Your MLR-friendly medication adherence software
As pharmaceutical companies embrace digital platforms to become more agile and connect with patients in a rapidly changing market, it becomes imperative to also improve efficiencies and evolve long and (often) complicated processes used to review, approve, and submit promotional material subject to regulatory compliance. With more programs moving to a digital space, making sure that content within those communication channels must also pass muster through appropriate review process, and some companies are helping to advance this process with greater efficiencies and innovation.
What is MLR? the medical, legal, and regulatory review (MLR) process ensures that all pharmaceutical product promotions are medically accurate and comply with FDA regulations and other applicable laws. This process is carried out within pharma companies by the regulatory affairs and legal departments in conjunction with medical affairs (medical staff). All educational, technical and promotion materials are reviewed. Some companies may also refer to this as MRL, MAP, Co-creation, etc.
Why is it important? The MLR process is vital to minimize financial, legal, and reputational risks inherent to the production of drugs. Similarly, the regulations help to ensure patients have access to accurate claims around drug efficacy, side effects, and other pertinent information that may influence their decisions.
How pharma uses MLR? Typically, MLR members review all pieces of communications or training content to ensure it is medically accurate, complies with applicable federal regulations, and doesn’t communicate anything that creates risk for the company, patients, healthcare providers, or others.
Using digital tools to support MLR can help to save hours of time for MLR members who are responsible for reviewing (potentially) hundreds of pages of content. For pharma companies who are utilizing digital drug companions, MLR members must review all content that users might encounter. This makes the MLR process quite lengthy and exhaustive. But by creating a digital master database of content, review members can quickly home in on key words and terms that may become problematic.
Medisafe has created a new command center called Medisafe Maestro that enables faster review by orchestrating full patient journeys all at one glance. The platform provides real-time visibility and insights into patient engagement, patient adherence tools, and survey questions, all of which typically requires MLR review.
Digital connectivity can enhance MLR for pharma, but with Medisafe Maestro the process can be reduced from months to just a few weeks. Working through all potential patient engagement points within a digital drug companion requires the careful and important scrutiny of MLR members. Under normal processes this review could take months, but by digitizing the patient journey all in one view, the review and analysis is reduced and able to be examined in full context.
Understanding the patients are becoming more tech savvy, and more patients turn to digital formats for guidance and support, pharma is stepping up to the plate by engaging digital resources. This shift to digital also means the MLR process has gone digital, which can sometimes make the review process more arduous and lengthy, yet still essential. Tech-focused companies understand this complexity and are introducing new advancements that improve the digital patient experience as well as improve the digital MLR review. It’s clear that the world has gone digital and so too must the processes that keep patients safe and support better outcomes.