A Medical Information Request (MIR) is a formal, unsolicited inquiry from a healthcare professional (HCP), patient, payer, or other stakeholder to a pharmaceutical or life sciences company seeking specific, factual information about its products. These requests can range from questions about on-label dosage and administration to more complex inquiries regarding off-label uses or adverse events.
The handling of a Medical Information Request is a critical function within Medical Affairs, serving as a primary channel for disseminating accurate, non-promotional scientific data. Strategically, this process is vital for building trust with the medical community, ensuring patient safety, and managing regulatory risk. Each request is an opportunity to provide value, clarify misunderstandings, and gather valuable real-world insights into how a product is being used and perceived.
A compliant and effective Medical Information Request process is built on four foundational pillars:
Intake: Accurately capturing the full details of the inquiry, including the identity of the requestor, the specific question, the communication channel, and any potential mention of an Adverse Event (AE).
Triage & Routing: Immediately categorizing the request (e.g., on-label, off-label, product complaint) and routing it to the appropriate internal team, such as Medical Information specialists or Pharmacovigilance (PV).
Response Formulation: Researching and developing a balanced, evidence-based, and non-promotional response, often in the form of a standard response letter or a custom reply, which must be approved by medical and regulatory reviewers.
Fulfillment & Documentation: Delivering the response to the HCP or patient in a timely manner and meticulously documenting the entire interaction—from initial query to final answer—in a compliant system for audit purposes.
Medical Information Requests are most common in the post-launch phase of the drug lifecycle, once a product is on the market and being used by a wider patient population. The insights gathered from these requests can have a significant practical impact, informing the creation of new FAQs, guiding future clinical trial design, and identifying educational gaps among HCPs.
The success of a Medical Information department is often measured by:
Response Time: The average time taken to provide a complete and accurate answer.
Response Quality: The scientific accuracy and clarity of the information provided, often measured via HCP satisfaction surveys.
Compliance Adherence: A rate of 100% adherence to all documentation and response protocols, with zero compliance breaches.
Handling a Medical Information Request efficiently and compliantly is a core function of modern Medical Affairs platforms. TikaMobile’s Medical Affairs solutions enhance this process by providing field teams (like MSLs) with integrated mobile forms to capture inquiries directly within their CRM. This triggers automated, workflow-based routing to internal medical teams, ensuring no request is lost and that a complete, auditable record of the interaction is maintained from start to finish.