Who benefits most from a summary of product characteristics, patient (individual receiving medical care) or healthcare professional (HCP)?

Summary of Product Characteristics: Primary Audience

The Summary of Product Characteristics (SmPC) is designed primarily for healthcare professionals, not patients. 1

Regulatory Purpose and Target Audience

The SmPC serves as the reference document for healthcare professionals containing all necessary and legally binding information for therapeutic use of medications. 1 This document is:

• The major annex document of Marketing Authorization dossiers 1
• Deeply revised by regulatory authorities (national agencies and the European Medicines Agency) 1
• Structured with 12 technical sections covering clinical particulars, pharmacological properties, and pharmaceutical details 1

Evidence Supporting Healthcare Professional Focus

Healthcare professionals are the intended users based on multiple lines of evidence:

• The SmPC contains highly technical pharmacological information including pharmacodynamics, pharmacokinetics, and preclinical safety data that requires professional medical training to interpret 1
• Studies examining SmPC utilization specifically investigate "utilization of information presented in SmPC by different groups of physicians" including cardiologists, general practitioners, and internists 2
• User testing research explicitly states the SmPC's role is "to provide information for health professionals" and tests effectiveness with general practitioners and senior hospital doctors 3

Distinction from Patient Information

The regulatory framework clearly differentiates between documents for different audiences:

• Patient Information Leaflets underwent readability testing required by the European Commission to improve utilization by patients 2
• No such readability requirement exists for SmPCs, confirming they target healthcare professionals rather than patients 2
• The technical language, complex structure, and specialized content of SmPCs are designed for professional medical interpretation 3

Clinical Utility Considerations

While SmPCs are intended for healthcare professionals, research reveals important caveats:

• Current SmPC format shows "low perceived value to prescribers" and is "not central to clinicians' prescribing behavior" 3
• Only 6 of 15 tested information points in original SmPCs met the 90% comprehension target among physicians 3
• Recommendations include simplifying heading structure, adding "Key Information" summaries, using simpler language, and adding bullet points 3

Answer: 2 (Healthcare Professional)