At our 2023 forum in Cambridge, UK, we gathered with c.40 global drug safety leaders and cross-industry experts to explore the transition from compliance to value in drug safety.
Here’s what we learned.
A practising physician highlighted to the forum attendees how pharmaceutical risk minimisation (RM) tools and safety monitoring are often burdensome for healthcare professionals (HCPs) and, therefore, challenging to comply with, which can result in missed important investigations and patients potentially not receiving the treatment they need.
As risk management professionals, we should seek to understand the environment and needs of the end users better and involve them in the design and pre-launch evaluation of the RM interventions we create. There are many opportunities to do this, including co-creation activities and iterative testing, which can be carried out quickly and cost-effectively through digital platforms designed to capture feedback from potential users – an option described by Axian here.
In addition to improving the quality of our interventions, patient feedback should also play a key role in shaping our interactions with regulatory bodies. Our National Competent Authority (NCA) colleagues are increasingly open to exploring new methods of communicating risk information when these methods have supportive evidence on end-user (patient or HCP) preference and end-user input to designing interventions.
We explored the potential for innovation in risk management interventions in a discussion focussed on educational materials. It underscored that patients tend not to differentiate between RM materials such as brochures and patient cards and the other materials they may receive about their therapy or disease. They often get this information from multiple sources.
Given the variability of available information from sources outside the pharmaceutical industry, it is incumbent on pharmaceutical companies to provide user-centric and reliable sources of factual information about safe use, ideally accessible via multiple channels. To achieve this, we should prioritise collaboration to align our messaging and integrate communication planning cross-functionally to create assets to keep patients safe.
Continuing with our cross-functional perspective, we learned about the principles underpinning the communications created by Medical Affairs functions that have successfully embraced digital and value-driven models. From developing risk management strategies to deploying RM measures in the market, we concluded that greater cross-functional collaboration with Medical Affairs would benefit all concerned.
We also explored possibilities for harmonising EU and US risk management programmes, which may be catalysed by pharmaceutical companies’ desire for consistency, efficiency and cost savings, along with the increasing demands for routine evaluation of effectiveness in the EU. This harmonisation would require a shift from a regional ownership and operational mindset towards a collaborative strategic perspective focusing on lifecycle benefit:risk management and creating a “Core Company Position” for risk management, before deciding how this translates into a US REMS (Risk Evaluation and Mitigation Strategies) or an EU aRMM (additional Risk Minimisation Measure).
Our panel session on risk management challenges associated with ATMPs (Advanced Therapy Medicinal Products) highlighted how this area could act as a useful test bed for innovative and holistic approaches to risk management, including long-term patient follow-up using digital channels. The ATMP field offers abundant potential for companies to engage with regulators on any innovation in risk and quality management and the opportunity to learn from other related sectors, such as medical devices, where more practical solutions may already exist. It also highlights the need to standardise solutions for well-established risks across a class to avoid overburdening end users.
The ultimate goal of many risk management interventions is to influence the behaviour of an HCP or a patient, which could range from requiring HCPs to include additional tests as part of their care to strict avoidance of pregnancy for patients on potentially teratogenic drugs.
In our session on behavioural science, we examined the gap between the provision of information and the associated desired action. We explored some of the behavioural science theories and frameworks that can help us to improve the design of risk management interventions that are more likely to deliver the desired actions and ultimately improve overall outcomes.
In the context of the forum themes of better internal collaboration and greater HCP and patient involvement in the design of risk management interventions, it is perhaps time to apply these theories to ourselves to help bridge the gap between what we know needs to be done and taking action to change what we do.
Contact us to find out more about Working Groups, next year’s forum and other events at firstname.lastname@example.org