Your company wouldn’t launch a new product and wait for the end-of-year results before assessing whether the launch strategy was effective, correct? In fact, the process most pharmaceutical product managers employ includes weekly measurement of prescription volume, tracking product inventory, assessing distribution patterns of promotional materials, measuring knowledge/attitude/practices of prescribers, and adjusting marketing activities to achieve success.
So why would tracking and adjusting risk management activities be any different? FDA requires an assessment of REMS performance at intervals no less frequently than 18 months, 3 years, and 7 years post launch. What are you doing before and between formal assessments to actively manage and maximize the effectiveness of the REMS? Perhaps benefit-risk managers would benefit from adopting some of the effectiveness management techniques of our product management colleagues. Here are some examples to consider:
- Performance; No Excuses. The CEO of a pharmaceutical company adopted “Performance; No Excuses” as a core value of the organization. Do we as benefit-risk managers have the same commitment to manage the REMS program to achieve the effectiveness targets…no excuses?
- Engineer Customer Experience. Our marketing colleagues understand that customers will more readily adopt new products if their first few experiences with using it are favorable. As benefit-risk managers, one opportunity to improve REMS adoption and effectiveness is to orchestrate a favorable experience for clinicians and patients as they adopt and implement the REMS.
- Promote REMS. Products are “promoted” to increase awareness, interest, and adoption. Don’t we want to do the same for a REMS? Many REMS will not achieve their effectiveness targets if the only activities conducted to implement the REMS are those that were explicitly specified in the REMS document and commitment to FDA. Effectiveness can be enhanced by creating a communications campaign to promote and supplement the core REMS program.
- Rapid, Frequent Measurement. If we’re formally committed to achieving REMS effectiveness targets, we need to define and measure interim indicators of REMS performance early after REMS launch and frequently thereafter. Measures may include stakeholder awareness, % completion of communications, number of targeted physicians contacted, and usability feedback. Doing so may identify performance gaps that can be addressed with other activities.
- Continuous Improvement. FDA regulations make it challenging to update the REMS document and REMS materials/tools frequently or rapidly. But it is possible to frequently and continuously improve the communications activities that promote and supplement the REMS in order to enhance awareness, improve the customer experience, and ultimately drive adoption and effectiveness.
REMS is a commitment to patient safety. We can’t afford to wait to find out if we’re being effective. Measuring frequently and adjusting non-REMS elements early is our opportunity to maximize performance.