Risk Minimisation Methods

The ISoP Special Interest Group on Risk Minimization Methods (SIG Rmin)

The SIG Risk Minimization Methods (for Asian countries) was officially announced at the Prague General Assembly, in October 2015, during the 15th ISoP Annual Meeting in Prague (Czech Republic). The SIG Rmin Asia is pleased to share the poster which was presented at the Annual Meeting in Prague (Abstract P 046 – Drug Safety Abstracts book – Vol 38, No 10); click here

Founded in 2015, chaired by Prof. Hervé Le Louët (former president of ISoP and President of CIOMS), this SIG is a global group with a focus on the very diverse and fast developing Asian region.
The mandates of this SIG are to:

• Provide a forum to exchange experience on risk minimization methods, tools, and operational practices with a focus on Asian countries
• Elaborate an array of solutions for risk-based Risk Minimisation Interventions (RMIs) which can be operated in an array of counties with diverse health care systems
• Engage into the development of affordable solutions using mobile devices, capable of raising awareness on the adequate use of medicines and/or support Risk Minimisation Interventions
• Develop training materials to promote the deployment of those solutions elaborated by the group
• Communicate about those solutions and advocate for their deployment in the different sub-regions of Asia and beyond

After analysing the array of risk minimisation practices applied in different Asian countries, and developing a comprehensive model of Post-Approval Vigilance Program (PAVP), the SIG Rmin Asia engaged into a Delphi study program conducted by Prof Yola Moride. This study is aimed to determine the circumstances that should lead to consider implementing a Risk Minimisation Intervention (RMI), and determine their degree of stringency in consideration of the characteristics and capability of the health care system.

To overcome the lack of literature available on such criteria, conducting a preliminary interview phase proved to be necessary to collect the practice of experienced experts involved in risk management planning activities. The pre-Delphi interview phase being now completed, the core component of the Delphi study can start, involving a minimum of 25 responding panelists from wide range of Asian countries with diverse health care systems.

In parallel, members of the SIG Rmin Asia are developing as a satellite project, the Aspidium App: a versatile application for smartphones intended for patients and health care professionals. This App is aimed to enhance the impact of routine risk minimisation, or support educational RMIs for specific products including generics. This App is capable of hosting contents for multiple products. The supporting platform is designed to be customised and deployed on a per-country basis. (Poster #81, 17th Annual ISoP Meeting, Liverpool, October 16th, 2017)

Would you like to join or learn more about this group? Contact us at administration@isoponline.org