Risk Communication and Safety Information from BfArM

Overview of Risk Communication Tools

BfArM uses several established channels to disseminate urgent and important safety information related to authorised medicinal products. These communications aim to inform healthcare professionals and, where appropriate, patients about new or changed risks, updated risk minimisation measures, or other pharmacovigilance findings that may affect prescribing, dispensing, or patient management. Risk information - BfArM

Red-Hand Letters (Rote-Hand-Brief)

• The primary tool for urgent safety communications in Germany.
• Issued when new important safety information arises that requires immediate attention from healthcare professionals.
• Distributed electronically and/or by post to relevant prescribers, pharmacists, and specialist groups.
• Content typically includes a summary of the safety issue, recommended actions (e.g., monitoring, contraindications, dose adjustments), and references to updated product information (SmPC, PIL).
• Often coordinated with EMA and other EU authorities for consistency.

Direct Healthcare Professional Communication (DHPC)

• Used for serious safety concerns requiring targeted notification.
• Sent directly to healthcare professionals (e.g., physicians, pharmacists) by MAHs under BfArM oversight.
• May accompany or follow red-hand letters for particularly critical issues.
• Focuses on actionable recommendations to mitigate risks in clinical practice.

Other Communication Channels

• BfArM Website and Databases: Publishes all risk communications, including red-hand letters, safety alerts, and updated product information.
• Drug Safety Mailings: Periodic or ad-hoc mailings to healthcare professionals on emerging signals or class effects.
• Patient Information: When risks require patient-level communication, BfArM may coordinate with MAHs to update package leaflets or issue patient alerts via pharmacies or media.
• Press Releases and Public Statements: Used for high-impact safety issues affecting public health.

Coordination and Legal Basis

Risk communications are based on pharmacovigilance assessments under the German Medicines Act (AMG) and EU legislation. BfArM collaborates with PEI (for vaccines/biologics), EMA, and MAHs to ensure messages are evidence-based, consistent, and proportionate. MAHs are obligated to implement agreed risk minimisation measures following these communications.

Effective risk communication by BfArM helps maintain the safe use of medicines, supports informed clinical decisions, and contributes to continuous pharmacovigilance in Germany and across the EU. Risk information - BfArM