December 2024 • PharmaTimes Magazine • 22-23
// PHARMA //
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Revised additional risk minimisation guidelines – change for the better
As the pharmacovigilance landscape continues to evolve, the European Medicines Agency’s (EMA’s) revision of Module XVI of the Good Pharmacovigilance Practices (GVP) guideline is an important milestone.
The update, which was published at the beginning of August 2024, revises the framework for additional risk minimisation measures (RMMs), aligning them with emerging best practices in implementing, monitoring and evaluating drug safety measures, and provides updated definitions.
Background
GVP Module XVI was originally launched in 2014 to provide guidelines for additional risk minimisation measures to manage risks for certain medicines that cannot be managed through routine measures only, such as product labels and recommended use.
In cases where these routine RMMs were insufficient to maintain an acceptable benefit-risk ratio, additional RMMs are introduced to manage the risk more effectively.
These may include mandatory healthcare professional training, patient information cards, monitoring patient compliance, conducting specific tests or screenings for patients before and during treatment to ensure the suitability of the drug for them.
These measures have been integral to how we are able to introduce some new medicines into the market and monitor whether they are being prescribed and used safely.
The update
The widely anticipated Revision 3 of GVP Module XVI introduces changes to both the scope and application of risk minimisation measures.
There is a new emphasis on embracing behaviour changes and identifying barriers to change by healthcare providers and patients.
For example, if a patient needs to have a blood test every three months to continue using a certain medicine safely but isn’t able to do this, we need to know the reason to be able to support the patient to meet these requirements.
For healthcare professionals, they need to ensure that the patient doesn’t have a certain medical condition or doesn’t take concurrent medication that may interact with the drug and ensure that they check these things so the patient is able to take the medication safely.
This behavioural focus marks a proactive shift, aiming to improve compliance with safety protocols rather than simply providing information.
The update introduces a spectrum-based approach to monitoring effectiveness, which blends the process of implementing and monitoring the effectiveness of the additional RMM, for example, assessing whether safety communications were received, read and understood by the recipients, and outcome monitoring, which tracks whether the measures led to a reduction in adverse events that the measures aimed to prevent.
This updated approach ensures that the effectiveness of risk minimisation measures is assessed more holistically.
Recognising the widespread use of digital platforms, the update places greater focus on digital communication to deliver safety information effectively.
However, the update acknowledges that there are people who may lack access to digital tools.
Additionally, the update incorporates methods for monitoring the effectiveness of additional RMMs, including clinical evaluation and trend analysis, a technical epidemiological tool that examines safety trends over time and allows comparison of events before and after risk minimisation measures have been implemented to see whether certain adverse events have been reduced.
Adherence to additional RMMs is enhanced with alignment to clinical guidelines from organisations such as NICE.
Pharmacovigilance practices
The changes in Module XVI bring a range of advantages to pharmacovigilance practices and therefore have been broadly welcomed.
By refining the design and implementation of risk minimisation measures, the EMA encourages a shift to a results-oriented approach that ensures safety measures are effectively implemented.
By addressing potential behaviour barriers, we should see improved adherence to medicine regulations, which will lead to enhanced patient safety.
Our monitoring practices will be strengthened through clearer guidelines and frameworks for assessing effectiveness.
It is hoped that this will lead to earlier detection of issues and empower regulatory bodies and companies to act swiftly and adapt measures as necessary.
The application of trend analysis is especially key.
‘There is a new emphasis on embracing behaviour changes and identifying barriers to change by healthcare providers and patients’
This will be a powerful tool for assessing long-term risk minimisation measures’ effectiveness as it will assess whether they are genuinely effective in reducing adverse events and allow for timely adjustments if safety concerns persist.
Additionally, the focus on digital communications will streamline communication with the ways that most people are communicating these days, making it easier for regulators to reach healthcare professionals and patients quickly.
Pharmacovigilance professionals will be able to implement communication strategies that are more aligned with patient behaviours and access capabilities.
However, as we become more reliant on digital tools, as well as the implementation of AI in our working practices, we must use non-digital options where needed to ensure no patient group is excluded.
Final analysis
The EMA’s update to Module XVI strengthens medicine safety for patients through a greater focus on behavioural changes, comprehensive and robust monitoring, and enhanced communications.
In pharmacovigilance, we must plan to adopt these changes and embrace a more holistic approach to risk minimisation measures.
Professor Saad Shakir is Director of the Drug Safety Research Unit.
Go to dsru.org
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