[Overview of regulatory aspects guiding tablet scoring]

Area of Science:

• Pharmaceutical Sciences
• Regulatory Affairs
• Public Health

Background:

• Tablet scoring is a common but controversial practice for dose adjustment and cost reduction, particularly for pediatric and geriatric populations.
• Key risks associated with tablet scoring include dose inaccuracies and compromised drug stability.

Purpose of the Study:

• To provide a comprehensive overview of global guidelines concerning tablet scoring practices.
• To identify regulatory standards and gaps in tablet splitting recommendations worldwide.

Main Methods:

• A review of published guidelines and standards from international regulatory health agencies was conducted.
• Comparative analysis of tablet scoring regulations across different countries and regions, including Mercosur, South America, and the United States.

Main Results:

• Regulatory health agencies in Mercosur and other South American countries lack published standards for tablet splitting.
• The U.S. Food and Drug Administration (FDA) is unique in providing standards for tablet scoring, including manufacturing process regulations and splitting instructions.
• The FDA's concept of 'functional scoring' aims to ensure tablet suitability for splitting.

Conclusions:

• Current technical and scientific evidence is insufficient to inform robust health regulations on tablet scoring.
• The absence of detailed regulation leads to inconsistent and potentially risky practices, jeopardizing public health and medication safety.
• There is a critical need for enhanced regulatory frameworks to ensure the safe and effective use of scored tablets.