Medical Information deals with the collection, handling and dissemination of information on medicines, and their safe and correct use. The med info department acts as the link between the Marketing Authorisation Holder and the patient, caretaker or healthcare professional (HCP).

For educational purposes only

Ref: https://pipaonline.org/wp-content/uploads/2022/02/Pipa-MI-Guideline-Document_Jan-2022_final.pdf

Student Guide: The Role and Practice of Medical Information in the Pharmaceutical Industry

1. Introduction to Medical Information (MI)

Medical Information (MI) serves as the strategic epicenter for scientific evidence dissemination within the broader Medical Affairs (MA) organization. Far from being a mere help desk, MI is a critical conduit that informs healthcare decision-making by providing trusted, clinical, and scientific product information. This function bridges the gap between the pharmaceutical manufacturer and those who seek scientific clarity—whether through interactions with field sales or through independent research.

In its customer-facing capacity, the Medical Information department acts as the primary “face” of the manufacturer. By managing scientific inquiries with clinical precision, MI professionals directly facilitate the safe and effective use of marketed products across the global healthcare landscape.

2. Core Objectives of a "Best-in-Class" MI Organization

To elevate the practice of MI from a functional task to a strategic asset, the industry relies on a joint collaboration between the Medical Affairs Professional Society (MAPS), Medical Information Leaders in Europe (MILE), and phactMI. These organizations have established a standardized framework to achieve the following:

• Establish a blueprint for building a structured, high-performing Medical Information organization.
• Create global consistency and harmonization across the pharmaceutical industry.
• Identify and articulate MI value for both internal and external stakeholders.
• Elevate the practice of Medical Information to ensure it remains a cornerstone of Medical Affairs.

3. Understanding the MI Customer Base

MI professionals must tailor their communication to a diverse array of stakeholders. Understanding these categories is essential for maintaining professional and regulatory compliance.

4. The Value of Medical Information

The value proposition of an MI department is twofold, supporting the external medical community and the internal corporate strategy.

External Value: Scientific Exchange and Trust

• Aids HCP Education: Supports clinical decision-making by providing accurate, fair-balanced data to ensure optimal treatment outcomes.
• Safe Harbor for Scientific Exchange: MI acts as the legally protected "safe harbor" for responding to unsolicited requests for off-label information. This allows for the dissemination of scientific data that commercial or sales teams are prohibited from discussing.
• Patient Support: Serves as a reliable resource for patients and caregivers, which can significantly improve treatment adherence and safety.
• Formulary and Guideline Support: Prepares complex submissions for AMCP dossiers, clinical pathway documents, and guideline bodies like the NCCN.

Internal Value: Cross-Functional Synergy

MI is a hub of internal intelligence, partnering with a wide array of departments:

• Strategic Planning: Collaborates with Clinical Development, Publication Planning, and Marketing to prepare for successful product launches.
• Compliance & Accuracy: Reviews promotional and medical materials to ensure every claim is scientifically grounded.
• Operational Support: Provides critical data to Finance, Manufacturing, and Business Technology to align supply and digital infrastructure with medical needs.
• Customer Insights: Captures and shares trends from customer inquiries to help shape future medical strategies and commercial campaigns.

5. Regulatory Frameworks and the Code of Practice

MI professionals operate within a strict ethical and legal framework to maintain the distinction between scientific exchange and promotion.

The phactMI Code of Practice

When responding to HCP requests, MI leaders adhere to three foundational pillars:

1. Clinical & Pharmaceutical Expertise: Professionals possess relevant healthcare degrees and specialized training in Medical Information Science.
2. Scientific Balance: All written responses must be evidence-based, accurate, truthful, non-misleading, and strictly non-promotional.
3. Quality Standards: Content must undergo a rigorous review and approval process, with regular updates to ensure currency.

Global Regulatory Distinctions

Navigating the regulatory landscape requires an understanding of regional nuances:

• United States: Guided by the FDA Guidance for Industry, which specifically addresses responding to unsolicited requests for off-label information and the distribution of scientific publications on unapproved uses.
• Europe: Operations are governed by EMA overarching directives; however, students must recognize that specific interpretations of what constitutes "scientific exchange" vary significantly by individual country.

6. Integration with Pharmacovigilance and Quality

MI is an essential intake point for information regarding the safety profile and physical integrity of a product.

• Pharmacovigilance (PV) Support: MI professionals are trained to identify and process Adverse Events (AEs), supporting the Drug Safety and Labeling departments.
• Product Integrity: MI serves as a primary source for identifying Product Quality Complaints (PQCs), ensuring manufacturing or packaging issues are escalated to Quality Assurance (QA).

7. Operational Skills and Technology

The modern MI professional must combine deep clinical knowledge with technical proficiency.

• Professional Expertise: Mastery of Medical Information Science, literature review methodologies, and regulatory compliance.
• Core Deliverables:
  • Scientific Response Documents (SRDs) / Standard Response Letters (SRLs): Evidence-based, peer-reviewed answers to common inquiries.
  • Frequently Asked Questions (FAQs): Structured data for rapid retrieval.
• Innovation: The industry is currently integrating Artificial Intelligence (AI) and Natural Language Processing (NLP) to optimize search capabilities and delivery channels while maintaining GDPR and data privacy standards.

8. Essential Abbreviations for Students

This table provides the pedagogical foundation for navigating industry-specific terminology.

9. Conclusion: The Blueprint for Success

As you have seen, Medical Information is not merely a supportive role but a strategic pillar within the pharmaceutical industry. By adhering to a global blueprint for excellence, MI fulfill legal and ethical obligations while serving as the vital link between clinical data and patient care. Mastering these elements ensures that you contribute to a culture of transparency, scientific integrity, and ultimately, improved health outcomes.

For educational purposes only 

Ref: https://www.pmcpa.org.uk/media/r0anf5ya/2024-abpi-code.pdf

For educational purposes only

Ref: https://www.mile-association.org/wp-content/uploads/2023/06/MedInfo-SG-2022-12-1.pdf