[Educational material as part of risk minimisation]

Area of Science:

• Pharmaceutical Sciences
• Public Health

Background:

• Educational materials, including booklets and videos, supplement drug information and are crucial for safe medicinal product use.
• These materials are approved by national authorities like the Federal Institute for Drugs and Medical Devices (BfArM) and Paul Ehrlich Institute (PEI).
• Since December 2016, approved educational materials in Germany feature a blue-hand logo.

Purpose of the Study:

• To provide an overview of educational materials for medicinal products.
• To describe key elements of these patient-focused risk minimization tools.
• To highlight the current status and regulatory context of educational materials in Germany.

Main Methods:

• Review of regulatory frameworks and availability of educational materials.
• Description of the role of educational materials as a risk minimization measure.
• Identification of existing educational materials for 202 active substances.

Main Results:

• Educational materials are a common additional risk minimization measure for medicinal products.
• Specific materials exist for 202 active substances, offering guidance on risk reduction.
• The effectiveness of these materials, including process and outcome indicators, is not well-established.

Conclusions:

• Educational materials are an integral part of medicinal product marketing authorization.
• While widely used, further research is needed to understand the effectiveness of educational materials.
• Key elements and an overview of these materials are presented.