablers and barriers to behaviours both to the individual and healthcare system are key when developing a risk management strategy. Early engagement with healthcare professionals and patients is recommended to support decision making.

The advancement of technology and what this means for risk minimisation was a key discussion point with the use of digital tools for risk minimisation increasing.

The aRMM should be tailored to the target population with consideration of any special requirements specific to that population. aRMMs should not be promotional.

Where multiple companies are involved, collaborations are helpful for providing joint aRMM.

Dissemination

Clearly thought through and tailored dissemination is important. The same healthcare systems are not in place for every Member State and should be taken into account.

Implementation

The implementation pathway for selecting, tailoring and evaluating aRMMs should be thoroughly contemplated with contributions from regulatory authorities, marketing authorisation holders (MAHs), healthcare professionals and patients.

Timely implementation is important taking into account the expected marketing of the medicinal product in individual Member States.

Evaluation

All aRMM should have clearly defined intended outcomes including whether the aRMM reached the target population, whether the target population understood and took the intended actions, and whether this resulted in an overall reduced incidence or severity of the adverse reaction or reduced the adverse impact on the patient or public health (health outcomes).

Unintended outcomes should also be considered including the undue burden of the aRMM on the patient, healthcare professional or healthcare system and/or unintended changes in the use of the medicinal product.

Evaluating the effectiveness of aRMMs is recognised to be challenging. Traditional post-authorisation safety studies (PASS) that evaluate dissemination, knowledge and behaviours can be time consuming and the data sometimes difficult to interpret.

Digital tools can be beneficial in helping to evaluate the effectiveness of aRMM as their integration into risk minimisation increases.

Conclusion

Risk minimisation needs to be fit for purpose – achievable and without unnecessary burden on healthcare professionals and patients. Incorporating early input from key stakeholders and understanding intended and unintended outcomes are helpful initiatives to reduce the risk to the patient. MAHs and regulatory authorities need to work together to achieve this.