Risk minimization measures and implementation

 Implementation of risk minimization measures 

In my earlier blog on Risk minimization measures (Apr 2026), we covered what risk is in PV and what routine and additional risk minimisation measures are. Today, we will see the implementation of these risk measures. Implementation drives the success of anything rather than only the idea itself.

Risk minimization measure:

To understand the implementation it's critical to understand the difference between messages and tools about RMM.

RMM messages	RMM tools
the key information (i.e. not the full wording) about the risk and the actions intended to be taken by the healthcare professional or the patient for minimising the risk	The tool by which the RMM messages are disseminated and adherence to the intended actions for risk minimisation is supported and/or controlled, belonging either to the category of routine or additional RMM tools.
Scientific content, but as per the targeted audience and platform e.g. HCP vs patients, Patients vs caregivers, and digital vs physical copies	Educational/Safety advice tools that include a patient alert card, an HCP checklist for the risk, HCP educational leaflet
No promotional language	Risk minimisation control tools that include HCP qualification, Hospital accreditation, traceability systems, patient certificates, and a systematic process for patient documentation in the product prescribing programs
The key messages should not be duplicative of Smpc or PIL . The main outcome we should achieve is that the educational advice to patients should be about the particular risk and its management.	To select the correct tool, the following criteria need to be considered: seriousness, severity of risk, patient target population, Healthcare professional target population for the RMM, product classification and details (dosing, administration, etc.), possible burden of the RMM on the healthcare system, and effectiveness of the RMM.

Once the RMM message is finalized, for the implementation the tool should be selected accordingly.

A. Develop the plan for implementation: Some questions/points that need to be answered are

•  Is the RMM implementated gloablly or locally?
• Who is the target audience?
• Ensure that while choosing the healthcare system and settings and the typical patient environments are considered.
•  RMM message should be considered for adequacy, comprehensibility of language, and usability as well as user-friendliness of the RMM material

B. Distribution plan:

• Who /Which functions will be leading the distribution globally and locally?
• Number or recipients as per the classification ( e.g. how many HCPs are subdivided into printed vs web form)
• Electronic and physical systems for the distribution (Webpage for HCP alert card distribution, patient enrollment database to monitor and archive tests)
• Map all the steps with start date and end date (if available)

It is critical to ensure the outcome expected from RMM and RMM tools is well thought out for patient safety and they should be supportive for achieving it rather than causing a burden of PV and healthcare systems. RMM tools and RMM messages are key to reducing the burden of risk by helping with prevention and early diagnosis and treatment.

Written by:

Dr.Shraddha Bhange.

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References:

GVP Module Risk Minimisation Measures